The Fallen molecules, loratadine

and desloratadine !!

 

 

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The Fallen molecules, Loratadine(Claritin) and desloratadine (Clarinex) !!!

Las Moleculas caidas, Loratadina (Clarityne) y desloratadina  (Aerius) !!!   

Data-Medicos 
Dermagic/Express No. 4-(112) 
30 Marzo 2.002 /30 March   2.002 

EDITORIAL ESPANOL 
================= 
Hola amigos de la red, DERMAGIC de nuevo se lanza a la red en una REVELADORA revision la
cual he titulado: LORATADINA Y DESLORATADINA, MOLECULAS CAIDAS ??? 
- Despues de hablar con PERIODISTAS, donde mencione lo que estaba pasando con EL
DERMAGIC y sus publicaciones. 
- Despues de haber RECIBIDO una buena cantidad de CORREOS diciendome QUE no me
detuviera. 
- Despues de ENTERARME QUE el DERMAGIC/EXPRESS TIENE mas de 100 listados en
GOOGLE Y YAHOO, Y todas las revisiones estan MONTADAS EN ELLOS. 
- Despues de ANALIZAR QUE EL DERMAGIC tiene mas de 20 ENTRADAS DIARIAS a sus
revisiones, y que LA FDA, PUBLIC CITIZEN y muchos otros mas SIGUEN PASO A PASO el
DERMAGIC dia a dia. 
- Despues de convencerme QUE EL DERMAGIC realiza una LABOR ACADEMICA total para
EDUCAR a DERMATOLOGOS MEDICOS Y PACIENTES alrededor del mundo, SIN
NINGUNA MALA INTENCION. 

He llegado a la conclusion de que DERMAGIC/EXPRESS DEBE SEGUIR ADELANTE, quiza la
ultima sobre MOLECULAS, "por ahora". 

En estos documentos que les traigo para hoy DERMAGIC/EXPRESS quiere ser lo mas objetivo
posible y VOY A OPINAR SOBRE ELLOS, leanlos ustedes tambien y saquen sus conclusiones,
TAN EVIDENTES que NO FALTA DECIR MUCHO, porque son TAN OBVIAS Y CLARAS
QUE no se puede tapar el SOL con un dedo. 

CONCLUSIONES DE LA REVISION: 
---------------------------------------------------- 

1.) CLARITYNE PASARA A SER UN PRODUCTO OTC (VENTA LIBRE) en los estados
UNIDOS. las aseguradoras, LA FDA Y EL GOBIERNO presionaron al laboratorio para este
evento, esto significara que LAS ASEGURADORAS ya no cubriran GASTOS POR clarityne EN
USA, y su precio bajara en el mercado, las ganancias no seran las mismas, PUES entrara a
COMPETIR CON LOS GENERICOS que seran mas baratos. 

2.) EL 7 DE MARZO 2001, un dia despues que DERMAGIC/EXPRESS salio a la red
SCHERING-PLOUGH anuncio "ORGULLOSAMENTE" que su producto estrella
(CLARITYNE) IRA A VENTA LIBRE. (OTC), cuando meses atras SE NEGO
ROTUNDAMENTE a ello alegando QUE EL TRATAMIENTO DE LAS ALERGIAS ERA
COMPLEJO y que el clarityne debia salir solo CON PRESCRIPCION MEDICA. 

3.) La competencia DEJO SUS PRODUCTOS con prescripcion MEDICA.
(CETIRIZINA-Searle-Pfizer, FEXOFENADINA-Aventis). 

4.) EL LABORATORIO RECONOCIO PUBLICAMENTE el 19 febrero 2.001 que SACO AL
MERCADO LOTES DE CLARITIN D (FEDYCLAR) con problemas de manufactura en su
ingrediente ACTIVO, y tambien reconocio lo mismo CON LOS PRODUCTOS
VANCERIL-ALDECINA (dipropionato de beclometasona), Garamycin-GARASONE (gotas
oftalmicas, Y ALBUTEROL (PROVENTIL). Recordemos que el AÑO PASADO 9 agosto 2.001
EL LABORATORIO NEGO TOTALMENTE QUE HABIA SACADO AL MERCADO EL
PRODUCTO ALBUTEROL sin ingrediente activo. LA VERDAD FUE OTRA. 

5.) Tambien tuvieron defectos de manufactura EL UNGUENTO DIPROLENE, EL MISMO
CLARITINE, NASONEX SPRAY nasal Y EL INTRON A. 

6.) PROBABLES CARGOS por SOBORNO y criminales. Las acciones de Claritin D
(FEDYCLAR) cayeron en el Wall Street, el dia del anuncio de la falla en el producto. 

7.) 59 MILLONES DE INHALADORES (PROVENTIL) sacados al MERCADO sin 
INGREDIENTE ACTIVO, segun algunos reportes murieron 17. 

8.) La difusion MUNDIAL de los 11O EFECTOS ADVERSOS DE LA LORATADINA Y SU
TOXICIDAD HEPATICA Y CARDIACA probablemente FUE uno de los detonantes PARA que
el GOBIERNO, LA FDA Y LAS ASEGURADORAS presionaran al laboratorio para pasar el
producto A OTC (VENTA LIBRE). Asi como tambien el hecho de que se comprobo que LA
LORATADINA SOLO tiene 50 A 55 % de efectividad. 

9.) LA DESLORATADINA LA SUPUESTA NUEVA Y MEJORADA MOLECULA DE LA
LORATADINA es el metabolito ACTIVO, y segun algunos estudios MAS CARDIOTOXICA que
la misma loratadina ,Y SUS EFECTOS adversos CASI LOS MISMOS EXCEPTO LOS
HEPATICOS. Hecho DEVELADO en PREVIAS REVISIONES por el DERMAGIC. 

10.) POR ELLO: "Doctores no prescribirán Clarinex (DESLORATADINA). Esa droga va a
enfrentar barreras significantes," dijo Dr. Girish Tyagi, analista a ABN Amro Inc. LO MISMO que
DIJO DERMAGIC/ EXPRESS , COINCIDENCIA ??? o LAS REVISIONES fueron leidas por
este Dr. 

11.) SE MOVIERON MILLONES DE DOLARES EN EL CONGRESO
NORTEAMERICANO, entre Republicanos y Democratas. 

12) LAS DEMANDAS CONTINUAN. 

13.) Los grandes LIDERES de que TODO EL PLANETA SE ENTERARA DE ESTE AFFAIR 
fueron PUBLIC CITIZEN, organismo encargado de defender la salud en los Estados Unidos, La
FDA, ente regulador de DROGAS en USA y el DERMAGIC/EXPRESS quien REVELO la
VERDADERA HISTORIA SOBRE LA LORATADINA, DESLORATADINA, y EL
AULIN.(nimesulide) 

14.) El laboratorio fabricante DEBERA CAMBIAR sus AGRESIVAS estrategias de
MERCADEO, sincerandose CON EL GREMIO MEDICO sobre las verdaderas VENTAJAS Y
DESVENTAJAS de sus productos, PUES hoy dia camina en el borde de un ABISMO, al cual esta
a punto de caer, si es que ya no cayo. 

15.) EXTRAOFICIALMENTE SE SUPO que el laboratorio ROCHE estuvo a punto de
COMPRAR AL LABORATORIO Scheringh-PLOUGH, al final el negocio NO SE EJECUTO. 

Para finalizar quiero AGRADECER a todos aquellos que dia a dia me brindan su apoyo,
DERMAGIC/EXPRESS seguira en su linea de publicar articulos de interes para TODOS. 

15.) Particularmente LE DESEO a todos los LABORATORIOS que AFINEN BIEN SUS
ESTRATEGIAS DE VENTA y sean SINCEROS en cuanto a LAS VENTAJAS Y
DESVENTAJAS DE SUS PRODUCTOS, pues NO SOLO se trata de venderlos SE TRATA DE
LA SALUD DE LOS PACIENTES, alli RADICA EL PRESTIGIO DE UN LABORATORIO, no
en el numero de VENTAS, sino en LA CALIDAD DE SUS PRODUCTOS. 

En las referencias los hechos... 

Atentamente 

Dr. Jose Lapenta


EDITORIAL ENGLISH 
================= 

Hello friends of the net, DERMAGIC again rushes to the net in a AMAZINGLY revision which I
have titled: LORATADINE AND DESLORATADINE, THE FALLEN MOLECULES ??? 
- After speaking with JOURNALISTS, where I mentions what was passing with THE DERMAGIC
and their publications. 
- After having RECEIVED a good quantity of MAIL saying me THAT I didn't stop. 
- After FINDING OUT THAT the DERMAGIC/EXPRESS HAS but of 100 listings in GOOGLE
AND YAHOO, AND all the revisions are MOUNTED IN THEM. 
- After ANALYZING THAT THE DERMAGIC has but of 20 DAILY ENTRANCES to its
revisions, and that THE FDA, PUBLIC CITIZEN and many other but they FOLLOW STEP TO
STEP the DERMAGIC day by day. 
- After convincing me THAT THE DERMAGIC carries out a WORK ACADEMIC total to
EDUCATE DERMATOLOGIST, MEDICAL AND PATIENT around the world, WITHOUT
ANY BAD INTENTION. 

I have reached the conclusion that DERMAGIC/EXPRESS should CONTINUE AHEAD, it maybe
the last one on MOLECULES, " for now ". 

In these documents that I bring you today DERMAGIC EXPRESS he wants to be it but possible
objective and I will SAY ON THEM, read them you also and reach your conclusions, SO
EVIDENT that he doesn't LACK to SAY A LOT, because they are SO OBVIOUS AND CLEAR
THAT can not cover you the SUN with a finger. 

CONCLUSIONS OF THE REVISION: 
----------------------------------------------------- 

1.) CLARITIN BECAME A PRODUCT OTC (FREE SALE) in the UNITED states. The
insurance companies, THE FDA AND THE GOVERNMENT pressed to the laboratory for this
event, this meant that THE INSURANCE COMPANIES will no longer cover EXPENSES FOR
claritin IN USA, and their price lowered in the market, the earnings won't be the same ones,
BECAUSE he entered to COMPETE WITH THE GENERIC ones that will be but cheap. 

2.) MARCH 2001 7, one day after DERMAGIC/EXPRESS came out TO THE net,
SCHERING-PLOUGH "PROUDLY" announcement that its STAR PRODUCT, CLARITIN it will
pass TO FREE SALE. (OTC), when months behind he REFUSED TOTALLY to alleging it THAT
THE TREATMENT OF THE ALLERGIES was COMPLEX and that the claritin should come out
alone WITH medical PRESCRIPTION. 

3.) The competition LEFT THEIR PRODUCTS with medical prescription. (CETIRIZINE-
Searle-Pfizer, FEXOFENADINA-Aventis). 


4.) THE LABORATORY RECOGNIZED OPENLY the 19 February 2.001 that I TAKE OUT
TO THE MARKET LOTS OF CLARITIN D (FEDYCLAR) HAD PROBLEMS OF
MANUFACTURES with the ACTIVE ingredient, and it also recognized the same thing WITH THE
PRODUCTS VANCERIL-ALDECINA (beclomethasone dipropionate), Garamycin,
GARASONE, (ophthalmic drops) AND ALBUTEROL (PROVENTIL). Let us remember that last
year 9 August 2.001 THE LABORATORY DENIED TOTALLY THAT it had TAKEN OUT TO
THE MARKET THE PRODUCT ALBUTEROL without active ingredient. THE TRUTH was
ANOTHER. 

5.) they also had factory defects THE DIPROLENE OINTMENT, THE SAME CLARITIN,
NASONEX nasal SPRAY AND THE INTRON A. 

6.) PROBABLE CHARGES for BRIBE and criminals. Claritin D'S actions fell in the Wall Street,
the day of the announcement of the flaw in the product. 

7.) 59 MILLION INHALERS (PROVENTIL) taken out to the MARKET without ACTIVE
INGREDIENT, according to some reports 17 died. 

8.) The WORLD diffusion of the 110 ADVERSE EFFECTS OF THE LORATADINE AND
THEIR HEPATIC AND HEART TOXICITY was probably one of the exploxives so that the
GOVERNMENT, THE FDA AND THE INSURANCE COMPANIES pressed to the laboratory
to pass the product TO OTC (FREE SALE). As well as the fact that he was proven that THE
LORATADINE has 50 TO 55% of effectiveness. 

9.) THE DESLORATADINE, THE SUPPOSED new AND IMPROVED LORATADINE is the
ACTIVE metabolite, and according to some studies MORE CARDIOTOXIC that the same
loratadina ,AND ITS adverse EFFECTS ALMOST THE SAME ones EXCEPT THE HEPATIC
ones. FACTS EXPOSED in PREVIOUS REVISIONS for the DERMAGIC. 

10.) FOR IT: "My impression is, doctors won't prescribe Clarinex.(desloratadine) That drug is going
to face significant hurdles," said Dr. Girish Tyagi, an analyst at ABN Amro Inc. THE SAME thing
that DERMAGIC/EXPRESS SAID, COINCIDENCE??? or THE REVISIONS were read by this
Dr. 

11.) MILLIONS OF DOLLARS MOVED IN THE NORTH AMERICAN CONGRESS, among
Republicans and Democrats. 

12) THE DEMANDS CONTINUE. 

13.) The big LEADERS that THE whole PLANET FOUND OUT THIS AFFAIR they were
PUBLIC CITIZEN, organism in charge of defending the health in the United States, The FDA,
entity regulator of DRUGS in USA and the DERMAGIC/EXPRESS who I REVEAL the TRUE
HISTORY ON THE LORATADINE, DESLORATADINE, and THE AULIN. (nimesulide) 

14.) the manufacturing laboratory will CHANGE its AGGRESSIVE strategies of MARKETING,
being honest WITH THE MEDICAL SOCIETY on the true ADVANTAGES AND
DISADVANTAGES of its products, BECAUSE nowadays he walks in the border of an ABYSS,
to the one which is about to fall, if it is that no longer MADE IT. 

15.) UNOFFICIALLY it was KNOWN that the laboratory ROCHE was about to BUY TO THE
LABORATORY Scheringh-PLOUGH, at the end, the business I doesn't EXECUTE. 

To conclude I want to THANK to all those that day by day offer me their support,
DERMAGIC/EXPRESS will continue in its it lines of publishing articles of interest for ALL. 

15.) particularly I WANT to all the LABORATORIES that TUNE THEIR STRATEGIES OF
SALE WELL and be SINCERE as for THE ADVANTAGES AND DISADVANTAGES OF
THEIR PRODUCTS, because NOT ALONE it is to sell them it is THE HEALTH OF THE
PATIENTS, there THE PRESTIGE OF A LABORATORY RESIDES, not in the I number of
SALES, but in THE QUALITY OF ITS PRODUCTS. 

In the references the facts... 

Sincerely 

Dr. José Lapenta. 
================================================================== 
REFERENCIAS BIBLIOGRAFICAS / BIBLIOGRAPHICAL REFERENCES 
================================================================== 
1.) SCHERING-PLOUGH REBUTS PUBLIC CITIZEN ALLEGATIONS 
2.) Asthma Inhalers Recalled 
3.) Medical News: Deaths Caused by Defective Asthma Inhalers, Group Charges 
4.) Group says company knowingly sold faulty inhalers 
5.) Group urges criminal probe of drug maker 
6.) Schering-Plough sharply lower after allergy drug Claritin-D recall 
7.) Schering-Plough stock also dropped after the drugmaker 
8.) Health News / Albuterol Inhaler Recall Announced 
9.) DRUG: Vanceril 84 mcg DOUBLE STRENGTH (beclomethasone dipropionate) 
10.) Schering-Plough Recalls Some Claritin-D 12-hour tablets 
11.) SCHERING-PLOUGH RECALLS SPECIFIC LOTS OF CLARITIN-D 12 HOUR
TABLETS 
12.) Claritin D Recall 
13.) Garamycin Ophthalmic SOlution Gentamicin Sulfate Ophthalmic 
14.) Request to HHS to investigate charges against Schering-Plough for possibly knowingly shipping
millions of asthma drug inhalers that may not have contained any active ingredient (HRG Publication
#1559) 
15.) Schering-Plough y dos firmas de medicinas genéricas son acusadas de soborno 
16.) SCHERING-PLOUGH DISAGREES WITH FDA ADVISORY PANEL’S
RECOMMENDATION REGARDING CLARITIN (LORATADINE) 
17.) SCHERING-PLOUGH AIMS TO MAKE CLARITIN PREMIER BRAND IN OTC
CATEGORY, ESTABLISH CLARINEX AS PREMIER BRAND IN PRESCRIPTION
CATEGORY 
18.) Class-Action Lawsuit Filed Against Claritin's Maker 
19.) Group sues Schering-Plough over Claritin ads 
20.) Class Actions against Shering-Plough 
21.) Consumer Groups Sue Over Direct-to-Consumer Advertising by Schering-Plough 
22.) Schering Plough's Low Blow 
23.) Misleading company data: Schering-Plough sued by shareholders 
24.) ABC and NBC ignored a drug company's arguments for extending a patent as both followed
Public Citizen's script: a greedy corporation contributes to cynical politicians. 
25.) Did Defective Inhalers Cause 17 Deaths? 
26.) Wall Street Journal: Schering fines could total $500 million Wednesday, January 2, 2002
06:50:47 PM - Wall Street Journal 
27.) Schering-Plough Announces Ongoing Negotiations with FDA for Consent Decree on
Manufacturing Issues 
Wednesday, December 26, 2001 07:46:13 PM - PR Newswire 
28.) Schering-Plough's Woes Continue 
29.) [e-drug] Serious Manufacturing Problems at Schering-Plough 
30.) FDA Should Investigate Sloppy Manufacturing Practices at Drug Maker Schering-Plough,
Public Citizen Says 
Confidential Audit, FDA Inspection Uncover Problems at Kenilworth, N.J., Plant 
31.) Claritin Maker Accused of False Advertising 
32.) Maker of Claritin plans over-the-counter sales 
Schering-Plough reacts to pressure from regulators, rivals 
============================================================= 
============================================================= 
1.) SCHERING-PLOUGH REBUTS PUBLIC CITIZEN ALLEGATIONS 
============================================================= 
KENILWORTH, N.J., Aug. 9, 2001 –Schering-Plough Corporation (NYSE: SGP) today issued
the following response to allegations made by the Public Citizen activist group regarding recalls
conducted in 1999 and 2000 of the company’s albuterol inhaler products for asthma. 

Schering-Plough is confident that all of its products on the market are safe and effective. The health
and safety of patients who use our products remain our No. 1 priority. 

The company is extremely disturbed that the letter by Public Citizen misrepresented data and drew
unfounded conclusions, which could unnecessarily alarm asthma patients. Schering-Plough
emphasized that asthma patients should continue to take their medications as prescribed. 

Contrary to Public Citizen’s allegations, in all adverse event reports involving deaths where an
albuterol canister was tested by the company, the canister was shown to contain active ingredient.
Further, every inhaler involved in a patient’s claim of injury that has been tested by the company has
been shown to date to contain active ingredient. 

Schering-Plough knows of no death or injury to a patient shown to have been caused by an inhaler
lacking active ingredient. While there are some lawsuits claiming otherwise, the company is
contesting them vigorously. 

Schering-Plough is committed to manufacturing products of the highest quality and took
extraordinary measures in 1999 and 2000 to ensure that all of its inhalers in the marketplace were
safe and effective. In all instances, the company acted promptly and responsibly with respect to the
above product recalls, and in consultation with the U.S. Food and Drug Administration (FDA). 

Asthma is a very serious disease and causes more than 5,400 deaths in the United States annually.
Under FDA regulations, adverse event reports are routinely reported to the FDA. Public Citizen’s
allegations are based on a flawed analysis of a small number of events, which does not address event
rates that occur with similar asthma rescue inhaler products. 

Schering-Plough is a research-based company engaged in the discovery, development,
manufacturing and marketing of pharmaceutical products worldwide. 

============================================================== 
2.) Asthma Inhalers Recalled 
============================================================== 
SOURCE: HELIOSHEALTH.COM 

On March 29, 2000, Schering Laboratories announced the voluntary recall of certain prescription
asthma inhalers. The company issued a press release detailing the recall and sent out letters
containing recall information to healthcare providers across the country. The recall was issued with
the full knowledge of the Food and Drug Administration (FDA). 

The inhalers affected by the recall were manufactured before Sept. 30, 1999 (see table below).
Schering recalled the inhalers because they might not contain an active ingredient. The brands
covered by the recall are Proventil®, Vanceril®, and a number of generic inhalers. Schering
Laboratories, a division of Schering-Plough, emphasized that the recall does not include any inhalers
that are already opened and working or with expiration dates of 10/01 or later. 

Schering representatives stated that they believe “that all of (our) aerosol products currently in the
marketplace are safe and effective.” However, they also said that having an inhaler without an active
drug “is a serious matter that merits immediate attention.” 

If you have any unused inhalers covered by the recall, you can return them to the pharmacy where
you purchased them for a refund. For more information, call Schering at 1-800-621-9760 or the
FDA Medwatch program at 1-800-FDA-1008. You can read the Schering press release at
http://www.rxrecall.net/ 

Recall Recap 

What Is Recalled? 

Certain aerosol asthma inhalers with expiration dates before October 2001 with certain lot numbers.
Lot numbers and expiration dates are on either the top or bottom flaps of the inhaler package and on
the canister label. 

The following lot numbers of unopened Proventil® (but not Proventil HFA®),Warrick brand
inhalers, and certain generic inhalers manufactured by Schering: 
Lots 7-BBS-303 up to and including 7-BBS-642 
All lots starting with the prefix #8 
Lots 9-BBS-500 up to and including 9-BBS-832 
Vanceril® 84 mcg double strength inhalation aerosol: 
Lots 8-DMT-644 and 8-DMT-646 
Lots 9-DMT-133 up to and including 9-DMT-621 
Vanceril® 42 mcg inhalation aerosol: 
Lots 8-AMA-208 up to and including 8-AMA-703 
Lots 9-AMA-200 up to and including 9-AMA-404 

What Do You Do? 
You can return unopened inhalers with these lot numbers to the pharmacy where you bought them. 

Contact Information 
Schering: 1-800-621-9760 or http://www.rxrecall.net/ 
FDA Medwatch Program: 1-800-FDA-1088 

============================================================== 
3.) Medical News: 
============================================================== 
SOURCE: Braytonlaw.com 

Deaths Caused by Defective Asthma Inhalers, Group Charges 

WASHINGTON D.C. -- August 17, 2001 -- Seventeen people may have died as a result of
defective asthma inhalers manufactured by Schering-Plough, according to Public Citizen, a consumer
watchdog organization. The group asked Tommy Thompson, Secretary of Health and Human
Resources, to begin a criminal investigation into the practices of Schering-Plough, including its
handling of the recall of 59 million inhalers. 

"... Schering-Plough not only failed to recall millions of defective asthma inhalers for three months
after learning on January 4, 2000, of a death of a woman using one of these inhalers, but there were
many deaths that would have been avoided if there had been an earlier, September, 1999 recall of
the 59 million inhalers," charged Sidney Wolfe, MD, the director of of Public Citizen's research
group. Dr. Wolfe's conclusions were based on an analysis of the inhaler deaths that the company
was required to report to the Federal Drug Administration 

The inhaler recall was instituted because the devices may not have contained the asthma medication
albuterol. When there is no asthma drug in an inhaler, a patient is unable to treat and stop an acute
asthmatic attack, triggering a life-threatening situation 
============================================================== 
4.) Group says company knowingly sold faulty inhalers 
============================================================= 
SOURCE:LAURUSHEALTH.COM 

WASHINGTON, Aug 09 (Reuters Health) - Public Citizen, a prominent Washington, DC-based
consumer group, on Thursday renewed its call for a criminal investigation into Schering-Plough,
saying they had new evidence that the company knowingly shipped millions of faulty asthma inhalers. 

Problems with inhalers that delivered the asthma drug albuterol, made by Schering-Plough, may have
been linked to the deaths of 17 patients, including a 10-year-old child, Public Citizen said. The
products were pulled from the market in September 1999 and again in March 2000. Both times,
Schering-Plough said the recalls were precautionary measures taken because of the remote
possibility that the inhalers did not contain active drug. 

But in a letter to Department of Health and Human Services (HHS) Secretary Tommy Thompson
released on Thursday, Public Citizen said it has obtained documents from the US Food and Drug
Administration (FDA) showing that Schering-Plough was aware of at least one death 3 months prior
to the second recall. 

"According to FDA documents, a woman of unknown age who had a previous history of
'well-controlled asthma' who was using one of the inhalers from a lot eventually recalled in March
2000, died in September 1999 and the company was notified on January 4, 2000," the letter states. 

"Unfortunately, it was almost 3 months after Schering-Plough learned about her death that the
March...recall was belatedly undertaken. During these first 3 months of 2000, while Schering-Plough
was aware of her death but did not recall the inhalers, another five deaths occurred in people using
inhalers that were [subsequently] recalled on March 29, 2000," it continues. 

In addition, the letter charges that Schering-Plough was "reckless" in recalling only one lot of inhalers
in September 1999 "despite a long history of systemic problems involving the manufacture of
albuterol inhalers." 

"There were many deaths in people which would have been avoided if there had been an earlier,
September 1999 recall of the 59 million units" that were eventually pulled from the market, Public
Citizen said. 

This information "significantly adds to the compelling case for criminal prosecution of
Schering-Plough," the letter maintains. 

Public Citizen made similar allegations in a letter to Thompson in March. But at the time, the group
said only that an investigation was warranted because Schering-Plough had distributed the asthma
inhalers despite known quality control problems at its New Jersey plant. 

Schering-Plough spokesman William O'Donnell insisted that Public Citizen is misguided. 

"We have no evidence that a patient was harmed, and no evidence of a death because of a recalled
product," he told Reuters Health. He said that every inhaler returned to date by a patient has been
tested and found to contain active drug. 

O'Donnell confirmed that lawsuits have been filed against the company making accusations similar to
those in Public Citizen's letter. However, he said that the company intends to vigorously contest
them. 


Copyright 2000-2001 Reuters Limited. All rights reserved. Republication or redistribution of
Reuters content is expressly prohibited without the prior written consent of Reuters. Reuters shall not
be liable for any errors or delays in the content, or for any actions taken in reliance thereon. 

============================================================== 
5.) Group urges criminal probe of drug maker 
============================================================== 
SOURCE: SENRS.COM 

WASHINGTON (AP) -- A major drug maker's auditors said the company's workers complained
of being pushed to increase production at the expense of quality -- even after the government began
cracking down on Schering-Plough Corporation for violations that ultimately caused a recall of 59
million asthma inhalers. 

An internal report on a follow-up Food and Drug Administration inspection in January, almost a year
after the warning in that confidential auditors' report, said Schering-Plough had not yet fixed all the
quality problems. 

Citing the two documents, the consumer advocacy group Public Citizen called Thursday for a
criminal investigation of New Jersey-based Schering-Plough, questioning if the company knowingly
shipped defective medications. 

The complaint comes two weeks after Schering-Plough quietly signaled serious trouble with the
FDA by telling Wall Street investors the agency had indefinitely held up approval of the company's
long-touted new drug Clarinex, the successor to the blockbuster allergy drug Claritin. The problem:
FDA has shut down production lines in New Jersey and Puerto Rico factories because of repeated
quality violations, a move that affects Clarinex and some drugs already on the market. 

The confidential auditors report, provided to Schering-Plough last April and recently obtained by
Public Citizen, cited company employees complaining that "for many years they have been under
significant pressure" from management to increase production "sometimes at the expense of high
quality work." 

Public Citizen wrote Health and Human Services Secretary Tommy Thompson on Thursday urging
that he order FDA to investigate "the possibility of criminal behavior on the part of those
Schering-Plough officials who may have knowingly shipped defective pharmaceutical products for
use in unsuspecting patients." 

Thompson had not yet received the letter and had no immediate comment. But FDA spokesman
Lawrence Bachorik said the agency "takes these sorts of allegations seriously." 

Schering-Plough spokesman Robert Consalvo declined to address the call for an investigation, but
said the company is working diligently to resolve FDA's quality complaints. In 1999, it began buying
$50 million in new equipment and by year's end will have increased its quality-control employees by
30 percent, he said. 

Schering-Plough hired a Maryland-based auditor to visit its Kenilworth, New Jersey, factory
between February and April 2000. FDA already had begun citing violations at the factory; the first
recall of asthma inhalers made there began in late 1999 and a second recall of more than 58 million
inhalers began that March while auditors were on site. 

Schering had begun some quality improvements, the auditors said. But, it warned that the company
was "at serious risk of a significant FDA regulatory action" because of continuing and serious
deficiencies. 

The problems ranged from failure to routinely make sure asthma inhalers worked to factory sewage
leaks. 

A copy of FDA's Jan. 19 inspection report says the company had continued to violate federal quality
manufacturing rules for a number of medicines, from albuterol to Claritin. 

"Schering-Plough is confident that all prescription and over-the-counter products currently in the
marketplace are safe and effective," Consalvo responded. 

============================================================== 
6.) Schering-Plough sharply lower after allergy drug Claritin-D recall 
============================================================== 
SOURCE: EARNINGS.COM 

NEW YORK, Feb 19, 2002 (AFX-Asia via COMTEX) -- Schering-Plough Corp shares were
sharply lower in midsession trade after the company said it is recalling allergy treatment Claritin-D
12-hour tablets, which were produced between Aug 1999 and June 2001, dealers said. 

At 12.20 pm, Schering-Plough was down 81 cents, or 2.3 pct, at 34.22 usd. 

The DJIA was down 91.06 points at 9,811.99, the S&P 500 down 14.73 at 1,089.45, and the
Nasdaq composite down 42.26 at 1,762.94. 

Earlier, Schering-Plough said it believes the products are clinically safe and effective and pose no
medical risk to patients. 

However, quality-control testing of specific lots of Claritin-D 12-hour extended release tablets
indicated that some tablets did not demonstrate full release of pseudoephedrine (the decongestant
ingredient), five hours after the drug was submitted to the test. 

In a research note, Merrill Lynch said it expects to lower its first-quarter earnings per share forecast
for Schering-Plough by one penny due to the recall of Claritin-D 12-hour tablets, which accounts for
over 50 pct of the Claritin-D family. 

Merrill Lynch also noted that Claritin-D 12-hour tablets had been out of stock at a major wholesaler
since Jan 11. 

"As a result, a portion of our first-quarter estimate of 108 mln usd for Claritin-D (Claritin and
Decongestant) could be at risk," said the brokerage. 

Merrill Lynch, however, reiterated its "buy/strong buy" rating on Schering-Plough. 

Schering-Plough earlier said the recall is being conducted with the knowledge of the US Food and
Drug Administration and will not affect its 2002 earnings guidance. 

============================================================== 
7.) Schering-Plough stock also dropped after the drugmaker 
============================================================== 
Source: MONEY.CNN.COM 

announced a recall of its best-selling allergy drug, Claritin, from stores and wholesalers because a
decongestant ingredient does not dissolve fast enough, but says patients with the drug do not need to
return it. 

============================================================== 
8.) Health News / Albuterol Inhaler Recall Announced 
============================================================== 
June 5, 2000 -- The pharmaceutical company Schering/Key has issued the following letter regarding
the recall of several types of Proventil and Warrick albuterol inhalers: 


URGENT -- DRUG PRODUCT RECALL 
Schering/Key 
PROVENTIL® brand of albuterol, USP Inhalation Aerosol (17g/200 inhalations). 
PROVENTIL® brand of albuterol, USP Inhalation Aerosol Refill (17g/200 inhalations). 
PROVENTIL® brand of albuterol, USP Inhalation Aerosol Institutional Pack (6.8%g/80
inhalations). 
Warrick brand of albuterol, USP Inhalation Aerosol (17g/200 inhalations). 
Warrick brand of albuterol, USP Inhalation Aerosol Refill (17g/200 inhalations) 
Batch Numbers: PROVENTIL® brand of albuterol, USP Inhalation Aerosol, and Warrick brand of
albuterol, USP Inhalation Aerosol: 

Batch numbers 7-BBS-303 thru 7-BBS-642, batch numbers 8-BBS-500 thru 8-BBS-826, and
batch numbers 9-BBS-500 thru 9-BBS-832, except for those already opened albuterol inhalers that
patients are currently using with good results. 

Dear Doctor: 

This letter is to inform you of a drug product recall; Schering/Key is recalling the following batches of
PROVENTIL brand of albuterol, USP Inhalation Aerosol, and Warrick brand of albuterol, USP
Inhalation Aerosol: Batch numbers 7-BBS-303 thru 7-BBS-642, batch numbers 8-BBS-500 thru
8-BBS-826, and batch numbers 9-BBS-500 thru 9-BBS-832, except for those already opened
albuterol inhalers that patients are currently using with good results. This recall also pertains to
products labeled as Major Albuterol Inhalation Aerosol, Martec Albuterol Inhalation Aerosol,
Novopharm Albuterol Inhalation Aerosol, Qualitest Albuterol Inhalation Aerosol, Schein Albuterol
Inhalation Aerosol, and URL Albuterol Inhalation Aerosol. 

Please note that no other batches of PROVENTIL® brand of albuterol, USP Inhalation Aerosol,
Warrick brand of albuterol, USP Inhalation Aerosol products are included in this recall. Also, this
recall does not affect PROVENTIL HFA (albuterol sulfate, USP) Inhalation Aerosol, or any
product with an expiration date of October 2001 or later (product manufactured after September
30, 1999). Schering is issuing this recall as a precaution to address the remote possibility that an
aerosol inhaler may not contain active drug, although the company believes that all of its aerosol
products currently in the market place are safe and effective. This recall relates to an aerosol
manufacturing problem that had been previously identified in October 1999 and information
regarding correction of this problem was provided to FDA. We are conducting this recall at the
patient, wholesale and retail level. 

Patients will be alerted to this recall through a press release and a notice displayed in the pharmacy.
Patients are being advised that if they are using their already opened PROVENTIL or Warrick
brand of albuterol inhaler with good results, they do not need to replace their inhaler. Additionally, if
patients have any PROVENTIL or Warrick brand of albuterol inhalers from these lots that were
never used, they are being instructed to return them to their pharmacy. If they have any questions,
they are instructed to call the Recall Services Center at 1-800-FDA-0178, or by mail to
MEDWATCH, HF-2, 5600 Fishers Lane, Rockville, MD 20857. 

We consider this matter to be serious and meriting immediate attention. This recall is being
conducted with the knowledge of the U.S. Food and Drug Administration (FDA). 

If you have any questions, please contact the Recall Service Center (toll free) at 1-800-621-9760. 

We apologize for any inconvenience this recall might cause and we thank you for your cooperation. 

Sincerely, 
Melvyn Bloom, M.D. 
Director Allergy 
Clinical Research/CNS 
============================================================== 
9.) DRUG: Vanceril 84 mcg DOUBLE STRENGTH (beclomethasone dipropionate) 
============================================================== 
FDA POSTING DATE: 12/02/1999 [FDA MedWatch Safety Information] 

COMPANY: Schering/Key Pharmaceuticals 

NOTES FROM SCHERING/KEY PRESS RELEASE: 

http://www.fda.gov/medwatch/safety/1999/vancer.pdf 

On the FDA MedWatch site, a Schering/Key press release has been posted which announces a
nationwide recall of five lots of Vanceril 84 mcg DOUBLE STRENGTH (beclomethasone
dipropionate, 84 mcg) Inhalation Aerosol Convenience Pack. The company states that it has
"determined that a number of canisters in the five lots…may not contain active drug. 

The press release states that patients using a canister without active drug "would be expected to
experience a lack of effectiveness which may result in increased asthma symptoms, need for other
asthma medications, emergency room visits or hospitalization." 

The press release also states that "(a)n affected MDI may appear to emit an aerosol even if it
does not contain active drug. 

The affected lot numbers are 

9-DMT-157 

9-DMT-158 

9-DMT-160 

9-DMT-161 

9-DMT-163 

The expiration date is listed as July 2000. The lot number and expiration date can be found on
"either the top or bottom flaps of the package and on the canister label." 

The Schering/Key Recall Services Center can be reached at 1-800-621-9760. 

============================================================== 
10.) Schering-Plough Recalls Some Claritin-D 12-hour tablets 
============================================================== 
Source: WFMYNEWS2.COM 

Web Producer: Lee Baber 
Modified: 2/19/2002 5:57:23 PM Send this story to a friend 
Printable Version 
Schering-Plough Corp. is recalling batches of its best-selling allergy drug Claritin from stores and
wholesalers because a decongestant ingredient does not dissolve fast enough, but says patients with
the drug do not need to return it. 
The company issued a voluntary recall Tuesday of certain lots of Claritin-D 12-hour extended
release tablets manufactured between August 1999 and June 2001 because some tablets did not
release enough pseudoephedrine within five hours. 

The company said adequate levels of pseudoephedrine were released about 25 minutes later than
called for under its specifications. It said the delay does not hurt the drug's effectiveness, and said
there is no medical risk in taking it. 

Company spokesman Robert Consalvo said federal regulations require drug manufacturers to meet
certain specifications in order to sell a particular drug. Because of the problem Schering-Plough
found with the Claritin lots, it had to recall the product from stores. 

Consumers who received prescriptions from pharmacies would not know which lots their pills came
from, he said. Because of this, and the company's belief that the drugs are still safe and effective, the
recall was not extended to the patient level, he said. 

Consalvo said it believes most of the affected lots have already been sold or used by patients. He
said the recall involved 97 lots, but would not say how many pills that constituted, saying that figure
is proprietary information. 

Affected lots carry a prefix number of "0" or "1" (representing the years 2000 and 2001). Five
additional lots, numbered 9-JRP-313, 9-JRP-338, 9-JRP-2040, 9-JRP-2041 and 9-JRP-2042,
which were manufactured in 1999, are also included in the recall. 

The company has begun manufacturing and shipping new batches of Claritin to retailers. 

Claritin is the company's top-selling product, bringing in $3.1 billion in 2001. But the drug's basic
patent expires at the end of this year, and competitors are already seeking permission to sell
over-the-counter versions. 

============================================================== 
11.) SCHERING-PLOUGH RECALLS SPECIFIC LOTS OF CLARITIN-D 12 HOUR
TABLETS 
============================================================== 
Source: Sch-plough.com 

Issue Involves Tablet Dissolution Rate; No Medical Risk Posed to Patients 

KENILWORTH, N.J., Feb. 19, 2002 — Schering-Plough Corporation (NYSE: SGP) today
announced a voluntary recall directed to wholesale accounts and retail pharmacies of specific lots of
CLARITIN-D 12 Hour (5 mg loratadine/120 mg pseudoephedrine sulfate, USP) Extended Release
Tablets that are still within their labeled expiration date. These products were manufactured between
August 1999 and June 2001. This recall does not extend to the patient level as the company believes
these products are clinically safe and effective, and pose no medical risk to patients. This recall is
being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). 

Schering-Plough as part of its standard quality-control procedures conducted stability testing of
specific lots of CLARITIN-D 12 Hour Tablets, including dissolution tests to determine the rate that
tablets dissolve and the amount of active ingredients released. Results of these tests indicated that
some tablets in these lots did not demonstrate full release of pseudoephedrine (the decongestant
ingredient) at the fifth hour per specification, although by 25 minutes later all tested samples met
specifications for releasing pseudoephedrine. The company believes that this short delay in achieving
full release of pseudoephedrine would have no clinical consequence on expected efficacy or safety of
these products, and that there is no medical risk to patients. The company reported the dissolution
test results to the FDA, and this issue was subsequently cited in an FDA inspection report (Form
FDA 483) dated Feb. 8, 2002. 

Schering-Plough believes that most of the trade inventory subject to this recall has been depleted.
The company is manufacturing CLARITIN-D 12 Hour Tablets and recently has begun shipping new
product to the trade. CLARITIN-D 12 Hour is an antihistamine/decongestant combination product
indicated for the relief of symptoms of seasonal allergic rhinitis. 

Individual units of CLARITIN-D 12 Hour Tablets are marked with a lot number that includes a
prefix number representing the year of manufacture. Any lot with a prefix number of "0" or "1"
(representing the years 2000 and 2001), respectively, is included in this recall. In addition, lots
9-JRP-313, 9-JRP-338, 9-JRP-2040, 9-JRP-2041 and 9-JRP-2042, which were manufactured in
1999, are also included in this recall. Any lot bearing a prefix number of 2 (representing 2002) is not
included in this recall. 

Only CLARITIN-D 12 Hour Tablets with the indicated lot numbers are subject to this recall.
Patients who may have CLARITIN-D 12 Hour Tablets do not need to return these products to their
pharmacies or to Schering-Plough. This recall does not affect any other product formulation in the
CLARITIN(R) (loratadine) family of nonsedating antihistamines. 

Schering-Plough emphasized that this recall of specific lots of CLARITIN-D 12 Hour Tablets will
not affect the company’s previously announced earnings guidance for 2002, as stated in press
releases issued on Dec. 21, 2001, and Jan. 24, 2002. 

Any questions regarding this recall should be directed to the CLARITIN-D Information Center at
1-866-300-1516. Anyone who should become aware of any adverse events associated with the
product subject to this recall should contact the CLARITIN-D Information Center or the FDA
MEDWATCH program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mail to
MEDWATCH, HF-2, 5600 Fishers Lane, Rockville, MD, 20857. 

DISCLOSURE NOTICE: In addition to historical information, this press release includes certain
"forward-looking" information relating to the company’s projected earnings for 2002, and the U.S.
market availability of CLARITIN-D 12 Hour Tablets. The reader of this release should understand
that the extent that CLARITIN products will be prescribed will be determined by market forces. In
addition, the risks and uncertainties relating to the company’s 2002 earnings projection are
described in detail in the company’s Dec. 21, 2001, and Jan. 24, 2002, press releases, which are
available on the company’s Web site at www.schering-plough.com. In addition, the forward-looking
statements may also be adversely affected by general market factors, competitive product
development, product availability, current and future branded, generic or OTC competition, federal
and state regulations and legislation, the regulatory process for new products and indications, existing
and new manufacturing issues that may arise, trade buying patterns, exchange rate fluctuations,
patent positions, litigation and investigations. For further details and a discussion of these and other
risks and uncertainties, see the company’s Securities and Exchange Commission filings, including the
company’s 2000 annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. 

Schering-Plough Corporation is a research-based company engaged in the discovery, development,
manufacturing and marketing of pharmaceutical products worldwide. 

============================================================== 
12.) Claritin D Recall 
============================================================== 
source: 12NEWS.COM 

A popular allergy drug is under recall today. The makers of Claritin announced a voluntary recall of
its 12-hour, extended release tablets. 

The problem has to do with the rate at which the decongestant ingredient dissolves in the body. 

In some cases, the medicine isn't released fast enough and users don't receive the necessary dose
until up to 25 minutes after taking the Claritin-D tablet. 

The drug's manufacturer, Schering-Plough, stresses that the pills are safe to take and that they're
recalling it from the pharmacies not the patients. 

If you have some of the recalled Claritin, the company says there's no need to return it to the
pharmacy. Continue using it until the prescription runs out. 

The recalled Claritin was made between August 1999 and June 2001. 

Individual units are marked with a lot number that includes the prefix "0" or "1." In addition, lots
9-JRP-313, 9-JRP-338, 9-JRP-2040, 9-JRP-2041 and 9-JRP-2042, which were manufactured in
1999, are also included in this recall. 

If you have any questions, you can call the Claritin-D information center at 1-866-300-1516. 

Story Posted: 02-19-2002 at 3:28 PM MST 

Last Modified: 02-19-2002 at 3:30 PM MST 

============================================================== 
13.) Garamycin Ophthalmic SOlution Gentamicin Sulfate Ophthalmic 
============================================================= 
Source SafetyAlerts.com April 12, 2001 

Solution and Gentak Sterile Solution Recalled 
Kenilworth, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Schering
Labortories has recalled certain Garamycin Ophthalmic Olution Gentamicin Sulfate Ophthalmic
Solution and Gentak Sterile Solution because of chemical contamination- Dicyclohexyl Phthalate
(DCHP) Product Label adhesive migration. 

This is the first public notice of this Class III recall issued by FDA. 

PRODUCT 
Garamycin Ophthalmic Olution Gentamicin Sulfate Ophthalmic Solution, USP) 3 GM/ML, 5 ML
Bottles, NDC 0085-0899-05 
Gentak Sterile Solution, DC 17478-283-0,PRIVATE LABEL for AKORN, INC., Buffalo Grove,
Illinois. 

Recall #D-161-1. 

CODE: 
LOT NO. EXP. DATE 
0-AMS-2 10/2003 
9-AMS-2 3/2002 
9-AMS-3 6/2002 
9-AMS-4 12/2002 
8-AMS-5 5/2002 
8-AMS-7 8/2001 
8-AMS-9 8/2001 
8-AMS-12 12/2001 

GENTAK LABEL 
9-AMS-1 2/2002 
8-AMS-3 2/2001 
8-AMS-4 5/2001 
8-AMS-5 5/2001 
8-AMS-8 8/2001 
8-AMS-10 11/2001 
8-AMS-11 11/2001 

MANUFACTURER: 
Schering Labortories, Kenilworth, NJ. 

RECALLED BY: 
Manufacturer, by letters on 3/8/01 and telephone on 2/16/01. FDA(Firm)-initiated recall ongoing. 

DISTRIBUTION: 
Nationwide. 

QUANTITY: 
Approximately 389,089 units. 

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA. 

Notice of this product warning was sent via email to SafetyAlerts subscribers April 12, 2001. For
more information regarding the SafetyAlerts free email alert service please click here. 

==============================================================14.)
Request to HHS to investigate charges against Schering-Plough for possibly knowingly shipping
millions of asthma drug inhalers that may not have contained any active ingredient (HRG Publication
#1559) 
============================================================== 

ATTACHMENT (pages of External Audit Report by AAC & FDA Inspection Report) * Note:
You will need Adobe Acrobat Reader to open and read this document. If you do not have Acrobat
Reader, you can access this free software by clicking on the graphic. You will only have to complete
this process once. 

March 1, 2001 

Tommy Thompson, Secretary, 
Department of Health and Human Services 
200 Independence Avenue, SW 
Washington, D.C. 20201 

Dear Secretary Thompson: 

During the past 15 months, 59 million asthma inhalers manufactured by Schering-Plough for treating
acute attacks of asthma had to be recalled because of dangerously sloppy manufacturing procedures
which resulted in many units failing to contain the active ingredient, albuterol (brand name
Proventil(1)). We have obtained a confidential external audit by the AAC Consulting Group of
Rockville, Maryland, contracted for by Schering-Plough, conducted at Schering-Plough's
manufacturing facility at Kenilworth NJ, where these life-sustaining products were manufactured.
This audit took place from February 28, 2000 to April 14, 2000(2). The auditors were extremely
critical of the general attitude of management personnel who described to them--- "an imbalance
between quality and production, leaning considerably toward production". They also found serious
specific problems with the quality control of the production of the asthma inhalers such as the fact
that "An in-process assay for the active ingredient in Proventil is not performed." Managers told the
auditors that "aerosol products are a major money maker for the company". But, the auditors
concluded, "significant manufacturing problems have been experienced with this product class, which
is indicative of insufficient technical expertise and managerial oversight...." 

In addition, we have obtained the summary of a very recent 31-day FDA inspection of the same
plant completed January 19th of this year in which FDA inspectors found a persistence of many of
the same kinds of problems with the quality of manufacturing uncovered one year ago during the
private audit of Schering. The FDA investigators concluded that "The process validation for many
products fails to support claims that manufacturing processes were capable of consistently producing
products with the same quality, purity and safety."(3) 

We urge you to launch an investigation into criminal charges against Schering-Plough based on the
possibility that the company knowingly shipped millions of the 59 million units of albuterol-containing
asthma drug eventually recalled between the time the company became aware of the seriously flawed
manufacturing processes and the time the recall was finally accomplished. We also urge that you
investigate the company for continuing to ship other prescription drug products while fully aware of
the serious violations of FDA good manufacturing practice (GMP) regulations during their
production. 

The current quality control problems found in that manufacturing plant during the recent FDA
inspection are so serious that there has been a "temporary interruption of some production lines"(4)
and it will not be allowed by the FDA to gain approval or start shipping its new allergy drug,
Clarinex, a metabolite of the active ingredient in its top-selling Claritin, which it had previously
planned to ship very soon. During that inspection, FDA investigators found that "There was no
assurance that the manufacturing process, parameters, equipment or protocols...conducted at
multiple sites for the production of Clarinex (Desloratidine tablets, 5 mg) are equivalent or capable of
producing product of the same quality." No other new Schering-Plough products will be approved
until these serious manufacturing problems are resolved. 

SCHERING'S PRIORITY OF PRODUCTION OVER QUALITY: A FORM OF CONTEMPT
FOR THE SAFETY OF PATIENTS 

Added to the findings of Schering-Plough's own consultants and the results of the FDA's most recent
inspection of the Kenilworth NJ facility, is the fact that the FDA has issued at least five Warning
Letters to the company since June, 1998 detailing serious GMP problems in its manufacturing
facilities in New Jersey, Puerto Rico, and Ireland. 

Table 1 below summarizes the five Warning Letters directed at various Schering-Plough plants since
June 29, 1998 for serious deviations from GMP guidelines. 

Table 1 ­ Warning Letters Issued to Schering-Plough by the Food and Drug Administration for
Good Manufacturing Practice Guideline Deficiencies for the Production of Human Drugs Since June
1998 
Date Facility Drug(s) Involved Examples of Problems Noted in Warning Letters 
6/29/98 (5) Las Piedras, Puerto Rico Theo-Dur, 
Claritin 10 mg Extension of expiration period for Theo-Dur, an asthma drug. 
Failure to investigate variability in Claritin 10 mg tablets, an antihistamine. 
10/23/98 (6) Kenilworth and Union, New Jersey Proventil Inhaler, Claritin D, 
Diprolene Oint., Nasonex Nasal Spray Proventil Inhaler, an important asthma drug, failing pressure
results. 
Claritin D, a combination antihistamine-decongestant, dissolution rate problems. 
Diprolene Ointment, a topical steroid, out of specification assay results. 
Nasonex Nasal Spray, used for allergy, failed to conform to all specifications. 
11/23/98 (7) Innishannon, County Cork, Ireland Intron A Intron A is an injectable used to treat a
variety of disorders including some cancers and chronic hepatitis C. Failure to establish appropriate
procedures to insure that Intron A is sterile. 
7/21/99(8) Kenilworth and Union, New Jersey Vanceril DS Inhaler, Proventil Inhaler Vanceril
Inhaler, used to treat chronic asthma, failure to follow test procedures and failure to meet
specifications. 
Proventil Inhaler, also for asthma, there was failure to properly test the content of canisters. 
5/8/00 (9) Manati, Puerto Rico Garamycin Ophthalmic Solution, 
Vancenase AQ, Nasonex Nasal Garamycin is an antibiotic used to treat eye infections. There was
failure to perform adequate investigation into the cause of out of specifications results for stability
testing for some batches of the drug. 
Vancenase AQ and Nasonex Nasal suspension are used for allergy treatment. There were
deviations from protocol for the Uniformity of Spray Content Assays for these products. 

Six months before the FDA began their most recent inspection of the Kenilworth NJ facility on
November 1, 2000, Schering-Plough's consultants, AAC Consulting Group, noted in their audit of
this plant on April 27, 2000: 

Upper management needs to demonstrate its long term commitment to product quality, such as
through increased staffing/budget resource allocations and investments in new equipment, in order to
supplant the traditional emphasis on production and firmly establish a company culture in which
quality is, in fact, the number one priority.(10) 

AAC Consulting found that "Most units fail to have documentation demonstrating that operators are
qualified in all required critical tasks. Some areas also lack approved training procedures." The
consultants noted that although Schering-Plough's upper management had recently placed some
emphasis on quality " there is staff concern that this commitment to quality may not be long
term."(11) 

The consultants asked supervisors, managers, and operators if they perceived a real change in the
company's commitment to improving product quality since the aerosol recalls and problems with the
FDA in late 1999. The consultants observed: 

Most managers/supervisors have adopted a wait and see attitude, to determine if upper management
will "walk the talk" with respect to long term commitment to product quality. They state that for many
years they have been under significant pressure to get production out and don't feel they have had
enough time or people to do a quality job. They indicated that there has been in the past a continual
push for increased production and decreased down time sometimes at the expense of quality work
and GMP compliance. They believe there has been an imbalance between quality and production,
leaning considerably toward the side of production.(12) 

After five Warning Letters for serious GMP violations in a period of only two years and an audit
conducted by outside consultants of the Kenilworth NJ facility, a plant that had previously had been
issued two Warning Letters, serious GMP violations were found seven months later by the FDA.
The first point in the FDA's report referred to the quality of products produced at this facility. The
FDA inspectors observed: 

The Quality Control Unit failed to assure that drug products were manufactured in compliance with
cGMPs and therefore have the safety, quality, and purity that they purport, or are represented to
possess.(13) 

CHRONOLOGY AND REPEATED MANUFACTURING DEFECTS WITH IMPORTANT
DRUGS 

Appendix 1, at the end of this document, is the chronological sequence of important events in the
Schering-Plough affair. 

ALBUTEROL (PROVENTIL) ASTHMA INHALERS 

Two of the Warning Letters, 10/23/98 and 7/21/99, involve manufacturing problems with albuterol
(PROVENTIL) aerosol inhalers. Albuterol is a drug of vital importance for asthmatics. It is
frequently used to stop acute asthma attacks. 

The 7/21/99 Warning Letter also reveals meetings and communications between Schering-Plough
and the FDA's Center for Drug Evaluation and Research (CDER). On 6/25/99, CDER informed
Schering-Plough's Vice President for Worldwide Regulatory Affairs of a four phase prior approval
program for the release of albuterol inhalers by the company. 

Defective manufacturing of albuterol led to almost 60 million canisters of this drug being recalled
because some canisters did not contain the active ingredient. The first recall took place on 9/9/99
and involved 190,679 units of the drug. The second, on 3/29/00, recalled 58,936,179 canisters of
albuterol. 

Schering-Plough knew of problems with the production of albuterol inhalers during the July 30, 1998
inspection of the Kenilworth NJ facility that resulted in the October 23, 1998 Warning Letter. By
late June of 1999, the company had to agree to prior approval by the FDA before any albuterol
inhalers could be distributed by the company. 

The AAC Consulting Group began their audit at Kenilworth NJ on February 28, 2000 and
submitted its final report to Schering-Plough on April 27, 2000. After two Warning Letters and two
recalls involving albuterol inhalers, the consultants made the following observations regarding the
manufacturing of albuterol inhalers: 

Evaluation of this manufacturing area disclosed significant changes in both procedures and record
keeping practices. Overall, these were found to be positive, but some observations did reflect
potential problem areas and perhaps even some degree of over-reaction to the recent aerosol
product recalls.(14) 
It is our understanding, based on interviews with supervisors and managers, that aerosol products
are a major money make for the company. In addition, significant manufacturing problems have been
experienced with this product class, which is indicative of insufficient technical expertise and
managerial oversight. This production area does not have the visibility and importance from an
organizational standpoint that it needs in order to quickly and effectively recover from past problems,
maintain satisfactory regulatory compliance, attract and retain necessary expertise, and grow in the
future.(15) 
Some components, such as aerosol valves from 3M Neotechnic, are received for testing already
pre-sampled by the vendor. There is no assurance that the samples provided to Schering were
collected by the vendor according to accepted sampling procedures and are representative of the
entire lot.(16) 
Updating aerosol test procedures should be given the highest priority in light of past problems with
this product class and the intense scrutiny Schering operations in this area is currently undergoing by
FDA.(17) 
An in-process assay for the active ingredient in Proventil is not performed. Reportedly, R&D has
been trying for several years without success to shorten the Proventil final release assay procedure,
so that it is suitable for in-process testing.(18) 
An in-process assay method for Proventil should be developed and validated as soon as possible so
that the active ingredient is quantified in-process as is done for all other Schering aerosol
products.(19) 
The AAC audit was completed six months before the FDA's most recent inspection of Kenilworth
NJ. Still the FDA observed deficiencies in the manufacture of albuterol inhalers: 

Aerosol Manufacturing Line 76 with the online stress testing heating blocks was validated in that the
two validation attempts have failed to meet the validation protocol acceptance criteria.(20) 
Validation Summary Report #Val-9-184, (validation for the use of the heating blocks for on-line
stress testing for Proventil/Albuterol) was inadequate in that 1 out of 3 original Validation Batches,
#9-BBS-640, was rejected for excessive downtime and rejected canisters (purged cans). An
additional Validation Batch, #9-BBS-643, was also rejected due to out-of-specification leak test
results.(21) 
A second validation attempt of the heating blocks for on-line stress testing was executed under
Validation Summary Report #VAL-00-48. This validation was inadequate in that Validation Batch
#'s 0-BBS-572m 0-BBS-573 & 0-BBS-574 failed to meet the process validation acceptance
criteria for total content of Albuterol. Additionally, the rinse method utilized by the laboratory to
retest the total content of Albuterol per canister was never validated.(22) 
The Product Quality Review (PQR) methods for the Delivery of Albuterol through the Actuator and
Particle Size for Proventil Aerosol Inhaler were inadequate in that the methods exhibit various
unidentified extraneous peaks. PQR Methods for Total Content of Albuterol per Can Assay and
Estimation of Degradation Products were also inadequate in that there was a lack of resolution
between typical unknown peaks from neighboring active or placebo peaks. These methods were
used to test and release product batches, as well as stability samples, from 10/11/99-12/7/00.(23) 
LORATADINE WITH PSEUDOEPHEDRINE (CLARITIN D) 

Problems with the production of the antihistamine loratadine in combination with pseudoephedrine
(CLARITIN D) were identified in the July 30, 1998 inspection of the Kenilworth NJ plant that
resulted in the October 23, 1998 Warning Letter. 

Eighteen months later AAC Consulting continued to find problems with the production of Claritin-D: 

Previously filed validation reports for Claritin-D (Once-a-Day), with the same product ID (GJKS),
were performed in 1993. The protocols and final reports were reviewed and approved by
production and quality in 1995. One of the batches manufactured failed final blend specifications, but
this validation was approved by management nearly two years later. There was no statement as to
the batch's disposition.(24) 
The annual product review for Claritin-D 24 reflected 45 of 752 finished tablet batches were
rejected. Of those there were 35 rejected for high moisture, 5 for variable loratadine content. This
would seem to reflect that the process is not validated. There also were 44 batches that had low
granulation yield based on product hang-up in the equipment. This same issue has been seen with
other products and it is not apparent that there has been a for cause investigation done to determine
why product is hanging up in the equipment. There also were 307 batches that had low yield. This
has caused variance and MRB reports. It appears that the specs may not be appropriate and/or the
process is not validated. Addressing this issue could cut down on a lot of unnecessary investigation
time.(25) 
The FDA also continued to find deficiencies in the production of Claritin-D in their most recent
inspection of the Kenilworth NJ plant: 

Validation of the Claritin D-24hr. ER Tablet process, using a drug substance from a new source
(Schering, Singapore) was not adequate in that only one batch was manufactured. Change
Authorization #CA-99-248 allows for the use of this alternate source. The new drug substance was
used to manufacture batch #'s 0-DCS-257 through 0-DCS-340, approximately 95 batches.(26) 
The current revalidation Protocol, #VAL-0-61, for Claritin D-24 hr. ER Tablet Cores contained
incorrect acceptance criteria, but was signed and approved by Validation, QC, and Manufacturing
Departments. Specifications for two finished product tablet tests were erroneously included as the
acceptance criteria for the tablet cores.(27) 
DESLORATADINE (CLARINEX) 

Desloratadine (CLARINEX) is Schering-Plough's replacement for its overpriced antihistamine
loratadine (CLARITIN). Desloratadine is the major metabolic breakdown product of loratadine. It
appears from the FDA's recent Kenilworth NJ inspection that there are serious problems with the
production of desloratadine that will prevent final approval of the drug. The FDA observed the
following in their recent inspection: 

There was no assurance that the manufacturing process, parameters, equipment, or protocols and
acceptance criteria, conducted and generated at multiple sites for the production of Clarinex
(Desloratadine Tablets, 5 mg) are equivalent, or capable of producing product of the same quality. 
The test method transfer from Schering, Kenilworth to Schering, Puerto Rico failed to demonstrate
that accurate and reliable results could be obtained from the QC laboratory. 
There was insufficient comparability data for the drug substance, Desloratadine, manufactured at the
firm's Ireland and Singapore sites to assure equivalence of the drug substance supply.(28) 
In conclusion, it is clear that there are an extraordinary variety of serious problems at the
Schering-Plough manufacturing plant in Kenilworth, New Jersey which threaten the safety of drugs
already shipped out of the facility and bespeak the need for extreme caution in allowing any further
products to be shipped from that plant. In addition, we hope you insist that the FDA investigate the
possibility of criminal behavior on the part of those Schering-Plough officials who may have
knowingly shipped defective pharmaceutical products for use in unsuspecting patients. We expect a
prompt response to this urgent request. 

Sincerely, 

Larry Sasich, Pharm.D., MPH 
Research Associate 

Sidney M. Wolfe, M.D., Director 
Public Citizen's Health Research Group 

Appendix 1 ­ Chronological Sequence of Events 
Date Action Drugs Mentioned Documentation 
5/7/98 Inspection - Las Piedras, PR >From the 6/29/98 Warning Letter 
6/29/98 Warning Letter - Las Piedras, PR Theo-Dur Claritin 10 mg
www.fda.gov/foi/warning_letters/d1423b.pdf accessed 2/19/01 
7/30/98 Inspection - Kenilworth and Union, NJ >From 10/23/98 Warning Letter 
10/23/98 Warning Letter - Kenilworth and Union, NJ 
"Current regulations specify that drug products failing to meet standards or specifications and any
other relevant quality control criteria shall be rejected. Reprocessing may be performed, provided
certain criteria are met according to written procedures. The practice of partial releases, no matter
how stringent the re-sampling, raises doubt as to the safety and efficacy of the product being
released. It is not acceptable to substitute testing over adequate control of a process." Claritin-D,
Diprolene Oint, Proventil Inhaler, Nasonex Nasal Spray
www.fda.gov/foi/warning_letters/m2366n.pdf accessed 2/19/01 
11/23/98 Warning Letter - County Cork, Ireland Intron A
www.fda.gov/foi/warning_letters/m2327n.pdf accessed 2/19/01 
5/28/99 Inspection Union and Kenilworth, NJ >From 7/21/99 Warning Letter 
6/7/99 Teleconference in NJ between S-P and CDER concerning Proventil and Vanceril inhalers. 
From 7/21/99 Warning Letter 
6/17/99 Meeting at FDA between S-P and CDER to discuss conditions under which S-P may
resume shipment of Proventil Inhalers. >From 7/21/99 Warning Letter 
6/25/99 CDER letter to Dr. Alexander Giaquinto, Sr. VP, Worldwide Regulatory Affairs detailing a
four-phase proposal for the release of Proventil Aerosol. S-P must strictly adhere to the proposal to
continue distributing Proventil Inhalers. This amounts to "prior approval" by the FDA. From
7/21/99 Warning Letter 
7/21/99 Warning Letter - Union and Kenilworth, NJ 
The 6/15/99 response to the 10/23/98 Warning Letter was not satisfactory. Drug products failing to
meet established standards or specifications and any other relevant quality control criteria shall be
rejected. Retesting later is not an acceptable practice. Vanceril 
Proventil www.fda.gov/foi/warning_letters/m2818n.pdf accessed 12/19/01 
9/9/99 Class I Recall ­ Warrick Pharmaceuticals Albuterol Aerosol. 190, 679. AL, CT, FL, GA,
KY, MD, MA, NJ, NY, NC, OH, PA, RI, TN, VA, WV. Some units fail to contain active
ingredient. 
The recall affects a lot that was distributed between late April and early May 1999. Schering-Plough
Press Release 9/9/99 
12/2/99 Class II Recall - Vanceril Double Strength Aerosol. 82,029 units nationwide. Some units
may not contain active drug. Drug was distributed in November 1999. 
"The cause of the problem has been identified as inadequate batch start-up practices that occurred
for a short period during filling of the subject lots. The company has taken corrective actions to
prevent a recurrence." Schering-Plough Press Release 12/2/99 
3/28/00 Inspection - Manati, PR 5/8/00 ­ Warning Letter 
3/29/00 Class II Recall ­ Proventil/Albuterol inhalers, 58,936,179; Vanceril 84 mcg, 831,594 units;
Vanceril 42 mcg, 5,274,819 units; Vancenase, 2,706,424 units nationwide, PR, and Canada. Some
canisters may not have active ingredient. 
This recall relates to an aerosol manufacturing problem that had been previously identified in October
1999. 
Does not involve any inhaler manufactured after September 30, 1999. These inhalers would have an
expiration date of Oct 2001 or later. Schering-Plough Press Release 3/29/00 
4/27/00 AAC Consulting Group audit of Kenilworth, NJ. Audit began 2/28/00 
AAC found that an in-process assay for the active ingredient in Proventil is not performed. AAC
Audit Report 
5/8/00 Warning Letter - Manati, PR Garamycin Ophthalmic Solution, Vancenase, Nasonex
Diprolene Gel 
Celestone Injection www.fda.gov/foi/warning_letters/m3847n.pdf accessed 2/19/01 
1/19/01 FDA 483 Observations of Kenilworth, NJ 
The Product Quality Review (PQR) methods for the Delivery of Albuterol through the Actuator and
Particle Size for Proventil Aerosol Inhaler were inadequate in that the methods exhibit various
unidentified extraneous peaks. PQR Methods for the Total Content of Albuterol pr Can Assay and
Estimation of Degradation Products were also inadequate in theat there was a lack of resolution
between typical unknown peaks from neighboring active or placebo peaks. These methods were
used to test and release product batches, as well as stability samples, from 10/11/99-12/07/00.
(page 12) FDA 483 Inspection Report 

-------------------------------------------------------------- 

1. The first recall, 9/9/99, involved 190,000 units and the second, 3/29/00, involved 58.9 million
units. Some units manufactured by Schering in the same New Jersey facility were sold under the
name of their subsidiary, Warrick, as generic albuterol. In a Q & A accompanying the second recall,
Schering-Plough explained that the purpose of the recall was to "address the remote possibility that
an aerosol container may not contain active drug" and said, in an extraordinary and reckless
understatement of what could be a life-threatening situation, "Proventil and Warrick brand albuterol
patients using a canister without active drug will not obtain their usual relief from asthma symptoms." 

2. Audit of Schering Laboratories Manufacturing Facility Kenilworth, NJ, Audit Report, AAC
Consulting Group, February 28, 2000 ­ April 14, 2000. Final report is dated April 27, 2000. 

3. Department of Health and Human Services, Food and Drug Administration. Form FDA 483
(8/00) Inspectional Observations, Schering-Plough Corporation, 2000 Galloping Hill Road,
Kenilworth, NJ 07033, dated January 19, 2001, page 1. 

4. Schering-Plough press release, February 15, 2001. 

5. Warning Letter addressed to Mr. Francisco R. Rodriquez, General Manager, Schering-Plough
Products Inc., Las Piedras, Puerto Rico from Samuel Jones, District Director, Puerto Rico District,
Food and Drug Administration dated June 29, 1998. 

6. Warning Letter addressed to Mr. John E. Nine, President, Technical Operations, Schering
Laboratories, Schering-Plough Corporation, Kenilworth NJ 07033-0503 from Douglas I. Ellsworth,
Food and Drug Administration, District Director, New Jersey District dated October 23, 1998. 

7. Warning Letter addressed to Colman Casey, Ph.D., Managing Director, Schering-Plough
(Brinny) Co., Innishannon, Couny Cork, Ireland from Jerome A. Donlan, M.D., Ph.D., Acting
Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research,
Food and Drug Administration dated November 23, 1998. 

8. Warning Letter addressed to Mr. John E. Nine, President, Technical Operations, Schering
Laboratories, Schering-Plough Corporation, Kenilworth NJ 07033-0503 from Douglas I. Ellsworth,
Food and Drug Administration, District Director, New Jersey District dated July 21, 1999. 

9. Warning Letter addressed to Mr. John E. Nine, President, Technical Operations, Schering
Laboratories, Schering-Plough Corporation, Kenilworth NJ 07033-0503 from Mildred R. Barber,
District Director, Food and Drug Administration dated May 2, 2000. 

10. Audit of Schering Laboratories Manufacturing Facility Kenilworth, NJ, Audit Report, AAC
Consulting Group, February 28, 2000 ­ April 14, 2000, page 6. 

11. Audit of Schering Laboratories Manufacturing Facility Kenilworth, NJ, Audit Report, AAC
Consulting Group, February 28, 2000 ­ April 14, 2000, page 5. 

12. Audit of Schering Laboratories Manufacturing Facility Kenilworth, NJ, Audit Report, AAC
Consulting Group, February 28, 2000 ­ April 14, 2000, page 76. 

13. Department of Health and Human Services, Food and Drug Administration. Form FDA 483
(8/00) Inspectional Observations, Schering-Plough Corporation, 2000 Galloping Hill Road,
Kenilworth, NJ 07033, dated January 19, 2001, page 1. 

14. Audit of Schering Laboratories Manufacturing Facility Kenilworth, NJ, Audit Report, AAC
Consulting Group, February 28, 2000 ­ April 14, 2000, page 36. 

15. Audit of Schering Laboratories Manufacturing Facility Kenilworth, NJ, Audit Report, AAC
Consulting Group, February 28, 2000 ­ April 14, 2000, page 65. 

16. Audit of Schering Laboratories Manufacturing Facility Kenilworth, NJ, Audit Report, AAC
Consulting Group, February 28, 2000 ­ April 14, 2000, page 91. 

17. Audit of Schering Laboratories Manufacturing Facility Kenilworth, NJ, Audit Report, AAC
Consulting Group, February 28, 2000 ­ April 14, 2000, page106. 

18. Audit of Schering Laboratories Manufacturing Facility Kenilworth, NJ, Audit Report, AAC
Consulting Group, February 28, 2000 ­ April 14, 2000, page106. 

19. Audit of Schering Laboratories Manufacturing Facility Kenilworth, NJ, Audit Report, AAC
Consulting Group, February 28, 2000 ­ April 14, 2000, page106. 

20. Department of Health and Human Services, Food and Drug Administration. Form FDA 483
(8/00) Inspectional Observations, Schering-Plough Corporation, 2000 Galloping Hill Road,
Kenilworth, NJ 07033, dated January 19, 2001, page 3. 

21. Department of Health and Human Services, Food and Drug Administration. Form FDA 483
(8/00) Inspectional Observations, Schering-Plough Corporation, 2000 Galloping Hill Road,
Kenilworth, NJ 07033, dated January 19, 2001, page 3. 

22. Department of Health and Human Services, Food and Drug Administration. Form FDA 483
(8/00) Inspectional Observations, Schering-Plough Corporation, 2000 Galloping Hill Road,
Kenilworth, NJ 07033, dated January 19, 2001, page 3. 

23. Department of Health and Human Services, Food and Drug Administration. Form FDA 483
(8/00) Inspectional Observations, Schering-Plough Corporation, 2000 Galloping Hill Road,
Kenilworth, NJ 07033, dated January 19, 2001, page 12. 

24. Audit of Schering Laboratories Manufacturing Facility Kenilworth, NJ, Audit Report, AAC
Consulting Group, February 28, 2000 ­ April 14, 2000, page 9. 

25. Audit of Schering Laboratories Manufacturing Facility Kenilworth, NJ, Audit Report, AAC
Consulting Group, February 28, 2000 ­ April 14, 2000, page 85. 

26. Department of Health and Human Services, Food and Drug Administration. Form FDA 483
(8/00) Inspectional Observations, Schering-Plough Corporation, 2000 Galloping Hill Road,
Kenilworth, NJ 07033, dated January 19, 2001, page 2. 

27. Department of Health and Human Services, Food and Drug Administration. Form FDA 483
(8/00) Inspectional Observations, Schering-Plough Corporation, 2000 Galloping Hill Road,
Kenilworth, NJ 07033, dated January 19, 2001, page 3. 

28. Department of Health and Human Services, Food and Drug Administration. Form FDA 483
(8/00) Inspectional Observations, Schering-Plough Corporation, 2000 Galloping Hill Road,
Kenilworth, NJ 07033, dated January 19, 2001, page 15. 

============================================================== 
15.) Schering-Plough y dos firmas de medicinas genéricas son acusadas de soborno 
============================================================== 
Por John R. Wilke / SOURCE: wsj.com / 2 abril 2.001 
Redactor de The Wall Street Journal 

WASHINGTON - Funcionarios antimonopolio en Estados Unidos están preparando cargos civiles
contra Schering-Plough Corp. y dos fabricantes más de medicamentos genéricos, argumentando que
los acuerdos de la patente entre las compañías incluían pagos ilegales para retrasar la llegada al
mercado de un medicamento genérico de bajo costo. 

Se espera que la Comisión de Comercio Internacional de Estados Unidos (FTC, por sus siglas en
inglés) envíe el lunes una queja contra Schering-Plough y las compañías genéricas, Lederle, filial de
American Home Products Corp. y Upsher-Smith Inc., según abogados cercanos al asunto. 

Esta es la última estrategia en la cada vez más extendida guerra de la FTC, que alega que un gran
número de grandes compañías farmacéuticas han sobornado a sus rivales más pequeños para
demorar la entrada al mercado de los medicamentos genéricos, su competencia. El año pasado, la
FTC atacó a otros cuatro fabricantes de medicamentos por realizar el mismo tipo de prácticas, y
recuperó US$100 millones de una quinta empresa por tratar de monopolizar el mercado para un
medicamento genércio antiansiolítico. 

El esfuerzo de la FTC expone la tensión existente entre la ley antimonopolio, que busca proteger a
los consumidores, y la ley de patentes, que está dirigida a premiar la innovación dándole a las
compañías monopolios temporales en la nueva tecnología. En la industria de los medicamentos, las
compañías han buscado extender lo más que han podido los monopolios de lucrativos productos
para bloquear las medicinas genéricas, cuya entrada puede reducir hasta 80% el precio de una
medicina. 

En la demanda contra Schering-Plough, la FTC espera acusar a la compañía de haber pagado a
Upsher US$60 millones disfrazados de pagos de permisos por otros fármacos y por otro lado
US$39 millones a Lederle. La FTC dirá que esos pagos fueron estrategias ilegales para demorar a
los competidores en su lanzamiento de K-Dur, un suplemento de cloruro de potasio de bajo precio
ampliamente utilizado. 

Cada una de las compañías que la FTC nombró han defendido los acuerdos como el ejercicio logal
de los derechos de patente, o acuerdos de permisos legales que no afectan a los consumidores. 

El futuro de los agresivos esfuerzos de la FTC para que se cumpla la ley es menos claro bajo un
régimen republicano. Mientras que los republicanos tienden a otorgar mayor deferencia a las
patentes, muchos de los votos acerca de casos de acuerdos de patentes en la FTC han obtenido el
apoyo unánime de los cinco miembros del directorio, incluyendo a sus dos miembros republicanos. 

============================================================= 
16.) SCHERING-PLOUGH DISAGREES WITH FDA ADVISORY PANEL’S
RECOMMENDATION REGARDING CLARITIN (LORATADINE) 
============================================================= 
KENILWORTH, N.J., May 11, 2001 – Schering-Plough Corporation (NYSE: SGP) today said it
strongly believes that CLARITIN (loratadine), the company’s nonsedating antihistamine, should
remain a prescription product following a non-binding recommendation by the joint meeting of the
U.S. Food and Drug Administration’s (FDA) Nonprescription Drugs Advisory Committee and the
Pulmonary–Allergy Drugs Advisory Committee, which examined questions relating to the possible
use of CLARITIN in an over-the-counter (OTC) setting. 

The panel voted 19 to 4 to recommend that loratadine has a safety profile acceptable for OTC
marketing. The panel also had serious concerns regarding appropriate OTC labeling. Additional
issues on the lack of use studies as well as patient access were noted. 

In making its recommendation, the panel rejected testimony from the leading medical and consumer
associations, including the American Academy of Asthma, Allergy and Immunology (AAAAI) and
the American Academy of Otolaryngic Allergy (AAOA) and the patient-advocacy group Allergy
and Asthma Network/Mothers of Asthmatics, groups that spoke in support of maintaining the
prescription status of second-generation antihistamines, including loratadine. 

In his presentation today before the joint advisory committees, Robert J. Spiegel, M.D., chief
medical officer of Schering-Plough and senior vice president, medical affairs, said "We believe that
prescription status of these medications is necessary to protect and optimize public health." 

Today’s hearing was prompted by a petition to switch CLARITIN from prescription to OTC status,
which was brought by the health insurance company WellPoint/Blue Cross of California.
Schering-Plough maintains that such a switch would force patients to self-diagnose, self-treat and
pay the entire cost of their allergy medications, thus raising serious questions about quality of care
and costs for patients. 

In opposing the switch, Schering-Plough has also said it believes there are significant legal and public
policy issues that would be raised if the FDA were to require a switch without drug-sponsor
support. An Rx-to-OTC switch over a sponsor’s objections would constitute an unprecedented
departure from past agency policy and implicate the sponsor’s statutory and constitutional rights. 

The company emphasized that the advisory panel’s action today constitutes a recommendation that
is not binding on the FDA, which may accept or reject the recommendation, modify it, request
additional information, or take no action. 

Schering-Plough is a research-based company engaged in the discovery, development,
manufacturing and marketing of pharmaceutical products worldwide. 
============================================================== 
17.) SCHERING-PLOUGH AIMS TO MAKE CLARITIN PREMIER BRAND IN OTC
CATEGORY, ESTABLISH CLARINEX AS PREMIER BRAND IN PRESCRIPTION
CATEGORY 
============================================================== 
Company Reports FDA Accepts Filings of Applications To Market CLARITIN Line as OTC
Antihistamines 

KENILWORTH, N.J., March 8, 2002 - Schering-Plough Corporation (NYSE: SGP) today
announced that the U.S. Food and Drug Administration (FDA) has accepted for filing supplemental
New Drug Applications (sNDAs) to switch all indications and market all formulations of the
company’s CLARITIN (loratadine) brand of nonsedating antihistamine as over-the-counter (OTC)
products. 

"With the market introduction of CLARINEX as the first and only prescription nonsedating
antihistamine approved for the treatment of indoor and outdoor allergies, moving CLARITIN to
OTC status would give Schering-Plough an opportunity to establish brand leadership in both the
prescription and OTC categories," said Richard W. Zahn, president of Schering Laboratories, the
U.S. prescription pharmaceutical marketing arm of Schering-Plough. "Schering-Plough has more
than 50 years of experience in marketing prescription and OTC products, and we expect to build on
our heritage as a leader in the allergy/respiratory category." 

The applications to switch CLARITIN to OTC status have been assigned a "standard review" by
FDA, with a targeted action date of Nov. 28, 2002. The company reported that, as part of a
previously scheduled meeting on April 22-23, 2002, the FDA’s Nonprescription Drugs Advisory
Committee will consider, among other scheduled items, whether loratadine can be appropriately
labeled to treat chronic idiopathic urticaria (CIU) in an OTC setting. 

Schering-Plough said that, in concert with the rapid market acceptance of the company’s new
prescription antihistamine CLARINEX (desloratadine) Tablets, the proposed conversion of
CLARITIN to OTC status represents a strategic business and medical decision designed to: address
potential changes in the regulatory, health and legal environment; introduce a safe, nonsedating
anthistamine into the OTC marketplace; position these products as the premier brands in the
prescription and OTC categories, respectively; and maximize the combined value of the CLARITIN
and CLARINEX brands. 

As noted in a prior public filing with the Securities and Exchange Commission, the company believes
that the introduction of generic prescription or OTC loratadine or OTC CLARITIN in the U.S.
market would likely have a material adverse effect (as described in the disclosure notice below) on
the company’s results of operations, the impact of which may be mitigated by the successful defense
of its CLARITIN patents. 

The company today reiterated its previously stated earnings projection for 2002, given that the
market introduction of OTC CLARITIN is not likely to occur until later in 2002. As reported in
press releases issued on Dec. 21, 2001, and Jan. 24, 2002, Schering-Plough in 2002 expects to
achieve a percentage increase in earnings per share in the low double-digits (excluding a 2001
provision for a consent decree payment). 

ALLERGIES AND THE ANTIHISTAMINE MARKETPLACE 
From a medical perspective, Schering-Plough believes that allergies are a complex disease that often
requires physician oversight and management, particularly for patients with more chronic conditions
and related illnesses such as asthma. The availability of prescription antihistamines, including
CLARINEX, will continue to provide physicians with a broad range of treatments for managing their
allergy patients. 

The company is prepared to introduce CLARITIN as an OTC product with a comprehensive
medical education campaign directed at the treatment of allergies and CIU. The program would
provide consumers with information on allergies and potentially accompanying conditions such as
asthma, and recommendations for recognizing when there is a need for patients to remain in close
communication with their treating physicians. 

Allergies affect an estimated 45 million people in the United States and can have a significant impact
on daily activities at work, school and leisure time. It is estimated that 77 percent of Americans with
allergies use some form of medication to treat their allergy symptoms. Of those who use a
medication, an estimated 37 percent only use a prescription medication; 32 percent use a
combination of prescription and OTC medications; and 31 percent rely solely on OTC products. 

BACKGROUND INFORMATION 
In May 2001, a joint meeting of the FDA’s Nonprescription Drugs Advisory Committee and the
Pulmonary-Allergy Drugs Advisory Committee made a non-binding recommendation that loratadine
has a safety profile acceptable for OTC marketing. 

Schering-Plough stated that it believes its patents for CLARITIN are valid and enforceable and it
intends to continue with a vigorous prosecution of challenges to its CLARITIN-related patents.
Schering-Plough owns or has licensed several loratadine-related patents. In August 2000, the FDA
granted CLARITIN six months of additional marketing exclusivity, covering all five formulations of
the product, as a result of the company having conducted pediatric clinical trials. The six-month
period of marketing exclusivity commences at the expiration dates of all patents covering
CLARITIN. For the loratadine compound patent, the six-month period provides marketing
exclusivity in the United States through Dec. 19, 2002, and, for the compound patent for
desloratadine, through Oct. 21, 2004. A fluoroloratadine patent expires in 2008, and a formulation
patent for CLARITIN-D 24 Hour expires in 2012. 

The CLARITIN line of products includes: CLARITIN Tablets, CLARITIN-D 24 Hour
(loratadine/pseudoephedrine sulfate) Extended Release Tablets, CLARITIN-D 12 Hour Extended
Release Tablets, CLARITIN Syrup and CLARITIN RediTabs. 

Copies of the package inserts for the CLARITIN brand are available at: www.claritin.com. 

CLARINEX is the first and only nonsedating antihistamine approved for the treatment of symptoms
caused by year-round indoor allergens and seasonal outdoor allergens. CLARINEX was approved
in December 2001 for the treatment of seasonal allergic rhinitis (SAR), which involves symptoms
caused by seasonal outdoor allergens. The indications for CLARINEX were expanded in February
2002 with FDA approval for the treatment of allergic rhinitis, which encompasses SAR and the
treatment of perennial allergic rhinitis caused by year-round indoor allergens, as well as for approval
of chronic idiopathic urticaria. 

A copy of the CLARINEX package insert is available at www.clarinex.com. 

DISCLOSURE NOTICE: The information in this press release includes certain forward-looking
statements concerning the sNDAs submitted by the company for OTC marketing of CLARITIN
products, the market potential for CLARINEX and OTC CLARITIN, and the company’s
projected earnings for 2002. There are no assurances that the FDA will approve any of the
CLARITIN products for OTC marketing and sale or, if approved, as to the timing of that approval
or the indications approved. The reader of this press release should understand that the extent to
which CLARINEX and OTC versions of CLARITIN, if any, will be prescribed or used will be
determined by market forces and is subject to substantial risks and uncertainties. The reader of this
press release should also understand that the company has stated in public filings with the Securities
and Exchange Commission (SEC) that management believes that either the introduction of generic
prescription or OTC loratadine or OTC CLARITIN in the U.S. market would likely have a rapid,
sharp and material adverse effect on the company’s results of operations beginning at the occurrence
of such an event and extending for an indeterminate period of time thereafter. As the company has
also reported, that effect on the company’s results of operations may be mitigated if the company is
successful in its patent litigations, as described in the SEC filings and the company’s press release
dated January 31, 2002. However, there can be no assurance that the company will prevail in those
litigations. The risks and uncertainties relating to the company’s 2002 earnings projection are
described in detail in the company’s Dec. 21, 2001, and Jan. 24, 2002, press releases, which are
available on the company’s Web site at www.schering-plough.com. In addition, the forward-looking
statements may also be adversely affected by general market factors, competitive product
development, product availability, current and future branded, generic or OTC competition, federal
and state regulations and legislation, the research and regulatory processes for new products and
indications, existing and new manufacturing issues that may arise, trade buying patterns, exchange
rate fluctuations, patent positions, litigations and investigations. For further details and a discussion of
these and other risks and uncertainties, see the company’s SEC filings, including the company’s
2000 annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. 

Schering-Plough is a research-based company engaged in the discovery, development,
manufacturing and marketing of pharmaceutical products worldwide 

============================================================== 
18.) Class-Action Lawsuit Filed Against Claritin's Maker 
============================================================== 
Consumer Groups Charge Schering-Plough's Ad Campaign 'Deceptive' By Jeff Levine 

Source: WebMD Medical News 

Aug. 9, 2001 (Washington) -- In what is apparently a first, a coalition of health-oriented consumer
groups has filed a class-action lawsuit against pharmaceutical giant Schering-Plough. The complaint,
brought to a New Jersey state court, accuses the drug company of "deceptive advertising and
overpricing" for Claritin, America's most widely prescribed allergy drug. 


Whether it be an ad on TV, in print, or over the Internet, the plaintiffs charge that Schering-Plough
has falsely promised Claritin users relief from their symptoms without drowsiness when relatively few
benefit. The suit covers the period from 1997 to the present and is the creation of Prescription
Access Litigation (PAL), an alliance of 53-activist groups around the country. 


"The scale of Schering-Plough's misleading direct-to-consumer advertising exceeds all others in
American prescription drug history," said lead plaintiff's attorney Tom Sobol at a news conference
announcing the suit. Sobol maintains that during the years under scrutiny, Schering-Plough has spent
more than $100-million annually to promote Claritin. 


Meanwhile, allergy sufferers have paid $10 billion during the last four years for a drug that Sobol
claims is little better than a "sugar pill." 


Some of Claritin's commercial images have become a part of American pop culture, like the woman
running through the field of yellow flowers, seemingly oblivious to the onslaught of noxious pollens. 


"Claritin television advertisements are replete with images and references to celebrities [and] outdoor
activities ... but ... devoid of any reference to the limited efficacy of the drug," says Sobol. PAL
contends that Schering-Plough's own studies have shown the drug is effective for only half its users. 


Lisa Tyson, one of the plaintiffs, says she took Claritin for more than five years and it did nothing.
"My doctor was very clear, telling me it was going to help me. And I just kept waiting and waiting
for this thing to help me, and it wasn't helping me," she says. 


The suit has two basic goals: get the court to give consumers a refund for the product and put an end
to the allegedly deceptive ads, which PAL says inflate rapidly rising drug costs. "Price is the key, and
we believe that our contribution is to attack price," says Stephen Rosenfeld, a legal advisor to PAL.
Drug inflation is the main thing that's preventing Congress from passing a prescription drug benefit for
Medicare, he says. 


Schering-Plough spokeswoman Denise Foy says she can't comment directly on the lawsuit, since she
hasn't seen it. Still, she says the company follows the FDA's rules on consumer ads.
"Schering-Plough is committed to full compliance with all regulations, pertaining to promotional and
education materials," Foy tells WebMD. 


She also insists that the nonsedating antihistamine is the most popular because it works. "No amount
of marketing can sustain a drug that's not effective," she says. 

The plaintiffs say their suit isn't passing judgement on the FDA's effectiveness at supervising
direct-to-consumer advertising one way or the other, even though it's an agency responsibility. Sobol
says his group's goal is not to stop direct-to-consumer ads, but to focus on abuses where they exist. 


Meanwhile, WebMD has obtained a copy of a notice of violation written from the FDA to
Schering-Plough on Aug. 18, 2000 alleging violations in two Claritin print ads. 


"The [agency] has reviewed these ads and concluded that they are misleading and violate the Federal
Food, Drug and Cosmetic Act and applicable regulations and should be discontinued immediately,"
says the letter from Joan Hankin, JD, a consumer promotion analyst at the FDA. 


Specifically, the correspondence accuses the company of "misleading" readers by failing to list
information on the product's side effects. TV personality Joan Lunden was featured in the magazine
spread, which focused in part on the importance of school attendance. 


"Like all parents, I want what's best for my children, especially when it concerns their health. So
when my daughter, Lindsay, kept sneezing and sniffling, we visited her doctor. He said seasonal
allergies were the cause ... Once he prescribed a medication that wouldn't make her drowsy, she felt
better and so did I," said Lunden in the ad. 

============================================================== 
19.) Group sues Schering-Plough over Claritin ads 
============================================================== 
Source: Reuters Health 

NEW YORK, Aug 09 (Reuters Health) - The Prescription Access Litigation project (PAL), a
Boston-based advocacy group, on Thursday announced it has filed a class action lawsuit against
Schering-Plough over allegedly deceptive direct-to-consumer (DTC) advertising and overpricing of
the blockbuster allergy drug Claritin (loratadine). 

The complaint, filed in a New Jersey Superior Court, charges that Schering-Plough "falsely
promise[s] all Claritin purchasers complete relief from their allergy symptoms, without qualification,
when in fact a large percent of Claritin users report no benefit at all." 

The "language and imagery" of Schering-Plough's print, Internet and television promotions
"effectively portray Claritin as the cure for everyone's allergy-related symptoms," according to the
suit. 

The document points out that, in fact, Schering-Plough's "own studies indicate that Claritin does not
work for between 50% and 55% of all potential customers." 

The company's marketing approach has helped "create an artificial and illegitimate demand" for
Claritin products, and allowed the firm to "charge unconscionable prices" as a result of the demand,
the complaint alleges. 

The suit seeks a declaration that the Claritin ads violate New Jersey law, injunctive relief to prevent
similar misleading advertising by Schering-Plough in the future and a portion of the $10 billion that
consumers have spent on the prescription drug since mid-1997, Tom Sobol, a lead attorney for PAL
told Reuters Health. 

A Schering-Plough spokeswoman said the company has not been served with the lawsuit and cannot
yet comment on specific charges. 

However, she did state that "Claritin is the world's leading non-sedating prescription antihistamine
because it works. There's no amount of marketing that can sustain a drug that's not effective." 

She added, "All advertising, all promotional and educational materials that the company uses are
used under rules and regulations established by the Food and Drug Administration (FDA)." 

In September 2000, the FDA requested that Schering-Plough pull Claritin ads that the agency said
contained unsubstantiated claims about the drug's benefits and failed to adequately inform consumers
about side effects. The spokeswoman was not able to comment on whether the FDA has cited the
company over promotional practices for Claritin since then. 

PAL's litigation against Schering-Plough marks the latest in a string of recent legal actions taken by
the group against the pharmaceutical industry. In June, PAL filed suits against Schering-Plough,
American Home Products and Upsher-Smith Laboratories alleging that the companies entered into
illegal agreements that kept inexpensive generic versions of K-Dur 20, a prescription potassium
chloride supplement, out of the hands of patients. 

In May, PAL sued AstraZeneca and Barr Laboratories for what it claims was a collusive agreement
that inflated the price of the breast cancer drug tamoxifen. And the advocacy group charged
Bristol-Myers Squibb in April with illegally filing secondary patents on the anti-anxiety drug
buspirone in order to block generic competition. 

In a recent interview with Reuters Health, PAL Director Kim Shellenberger said that the group's goal
is to file a suit at least every couple of months. 

"Ms. Shellenberger's words were accurate then and are now," Sobol said on Thursday. He noted
that there is a "high probability" that the group will file another suit within the next 60 days. 

"The point of filing the lawsuit is to in some way deter other pharmaceutical companies from engaging
in [similar] conduct, and hopefully start a dialogue where some more sense could be made of the
madness of drug prices in America," Sobol said. "Our position is...that the FDA has a regulatory role
to fulfill, but that private, civil enforcement actions are also an additional way to make sure that
effective and accurate communication happens to American consumers." 

"We aren't trying to preempt, or in any way affect or comment on, the FDA's role," he added.
"We're simply trying to pursue other roles that the law not only makes available, but expects will be
exercised." 

============================================================== 
20.) Class Actions against Shering-Plough 
============================================================== 
Source: SteveWeisman.com, Attorney and Counsellor at law. 

NewsLetter: 

Schering-Plough Corp., the maker of Claritin, the country's most widely prescribed allergy medecine
is finding that class actions are nothing to sneeze at. Recently a number of consumer groups filed a
class action against Schering-Plough alleging that the pervasive television ads we have all seen touting
the effectiveness of Claritin as an allergy symptom fighter are deceptive and misleading. The plaintiffs
allege that Claritin is effective only half of the time. 

============================================================== 
21.) Consumer Groups Sue Over Direct-to-Consumer Advertising by Schering-Plough 
============================================================== 
Source: Milberg Weiss, Berhand Hynes, and Lerach LLP. 

Maker of Claritin Misleads the Public and Illegally Inflates Prices, Complaint Alleges 
WASHINGTON, D.C., August 9 – The Boston-based Prescription Access Litigation project
(PAL) announced today the filing of a class action lawsuit in New Jersey against Schering-Plough
Corp. (NYSE: SGP) for deceptive advertising and overpricing of Claritin, America's most widely
prescribed allergy drug. Plaintiffs allege that Schering-Plough has engaged in a campaign of
misrepresentation that has artificially increased the demand and price for the drug—a drug that
Schering-Plough's own studies have shown to be effective for only 50% of its users. 

The lawsuit was announced today a National Press Club Newsmaker news conference. The
complaint, filed in state Superior Court in New Jersey, alleges that Schering-Plough's
direct-to-consumer ads falsely depict the benefits of its drug, Claritin, and fail to disclose the limited
efficacy of Claritin products, which also include Claritin-D, Claritin-D 24 Hour, Claritin Syrup, and
Claritin Reditabs. The lawsuit alleges that Schering-Plough's campaign of deceptive, unfair
advertising has turned it into the top-selling antihistamine in the U.S., with annual sales of over $2
billion. 

Last year, Schering-Plough spent $111 million on direct-to-consumer ads promoting the allergy
drug, according to PAL's lawsuit, which says the ads consistently make a false promise: that Claritin
works for everyone. In fact, medical research indicates that Claritin fails to provide allergy relief
roughly half the time, and performs only slightly better than a placebo, i.e., a sugar pill. 

Plaintiffs in the actions, members of the PAL coalition, include Citizen Action New York, Citizen
Action New Jersey, and Health Action New Mexico, as well as individual users of the drug. The
plaintiffs are represented by; New York-based Milberg Weiss Bershad Hynes & Lerach LLP
(www.milberg.com); Carey & Danis, LLC of St. Louis (www.careydanis.com); and Lieff,
Cabraser, Heimann & Bernstein, LLP of San Francisco (www.lchb.com). 

"This is not a mere oversight," said attorney Stephen Rosenfeld, consumer advocate and PAL
spokesman. "We believe Schering-Plough has deliberately left out any information about the drug's
efficacy, instead serving up glowing ads to push this product in America's living rooms. This suit
alleges that the ads are misleading, incomplete, and designed to fool the public into paying top-dollar
for a drug that often as not, just doesn't work. We see this as one of the most egregious examples of
inflating the prices of a drug beyond its worth." 

PAL (www.prescriptionaccesslitigation.org) was formed earlier this year on behalf of consumer
groups to combat the tactics drug companies use to maintain artificially high prices for prescription
drugs. The Claritin litigation is the fourth filed by PAL since April against pharmaceutical companies. 

The newest PAL lawsuit notes that during the class period, about $10 billion was spent in the US for
Claritin products; a substantial portion of which, the complaint alleges, is directly attributable to
Schering-Plough's unlawful conduct. 

"This is a case about a pharmaceutical company's direct-to-consumer advertising, and how that
advertising distorted the market. We allege that Schering-Plough induced Americans to spend
billions of dollars on Claritin in the belief that it would bring complete allergy relief for each user. That
belief sprang from the false claims in Claritin ads and the absence in the ads of information about
Claritin's true level of efficacy, the Complaint alleges, and it inflated sales and prices throughout the
market," noted a PAL lead attorney, Thomas M. Sobol. "Deliberate concealment and false promises
are at the heart of the New Jersey Consumer Fraud Act." 

In April, PAL filed six lawsuits alleging that Bristol-Myers Squibb illegally kept a generic version of
BuSpar, an anti-anxiety drug, off the market. In May, PAL filed lawsuits against AstraZeneca and
Barr Laboratories alleging price collusion over tamoxifen, a breast cancer drug that is the most
widely prescribed anti-cancer drug in the world. In June, PAL filed suits alleging that
Schering-Plough, Upsher-Smith Labs & American Home Products entered into illegal agreements to
maintain artificially high prices of K-DUR20, potassium supplement that is the fourth most prescribed
drug among the elderly. 

The Prescription Access Litigation Project was organized by Community Catalyst
(www.communitycatalyst.org), a Boston-based nonprofit organization. PAL, comprised of more
than 50 consumer and senior advocacy groups in 25 states, was formed earlier this year to target
pharmaceutical companies whose unfair market conduct has pushed the cost of prescription drugs
beyond the reach of many U.S. consumers. 

============================================================== 
22.) Schering Plough's Low Blow 
============================================================== 
Source: Steven j. Milloy 

Take a bow Schering Plough. You've made junk science history. 

Recently, (junk) scientists from the U.S. Food & Drug Administration announced that the chemical
phenolphthalein may cause cancer. This announcement was news because phenolphthalein is used in
Ex-Lax, the popular laxative. 

But the announcement is based on rodent bioassays -- a type of study recently found to be seriously
flawed. Also, the mice in these studies were fed very high levels of phenolphthalein -- much higher
than any human would ever be exposed to. So these studies are of dubious relevance to humans.
Moreover, there is no human data linking Ex-Lax to increased cancer risk despite the product being
used for many years. 

Pharmaceutical giant Schering Plough saw it differently though. 

On June 3, 1997, Schering Plough took out full-page ads in The New York Times and USA Today
with the following text: 


A GOVERNMENT PANEL HAS DETERMINED 

SOME LAXATIVES CAUSE CANCER. 
An FDA committee has concluded that phenolphthalein, the active ingredient found in many
laxatives, may poses a risk of cancer. 

As a result, the government is considering regulatory action that may even include a recall of laxatives
containing phenolphthalein. This would include most ex-lax products. 

Fortunately, today there's Correctol Laxative which does not contain phenolphthalein. 

Because of the importance of this issue, Correctol invites you to call 1-888-570-4200. 


Picking on a competitor's product with junk science? Shame on you Schering Plough! 

Of course, Schering Plough failed to mention that the last time a study linked phenolphthalein with
cancer, Schering Plough laxatives Correctol and Feen-a-Mint contained phenolphthalein! At the
time, Schering Plough's comment was the study wasn't relevant to humans. 

So what's happened to Schering Plough? Well as it turns out, although Correctol no longer contains
phenolphthalein, product sales are in the toilet (pun intended?). 

Hey Schering Plough... in 1994 Canadian researchers linked your antihistamine marketed as Claritin
with cancer. Have you got a toll-free number for consumers to call for that one? Perhaps we should
send out an alert to the trial lawyers. I'm sure there are plenty of people with cancer who used
Claritin. In the junk science world, that's good enough for a cause-and-effect relationship! 

So watch out Schering Plough. Those who live by junk science shall perish by it! 

Material presented on this home page constitutes opinion of the author and does not necessarily
reflect the views of TASSC or its members. 

============================================================= 
23.) Misleading company data: Schering-Plough sued by shareholders 
============================================================== 
13-19 february 2.001 

Sorce: Chemicalsnewsflash.de 

U.S.-company Schering-Plough has been sued by shareholders because of false and misleading
statements concerning profit and growth. According to the shareholders, Schering-Plough has only
now revealed the true extent of its problems in the production process and announced a decline in
turn-over and profits for the first quarter and the whole of 2001. 

============================================================== 
24.) ABC and NBC ignored a drug company's arguments for extending a patent as both followed
Public Citizen's script: a greedy corporation contributes to cynical politicians. 
============================================================== 
Spource: mediaresaerch.org 
Nomvember 22/ 1999. 

Instead of exploring why a drug company might want an extension on a patent, and airing views on
both sides of the issue about which policy would most benefit consumers while also encouraging
continued expensive pharmaceutical research, a couple of weeks ago ABC and NBC assumed all
that mattered was campaign money and how much the company gave to whom. 

The rest of this item as recited below was written by Rich Noyes, the MRC's new Director of
our Free Market Project: 

On Wednesday night, November 17, Peter Jennings read a brief item from Washington: "The
headline here would have to be the power of the spotlight," Jennings said. "The Senate Judiciary
Committee has decided not to go ahead with a bill that would have made it possible to extend the
patent for the best-selling allergy drug Claritin beyond the year 2002. The drug's maker,
Schering-Plough, had lobbied very aggressively in favor of the bill, which would have kept less
expensive generic versions of Claritin off the market longer." 

While Jennings didn't say so, the "spotlight" that proved so consequential belonged to ABC. The
week before, World News Tonight ran two reports by Jackie Judd apparently designed to thwart
the lobbying campaign by Schering-Plough. NBC Nightly News carried one report by Lisa Myers
on the same story. "The drug maker would have liked the legislation to pass -- quietly," Jennings told
viewers on Monday, November 8. 

The impetus for the networks' expose seems to have come from Public Citizen, a Nader-ite
liberal activist group that issued its own anti-Schering-Plough report. Both Myers' and Judd's reports
closely followed Public Citizen's press release, (http://www.citizen.org/Press/pr-drugs10.htm) and
representatives from Public Citizen were featured in all three network stories. 
Meanwhile, Schering-Plough company spokesmen wouldn't talk to either Myers or Judd, so both
reporters briefly paraphrased a company statement which argued that the patent extension was
justified by FDA delays during the approval process. 

In fact, after Schering-Plough obtained the original 17-year patent for Claritin in 1983, it was
forced to wait eight years before the government said it could begin selling the drug. A two-year
extension was later granted, but that runs out in 2002. Schering-Plough wanted to extend its patent
another three years, to 2005, before generic drug companies could copy its formula and sell cheaper
versions of Claritin. 

The networks ignored those pesky details, however, as both journalists followed Public Citizen's
script: a greedy corporation contributes to cynical politicians in order to obtain political support.
Myers called it "a classic case of how Washington works." Judd reported that "Schering-Plough is
pushing hard, having spent millions in lobbying Congress to get the patent extended." Myers, echoing
Judd, reported that "documents also revealed the company spent $11 million for an army of
lobbyists to work the halls of Congress, and it increased campaign contributions more than a million
dollars to Republicans, $300,000 to Democrats." 

Both reporters pointed out that Democratic Senator Robert Torricelli, who introduced the bill,
received a substantial contribution from Schering-Plough, which is based in his home state of New
Jersey. And, both reported that Senate Judiciary Chairman Orrin Hatch leased Schering-Plough's
corporate jet for campaign trips -- legal, both reporters admitted, but perhaps too cozy an
arrangement. 

These are the same details contained in Public Citizen's press release, making one wonder how
hard either Judd or Myers really worked on the story. Public Citizen makes no bones about its
liberalism on this issue. "This bill is about whether prescription drugs are going to continue to be
unaffordable for too many Americans, including seniors and people with disabilities on Medicare
who have no prescription drug coverage," Public Citizen's Frank Clemente said in the press release. 

But in hewing so closely to Public Citizen's anti-corporate line, Myers and Judd ignored a crucial
fact: Drug companies won't research and develop new drugs such as Claritin unless they can recoup
those costs in the marketplace. That's the reason new medicines get patent protection from the U.S.
government, and it's a process that ultimately benefits consumers. 

============================================================== 
25.) Did Defective Inhalers Cause 17 Deaths? 
============================================================== 
Source: ClassActionAmerica.com 

Did Defective Inhalers Cause 17 Deaths? 
A number of possible legal actions against drug maker Schering-Plough Corp. are being investigated
after reports that 17 people using the company's albuterol-based asthma inhalers died during a
period of time in which potentially defective inhalers were on the market. 

A number of possible legal actions against drug maker Schering-Plough Corp. are being investigated
after reports that 17 people using the company's albuterol-based asthma inhalers died during a
period of time in which potentially defective inhalers were on the market.The allegations were made
by consumer advocacy group Public Citizen, which reviewed records from the federal Food and
Drug Administration. Public Citizen made the claims in an August 9, 2001 letter to Tommy
Thompson, U.S. Secretary of Health and Human Services. 
Schering-Plough recalled a small batch of albuterol-based inhalers in September, 1999 and 58
million more in March, 2000. According to Public Citizen, FDA records show 17 deaths for which
this inhaler was listed as the 'primary suspect' from late 1998 through spring 2000, the period that
potentially defective inhalers were on the market. Ten patients had used inhalers from batches later
recalled, while identifying lot numbers aren't listed for the other seven. Albuterol-based inhalers made
by Schering-Plough are sold under both its Proventil brand name and as a generic version from
Warrick Pharmaceuticals, a subsidiary of Schering-Plough. 

The first death was reported to Schering-Plough on January 4, 2000, yet the company didn't expand
the recall until March. That woman had had well-controlled asthma until abruptly dying in
September, 1999 while using an inhaler that ultimately would be recalled. Between her death and the
March, 2000 recall, five more inhaler users died, according to Public Citizen. 

Schering-Plough has responded that 'To date, every inhaler returned to us by a patient claiming
injury and alleging that the canister lacked active ingredient has been tested and found to contain
active ingredient.' 

============================================================== 
26.) Wall Street Journal: Schering fines could total $500 million Wednesday, January 2, 2002
06:50:47 PM - Wall Street Journal 
============================================================== 

Dec 24, 2001, (Wall Street Journal /FT Information via COMTEX) -- 
Schering-Plough Corp., the pharmaceutical company, says it may have to pay up to 
$500m in fines after a federal investigation into its manufacturing practices by 
the Food and Drug Administration. The firm also warned that this quarter's 
earnings will fail to meet analysts' forecasts. In separate news the company 
announced it has received regulatory approval to sell Clarinex, its allergy 
drug. 

Abstracted from: The Wall St Journal (US Edition) 

Schering-Plough Announces Ongoing Negotiations with FDA for Consent Decree on Manufacturing
Issues 
Wednesday, December 26, 2001 07:46:13 PM - PR Newswire 


============================================================== 
27.) Schering-Plough Announces Ongoing Negotiations with FDA for Consent Decree on
Manufacturing Issues 
Wednesday, December 26, 2001 07:46:13 PM - PR Newswire 
============================================================== 
SOURCE Schering-Plough Corporation 

KENILWORTH, N.J., Dec 21, 2001 /PRNewswire via COMTEX/ -- Schering-Plough 
Corporation (NYSE: SGP) today announced that it is in negotiations with the U.S. 
Food and Drug Administration (FDA) for a consent decree to resolve issues 
involving the company's compliance with current Good Manufacturing Practices 
(GMPs) at manufacturing facilities in New Jersey and Puerto Rico. 

Terms of the consent decree under negotiation include a possible payment by 
Schering-Plough to the federal government that may be as high as $500 million, 
subject to resolution of other terms of the final agreement. Schering-Plough 
intends to work closely and cooperatively with the FDA to reach a negotiated 
agreement resolving outstanding issues. However, the company notes that there 
are a number of issues being discussed and no assurances can be given that a 
negotiated agreement will be reached or as to what the terms of any such 
agreement would be. Any agreement would be subject to approval by the U.S. 
District Court for the District of New Jersey (Newark). 

DISCLOSURE NOTICE: The information in this press release includes certain 
"forward-looking" statements relating to the manufacturing process and control 
and current Good Manufacturing Practices (GMP) issues identified by the FDA, the 
company's efforts going forward to resolve those issues, remedies the FDA may 
seek with respect to those issues, and the prospect and potential terms and 
effects of a negotiated consent decree resolving the GMP issues. The resolution 
of the issues with the FDA is subject to substantial risks and uncertainties. 
Many factors could cause the resolution of those issues through a consent decree 
to differ materially from the company's forward- looking statements, including 
that the timing, scope and duration of a resolution of the manufacturing process 
and control and GMP issues will depend on the ability of the company to assure 
FDA of the quality and reliability of its manufacturing systems and controls. 
The reader of this release should understand that the failure to reach 
resolution of the GMP issues through a consent decree or otherwise could result 
in delays in approval of new products, seizure or recall of products, suspension 
or revocation of the authority necessary for the production and sale of 
products, fines and other civil or criminal sanctions. In addition, the 
forward-looking statements may also be adversely affected by general market 
factors, competitive product development, product availability, current and 
future branded, generic or OTC competition, federal and state regulations and 
legislation, the regulatory process for new products and indications, existing 
and new manufacturing issues that may arise, trade buying patterns, patent 
positions, litigation and investigations. For further details and a discussion 
of these and other risks and uncertainties, see the company's Securities and 
Exchange Commission filings, including the company's 2000 annual report on Form 
10-K and subsequent quarterly reports on Form 10-Q. 

Schering-Plough Corporation is a research-based company engaged in the 
discovery, development, manufacturing and marketing of pharmaceutical products 
worldwide. 
============================================================== 
28.) Schering-Plough's Woes Continue 
============================================================== 
by Brett Pope 
Source: ideaavisor.com 

1:37:00 PM March 01, 2001 GMT 


Schering-Plough’s [SGP: NYSE] stock is suffering Thursday after Public Citizen, a consumer
advocate group founded by Ralph Nader, released alleged FDA documents showing that
Schering-Plough reacted slowly and inadequately to FDA recommendations for manufacturing
improvements. The drugmaker, which is currently subject to several shareholder lawsuits, has not
commented on the matter. We believe that the stock’s valuation is starting to look attractive at
current levels, however, we do not believe the stock will have a substantial rally until its
manufacturing problems are resolved. We are maintaining our Neutral rating on Schering-Plough at
this time. 

The released documents show that Schering-Plough was aware for some time of the manufacturing
deficiencies, yet did not take the steps to correct the problems. One of the main issues is
Schering-Plough’s timing of its disclosure to investors. The company did not disclose the FDA
warnings to investors in its previous documents. In addition, the company was warned in January
that the approval of its new allergy drug Clarinex would be delayed until the manufacturing issues
were resolved. Despite this warning, this fact was not made public until mid-February. 

In addition to facing shareholder lawsuits, Public Citizen has requested that the FDA consider
possible criminal charges for the company allegedly knowingly shipping products made with flawed
manufacturing processes. Although we do not expect the various legal charges to result in material
fines, we believe the uncertainty created by the manner will put near-term pressure on the stock. In
addition to these matters, we are still concerned about the lack of visibility regarding the approval of
Clarinex. 

Market Timing 
From the Technical Desk 

On Feb. 16, we said: " Schering Plough [SGP: NYSE] plummeted 17% today on very heavy trading
volume. Although the stock has bounced off the intraday low, we expect SGP to retest it in the
near-term. Look for the stock to fall to $38.50/$37.50 in one to two weeks. It is trading at $40.03."

Schering-Plough hit our downside target of $38-1/2. The bias is for the stock to sink lower to $35 in
one to two weeks. However, support at $37-1/2 has to be first broken. It is trading at $39. 
============================================================== 
29.) [e-drug] Serious Manufacturing Problems at Schering-Plough 
============================================================== 
Source: [email protected] 

To: [email protected] 
Subject: [e-drug] Serious Manufacturing Problems at Schering-Plough 
From: "Larry Sasich" <[email protected]
Date: Fri, 2 Mar 2001 00:14:44 -0500 (EST) 
Reply-To: [email protected] 
Sender: [email protected] 


E-drug: Serious Manufacturing Problems at Schering-Plough 
--------------------------------------------- 
Dear Colleagues, 

This morning (March 1, 2001) we wrote to the U.S.'s new Secretary of 
Health and Human Services urging him to launch an investigation into 
criminal charges against Schering-Plough based on the possibility 
that the company knowingly shipped millions of albuterol (Proventil 
in the U.S.) metered dose inhalers that were eventually recalled, 
between the time the company became aware of the seriously flawed 
manufacturing processes and the time the recall was finally 
accomplished. Some albuterol canisters contained no active 
ingredient. We also urged the Secretary to investigate the company 
for continuing to ship other prescription drug products while fully 
aware of the serious violations of Food and Drug Administration Good 
Manufacturing Practice (GMP) guidelines during their production. 

The full text of our letter and documentation can be found on our web 
site at: www.citizen.org/hrg/PUBLICATIONS/1559.htm. 

Warmest regards, 

Larry 

Larry D. Sasich, Pharm.D., M.P.H., FASHP 
Public Citizen's Health Research Group 
1600 20th Street, NW 
Washington, DC 20009 
Voice: 202-588-7782 
FAX: 202-588-7793 
E-Mail: [email protected] 
Web Site: www.citizen.org/hrg 
-- 
Send mail for the `E-Drug' conference to `[email protected]'. 
Mail administrative requests to `[email protected]'. 
For additional assistance, send mail to: `[email protected]'. 

============================================================== 
30.) FDA Should Investigate Sloppy Manufacturing Practices at Drug Maker Schering-Plough,
Public Citizen Says 
Confidential Audit, FDA Inspection Uncover Problems at Kenilworth, N.J., Plant 
============================================================== 
Source: commondreams.com 

WASHINGTON - March 1 - Public Citizen is urging the U.S. Food and Drug Administration
(FDA) to investigate quality control problems at a New Jersey plant owned by pharmaceutical giant
Schering-Plough. 
In a letter sent today to Department of Health and Human Services Secretary Tommy Thompson,
Public Citizen urges the FDA to look into manufacturing practices associated with asthma inhalers
and other drugs. During the past 15 months, the drug manufacturer has been forced to recall 59
million asthma inhalers because many units lacked the active ingredient. 

Documents obtained by Public Citizen show that external auditors last year found significant
problems at Schering-Plough’s Kenilworth, N.J., plant, and that more recently, FDA inspectors who
visited the plant found that similar manufacturing problems still existed. 

Auditors of AAC Consulting Group of Rockville, Md., visited Schering-Plough’s Kenilworth plant
between Feb. 28, 2000, and April 14, 2000. They were extremely critical of the general attitude of
managers, who told them about "an imbalance between quality and production, leaning considerably
toward production." 

The problems with the inhalers indicate "insufficient technical expertise and managerial oversight," the
auditors wrote. 

Meanwhile, in a recent 31-day FDA inspection of the same facility, which was completed on Jan.
19, inspectors found similar quality control problems and concluded that "[t]he process validation for
many products fails to support claims that manufacturing processes were capable of consistently
producing products with the same quality, purity, and safety." 

The problems found by the FDA inspection are so serious that some production lines have been
temporarily halted and the company will not be allowed by the FDA to gain approval of or start
shipping Clarinex, its new allergy drug, as planned. FDA investigators found "no assurance that the
manufacturing process, parameters, equipment or protocols . . . conducted at multiple sites for the
production of Clarinex . . . are equivalent or capable of producing product of the same quality." 

In the letter, Public Citizen asks the FDA to consider whether criminal charges are warranted
because of the possibility that the company was aware of the quality control problems when it
shipped some of the defective inhalers. The FDA also should investigate the drug manufacturer for
continuing to ship other prescription drug products while aware of the manufacturing problems,
Public Citizen wrote. 

"The practices uncovered are dangerously sloppy and threaten the health of consumers," said Dr.
Sidney M. Wolfe, director of Public Citizen’s Health Research Group. "The auditors essentially
found that the practices at the plant are so poor that there’s no guarantee that drugs have the right
amount of active ingredients, or that they are manufactured consistently enough to ensure that they
contain what they purport to contain. This is no way to run a drug company." 

============================================================= 
31.) Claritin Maker Accused of False Advertising 
============================================================= 
Source: chirolifeline.com 

Reuters Health news service reports on August 9, 2001 that The Prescription Access Litigation
Project (PAL), a Boston advocacy group, announced that it has filed a class action lawsuit against
Claritin maker Schering-Plout over deceptive direct-to-consumer (DTC) advertising. 


According to the complaint, Schering-Plough "falsely promises all Claritin purchasers complete relief
from their allergy symptoms, without qualification, when in fact a large percent of Claritin users
report no benefit at all." 


The complaint goes on to say that the company's ads "effectively portray Claritin as the cure for
everyone's allergy-related symptoms" even though Shering-Plough's "own studies indicate that
Claritin does not work for between 50% and 55% of all potential customers." 

In Touch, Vol. 5 No. 10, October 2001 

============================================================== 
32.) Maker of Claritin plans over-the-counter sales 
Schering-Plough reacts to pressure from regulators, rivals 
============================================================== 
Associated Press 
Originally published March 9, 2002 

NEW YORK - Under immense regulatory and competitive pressure, Schering-Plough Corp. said
yesterday that it plans to switch its blockbuster allergy prescription medicine Claritin to an
over-the-counter drug. 

The switch means sales of the company's top selling drug will shrivel, and marketing Claritin's
recently introduced successor will be more challenging. Schering-Plough's stock fell 5.5 percent on
the news. 

Last year, Claritin had sales of $2.7 billion, but analysts said that could sink to $400 million next year
if the switch is approved as expected. Over-the-counter drugs can cost as much as 50 percent less
than prescription medicines. 

Analysts said the company has little choice. 

Late last year, an FDA advisory panel said Claritin and two competing products - Pfizer's Zyrtec
and Aventis' Allegra - were safe enough to be sold over the counter. 

The FDA, which has said it agrees with the panel's finding, is expected to make a formal ruling in a
few weeks. What remains unclear is whether the FDA would force the companies to switch the
products to over-the-counter status, and if it has the power to do so. 

Schering-Plough is under more pressure than Pfizer or Aventis because Claritin is its largest-selling
drug, and it is expected to lose patent protection in December. 

The company has filed numerous lawsuits against generic firms seeking to bring cheaper versions of
Claritin to market. 

Even more threatening, analysts said, are applications filed with the FDA by rivals Johnson &
Johnson and American Home Products Corp. to bring to market generic over-the-counter versions
of Claritin, which could have frozen Schering out of the market if it didn't act. 

At least now Schering will be able to build on its reputation and customer base as it brings its
product out, analysts said. 

Schering said yesterday that it filed an application to switch the brand with the FDA and expects to
have a drug on the market by November. 

Schering introduced Clarinex, a successor to Claritin, late last year in a bid to extend its franchise.
But analysts say Clarinex isn't a vast improvement over its predecessor, so insurance companies
might not reimburse patients for a more expensive prescription drug with only marginal benefits when
an over-the-counter remedy will suffice. 

"My impression is, doctors won't prescribe Clarinex. That drug is going to face significant hurdles,"
said Dr. Girish Tyagi, an analyst at ABN Amro Inc. 

Schering-Plough shares tumbled $1.96 to $34 yesterday on the New York Stock Exchange. 
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DATA-MEDICOS/DERMAGIC-EXPRESS No 4-(112)  30/03/2.002 DR. JOSE LAPENTA R. 
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