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News
01/24/01 - Dr.
Janet Woodcock, FDA to LAG Coordinators
January 24, 2001
Dear Messrs. Fireman, Miller, Bell, and Roberts:
Thank you for your letter of January 5,2001, sharing the objectives of your Lotronex Action Group. I understand that Mr. Miller spoke with Drs. Rackowski
and Jolson of our staff and discussed the goal of obtaining continued access to Lotronex to patients. Also, I corresponded with Mr. Miller on December 22,
2000, in response to his December 12, 2000, letter.
We have stated publicly and personally to Glaxo Smith Kline (formerly Glaxo Wellcome) that we are available to assist in the development of risk management
plans to make Lotronex available to patients who have benefited from the drug and have no other options available. Your offer of assistance in starting
dialog between FDA and Glaxo Smith Kline is appreciated, however confidentiality
rules prohibit us from including non-FDA perosnnel in discussion about such a clinical development program. The sponsor, however, may do so. You may want to
contact Glaxo Smith Kline to let them know of your interest.
I would like to reaffirm that we are committed to working with pharmaceutical sponsors to facilitate the availability of treatment options for patients with
this serious disease.
Sincerely,
Janet Woodcock, M.D.
Director
Centor for Drug Evaluation and Research
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