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01/05/01 - LAG
Coordinators to Dr. Janet Woodcock, FDA
Lotronex Action Group
Dr. Janet Woodcock, MD.
Director
Center for Drug Evaluation and Research
Food and Drug Administration
HFD-001 WOC2 Room 6027
1451 Rockville Pike
Rockville, MD 20852
January 5, 2001
Dear Dr. Woodcock:
We are writing to you on behalf of the newly-formed Lotronex Action Group, a large, active and rapidly growing organization of former
Lotronex users. The Lotronex Action Group seeks immediate access to the medicine Lotronex (alosetron hydrochloride) under
'compassionate use' or 'investigational new drug' guidelines while
avenues for 'continued marketing' are explored between Glaxo Smith Kline and the Food and Drug Administration.
We have read your letter about Lotronex posted on the CDER Website
and we take particular note of your statement that the FDA is willing to work with Glaxo Smith Kline to develop an acceptable
Risk Management Plan, so that current Lotronex patients can
continue to receive this necessary medication. We would be more
than willing to comply with any Risk Management Plan established by both parties, as long as it provides that prior users would have
access.
The LAG understands and respects the FDA's concerns regarding
unlimited distribution of the medicine, as well as GSK's desire to
market and sell Lotronex with as few restriction as possible.
The Lotronex Action Group would like to offer its assistance in
starting an immediate dialog between FDA and GSK.
The Lotronex Action Group believes that the benefits of Lotronex
far outweigh the potential risk of adverse side effects. For many
with diarrhea-predominant IBS Lotronex was the only effective
treatment they ever received. Therefore, we respectfully request
cooperation from both the FDA and Glaxo Smith Kline in restoring
access to Lotronex for those desperately in need (both men and
women).
Sincerely,
The Lotronex Action Group
Richard A. Fireman, Coordinator
Tom Bell, Coordinator
Corey Miller, Coordinator
Jeffrey Roberts, President, IBS Group
cc. M. Baumgartner (GSK Product Director, Regulatory Affairs)
Ramona Dubose (GSK Mgr. Production Communication / Media Relations)
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