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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID
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To: Maurice Winn who wrote (1434)1/18/1998 2:37:00 AM
From: DMB1 Recommendation  Read Replies (2) of 1762
 
Allow me to drop in on this conversation. I am a physician and somewhat familiar with the FDA's approval process. For at least the last 15 years, as long as I have been in practice, many promising drugs that are had yet been fully approved have been made available to patients through the FDA's "compassionate use" program. Granted, there is paper work to fill out, but in recent years the process has been made quite user friendly. The idea that patients are unable to get access to beneficial drugs makes good press but once a drug has shown enough promise in clinical trials it is often available before full approval. Sure, there are exceptions...the Genentech monoclonal antibody for breast cancer, Herceptin, is in short supply because of manufacturing limitations. But attempts have been made to mae it available ... there is a lottery. In fact, Rituxan was available through a compassionate use program before full approval was granted. I have found the FDA to be very cooperative.
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