Question:

Are delays in approving new drugs caused by the lack of a commissioner to head the FDA or pressure to keep unsafe drugs off the market "at any cost?" According to a report by SG Cowen’s health care researchers, U.S. drug regulators have, in affect, been told to stop unsafe drugs from being marketed at any cost.  The conclusions of the report were based on anonymous conversations with two people who had held senior positions at the FDA and a third "insider." The suggestion has been made that once President Bush picks someone to head the FDA, things will return to normal. "Unfortunately, the selection process has become so politicized that many of the most qualified people are taking themselves out of the running," according to SG Cowen biotech analyst Erick Schmidt.  "They just don’t want to take a job where they’re going to have to deal with the stem cell or abortion issues all the time," he says. One executive was considered a front-runner until Senator Ted Kennedy made it clear he wouldn’t supprt any candidate with strong biotech or drug industry ties.  Lynn Drake, a Harvard Medical School professor said to have Republican party ties, is said to be the current frontrunner for the job.  A current FDA employee, Richard Pazdur, is also said to be under consideration. There are some who feel, though, that the FDA situation is due to a change in attitude rather than the lack of a commissioner.  Since 1997, 14 drugs have been pulled from the shelves because of safety concerns. Congress is said to have told the FDA that it must implement a zero-tolerance policy to keep unsafe drugs from doctors and patients, according to the SG Cowen report.  The report suggests that an environment has been created at the FDA in which no one wants to assume any risk approving new drugs. The agency’s regulators are said to believe that doctors share some of the blame because many of the drugs pulled off the market had warning labels that, had they been followed closely by doctors, would have prevented the safety problems.  The SG Cowen report says that when the FDA realized it couldn’t rely on doctors to manage the risks associated with new drugs, it lost an important "tool" for risk management.  As a result, the FDA has demanded more safety data from companies.  In some cases, according to the report, regulatory rules were suddenly changed on the companies.  The FDA asked Genentech and Novartis to design a safety database to capture adverse events that could affect about 5% of the patients who took their asthma drug.  While trials were being conducted, the FDA suddenly demanded a much more stringent "safety collar," according to the SG Cowen report. The result was that the companies were asked to submit additional information on the drug, which now may not reach the market until 2003. (Information based on a report that appeared on The Street website 8/24/01)

Response:

Are delays in approving new drugs caused by the lack of a commissioner to head the FDA or pressure to keep unsafe drugs off the market "at any cost?"

well, they should keep unsafe drugs off the market!  over the past 5 years, the FDA’s record has been pretty spotty — there have been a number of recalls, and IMHO far too many drugs approved when they shouldn’t have been.  we don’t need more folks with drug-induced heart problems and other life threatening adverse reactions. there are very good reasons for not approving drugs hastily.  if you had ever met a thalidomide baby (one was in one of my college classes) you’d want them to take a reasonable amount of time and be very, very cautious.

Response:

i didn’t see the original post, but just caught the last few about the FDA "taking so long".  as a pharmacist, maybe i can shed some light on this.  the FDA does a wonderful job in research and development of new medications…..and yes, there ARE recalls, many of which are mandatory, the latest occurring with the drug, Baycol, for cholestrol.  the FDA is run by individuals who ARE human, and unfortunately aren’t perfect.  but the times there have been recalls,  i can recall in the last 10 to 15 years or so, there have been a VERY small number of incidences…..i’d say the FDA has done a marvelous job.  i’d rather they take their time, like they now do, and make it worthwhile for all of us. Carole

Response:

Another fly in the ointment here is that determining drug safety can be a short-term or long-term exercise, and you never know which until after-the-fact.  In the meantime, people are demanding access to new drugs in the hope that they will be the magic bullet. I have a friend who is a caring and thorough person at FDA, and he really tries to weigh all the evidence when making recommendations.  He is always happy when the drug has already been in use in another country before it hits the U.S., but that means the U.S. companies don’t get the income from patents, and they are always looking for funding to try to find and test new drugs, and patents are a great source.  It’s a very complex process to get a drug to market and potential litigation makes it a daunting task. –Jane

– Hide quoted text — Show quoted text – i didn’t see the original post, but just caught the last few about the FDA "taking so long".  as a pharmacist, maybe i can shed some light on this. the FDA does a wonderful job in research and development of new medications…..and yes, there ARE recalls, many of which are mandatory, the latest occurring with the drug, Baycol, for cholestrol.  the FDA is run by individuals who ARE human, and unfortunately aren’t perfect.  but the times there have been recalls, i can recall in the last 10 to 15 years or so, there have been a VERY small number of incidences…..i’d say the FDA has done a marvelous job.  i’d rather they take their time, like they now do, and make it worthwhile for all of us. Carole

Response:

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