The FDA has major responsibilities for the nation's physical well-being, particularly since drugs have become such an important component in medicine. I'm old enough to recall a time when it was a big deal to be taking drugs. Now, there are very few people I know who don't take at least one drug a day. However, in the past few years - vide the VIOXX scandal - the FDA has had difficulty fulfilling its responsibilities.
The GAO (General Accountability Office) has just released a report focused on the FDA's oversight of approved drugs. The oversight is not very clear and seems to be needlessly complex. First of all, there are two groups within FDA that are involved with what they call postmarket drug safety: the Office of New Drugs and the Office of Drug Safety. The GAO found that the offices seem to be confused about who should do what, which leads to a question of what should be done when. The drug safety office has had a number of management changes over the past ten years (eight directors in that time period). That may explain why the office does not track information about drug safety or participate much in advisory committees or have their views listened to. What do they do?
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It is possible there are clashes of interest within these departments. It is known that the drug companies have influence within the FDA. How much is uncertain, but while not of itself damning evidence, it is noteworthy that the present Director of ODS, Gerald Dal Pan, worked for Guildford Pharmaceuticals before joining the FDA, and CDER Director, Steven K.Galson, appears to be under the thumb of his political masters - or at least he was in 2004.
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