Posted by Alan on November 8, 2002, at 9:27:12
In reply to FDA » Alan, posted by Anyuser on November 7, 2002, at 18:53:02
> How would you improve the FDA regulatory process, and what would be the practical consequence to patients of such improvement?
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Take oversight of clinical trials away from the FDA and give it to the NIH. That is, accept as evidence only trials designed and supervised by the NIH.Failing that, ban cross-employment between the FDA and any company that it regulates for 10 or 15 years in either direction. Right now, there is a revolving door between the fox's house and the henhouse. It's bad enough that regulators are hired directly from the regulated companies. It's even worse that the FDA's "internal advocate" for a drug can and often does leave the FDA after approval of the drug to earn hundreds of thousands of dollars a year working for the maker of the drug.
Actually, we probably need both of the steps above.
And of course we need a law placing all directly or indirectly maker-funded research about a drug into the public domain when that drug receives FDA approval.
I also believe the "control groups" in the research should be better defined.
Alan
poster:Alan
thread:109458
URL: http://www.dr-bob.org/babble/20021108/msgs/126946.html