New rules announced by the FDA yesterday would bar advisers from the agency's expert committees if they have received more than $50,000 in a year's time from drug companies and medical device makers. Those who receive less than that amount would be allowed to participate and discuss products in meetings but would be barred from voting on an approval for a company or competitor of a company they had financial ties to. These are the first major rule changes announced since Dr. Andrew von Eschenbach was approved as FDA commissioner. They go a long way toward addressing complaints that drug makers had obtained undue influence on the committees, whose recommendations play a key role in the approval process. In one controversial vote in 2005, 10 committee members voted to allow Bextra to remain on the market and Vioxx to return to the market after they had received money from the drug makers. Under these new rules, they would not have been allowed to vote and the committee would have decided against the drugs.
- read The New York Times article on the FDA rules
- check out the report from The Washington Post