Editorial: Experts’ ties questioned

Saturday, March 24, 2007 | 7:02 a.m.

The U.S. Food and Drug Administration has proposed new guidelines designed to prevent experts who are paid by drug companies from advising the agency on the drugs and products that those companies make.

In the policy announced Wednesday, the FDA says that scientific experts who receive $50,000 or more in grants or consulting fees from companies, or who own $50,000 or more of stock in companies, may not sit on advisory committees that are considering those companies' products for approval.

Experts with financial ties to companies that amount to less than $50,000 can still sit on the FDA committees, but they cannot vote on the companies' products.

The guidelines, subject to a 60-day comment period, come after widespread criticism that FDA advisory panels - which are highly influential - are stacked with people who stand to gain financially from the agency's decisions.

One example, cited by The New York Times, involves the painkillers Bextra and Vioxx, both of which were removed from the market after reports of deaths or severe side effects. The drugs' manufacturers had paid 10 of the 32 FDA advisers who in 2005 voted to keep Bextra on the market and voted to return Vioxx to the market. Under the proposed rules, these members would not have been allowed to vote, and votes to keep them off the market would have prevailed.

Rep. Maurice Hinchey, D-N.Y., already had proposed legislation to require such a policy. One former FDA general counsel suggested that the agency issued its proposal to head off Hinchey's legislation. Hinchey has lauded the FDA proposal but has not withdrawn his bill.

These guidelines are long overdue, but we think they should be more strict. Certainly, $50,000 is still a lot of money, and the limit for these experts' financial ties to medical companies should be much lower.