F.D.A. tired of bad PR

Cut Rate Drugs

The F.D.A. should have instituted such a rule years ago, but at least something is being done now. Too many instances of corruption, or perceived corruption. Now the F.D.A. (and other regulatory agencies) should decree that former agency officials cannot work for the companies they are supposed to be regulating for ten after years after leaving their position.

F.D.A. Rule Limits Role of Advisers Tied to Industry
Expert advisers to the government who receive money from a drug or device maker would be barred for the first time from voting on whether to approve that company’s products under new rules announced Wednesday for the F.D.A.’s powerful advisory committees.

Indeed, such doctors who receive more than $50,000 from a company or a competitor whose product is being discussed would no longer be allowed to serve on the committees, though those who receive less than that amount in the prior year can join a committee and participate in its discussions.

A “significant number” of the agency’s present advisers would be affected by the new policy, said the F.D.A. acting deputy commissioner, Randall W. Lutter

for instance:

The changes are intended to respond to a growing chorus of critics who contend that drug and device makers have hijacked the Food and Drug Administration’s approval process by paying those who serve on the agency’s advisory panels.

In one famous example, 10 of the 32 advisers who voted in 2005 to allow the painkiller Bextra to remain on the market and the painkiller Vioxx to return to the market despite safety worries had taken money from the drug makers. Under the new rules, their votes would not have counted and the committee would have voted to keep both drugs off the market.

and not to be a cynic, but I'm with Representative Rosa DeLauro:

Representative Rosa DeLauro, Democrat of Connecticut and chairwoman of a subcommittee that has oversight over the F.D.A. budget, said there might be undisclosed loopholes that make the new rules toothless. “I am skeptical, given their recent track record of putting political and corporate interests above science,” Ms. DeLauro said.

Tags: , /, /

About this Entry

This page contains a single entry by Seth A. published on March 22, 2007 6:19 AM.

links for 2007-03-22 was the previous entry in this blog.

HRC as Big Blue is the next entry in this blog.

Find recent content on the main index or look in the archives to find all content.

Pages

Powered by Movable Type 4.37