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What To Do About Dysfunctional FDA

H. Sandra Chevalier-Batik · June 8, 2009 ·

FDA needs overhaul, but what to do?

It’s no secret that the knives are out in Washington for the FDA. There’s just been too much bad publicity for the agency over the last few years. From drug safety snafus dating as far back as Vioxx to last year’s heparin scandal, from melamine in dog food to salmonella in peanut butter, the FDA has spent beaucoups hours fighting fires. Meanwhile, dispassionate observers such as the Government Accountability Office have advised big-time changes for the agency, and its own Science Board said it was so seriously understaffed and underfunded that it couldn’t ensure the safety of food or drugs in the U.S.

Frequent agency critic John Dingell succinctly describes his view for the Associated Press: “You’ve got an agency that quite frankly is either non-functional, or dysfunctional, or maybe all of the above. Bet yourself a new hat or a fine dinner that you are going to have a scandal a month. They are running around like a lot of headless chickens.”

Enter a new Congress and new administration. Some are eager to make changes at the agency. And fixing the FDA is one area where politicians on both sides of the aisle agree that change needs to come. “One area where we could see bipartisan cooperation might be the strengthening of the FDA,” Dr. Paul Stolley, who had a stint as a visiting scientist at the FDA, told the AP. “I don’t think ideological differences should interfere.”

What to do, though? Some say the FDA is “fundamentally broken,” so it needs to be replaced, rather than fixed: The Center for Science in the Public Interest is advocating an entirely new food-safety agency, for instance. But we probably won’t see the shape of a new FDA forming until a permanent commissioner is named. Now that HHS has a nominee, the FDA could–finally–be next.

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Filed Under: FDA Tagged With: FDA, GAO, Heprin, Vioxx

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