The Magazine

Who Runs the FDA?

So far, not the Bush administration.

Aug 5, 2002, Vol. 7, No. 45 • By MELANA ZYLA VICKERS
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For the purposes of getting the FDA bureaucracy to act, though, the quality of the analysis in the deadly fish reports didn't matter. After wire services and the nation's major newspapers carried the scare reports prominently, some on page one, political pressure mounted. By March 2002, the FDA had agreed to review its own brand-new advice, and with last week's decisions slid further still.

American women and indeed anyone who eats fish would have been far better served by an FDA working to hold its ground--with explanations of why the standards are tough enough, challenges to the rigor of the activist groups' research, and efforts to lay at the feet of Public Citizen and the Environmental Working Group the blame for confusing the public. That's a job for a politically appointed commissioner, someone who can dish out the heat rather than just take it.

The FDA rollover on mercury is reminiscent of another instance in which the agency has been bullied and Public Citizen has been involved. Namely, the false accusation that since 1993, when the FDA began charging user fees for pharmaceutical companies to get drugs approved, the regulatory agency has let a record number of deadly drugs slip into the market. The diabetes drug Rezulin and the diet pill Redux come to mind. The deadly drugs claim has been so widely covered--not least by a 13,000-word article in the Los Angeles Times in late 2000--that it has gained the veneer of respectability, scaring Americans away from new drug therapies.

Yet it's baloney. Between 1993 and 2000, nine new drugs were withdrawn for reasons of health risk, out of 259 drugs that were approved. That's a 3.5 percent withdrawal rate, and it's actually lower than the 4.1 percent withdrawal rate before user fees. Between 1985 and 1992, seven of 170 new drugs were withdrawn for reasons of health risk.

FDA insiders say they try to educate the public about such misrepresentation. They claim, for instance, that reporters who call about the drug approvals are always told the withdrawal rates have been lower, or similar, since user fees began. That doesn't come through in the mainstream coverage, though, suggesting the FDA's public-education efforts are no match for the aggressive tactics and media-darling status of the agency's detractors.

Activist groups aren't the only ones giving the FDA a trouncing. In June, a congressional committee sought to grill the agency about a controversial cancer drug called Erbitux, developed by ImClone Systems Inc. Since the FDA has no commissioner, lower-ranking FDA officials had to face the blast. By rights, these officials should be left to occupy themselves with the science of drug approvals, not the politics.

To be sure, the absence of a leader at the helm isn't the only reason the FDA is yawing. FDA insiders say that activist groups have their share of sympathizers within the agency and that the groups have been clearing paths of influence at the FDA for over 20 years. The mercury offensive is then just more of the same, and Public Citizen et al. are sure to redouble their efforts when the agency gets a commissioner rather than to go quietly. And if the FDA continues to wobble, it's going to be a bad time for worried pregnant women--and other Americans who rely on the agency for safe, speedy drug approvals and reliable information on the safety of medical treatments and food.

Melana Zyla Vickers is a senior fellow at the Independent Women's Forum and a columnist at TechCentralStation.com. Her research paper on this topic is available at IWF.org.