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A Rudderless, Leaderless FDA

Jan 18, 2005 | Los Angeles Times James Guest is president of Consumers Union, which publishes Consumer Reports; Marvin M. Lipman MD is chief medical advisor at Consumers Union.

It's been a rough time for the Food and Drug Administration. Daily revelations about the potentially serious side effects of nationally known pain relievers Vioxx, Paxil, Celebrex, Aleve, Bextra have cast doubt over the agency's ability to ensure drug safety. Those doubts were reinforced in November when the agency's drug-safety-reviewer-turned-whistle-blower, Dr. David Graham, testified before a Senate committee, saying, "Simply put, FDA and its Center for Drug Evaluation and Research are broken."

And drug safety is not the only area where the FDA draws poor grades. In May 2004, Consumer Reports identified a "dirty dozen" list of herbal supplements that, according to government warnings, reports of adverse reactions and top experts, are too dangerous to be on the market. Yet they remain accessible. Hamstrung by the 1994 Dietary Supplement Health and Education Act, the FDA must prove that a supplement is unsafe before it can act, a difficult and costly task.

The safety of the food supply also falls squarely under the agency's jurisdiction. Yet despite the 2003 discovery of the first case of mad cow disease in the United States and the most recent discoveries in Canada, the FDA still has not closed a dangerous loophole that allows cattle parts to be fed to other animals, such as pigs and chickens, whose remains can then be fed back to cows. Even the remains of an animal known to carry one form of mad cow disease could go into rendered feed under current FDA rules.

Despite these problems, the FDA still is without a permanent, authoritative and accountable commissioner, as it was for about two-thirds of the first Bush term. Instead, the post has been primarily occupied by an acting commissioner. There is no question this is a sensitive political nomination because of the importance to special interest lobbies and to consumers. But the decision not to address this power vacuum in an election year has left the public vulnerable.

With all the responsibilities the FDA has, it must have a dedicated leader and advocate who is fully responsible to the public. An acting commissioner, who has not been vetted by Congress, cannot set long-term strategy and goals for the agency. And leaving the post open sends a message that it is not a priority. Senate confirmation hearings for a permanent FDA chief are exactly what the country needs to jump-start important debates about drug and food safety.

Topping our list of tough questions that need to be asked is how could the FDA and a manufacturer know of serious side effects associated with a drug and not alert the public to those risks? Pharmaceutical companies are required to report to the FDA all findings related to a drug's safety before the drug is approved. But regulations protecting confidential commercial information essentially prohibit the agency from making the studies public before the drug is on the market.

If parents knew what the FDA and GlaxoSmithKline, the maker of Paxil, knew — that the antidepressant was not effective in children and that it could increase the risk of suicide in children and teens — they may have made a different choice. Consumers deserve the same information the FDA and the companies have about drugs so they can make informed decisions.

Withholding information about risks or how poorly a drug works is unacceptable. Several influential groups agree that transparency is an essential ingredient. The American Medical Assn. has urged Congress and federal health officials to establish a national clinical-trials registry. Consumers Union supports a registry because all study results bad and good should be available to the public so that doctors, researchers and consumers can have access to potentially lifesaving information.

Other key questions to ask prospective nominees include: Do you support an independent office of drug safety? What is your position on drug re-importation? Do you support mandatory adverse-reaction reporting for dietary supplements? Do you support closing loopholes in animal feed rules? Will you be a highly visible figure, both in the media and across the country, advocating on behalf of the American consumer in fulfilling the mission of the FDA to protect the public?

Right now all of us have a lot of real questions about the safety of the drug and food supply. What we need are some real answers. The first step toward that end is to name an FDA commissioner capable of guiding the agency through difficult times with authority and resolve. The lives of all Americans depend on it.

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