Stupak’s Effort to Arm the FDA with Subpoena Power Over Company Records

After years of discussion, Rep. Bart Stupak, the Michigan Democrat who runs the investigations panel of the House Commerce Committee, has, again, wisely urged the FDA to support Congress’s addition of subpoena power to FDA’s arsenal of tools needed to make our food and drug supply safe. Some food and drug industry folks immediately criticized the idea, claiming the result would simply be more bureaucratic meddling in their affairs. To date, there has been no official response from the FDA.

Recent episodes of contaminated foods and drugs again raise disturbing questions about whether the Food and Drug Administration has the tools and resources necessary to protect the public. Often the agency, it seems, is the last to learn of hazards threatening us all.

The FDA does no testing of its own, and in making decisions it must rely on the test results submitted by manufacturers. Dr. Sidney Wolfe, director of Public Citizen’s Health Resource Group, previously noted that “the FDA is extraordinarily dependent on the companies to be honest.”

If the FDA is really serious about cracking down on unsafe products, why doesn’t it accept Stupak’s offer to authorize the subpoena power?  Some fear that the FDA no longer has consumer protection as its first priority, but has been co-opted by the industry it is supposed to oversee.

Stupak tried to give the FDA subpoena power back in 2002, but the FDA and industry nixed the idea. Stupak asked the FDA, at the time, to provide its reasons for opposing subpoena power in writing. The FDA answered that it had adequate enforcement tools and would inform Congress if it felt new authority became necessary.

In April this year, Dr. Janet Woodcock who runs FDA’s drug review branch and Deborah Autor, who heads the agency’s office of compliance, both testified in response to Stupak’s question that the power to subpoena would be a useful regulatory tool. Given the events at the FDA over the past six years, it is hard to imagine a regulatory agency that is serious about its responsibility for consumer safety could say any less.

The FDA is one of few federal agencies that do not have subpoena power. The Department of Agriculture, the Environmental Protection Agency, the Department of Transportation and the Federal Trade Commission all have subpoena power. FDA’s mission, protecting the American people from unsafe food and drugs, is no less important than the missions of these other agencies, and subpoena power would lend critical support to that mission.

Now, in a May 14 letter to FDA Commissioner Andrew C. von Eschenbach, Stupak has asked whether the FDA stands by the testimony of Woodcock and Autor that the FDA should be given subpoena power and asks if the FDA would support such a provision if it were added to the FDA Globalization Act that is currently being considered by Congress.

Critics immediately condemned the recommendation as an unnecessary bureaucratic intrusion into the affairs of the business community. Recent experience with fen-phen, Rezulin, Baycol, Vioxx, tainted hamburger, spinach, pet food, etc., demands that consumers’ confidence in the FDA to protect us from unsafe food and drugs be restored.
What’s the greater danger, the risk that a bureaucrat will issue a burdensome subpoena or that a dangerous food or drug will enter the market and kill or injure hundreds of innocent consumers? The answer is obvious. We should all support Stupak’s effort to arm the FDA with the power to issue subpoenas.

Comments

[Next generation star trek]

I love your blog so much, and there are just some differences with others'. Hope there will be more wonderful things in your blog. Happy every day!