On Not Regulating the Regulators

July 26th, 2004

Posted by: admin

An article in the New York Times this weekend describes the Bush administration’s opposition to consumer lawsuits regarding products approved by the FDA (“In a Shift, Bush Moves to Block Medical Suits”).

There are serious considerations involved in allowing a potential onslaught of such lawsuits, including their possible effect on health costs, the availability of medical products on the market, and the possibility that states would reach different conclusions regarding the safety of a medical device.

According to the article, the administration states that different conclusions would lead to “chaos for the regulated industry and F.D.A.” That may be so, and yet this possibility raises grave questions about the goal of having clear and straightforward regulatory policy if it comes at the expense of credibility in the eyes of the public.

The administration is banking on the credibility of the FDA: “if” (according to the article) “a local judge or jury finds that a drug or device is unsafe, it is in direct conflict with the conclusion reached by the F.D.A. after years of rigorous testing and evaluation.”

Surely, expensive and rigorous testing must count for something. But for how much? Unassailability on the part of the product once it has been approved? That argument may work when the buyer is held responsible for his or her decision to purchase and use a product. But making the FDA responsible arguably takes the responsibility away from the consumer and undercuts the “buyer beware” argument.

The case is complicated (alas, not simplified) by the role of expertise, namely scientific expertise. The government position is based on the belief that consumer lawsuits would “interfere with federal regulation of drugs and devices, by encouraging “lay judges and juries to second-guess” experts at the F.D.A.” (ibid).

Deciding that “tested” science is unassailable is not quite the same as deciding that “proven” science is unassailable. Few today would endorse dragging Galileo or his contributions to trail. Furthermore, no one wants to see competent science and engineering innovations senselessly punished. Yet, circularly making medical drugs and devices immune from lawsuits on the grounds of the scientific expertise that underlies them amounts to technocratic tyranny.

Should attending to the need for clear regulation come at the cost of the need for such regulation in the first place?

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