Misbegotten Preemptions

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Science  02 May 2008:
Vol. 320, Issue 5876, pp. 585
DOI: 10.1126/science.1159568

The notion of preemption has a long history in relation to the U.S. Food and Drug Administration (FDA). Its primary significance had to do with the Commerce clause in the Constitution, which (along with the Supremacy clause) gives the federal government power to regulate commerce between the states. When I was commissioner of the FDA in the late 1970s, my colleagues and I rather liked preemption. Suppose, for example, a state decided to set its own net weight requirements for packaged foods so as to favor its own manufacturers. Well, just because it wanted to disfavor out-of-state competition, it wouldn't be allowed to. Similarly, if it wanted to establish its own drug approval agency, that would also be preempted by the FDA's authority.

Of course, there are contemporary reasons for being less enthusiastic about this kind of regulatory preemption. Today it is being used to prevent states from undertaking actions to protect their environments when they are especially vulnerable to certain insults. Regulatory preemption, for example, has killed carbon-sparing gas mileage provisions undertaken by the state of California because it has particular problems with the Los Angeles airshed. And California can't even regulate soot produced by vessels off its own shore because the federal Clean Air Act preempts that, too.


But the very notion of preemption has taken on an entirely new guise, also involving the FDA, but in a far more troubling way than the older use of preemption in the regulatory sense. This radical change comes from the Bush Administration's chief counsel at the FDA, Daniel Troy. His private career, before his government appointment in 2001, included membership on the Legal Policy Advisory Board of the conservative Washington Legal Foundation. During his first year, Troy developed a reputation for having his door open to industry for private discussions, the notes on which could not be made public. After returning to private practice, he published a piece in Legal Times entitled “When the FDA Acts, State Torts Must Defer.” The title gives a clear message: If the FDA has approved a drug or device, the manufacturer is immune from product liability lawsuits.

This odd concept, gaining favor in some state courts, is not only bad policy; it could be dangerous to your health. Why? First, the FDA is badly underfunded. Recent flat budgets have hurt the agency, and despite efforts by FDA advocates, the outlook is grim. Congress has relied too much on the Prescription Drugs User Fee Act, first passed in 1992. Unfortunately, most of that user fee money can only be used in the process for approving new drugs; only a trivial fraction can be used to strengthen safety monitoring of already-approved drugs.

Second, the nature of the FDA's standard process makes it unable to make a secure guarantee of safety. Approval of a drug for a given indication follows a series of controlled clinical trials. But even for a drug expected to have millions of potential users, the experimental limb of the trial (in which participants receive the drug rather than a placebo) will have only a few hundred to a thousand patients. Once the drug is in wide distribution, it may have a thousand times as many users. It's no surprise that widely marketed drugs produce scary media accounts involving a threatening adverse reaction that appears suddenly, resulting in deaths or serious illness, and ending in withdrawal from the market or strengthened label warnings.

The FDA cannot claim infallibility in its premarketing procedures. Nor is the postmarketing safety monitoring system adequate. It depends on voluntary reporting of adverse reactions by doctors, and because there is no way of knowing how many patients are taking a particular drug, the rate of an adverse reaction cannot be determined. In view of these deficiencies, how can one seriously defend a no-liability clause to protect the manufacturer? In short, if you can't sue the maker of a product, you deserve some guarantee that it's safe. If the FDA can't provide that, why should you and I find the courtroom door closed?

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