"Misbegotten Preemptions"

Donald Kennedy has an editorial in the May 2nd edition of Science which brings a worrisome initiative of the Bush administration to light. The Constitution gives the federal government the right to regulate interstate commerce, and that right has been interpreted to include the right to preempt state laws if they are contrary to federally established rules for interstate commerce. Kennedy points out in passing that the preemption authority has become dangerous as the Bush administration wields it to limit state powers to protect their environments in favor of business interests to avoid restrictive state environmental regulations.

The editorial, however, focuses on the efforts of the Bush Administration's chief counsel at the Food and Drug Administration, Daniel Troy, to use preemptive power of the FDA to limit damage suites in the states. I quote:

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.

Comment: I don't know whether I am more worried by the weakening of the FDA by restrictions on staff and budget (and sources of funding) or the attempt to weaken the power of the courts with respect to safeguarding public health. Arghh! JAD