Hoover Daily Report

End the FDA's Monopoly

Monday, February 23, 2004

The Food and Drug Administration's (FDA's) recent ban on dietary supplements containing ephedra shows just how dysfunctional government regulation of drugs and dietary supplements is. Ephedra, according to the FDA, is a naturally occurring substance derived from a Chinese herb. Ephedrine, the main active ingredient of ephedra, has been used for centuries to treat respiratory symptoms and is also used to aid weight loss, enhance sports performance, and increase energy.

Why the ban? The FDA claims that dietary supplements containing ephedra pose "an unreasonable risk" for the consumer. The FDA states in its press release that it reviewed "a seminal report by the RAND Corporation." But in the fine print, you read that, of 16,000 adverse events RAND studied, there were two deaths, four heart attacks, nine strokes, one seizure, and five psychiatric cases. RAND said these events "may indicate a safety problem but do not prove that ephedra caused the adverse event" (emphasis added). Even Naderite Sidney Wolfe, a self-proclaimed consumer advocate, claims only 155 ephedra-related deaths over a decade.

Interestingly, many users of such dietary supplements rushed to stock up on their supplies before the ban begins. They judged, apparently, that the benefits were worth the risks. To the FDA, though, their judgment does not count. And therein lies the problem.

The same problem arises with the FDA's requirement that drug companies test for safety and efficacy before being allowed to sell a drug. This FDA monopoly power on new drugs slows new drug development by years. In December 1988, for example, the FDA approved Misoprostol, a drug that prevents gastric ulcers caused by aspirin. In some other countries, Misoprostol was available as early as 1985. Using the FDA's own estimates, Sam Kazman, an FDA expert at the Competitive Enterprise Institute, calculated that the FDA-caused delay cost more than 20,000 lives—and that's just for one delayed drug.

The tragedy is that these regulations are unnecessary. The FDA may have expertise on drug safety and efficacy, but on the main issue that matters—our trade-off among various risks, costs, and benefits—the FDA is a rank amateur. No one would advocate that the government plan the same vacation for everyone. Why, then, should the government be able to decide what drugs we ingest?

There is a simple solution: Pare back the FDA's powers to that of an information agency. Require that any drug marketed without FDA approval tout that fact in big letters. And let us make our own trade-offs. Then those who want to avoid all drugs not certified by the FDA can do so; the rest of us can rely on the American Hospital Formulary Service or other private certifiers and thus have wider choices. Those who stuck with FDA certification would be no worse off. Those who tried non-FDA-approved drugs would be, by their standards, better off.