The FDA Needs a Looser Rein

The Food and Drug Administration moved last week to crack down on the marketing of pills, tablets and teas containing ephedrine, an herbal stimulant that has been sold as an agent for weight loss, muscle development and energy. The agency’s proposed guidelines are thoughtful and necessary, limiting how much of the stimulant can be used in a dietary supplement, requiring manufacturers to tell users that too much can be fatal and banning any claims for weight reduction or muscle building.

But the regulations are also long overdue. The FDA says that since 1994 it has received reports of 800 adverse reactions and at least 17 deaths stemming from ephedrine use. It was unable to swiftly restrict ephedrine and order manufacturers to demonstrate its safety because in that year Congress put the burden of proof on the agency. So before last week’s crackdown on ephedrine, the FDA had to spend months documenting adverse reactions and meeting with industry groups.

Rather than correcting its mistakes, however, Congress is trying to further weaken the FDA’s authority. The chairman of the Senate’s Labor Committee, Sen. James M. Jeffords (R-Vt.), is threatening to hold up reauthorization of the Prescription Drug User Fee Act, a federal program allowing the FDA to hire more than 600 investigators and reviewers, unless several reforms are implemented.

One of these, by Sen. Tom Daschle (D-S.D.), would let physicians prescribe non-FDA-approved drugs for a broad range of uses. The Daschle bill began with the best of intentions--allowing doctors to give untested drugs to terminally ill cancer patients. That’s worth considering, for the agency has been stubborn in loosening restrictions for the sickest of patients. But the bill is worded so broadly that it deprives the FDA of much of its oversight function.

A second proposal, introduced last week by Jeffords, would require the FDA to collaborate more closely with makers of medical devices early in the research process so the companies wouldn’t undertake costly testing only to end up with a product that couldn’t be marketed. As presently worded, however, the proposal could lead the agency to make promises too early in the game, compromising a thorough evaluation.

The measure being held hostage, the user fee act, has been celebrated as an example of government and industry working together to mutual benefit. Fees paid by the pharmaceutical companies finance expanded FDA inspection and oversight, like the program that eventually tracked the ephedrine problem, and allow the FDA to streamline its approval process. It’s an FDA reform that works; its reauthorization should not be delayed on behalf of proposals that miss their intended mark.