A Misguided Rx for the FDA
One reason why the United States arguably provides the world’s best medical care is that the free market encourages productive but expensive procedures that the more government-controlled health care systems of other Western nations cannot afford.
That, at least, is the premise behind a bill the Senate is scheduled to consider before its August recess. Senate Bill 1477 would capitalize on the free-market mechanism. It aims to accelerate the Food and Drug Administration’s evaluation of drugs and medicine by involving private industry in that process.
A closer examination of this bill, however, suggests that the free market is better at motivating than it is at regulating. That’s why the senators ought to kill the measure and endorse instead the sensible evaluation reforms that FDA Commissioner David A. Kessler has been putting in place.
Sen. Nancy Kassebaum (R-Kan.), author of the bill, is trying to fine-tune it. But any amendment she proposes is unlikely to change the bill’s flawed premise: that if the FDA does not meet strict new deadlines for approving medical devices and products, private industry should be allowed to take over the approval process. The Kassebaum bill suggests two ways to do this, and both are troubling.
--First, the manufacturer of a drug, device or other medical treatment could request that its product be deemed approved by default if it had won previous approval from the European Union. The problem here is that the FDA has a much better record of keeping dangerous drugs off the market than do the Europeans. Between 1970 and 1992, for instance, the FDA approved only nine drugs that it subsequently had to ban due to safety concerns. During the same period, 31 drugs were approved and then withdrawn by France, and 30 by Germany.
--Second, the bill would allow the medical industry to use private reviewers if the FDA missed a deadline in completing its review process in more than 5% of a given “product category.” The danger here is that private reviewers would be economically motivated to grant approvals, for by doing so they might win future business from manufacturers.
The other major problem with the bill is its potential expense. While it is intended to streamline the FDA’s operations, the additional personnel and resources needed to implement it would cost the government $555 million over six years, according to recent estimates from the bipartisan Congressional Budget Office.
The goal of Kassebaum’s bill--to pressure the FDA to speed up its medical approval process--is a worthy one. Angry patients and frustrated pharmaceutical companies have rightly dubbed the FDA the “Foot Dragging Agency” for its history of subjecting products such as bandages to seemingly interminable approval procedures. But the bill fails to give the FDA a chance to allocate its limited resources thoughtfully. It fails, in other words, to differentiate between bandages, which may need little oversight, lifesaving drugs, which demand speedy evaluation, and medications of dubious benefit whose evaluation might well be delayed without causing public harm.
Responding to public pressure, the FDA has accelerated its approval process (by 40% between 1987 and 1992, the Congressional Budget Office says) while maintaining regulatory scrutiny. By forcing the FDA to make decisions even more rapidly, this bill would inevitably lower the quality of that oversight.
The FDA won expanded powers in 1962 when the United States saw how lax regulation in Europe led to the approval of thalidomide, a morning sickness sedative that was found to cause birth defects. It won additional responsibility in 1976 after a birth control device called the Dalkon Shield left thousands of women infertile. That authority was wisely given and well-deserved. There is no compelling reason to diminish it now by passing Senate Bill 1477.
