FDA vs. the Individual - Pharmaceutical Executive

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FDA vs. the Individual


Pharmaceutical Executive


Of course, this standard is not met simply by showing that certain subsets of the population are better off without a certain drug than with it. Rather the standard should mean that so long as some significant fraction of the population can benefit on net from the use of the drug, it should continue to be sold. Warnings—perhaps on occasion stringent black-box warnings—could be added to the package, and doubtless an extensive network of information about the drug's proper use would develop in the field, given the size of the stakes in question.

One approach to avoiding delays on the one hand and misallocation of funding on the other is to break the state monopoly over testing. Bowing to the inevitability of some FDA-like oversight, Henry Miller [of the Hoover Institute] has not examined the substantive standards for review that I have stressed, but has instead taken a different tack. He has proposed that the United States move to a system similar to European regulation of medical devices and drugs.

For the most part, devices are overseen there by "notified bodies," nongovernmental entities sanctioned by government; and the review of the equivalent of new drug applications is performed under contract by academics skilled in the various areas. Miller's proposal would convert the FDA from a certifier of products to a certifier of private-sector entities that would perform much of the day-to-day regulation of clinical trials and perform the initial NDA review.

The arrangement resembles the role of Underwriters Laboratories and its competitors in setting standards and certifying tens of thousands of categories of consumer products. In principle, the decentralization that Miller defends would be an improvement over the current situation in the United States. But the big concern is whether the practice can be transplanted from one legal culture to another.

More specifically, this proposal will work in the United States only if the FDA is limited by law to minimal influence over the entities that it certifies to perform oversight. But within our context, the single most powerful explanation for how the FDA works is the bureaucratic imperative that seeks to expand turf no matter what its consequences for others.

My own sense, therefore, is that any proposed system of decentralization could work only if the government removed the oversight from the FDA, with its ingrained habits, and transferred it to a new board, not staffed by FDA veterans, that took a very different view of its overall role in the grand scheme of things.

But in light of the FDA's rearguard efforts to maintain its own power against other initiatives, and the knee-jerk reaction in Congress for imposing stultifying drug regulation, the betting is that the future holds only more of the same. It is amazing the harm that can be done if the elimination of patient choice is regarded as proof of a diligent system of consumer protection.

This excerpt is taken from Overdose: How Excessive Government Regulation Stifles Pharmaceutical Innovation, published in October by Yale University Press. Used by permission. Copyright 2006 by Richard A. Epstein. All rights reserved.

Richard A. Epstein is the James Parker Hall Distinguished Service Professor of Law and the director of the Law and Economics Program at the University of Chicago, where he has taught since 1972. He is well known for his libertarian approach to law, and for the way he brings economic analysis to discussions of public policy. His recent books include Forbidden Grounds: The Case Against Employment Discrimination Laws (Harvard, 1992); Takings: Private Property and the Power of Eminent Domain (Harvard, 1985); and Modern Products Liability Law (Greenwood Press, 1980).


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