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Prescription for the FDA

Texas boy Mark McClellan has a tough job—heading up the controversial U.S. Food and Drug Administration.

To get a sense of just how important the U.S.Food and Drug Administration has become in the United States—and how vital it will be to the country�s future economic health—consider that the agency regulates more than 25% of the U.S. consumer economy.

This is because the agency, whose job it is to guarantee the safety of food and drug products, is not just responsible for the health and well-being of 300 million people, it also supervises the world�s largest and most profitable drug industry. With a simple yea or nay, the FDA can determine whether a drug company will become fabulously wealthy or find itself struggling for survival.

And yet, for all its influence and responsibility, the FDA is poorly funded and much abused. To hear its critics tell it, the FDA is so fatally flawed that it should be reformed out of existence. Right-wing politicians say the agency is too cautious; industry says it is too slow and inconsistent; consumer advocates say the FDA is not vigilant enough. Nevertheless, we urge a moment�s pity for the poor FDA. Caught, as it is, between altruism on the Left and pragmatism on the Right, it now finds itself headed by Mark McClellan, who must reconcile both.

Curiously, consumers, on the whole, seem satisfied. Perhaps it is because they are blissfully ignorant of the FDA�s mandate and its history. As Philip J. Hilts writes in his insightful and edgy new history of the FDA, Protecting America�s Health: The FDA, Business, and One Hundred Years of Regulation, nobody stops to think much about the FDA until they suffer the real or perceived side effects of its real or perceived failures.



» Prescription for the FDA

Perchance to Dream

Their Eyes Were Watching God


By Philip J. Hilts
Alfred A. Knopf, 352 pages, $27

1  Kolata, G. (April 29, 2003) Scientist at work: Mark B. McClellan; FDA chief�s fast start earns praise and doubt. The New York Times.