To America's Health: A Proposal to Reform the Food and Drug Administration

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To America's Health: A Proposal to Reform the Food and Drug Administration by Henry I. Miller

Hoover Institution Press * 2000 * 112 pages * $14.95 paperback

The Food and Drug Administration has a stranglehold on the introduction of new drugs, medical devices, and manufacturer-- written information about products. The rationale is to assure quality and safety. Although consumers demand quality and safety assurance, the free-enterprise and tort system are supposedly unable to supply it. The way to help consumers is, of course, to deny their freedom of choice, curtail their access to information, fetter the enterprises of their trading partners, and stunt the prerogatives of their doctors, hospital workers, pharmacists, insurers, and other agents and advisers.

Almost every economist who has written about the FDA has favored reform in the libertarian direction. A stream of literature has for decades explained why massive bureaucracy and the strangulation of enterprise are no aids to quality and safety. And the literature has in several ways proved the point empirically. Yet FDA feel-good fascism persists and expands, because enlightenment is unpopular at the NBC "Nightly News."

Physician and Hoover Institution fellow Henry Miller makes a splendid contribution. He covers briefly the familiar ground, including the history of drug control, the expansion of FDA power, its procedures and practices, the perversity of its incentives and agenda (such as the bias toward withholding approvals), the damage to drug development, and the consequent death and morbidity for the American people. The book enriches understanding with several insights that come by virtue of Dr. Miller's personal qualification: He worked in the FDA's regulatory apparatus from 1979 to 1994. Thus we have in Henry Miller a medical doctor, an expert on the pharmaceutical industry, and an expert on the internal workings of the FDA itself. His personal story must be a fascinating one of dissidence and eventual defection.

While enlightened criticism continues to hit at the exterior walls of the FDA, how do those inside respond? Not seriously. Miller writes, "[B]oxes on the organizational chart are arranged and rearranged, added and eliminated; names of entities are changed (and then changed back); and various pilot programs come and go. FDA managers avidly craft and meet new performance milestones, but there is little impact on the bottom line of timely patients' access to new therapies." FDA "reforms" are often merely the codification of old internal practices and its pronouncements are often merely criticism deflectors and public-relations exercises. When the House of Representatives in 1996 wrote a significant reform bill, the FDA and Clintonistas "pulled out all the stops to defeat it."

Miller supplies several glimpses into the banality of FDA evil. The agency is perfectly willing to lie through its institutional teeth, as was made plain in the assault on silicone breast implants. That assault killed Dow Coming, but the large pharmaceutical companies have developed "formidable regulatory affairs apparatuses [and] have become comfortable with the present system." They can beat any small outfit or newcomer in the fine art of "negotiating their way through the regulatory maze. …