PREVIEW

Hazardous to Our Health? FDA Regulation of Health Care Products (Book/ Paperback)

Product Overview

The U.S. Food and Drug Administration (FDA) is one of the most powerful of federal regulatory agencies, perhaps the most powerful, regulating about 25% of the consumer goods market in the United States. It routinely makes decisions that determine the well-being of millions of people in the United States and around the world concerning foods, drugs, medical devices, and dietary supplements.

Although the FDA was created to protect the public, could its actual operations have the opposite effect, causing enormous harm to public health? Assembling the work of three outstanding scholars, the new Independent Institute book, Hazardous to Our Health?,provides a lucid and comprehensive examination of the FDA: How has the FDA acquired its vast powers? What have been the effects of the FDA? Why has the FDA failed to achieve its goals? Who actually benefits and loses from the FDA? How has the FDA defended itself against criticism? What real alternatives exist to the FDA? and much more.

Hazardous to Our Health? brings together three analytical assessments of the FDA’s regulation of health care products: “FDA Regulation of the Pharmaceutical Industry,” by Ronald Hansen; “FDA Advertising Restrictions,” by Paul Rubin; and “FDA Regulation of Medical Devices,” by Robert Higgs, the editor. The book’s introduction and afterword, written by Robert Higgs, place the activities of the FDA in broader perspective by describing how the agency acquired its vast powers, how it tends to employ them, and how the harm caused by the agency might be diminished—ideally by abolishing the agency altogether.

The introduction emphasizes that although the FDA is regarded as a scientific body devoted to protecting public health, in fact it is a thoroughly politicized body, used by its top administrators and members of Congress to promote their own ends, often harming the public health. The FDA must necessarily fail to promote human welfare, because it makes one-size-fits-all rules for a population that varies immensely in the preferences, social circumstances, and physiological attributes of its individual members. The FDA attempts to promote the public health in the same way that socialist central planners attempt to promote economic prosperity, and FDA health planners fail for the same reason that the socialist economic planners fail. In neither case do the rulers know what promotes the public interest, individual by individual; and in neither case do the rulers have strong incentives to promote the public interest even if they somehow were to know what decisions would do so. The FDA has never seriously attempted to show that its benefits exceed its costs. It relies on sheer power augmented by gross propaganda.

Ronald Hansen’s chapter shows how the FDA’s current regime of drug regulation, instituted in 1962, causes major delays in the development and marketing of drugs, and discourages the initiation of many R&D projects. On average, products now require more than a decade to move from the laboratory to the pharmacy, and cost the companies more than $359 million (1990 dollars) each to develop. FDA delays in approval deprive Americans of access to new drugs—for about two years on average after consumers in other countries have begun using them. This is known as the “drug lag.”

Paul Rubin’s chapter shows that the FDA places outrageous restrictions on the marketing of drugs, seriously harming patients who therefore never encounter valuable information. A leading example is the agency’s ban on aspirin companies’ advertising that routine use of low-dose aspirin can reduce the risk of a first heart attack. FDA’s advertising restrictions are premised on several harmful assumptions (e.g., that all consumers should be treated as if they are childishly unsophisticated and easily misled, and that doctors are not much more reliable as judges of medicines). Many of FDA’s advertising restrictions amount to regulating the practice of medicine and suppressing the public’s Fir

About the Author(s)

Robert Higgs is Senior Fellow in Political Economy for The Independent Institute and Editor of the Institute’s quarterly journal The Independent Review. He received his Ph.D. in economics from Johns Hopkins University, and he has taught at the University of Washington, Lafayette College, Seattle University, and the University of Economics, Prague. He has been a visiting scholar at Oxford University and Stanford University, and a fellow for the Hoover Institution and the National Science Foundation. He is the recipient of numerous awards, including the Gary Schlarbaum Award for Lifetime Defense of Liberty, Thomas Szasz Award for Outstanding Contributions to the Cause of Civil Liberties, Lysander Spooner Award for Advancing the Literature of Liberty, Friedrich von Wieser Memorial Prize for Excellence in Economic Education, and Templeton Honor Rolls Award on Education in a Free Society.