Hazardous to Our Health?: FDA Regulation of Health Care Products

by Robert Higgs (Editor), Ronald W. Hansen, Paul H. Rubin

The US Food and Drug Administration (FDA) is one of the most powerful of federal regulatory agencies, if not the most powerful, regulating about 25 per cent of all consumer goods 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, Hazardous to Our Health? provides a lucid and comprehensive examination of the 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? goes beyond mere assumptions, conjectures, and political predilections to examine the facts and findings of independent authorities. Providing far more than just an account of the past and a warning for the future, this powe

113 pages, Paperback

First published February 1, 1995

About the author

Robert Higgs is an American economic historian and economist combining material from Public Choice, the New Institutional economics, and the Austrian school of economics; and a libertarian anarchist in political and legal theory and public policy. His writings in economics and economic history have most often focused on the causes, means, and effects of government power and growth.

Reviews

[Steven H · Rating 5 out of 5]

A SERIES OF ESSAYS CRITICAL OF FDA POLICIES

Editor Robert Higgs wrote in the Introduction to this 1995 collection of essays, "these studies provide ... a warning of what awaits us if, like trusting children, we continue to submit to the paternalism of the FDA, an agency whose officials utter reassuring words while augmenting our suffering and hastening our demise."

An essayist suggests that "The FDA has long regarded itself as focused on safety and medical effectiveness, not price... There does not appear to be room for a product that is almost as safe or almost as effective as existing products but cheaper." (Pg. 24) Another observes, "Why did no firm choose to litigate the issue? Firms are deathly afraid of the FDA... firms are generally afraid of antagonizing the FDA, and will commonly agree with regulatory actions rather than litigate." (Pg. 31)

An essayist argues, "When we think of the FDA and overregulation, we tend to think of the inexcusable delays in approval of new drugs... But this is only part of the problem. Once the FDA approves a drug, users must learn of it. This can occur through advertising and promotion either to physicians or directly to consumers. In both cases, the FDA's policies greatly retard the spread of such information." (Pg. 48)

Another essayist asserts, "Even if the FDA did not exist, normal market incentives combined with the terrors of product liability litigation are more than sufficient to encourage manufacturers to produce REASONABLY safe and effective products." (Pg. 81)

These essays are a fairly broad, and thought-provoking critical examination of various aspects of FDA policy.