Book Review

Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation

N Engl J Med 2003; 349:1578October 16, 2003

Article

Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation
By Philip J. Hilts. 394 pp., illustrated. New York, Knopf, 2003. $26.95. ISBN: 0-375-40466-X

The Food and Drug Administration (FDA) is one of the most misunderstood, underfunded, and important government agencies. In largely invisible ways, the FDA safeguards our food, drugs, cosmetics, and medical devices. In an engaging style, journalist Philip Hilts details a century of scientifically grounded work by the FDA and the commissioners who shaped the agency. He nimbly moves chronologically through FDA history, using key examples to illustrate shifts in power and policy.

Several themes recur throughout the book. One is the tension between business interests and public health. From the first hints of regulation in the early 20th century, trade groups have lobbied for reduced enforcement. Seldom do consumers act similarly. A second theme is the persistence and inventiveness of quackery. Patent medicine's dubious claims look remarkably similar to some health-related claims made for supplements and herbal products. A third theme is the evolution of changes in regulatory power. Almost every law strengthening the FDA passed because of a constellation of events: a proposed law, of which the public was aware, languished in Congress, and then serious injury or death spurred Congress to act. A fourth theme is the “drug lag,” real or imagined. Once a serious problem, the situation improved in the 1990s largely because the FDA itself worked with industry to facilitate quicker approval of drugs, not because of increased allocations.

Stories of deaths from sulfanilamide elixir in 1937, of problems caused by chloramphenicol in the 1950s, and of the near-disaster of thalidomide in the 1960s are all recounted. One of the strongest sections of the book examines the attempts of the “New Right” to dismantle the FDA in 1994. The account of political maneuvering is fascinating, from the witnesses flown in by pharmaceutical groups, none of whom were denied treatment because of FDA policy, to conference committee meetings, in which a group predicated on bipartisan support could not, and would not, advance policy to diminish the FDA's power.

Other items regulated by the FDA, however, including medical devices, cosmetics, food, and biologics, are not mentioned in the book. We read about the results of a 1976 law requiring safety testing for new medical devices, yet we learn nothing about the problems caused by the Dalkon Shield that led to that decision. The agreement to regulate vitamins in the 1970s, which generated more mail to Capitol Hill than did the impeachment hearings of President Richard Nixon, passes without notice. Some of these omissions reflect the author's sources. Hilts acknowledges the historians in the FDA's history office yet does not properly credit the FDA's oral-history collection, which he used effectively and extensively. The holes in his story mirror holes in that historically valuable collection; concomitantly, the FDA's strength in collecting interviews from its former commissioners and former field investigators is reflected in the rich text.

At heart, Hilts sees the FDA as negotiating between scientific standards that are intended to protect our health and, on the other side, pressures from industry. Because history does repeat itself, and because we depend on the FDA to ensure our safety, this book is important. Those who are curious about what the FDA can and cannot do will enjoy the revelations and thought-provoking argument.

Gwen Kay, Ph.D.
State University of New York, Oswego, Oswego, NY 13126
kay@oswego.edu