The FDA Follies: An Alarming Look at Our Food and Drugs in the 1980s.

One of the bones of contention in today's debate over products liability reform is how much weight courts should give to a defendant's compliance with federal regulations or to the approval of a product's design by a federal regulatory agency.

Under the traditional common law rule, evidence of compliance or approval is relevant, but not conclusive, on the issue of whether a defendant exercised due care in designing a product or whether it was defectively designed. However, business groups have long sought to convert compliance with federal standards and agency approval of a product's design into impenetrable shields against liability (or, at the very least, against the imposition of punitive damages).

The underlying assumption of those who argue that courts should not be allowed to set higher standards of care (or non-defectiveness) than the government's is that administrative bodies have the expertise, independence, and authority necessary to provide the public with reasonable protection against productrelated hazards. Consequently, there is no need to permit a separate institution --the judicial system--to serve as a second line of defense.

Books like The FDA Follies severely undermine this assumption by pointing out the serious shortcomings of federal regulatory agencies. The lessons they teach are that government standards may not always provide the level of consumer protection that products liability law mandates and that sound policy reasons cut in favor of letting courts decide whether a defendant should have done more than merely comply with federal regulations.

The Food and Drug Administration (FDA) is the oldest, most important, and most powerful of the federal agencies charged with protecting consumers from product-related hazards. As Herbert Burkholz points out in the The FDA Follies, "25 cents out of every dollar spent by the American consumer goes for products regulated by the FDA." No new drug may be introduced into interstate commerce until the agency has determined that it is both safe and effective. The agency preclears food additives for safety and has broad authority to regulate the production and sale of medical devices.

Although the public's perception of the FDA has generally been positive throughout its existence, the agency has had its share of critics. The pharmaceutical industry often complains that red tape and excessive caution on the part of FDA officials delay the approval of useful new drugs already available abroad.

Consumer advocates have attacked the FDA for its lack of decisiveness in dealing with health risks created by foods, drugs, devices, and cosmetics already on the market. Manufacturers of vitamin supplements and unorthodox therapeutic products denounce what they claim are the agency's prejudice and overzealousness in enforcing the law against them.

The FDA Follies examines a discreet period in the agency's history--the Reagan-Bush era--when keeping the government "off the backs" of regulated industries was the order of the day and gentle persuasion became the weapon of choice for watchdog agencies. For example, the Office of Management and Budget reviewed all proposed health and safety regulations to make sure they did not saddle businesses with "excessive" costs. And during the Bush administration, Vice President Dan Quayle's Council on Competitiveness eased regulatory burdens on industry.

The result, according to Burkholz's hard-hitting expose, was a procession of scandals and blunders that shook public confidence in the venerable agency. Among the specifics:

* FDA officials charged with approving generic drugs took bribes from companies whose products they were reviewing.

* Despite clear evidence of an association between Reye's syndrome and aspirin consumption by children, the FDA dragged its feet in mandating a warning label, and the delay may have caused 175 deaths.

* The agency reacted with unconscionable lethargy to reports of defects in artificial heart valves.

* FDA red tape and bureaucratic indifference slowed down the approval of AIDS drugs until pressure from AIDS sufferers forced the agency to rethink how it approves new drugs to treat life-threatening diseases.

As a critique of the agency's institutional shortcomings, The FDA Follies lacks historical perspective and tends to oversimplify complex issues. But as solid evidence that it would be imprudent to permit FDA rulings to control whether consumers of agency-regulated products should be compensated for product-related injuries, the book merits high marks.