The Fda Follies: An Alarming Look at Our Food and Drug Policies

This evenhanded, mild journalistic report charges that the Food and Drug Administration through the 1980s displayed bureaucratic ineptitude and catered to special-interest groups such as the pharmaceutical industry. Burkholz, a novelist ( Brain Damage ) who wrote a cover story on the FDA for the New York Times Magazine , tells how generic drug companies got speedy approval on applications in exchange for payoffs to FDA employees. He accuses the agency of inaction and of shirking its responsibilities in its assessments of medical inventions such as the Dalkon Shield intrauterine device and the Bjork-Shiley artificial heart valve. The FDA's pro-industry bias encouraged laxity in food labeling, charges Burkholz, but a dramatic improvement occurred in 1992 with the FDA's massive revision of food labeling regulations, he adds. After a decade of folly, he optimistically concludes, the agency has made significant reforms, including a more flexible, sensitive approach to drug approval, more inspections of drug plants and greater quality assurance in protecting the nation's blood supply. (Apr.)