FEW health-and-safety statutes enacted during the last three decades have been as heavily criticized as the Food and Drug Act Amendments of 1962. This legislation, a response to public outrage about the distribution of Thalidomide to pregnant women, made it more expensive and time-consuming for new pharmaceutical products to be approved for sale in the United States. Numerous studies have demonstrated that the 1962 statute, far from safeguarding the health of Americans, has actually impaired it by denying them access to drugs available elsewhere. Yet until recently, the amendments’ critics had virtually no political influence. The pharmaceutical industry lobbied for reforming the drug-approval process, but its efforts were thwarted by Ralph Nader’s Public Citizen Health Research Croup and its influential liberal Democratic allies in Congress—all of whom opposed any relaxation of the strict standards for the approval of new drugs.