The past year has witnessed an unprecedented flurry of governmental activity designed to modify the way drugs are investigated, marketed, and used. These regulatory efforts have been so intense that they have tended to overshadow the notable advances in therapeutics that have occurred simultaneously. Thus, the rhetoric from Washington has garnered the majority of media interest, stirred to greater alertness the drug consciousness of the consumer movement, and virtually monopolized large segments of the time and effort of those under attack— the regulated industry as well as the health professions' organizations. Notwithstanding these regulatory impediments, however, the pharmaceutical industry has managed to introduce a number of new drugs that represent major advances, if not breakthroughs, in therapeutics.
Drug Legislation and Regulation
The last major revision of the Food, Drug, and Cosmetic Act occurred in 1962 when the Kefauver-Harris Amendments were passed. Ironically, the hurried enactment of this legislation was in