Anti-Drug Operations, 1960s

Pharmaceutical Drugs

With the passage of the Food, Drug, and Cosmetic Act in 1938, federal regulatory authority over pharmaceuticals was increased, chiefly via a pre-market review of the safety of all new drugs and regulation of therapeutic claims made in drug labeling. During the two decades that followed, however, the FDA concentrated its regulatory activity on the abuse of amphetamines and barbiturates. During this period the FDA reviewed approximately 12,000 new drug applications, but by 1959 pressure was mounting for increased authority because of birth defects caused by the drug thalidomide.

The German pharmaceutical manufacturer Chemie Grünenthal marketed thalidomide between 1957 and 1962 as, among other uses, a cure for pregnant women's morning sickness. Thalidomide was found to cause children to be born with phocomelia, a congenital disorder involving the limbs. Over 10,000 children with phocomelia were born worldwide as a result of thalidomide. Although FDA reviewer Frances Oldham Kelsey had blocked approval of thalidomide in the United States, Richardson-Merrell, Inc. had distributed over two million samples of thalidomide under the trade name Kevadon to American doctors. Public fears regarding the safety of pharmaceuticals led to Congressional pressure for an expansion of FDA authority.

In 1962 President John F. Kennedy signed the Kefauver-Harris Amendment to the Food, Drug, and Cosmetic Act, which greatly increased the FDA's regulatory authority. Although concerns about the safety of prescription drugs initiated the change, the consequent ramifications were far reaching. Among other changes, all new drug approval applications were required to demonstrate substantial evidence of the drug's efficacy for a marketed indication.

Manufacturers of drugs the FDA had approved between 1938 and 1962 were compelled to submit proof of the drug's efficacy—failure to do so resulted in mandatory withdrawal from the market. From 1962 onward manufacturers were required to use the established or generic name of a drug along with its trade name. Drug advertising was restricted to FDA-approved indications, and the FDA's power to inspect drug-manufacturing facilities was greatly increased. While the FDA's increased scrutiny improved public safety, it slowed down the process for drug approval greatly, something that was to become an issue in future decades when a more speedy response to contagious diseases was desired.

Throughout the 1960s problems with patient tolerance of and dependence upon commonly prescribed medications such as amphetamines and barbiturates became increasingly understood. Other substances, such lysergic acid diethylamide (LSD), which originally were used for therapeutic purposes, found recreational uses among certain groups. Throughout the 1960s, the FDA took an increasingly more proscriptive stance toward substances that were popular for recreational use, for example banning LSD in 1968. Concerns regarding the misuse of prescription medications culminated in the Comprehensive Drug Abuse Prevention and Control Act of 1970, commonly referred to as the Controlled Substances Act (CSA). The CSA regulated the manufacture, importation, possession, use, and distribution of certain substances, ultimately creating five “schedules” (classifications) of drugs with specific criteria for inclusion in each schedule.

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