The 1980s witnessed increasing concern for drug regulation by patient advocacy groups, exemplified here by a 1988 protest at the Parklawn Building in Rockville by the AIDS Coalition to Unleash Power.

Additional laws and policies of the 1980s had an impact on drug approval and distribution. For example, the agency strengthened reporting requirements for adverse reactions in 1985. The new requirements addressed all prescription drugs, including older pharmaceuticals that predated FDA approval. New regulations for investigational drug development also went into effect in 1985. The new rules increased the availability of experimental drugs, including compassionate use of drugs under research for patients with serious and/or life-threatening conditions. In 1988 FDA promulgated treatment IND regulations. These allowed desperately ill patients to receive promising new drugs before full approval had been completed. Congress passed the Prescription Drug Marketing Act in the same year. This law prohibited the purchase, sale, trade, and -- with exceptions -- reimportation of drug samples. It also required drug wholesalers to register with states.