Prior to the enactment of the Prescription Drug Marketing Act (PDMA), problems regarding the safety, efficacy, storage and handling of pharmaceutical samples were being encountered by federal and state authorities with alarming frequency. In July of 1985, a congressional subcommittee reported that in many situations, American consumers were not able to purchase prescription drugs with the assurance that the products were safe and effective. Frequently, drug products were reported to be mislabeled, subpotent, adulterated, expired and even counterfeited. A secondary diversion market was identified by legislators as the primary source of the substandard drugs being introduced into the U.S. distribution system.

This diversion market was fed by three channels:

• Previously exported drugs reimported as American Goods Returned

• Diverted pharmaceutical samples

• Below wholesale-priced prescription drugs resold by healthcare organizations

To correct this situation, Congress voted to amend the Federal Food, Drug and Cosmetic Act of 1932, enacting the Prescription Drug Marketing Act of 1987 (PDMA).