The Prescription Drug Marketing Act (PDMA)

1. Domestic wholesale diversion of prescription drugs
2. Fraudulent re-importation of prescription drugs (also known as false export diversion)
3. Abuses related to the distribution of drug samples by manufacturer representatives

• American consumers could not purchase prescription drugs with the certainty that the products are safe and effective.
• The existing system of providing drug samples to physicians through manufacturer’s representatives had been abused for decades and resulted in the sale to consumers of misbranded, expired, and adulterated pharmaceuticals.
• The effect of these conditions created an unacceptable risk that counterfeit, adulterated, misbranded, sub potent or expired drugs would be sold to American consumers.

Distribution controls regarding the wholesale market were still not well defined following the passing of the PDMA and subsequent federal regulations.

Solution: Amendment to the Federal Food Drug and Cosmetic Act

The PDMA’s amendment included provisions to help ensure drug samples were distributed for their intended use and properly accounted for throughout the supply chain; effective October 20, 1988.

The FDA further strengthened sample distribution requirements when they issued a Proposed Rule setting forth additional guidance on the PDMA, and establishing specific administrative procedures related to the drug sample distribution.