Term: PDMA - Prescription Drug Marketing Act


The Prescription Drug Marketing Act (PDMA) of 1987 was signed into law on April 12,1988. This act amended the Federal Food, Drug, and Cosmetic Act and banned the reimportation of drugs produced in the United States, placed restrictions on the distribution of drug samples, banned certain resales of drugs by hospitals and other health care entities. It establishes legal safeguards for prescription drug distribution to ensure safe and effective pharmaceuticals. It was designed to discourage the sale of counterfeit adulterated, misbranded, subpotent, and expired prescription drugs. Congress decided that legislation was necessary because there were insufficient safeguards in the prescription drug distribution system to prevent the introduction and retail sale of substandard, ineffective, or counterfeit drugs. This was in response to the emergence of wholesale drug diversion submarket that had developed, to prevent effective control over or knowledge of the true source of drugs. The PDMA was modified by the Prescription Drug Amendments of 1992 (P.L. 102-353, 106 Stat. 941) on August 26, 1992.

Description:
The PDMA provides that prescription drug products manufactured in the United States and exported can no longer be re-imported, except by the product's manufacturer. It also establishes restrictions on sales of prescription drug products and samples. Samples of prescription drug products may be distributed only if a licensed prescriber requests them. Under the law, wholesale distributors must be licensed by the state and meet uniform standards. Penalties for violations of the law are also cited. According to FDA's advisory guidelines on the statute, the law
banned the resale of prescription drugs by hospitals, but will permit hospitals to return drug products. This is only provided if the return is made to the manufacturer or wholesaler and provided written notice is secured that the goods were received (from manufacturers) or the goods were destroyed.

Application:
In short the act created greater restrictions on the distribution on prescription drugs and prevented the sale of counterfeit drugs within the United States. With the exception of the amendments in 1992 the act has not changed and to this day remains in place.

Related Acts:
FDA Regulations
Medicare Prescription Drug Act of 2003

Web Resources:
http://www.fda.gov/
www.Wikipedia.com

Related Terminology:


  • Adulterated: Render (something) poorer in quality by adding another substance, typically an inferior one.
  • Subpotent: Reduction in potency, as of a drug.
  • Misbranded: branded or labeled falsely and in violation of statutory requirements; "confiscated the misbranded drugs"


Citations/References:

TheFreeDictionary.com


Graphics:

Summary of the PDMA
Summary of the PDMA
external image prescription_drug.jpg