The Prescription Drug Marketing Act and Sample Distribution

In 1987 Congress passed the Prescription Drug Marketing Act of 1987 ("PDMA") and the president signed it into law on April 22, 1988. In August of 1992 the PDMA was amended. Said amendments established requirements for drug sampling as well as the storage and handling of those samples. Report to Congress

Pharmaceutical companies rely heavily on sampling to get the "word" out about their drug. Giants like Pfizer, Merck and others spend a large portion of their marketing budget on getting samples of their drugs to doctors.

What does this all mean? Well, for starters, pharmaceutical companies have to follow federal regulations (enforced by the FDA) in order to sample their product. However, because states began passing laws and regulations pertaining to sample distribution, companies also have to be cognizant and abide by state laws and regulations. Somes states adopted the federal regulations, but others implemented different regulations (different, not meaning contradictory).

This is the way I look at it: The Federal Law is the ground floor. The state can make their law stricter than the federal but they cannot contradict it or make it less strict. Let me give you an example of what I mean. In the state of washington, if there is a "significant loss" of legend (prescription) drug, the company must notify the board within the next business day of determining the loss. The PDMA (Federal Regulation) requires that the company report the "loss/theft" within five (5) working days and send a report no later than 30 days after notification. 21CFR23.37.

The above is just one example of what a pharmaceutical company has to take into account when distributing samples of a prescription drug in various states. The company must be concerned, not only with the state where the manufacturer/distributor is located but also with the laws and regulations of the various states where the company is distributing their drug.

For more information regarding sampling regulations contact Ana P. Pierro at Advanced pHarma Trends (908) 419-4480 or email appierro@verizon.net