Final answer:
The Prescription Drug Marketing Act (PDMA) was established in 1987 to ensure the integrity of prescription drugs in the United States.
Step-by-step explanation:
The Prescription Drug Marketing Act (PDMA) was established in 1987 to safeguard the public from counterfeit, adulterated, misbranded, subpotent, and expired prescription drugs. The act implemented a legal framework for the safe and legitimate distribution of prescription drugs in the U.S. by addressing issues related to drug samples, the re-importation of drugs originally manufactured in the U.S., the sale of drugs by hospitals and other health entities, and the establishment of state licensing requirements for wholesale distributors.
Within the context of the Food and Drug Administration's regulatory framework, PDMA was a significant regulatory milestone. However, it is just one aspect of a broader system that over the years has incorporated numerous laws and amendments, such as the Pure Food and Drug Act of 1906, which created federal standards of inspection and imposed labeling requirements for food and drug products, and the more recent Food and Drug Administration Amendments Act (FDAAA) of 2007. The FDAAA further emphasized the FDA's responsibility for drug safety, particularly with respect to postmarketing commitments and surveillance.
Concerns Related to FDA Regulation
- When discussing the implications of FDA regulation, it is noted that the public benefits from protection against unsafe drugs due to the rigorous testing and approval process required for market entry. On the contrary, the more anonymous losers in this case are patients with urgent needs who may face delayed access to potentially life-saving drugs because the stringent regulatory process can significantly extend development time and increase costs. This in turn can delay the availability of innovative treatments to consumers and impact those who might have benefited from earlier access to emerging therapies.