Final answer:
The Prescription Drug Marketing Act (PDMA) of 1987 is the federal statute that regulates the distribution of prescription drug samples, ensuring that they only reach licensed practitioners and thus protecting consumers. It creates a safer system but can also delay drug availability and strain small pharmaceutical companies with the high costs of compliance.
Step-by-step explanation:
The federal statute that set standards for the distribution, storage, and records of prescription drug samples is the Prescription Drug Marketing Act (PDMA) of 1987. This act prohibits the distribution of prescription drug samples to anyone other than those licensed to prescribe them. The PDMA was designed to prevent the misuse of prescription drugs and ensure that drug samples are only used by individuals under the care of a licensed practitioner.
The winners in this regulatory system are the consumers who are safeguarded from the potential harms of counterfeit, expired, or mishandled drugs. However, among the more anonymous losers are patients who may face delays in accessing new and potentially life-saving medications due to the lengthy and costly FDA approval process. Additionally, smaller pharmaceutical companies might struggle to bear the financial burden of meeting these stringent regulations, which can stifle innovation and competition in the market.