Final answer:
The Federal Food, Drug, and Cosmetic Act (FD&C Act) establishes prescription and OTC drug classes, with the FDA overseeing prescription drug promotion and the FTC for OTC drugs. Consumers benefit from safety, whilst some patients may suffer delayed treatment access due to the approval process.
Step-by-step explanation:
Federal Statute Establishing Rx vs OTC Drug Classes
The federal statute that established prescription (Rx) versus over-the-counter (OTC) drug classes is the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act lays the foundation for the regulation of drugs in the United States, including the classification of drugs as either prescription or nonprescription (OTC). Prescription drugs require a medical prescription to be dispensed, while OTC drugs are available without a prescription and are deemed safe enough for use without a doctor's supervision.
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research is responsible for evaluating and approving new drugs, including decisions to change drugs from prescription to over-the-counter status. An NDA (New Drug Application) must be approved before a drug can be made available by prescription, and a separate process must be completed for a drug to be switched to OTC status.
While the FDA is responsible for overseeing prescription drug advertising and promotion, the advertising and promotion for OTC drugs falls under the jurisdiction of the Federal Trade Commission. This dual regulation helps maintain a balance between ensuring public safety and providing accessibility to medications.
To address the question about the winners and losers of the strict medical regulations enforced by the FDA, the clear benefactors are consumers who are protected from unsafe medications. Conversely, the 'losers' could be considered to be those patients who experience delayed access to potentially beneficial treatments due to the extensive and time-consuming drug approval process.