What is the primary role of the FDA in therapeutic equivalency?

The primary role of the FDA in therapeutic equivalency is to demonstrate through studies if a drug is therapeutically equivalent. This involves evaluating whether a generic or alternative drug can be expected to produce the same therapeutic effect as a brand-name drug. The FDA assesses various factors such as the active ingredient, dosage form, route of administration, strength, and intended use to determine therapeutic equivalency. This ensures that patients can rely on generic medications as safe and effective alternatives to brand-name products, ultimately promoting competition and allowing for cost-effective options in pharmaceutical care.

Other options focus on different aspects of the FDA's responsibilities. Classifying drugs by patent status pertains more to intellectual property rights than to therapeutic equivalency. Ensuring drug affordability falls under broader healthcare policy issues rather than the specific assessment of equivalency. Regulating marketing practices of pharmaceuticals involves overseeing promotion and advertising, which, while important for consumer protection, is separate from the determination of whether two drugs are therapeutically equivalent.