Which act requires drugs, biologics, and medical devices manufacturers to pay fees for product applications, supplements and other services, and is reauthorized every 5 years?

• A. Prescription Drug User Fee Act 1992
• B. Dietary Supplement Health and Education Act 1994
• C. Kefauver-Harris Amendments 1962
• D. Durham-Humphrey Amendments 1962

Answer: (A)

The key idea is that FDA review work for drug, biologic, and related product applications is funded by user fees paid by manufacturers, with a formal renewal schedule every five years to maintain that funding. This setup was created by the act that established the drug and biologic user-fee program, requiring sponsors to pay fees when submitting new drug applications, license applications, and supplements to already approved products. This funding mechanism helps FDA hire reviewers and aim for more predictable review times, and its five-year reauthorization cycle is a defining feature.

The other acts focus on safety and labeling in different areas (dietary supplements or historic drug regulations) and do not establish this ongoing, five-yearly user-fee funding model for reviewing submissions.