The Kefauver-Harris Amendments of 1962 led to which program intended to reevaluate older drugs for safety and efficacy?

• A. Abbreviated NDA (ANDA)
• B. OTC Monograph Development
• C. DESI program
• D. NDA Process for New Drugs

Answer: (C)

The main idea is that the Kefauver-Harris amendments created a process to reassess medicines that were already on the market to ensure they actually work, not just that they are safe. To make this happen, the FDA set up the Drug Efficacy Study Implementation (DESI) program. DESI evaluated drugs that had been approved or marketed before the 1962 changes, judging whether they demonstrated real efficacy based on the evidence available at the time. The result was a reevaluation that could lead to withdrawal of ineffective drugs or changes in labeling, ensuring that older medicines on the market met efficacy standards.

Other regulatory pathways address different goals: an abbreviated NDA is for generic versions of already approved drugs, OTC monograph development governs which ingredients can be used in over-the-counter products, and the NDA process for new drugs covers approving new medicines rather than reevaluating older ones.