During DESI, the FDA contracted which body to conduct clinical trials evaluating older drugs?

• A. Abbreviated NDA submission
• B. New drug discovery
• C. OTC monograph development
• D. FDA contracting NAS/NRC to evaluate older drugs

Answer: (D)

DESI aimed to determine whether drugs approved before the 1962 Kefauver-Harris amendments actually worked. Because evaluating thousands of older products would require extensive clinical trials, the FDA turned to an independent, authoritative science body to design and oversee the work. The National Academy of Sciences/National Research Council (NAS/NRC) was contracted to conduct the clinical evaluations of these older drugs, providing rigorous, impartial assessments of their efficacy. This arrangement ensured credible evidence without overburdening FDA’s internal resources. Other options describe processes not involved in DESI, such as in-house abbreviated NDAs for generics, new drug discovery, or OTC monograph development.