The DESI program targeted reevaluation of drugs approved in which years?

The DESI program targeted reevaluation of drugs approved in which years?

• A. 1938 to 1962
• B. 1950 to 1980
• C. 1963 to 1990
• D. 1920 to 1938

Answer: (A)

The key idea is why the FDA focused on older drugs that were approved before modern efficacy standards existed. The Kefauver-Harris amendments of 1962 required proof of effectiveness, so drugs that had been approved between the 1930s and early 1960s—before those tighter requirements—were chosen for reevaluation. The window 1938 through 1962 captures the period after safety was addressed by earlier law but before the 1962 changes mandated efficacy data. DESI was about checking whether those pre-1962 drugs still met current standards for effectiveness, and many were reevaluated or restricted accordingly. That’s why the correct timeframe is 1938 to 1962.

The key idea is why the FDA focused on older drugs that were approved before modern efficacy standards existed. The Kefauver-Harris amendments of 1962 required proof of effectiveness, so drugs that had been approved between the 1930s and early 1960s—before those tighter requirements—were chosen for reevaluation. The window 1938 through 1962 captures the period after safety was addressed by earlier law but before the 1962 changes mandated efficacy data. DESI was about checking whether those pre-1962 drugs still met current standards for effectiveness, and many were reevaluated or restricted accordingly. That’s why the correct timeframe is 1938 to 1962.