FDA’s Drug Review Gold Standard

Lexology November 22, 2024
Brownstein Hyatt Farber Schreck LLP

The evolution of the standard

Initially, in 1906, Congress had provided for no premarket review of drugs. By 1938, Congress required the premarket review of drug safety. Years later, in 1962, after thalidomide use in Europe caused severe birth defects, Congress required that the Food and Drug Administration (FDA) could only approve drugs if “safe and effective” as demonstrated by “substantial evidence.” This dual standard—safe and effective and substantial evidence, coupled with FDA’s practice of reviewing and analyzing submitted data itself, without relying solely on the drug sponsor’s presentation and analysis of the data—is the FDA’s gold standard of drug review.

FDA understands “safe and effective” to mean the benefit of the drug exceeds its risks. “Substantial evidence” is defined...

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