Drug Efficacy Study Implementation

Drug Efficacy Study Implementation (DESI) is a program initiated by the United States Food and Drug Administration (FDA) to classify over-the-counter drugs and prescription drugs that were approved for use between 1938 and 1962.

History

The DESI program was established in response to the Kefauver Harris Amendment of 1962, which required drugs to be proven effective for their intended use before they could be marketed. This amendment was enacted in response to the thalidomide tragedy, where a drug caused severe birth defects in thousands of babies.

Process

The DESI program evaluated over 3,000 separate drug products and over 16,000 therapeutic claims. The FDA contracted with the National Academy of Sciences/National Research Council (NAS/NRC) to perform these evaluations. The NAS/NRC would then provide a report to the FDA, who would then make a final determination on the drug's efficacy.

Impact

The DESI program led to the removal of many ineffective drugs from the market. It also led to the re-labeling of many drugs to reflect their true efficacy. This has had a significant impact on the pharmaceutical industry and has helped to ensure that patients receive effective treatments.

See also

• Food and Drug Administration
• Kefauver Harris Amendment
• National Academy of Sciences
• National Research Council
• Pharmaceutical industry