Drug Efficacy Amendment Implementation

The requirement that drugs be both effective and safe did not become law until 1962. The Kefauver-Harris amendment to the Food, Drug, and Cosmetic Act passed in 1962 required the FDA to review all drugs released after 1938 for effectiveness as well as safety. This program established the Drug Efficacy Study Implementation (DESI) and the job was assigned to the National Academy of Sciences—National Research Council, which reviewed the data presented for each drug that had been submitted to the FDA. 

The early phases of these efforts laid both the intellectual basis for the signing of the Drug Safety Law, namely the FDA Amendments Act (FDAAA), by President Bush on September 27, 2007, and the timing requirements for implementation under that Act. On March 4,2008, Senate Finance Committee member, Chuck Grassley (R-Iowa), called for a General Accountability Office investigation into how the FDA monitors safety and efficacy of approved drugs. 

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