What brought up enhancement of drug regulations?
The thalidomide tragedy resurrected Kefauver's bill to enhance drug regulation that had stalled in Congress, and the Kefauver-Harris Amendment became law on 10 October 1962. Manufacturers henceforth had to prove to FDA that their drugs were effective as well as safe before they could go on the US market. The FDA received authority to regulate advertising of prescription drugs and to establish good manufacturing practices. The law required that all drugs introduced between 1938 and 1962 had to be effective. An FDA - National Academy of Sciences collaborative study showed that nearly 40 percent of these products were not effective. A similarly comprehensive study of over-the-counter products began ten years later.
During the listing process, economic factors cannot be considered, but must be " based solely on the best scientific and commercial data available." The 1982 amendment to the ESA added the word "solely" to prevent any consideration other than the biological status of the species. Congress rejected President Ronald Reagan's Executive Order 12291 which required economic analysis of all government agency actions. The House committee's statement was "that economic considerations have no relevance to determinations regarding the status of species."