What are the Kefauver-Harris amendments?

October 2012 marks 50 years since the passage of the Kefauver-Harris Drug Act of 1962, known less formally as the Kefauver-Harris drug amendments. The bill, named for US Senator Estes Kefauver of Tennessee and US Representative Oren Harris of Arkansas, amended the Federal Food, Drug and Cosmetic Act of 1938 to require:

  • Substantial evidence from clinical trials of both safety and efficacy – the FD&C Act of 1938 only required safety data
  • FDA approval prior to marketing – previously, approval was automatic if FDA did not act on an application within 60 days
  • Adherence to current good manufacturing practices (cGMP)
  • Closer monitoring of clinical trials and informed consent of participants
  • Disclosure of side effects in advertising
  • Monitoring and reporting of post-marketing safety information

Oversight of prescription drug advertising was transferred from FTC to FDA. The bill also outlawed the then-common practice of repackaging generic drugs under new trade names, which generated huge revenues for pharmaceutical companies at the expense of the public. All drugs approved prior to 1962 were to be re-reviewed to determine whether they met the new efficacy standard (ultimately, about one third of the drugs approved between 1938 and 1962 did not). That process led to the establishment of the Abbreviated New Drug Application (ANDA) approval pathway for generic drugs.

Senator Kefauver had been working since 1959 to rein in the pharmaceutical industry, investigating economic issues such as patent protections, drug costs and advertising practices. Just as the 1938 FD&C Act was inspired by the elixir sulfanilamide tragedy, passage of the 1962 amendments was helped considerably by the thalidomide tragedy. Another important figure in shaping the legislation was pharmacologist and physician Dr. Frances Oldham Kelsey, the FDA reviewer credited with blocking the approval of thalidomide in the US.

Critics viewed the 1962 legislation as an excessive expansion of government power, since it greatly increased FDA’s control over pharmaceutical manufacturing and research. Following the revelation in 1961 that thalidomide caused severe birth defects, however, the American public – and Congress – were ready to support a stronger FDA.