The Thalidomide scandal prompted the FDA in the US to make significant changes to their drug laws. On October 10, 1962 the Kefauver-Harris Drug Amendments Act was passed to tighten “restrictions surrounding the surveillance and approval process for drugs to be sold in the US, requiring that manufacturers prove that they are both safe and effective before they are marketed. Now drug approval can take between 8 and 12 years, involving animal testing and tightly regulated human clinical trials.”