1962 was also the year in which President Kennedy brought in the Kefauver- Harris Drug Amendments, which required manufacturers to prove to the FDA that their product was both safe and effective prior to marketing.

In addition, the FDA gained control over advertising. The Investigational New Drug (IND) Protocol was also set up. A National Center for Drug Analysis was established.

These measures were introduced as a result of the Thalidomide tragedy.

(Britain lagged by five years, it being 1967 before the MCA was established).