‘Before 1962, US federal law did not require pre-marketing proof of effectiveness for drugs. But senate hearings revealing widespread false advertising of drugs—along with the thalidomide safety disaster—spurred Congress into action. From then on, approval of a New Drug Application (NDA) by the US Food and Drug Administration required proof of “substantial evidence” of effectiveness. This proof was defined as results from “adequate and well-controlled investigations, including clinical investigations,”1 with such evidence also required to advertise claims of safety and effectiveness. A National Academy of Sciences review underscored the need for these mandates, finding over 30% of pre-1962 marketed drugs to be ineffective’
Way more in link
www.bmj.com/content/381/bmj.p1061
BMJ is being to harsh.
They haven’t realised the FDA works at the speed of science.
h/t A Deplorable Neanderthal