The decline of science at the FDA has become unmanageable

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.2The FDA’s legally enforceable regulations detail what “substantial evidence” and “adequate and well-controlled investigations” mean in greater depth, supplemented by guidelines to industry which, although not legally binding, explain the FDA’s current interpretation of drug manufacturers’ legal obligations.3 However imperfect, the FDA’s enforcement of these provisions assures prescribers,…
Read Original Article: The decline of science at the FDA has become unmanageable »