On October 10, 1962 President Kennedy signed the Drug Industry Act Amendments of 1962, also known as the Kefauver-Harris Amendments. This amendment now required drug manufacturers to supply efficacy data to the Food and Drug Administration (FDA), previously it was just safety data, for their product to be considered for licensing. Intended to protect American consumers from “unsafe and ineffective drugs”. [1, 3]
In 1960 “Senator Estes Kefauver… decided that in dealing with medications, the government must do more than control their labels, contents, and safety and their marketing and distribution processes. It must also control their prices and enforce “competition….Although Kefauver’s main concern was pricing, another provision called for NDAs to show proof of both safety and efficacy.” The thalidomide babies tragedies paved the way for the passing of the amendments, though the “pricing and patent-sharing provisions were deleted”. [2]
The amendment expanded the power of the FDA. “The task of proving efficacy is much more difficult, expensive, and time-consuming than the task of proving safety. To a great extent, efficacy, which is sensitive to individual conditions and mediated by market process, had in the past always been judged jointly by doctors and consumers… In 1962, however, the FDA began to act on the premise that it could establish authoritative knowledge of efficacy prior to experience and experimentation in actual market processes….The time spent waiting for FDA approval and the expense and duration of the bureaucratically determined testing procedures combined to cause tremendous delays in drug development and production. Drug development declined significantly after 1962″ [2]
The FDA does no clinical testing, they rely solely on data selected and supplied by the drug manufacturer, called a ‘dossier’ [@16:50]
Before 1962 “controlled trials were still developing, and many marketed drugs were ineffective for their labeled uses. Now, the standard for evidence is the well-controlled study, and the FDA’s implementation of the 1962 amendments contributed greatly to that.”[4]
The Drug Amendments also addressed the use of drugs in clinical trials, including a requirement of informed consent by subjects. [2]
Immune induced “efficacy” in vaccine trials was measured by the production of neutralising antibody titres – which assumed “protection” from “disease” – the symptom from said pathogen.