FDA Chief Affirms Support for Effectiveness in Approving Drugs
The Food and Drug Administration (FDA) will not yank its requirement that drugs and devices must show they work before they can be sold on the market, the agency's commissioner said on Oct. 24.
The confirmation by FDA Commissioner Scott Gottlieb came in response to a question at a health summit and followed several of his speeches indicating the agency will rely more heavily on postmarket data. After President Donald Trump assumed office, there was speculation he would appoint a commissioner like investor Jim O'Neill, who has called for eliminating the effectiveness requirement and only demonstrating that investigational drugs are safe. Posed as a way of accelerating access to medicines, opponents say it would lower FDA's standards and ability to regulate medical products.