The Proper Role of the Fda for the 21st Century

The FDA’s mission is to permit safe and effective new drugs, biologics, and devices onto the market in an efficient and timely manner. But fear of being blamed for the failings of approved products has caused the FDA to become too restrictive. The FDA has strayed from the safety and effectiveness standards that are set out in the law, instead applying standards for approval that are based on predicting the benefits and risks—clinical utility, disease outcomes, survival—that an “average patient” will experience. But these outcomes are better evaluated in real-world, post-market settings—that is, in the medical marketplace, where knowledge about the value of a drug or device for different types of patients can grow over time. The FDA must return to its role as gatekeeper of safe and effective drugs and devices, and refrain from attempting to anticipate the future judgments of physicians and patients regarding benefits and risks.