Joseph Gulfo, MD: The proper role of the FDA for the 21st century скачать в хорошем качестве

Joseph Gulfo, MD: The proper role of the FDA for the 21st century

The current medical marketplace is vastly different from the marketplace that existed in the 1970s and ’80s when the Food, Drug and Cosmetic Act codified the Food and Drug Administration’s mission. Despite rapidly advancing technology and patients’ increasing desire to try new drugs and devices, the FDA has strayed significantly from the statutorily defined safety and effectiveness standards for drug approvals. The FDA now very often demands proof of clinical utility, including survival and disease outcomes, as a requirement for premarket approval. But hard proof of clinical utility is elusive, even for drugs that are clearly shown to be safe and effective as labeled. Rather than blocking safe and effective drugs on such grounds, we should allow physicians and patients to make outcome-oriented decisions, and rely on the medical marketplace to drive physician adoption of safe and effective drugs that prove to have great clinical utility in real-world settings. A new study for the Mercatus Center at George Mason University evaluates current FDA policy toward new medical products and concludes that the FDA must return to its role as gatekeeper of safe and effective drugs and devices. The FDA has made significant incursions into private health decisions by exercising its public health mandate in a manner that was not intended by Congress. Rather than allowing doctors and their patients to determine how best to use a drug and ensuring that drugs placed in the market are safe and effective, the FDA has increasingly become concerned with controlling the outcomes of future judgments by physicians and patients regarding benefits and risks. The new medical marketplace should refocus the FDA on safety and effectiveness, leaving patients and doctors to evaluate and determine benefits and risks based on their experiences with the drugs. To read the study and learn more about its authors, Joseph V. Gulfo, MD, economist Jason Briggeman, and graduate student Ethan C. Roberts, see “The Proper Role of the FDA for the 21st Century.”