A dozen sunscreens sold abroad are more effective than those available here, but U.S. regulators have yet to OK them. A promising new MS drug, Lemtrada, has been in use for years in Europe yet American officials have rejected it. And it can take 15 years for new drugs to go from the lab to the market because of regulatory hurdles they must clear.
These examples beg the question: Are effective new treatments being kept from American consumers because government red tape has tied the hands of Food and Drug Administration regulators?
Joseph V. Gulfo, M.D., a medical entrepreneur and author, tells Newsmax Health the answer is an unqualified yes. In his new book, “Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances,” Dr. Gulfo argues the FDA has raised the bar so high for new therapies that drug companies and biomedical firms are being stymied in their efforts to bring promising treatments to Americans.