The FDA Is Broken

Between 2010 and 2015, drug companies submitted data to the U.S. Food and Drug Administration (FDA) for three different drugs for Alzheimer’s disease, a devastating condition that afflicts six million Americans. The FDA rejected all three because the manufacturers failed to provide convincing evidence that their drugs actually improved symptoms of Alzheimer’s much less cured the disease. How times change. Last month, when biotech company Biogen came to the FDA with data on aducanumab, yet another Alzheimer’s drug, the evidence the company brought once again failed to show that the drug could slow or stop Alzheimer’s cognitive decline. This time, however, the FDA gave the drug a green light, prompting Michel Vounatsos, CEO of Biogen, to pronounce the decision “historic.”

It was historic all right, but not in the way Vounatsos probably meant it. The scientific data for aducanumab is so flimsy and contradictory, ten of 11 members of the FDA’s advisory committee of outside experts voted against approving the drug (the eleventh abstained). Even the FDA’s own statistician recommended the drug be rejected. When higher ups at...