In order to approve a new Alzheimer’s treatment, the Food and Drug Administration is rewriting its rulebook, an enormously risky move that could accelerate the public’s access to medicines but upend the future of drug regulation, forcing the 114-year-old agency to do the equivalent of redesigning a fighter plane in mid-flight.
With its conditional clearance of Biogen’s Aduhelm, the FDA is creating a framework that could require less certain evidence of safety and efficacy for medicines beyond Alzheimer’s treatments. In doing so, it is choosing to alter many of its well-established processes and standards, seemingly on the fly.
All this as the agency wades into a contentious debate that has confounded scientists for 30 years: What exactly causes Alzheimer’s, and how can we treat it?
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