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Alzheimer’s Drug Discord Puts FDA Accelerated System Under Fire

June 30, 2021, 11:30 AM

An accelerated approval program for U.S. drugs that’s been around for almost three decades is under fire for the criteria used by regulators to decide which therapies should be greenlighted, and for letting ineffective treatments linger on the market.

The Food and Drug Administration’s accelerated process has been hailed for quickly addressing unmet medical needs with novel treatments. But critics say changes are needed to make it more transparent, to better measure efficacy and to quickly stop the sales of drugs that fail confirmatory trials.

Approval of the Alzheimer’s drug Aduhelm has revved up debate on the program. Rather than ...