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Harvard Doctor Urges FDA Reforms After Biogen Alzheimer Nod (1)

July 13, 2021, 8:22 PM

A prominent Harvard doctor who was one of three experts to quit a U.S. advisory panel after Biogen Inc.’s Alzheimer’s drug Aduhelm was approved said regulators should have tougher standards for granting clearances to unproven medications.

The accelerated approval program used to approve the Biogen drug has been around for almost three decades. It’s been hailed for quickly addressing unmet medical needs with novel treatments. But it’s faced criticism after Aduhelm was cleared because it reduces amyloid, a physical biomarker or surrogate linked to Alzheimer’s, without proving it can slow or treat the disease.

In a viewpoint published Tuesday in ...