Prognosis
Doctors Blast Biogen Alzheimer Approval as ‘Regulatory Failure’
- Harvard, Hopkins, UCSF, and Mayo doctors publish FDA critique
- Agency at odds with data, New England Journal commentary says
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Top researchers who advised the U.S. Food and Drug Administration on Biogen Inc.’s Alzheimer’s drug blasted the agency for approving it, calling the decision a “regulatory failure” that is “at odds with the evidence.”
The New England Journal of Medicine opinion piece, signed by seven members of an advisory panel that opposed clearing Biogen’s Aduhelm, is another sign of persistent furor over the agency’s decision. Two committees of the House of Representatives investigating the approval have asked the Cambridge, Massachusetts-based biotech to turn over documents about the drug’s development and approval.