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FDA releases fresh details on internal debate over controversial Alzheimer's drug

FDA releases fresh details on internal debate over controversial Alzheimer’s drug Laurie McGinley © Jessica Rinaldi/Pool/Via Reuters Marc Archambault, who has early-stage Alzheimer s disease, receives his first dose Wednesday of the newly approved intravenous drug Aduhelm at Butler Hospital in Providence, R.I. (Jessica Rinaldi/Pool/Reuters) The Food and Drug Administration on Tuesday released fresh details on why it approved a controversial Alzheimer’s drug in hopes of quelling a fierce debate over whether the agency should have cleared the costly treatment. But the new information, included in interviews with agency officials and 83 pages of internal documents, might not quiet a furor over the drug Aduhelm that has drawn in Alzheimer’s doctors and patients, members of Congress, Medicare officials, and the agency itself.

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As the first Alzheimer s drug approved since 2003, advocates applaud the decision. Critics say the approval was based on inadequate proof that the drug works and balk at the price tag of $56,000 a year.