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FDA calls for investigation into Alzheimer’s drug approval

(KYMA, KECY/ CNN) - The current head of the Food and Drug Administration is asking for an investigation into the approval of a new Alzheimer's drug.

Acting Commissioner, Doctor Janet Woodcock made the request over the weekend and she wants the Department of Health and Human Services office of the Inspector General look into the controversial drug aduhelm.

Woodcock posted to Twitter saying an independent review and assessment should consider interactions between Biogen, the company that makes the drug, and the FDA during the process that led to it's approval in June.

The drug was approved with the FDA's "accelerated approval" to treat Alzheimer's disease, despite an earlier vote from an FDA advisory committee that there was not enough evidence to support the drug's clinical efficacy.

Three members of the advisory committee resigned following the approval decision. A high dose is expected to cost $56,000 per patient per year.

Article Topic Follows: Consumer

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