Although a new drug for treating Alzheimer's cleared the Food and Drug Administration's approval process, a pair of large health systems say it has not cleared theirs. The Cleveland Clinic and Mount Sinai Health System in New York won't administer Aduhelm to patients until they have more answers about the drug and the FDA's heavily criticized decision, the Wall Street Journal reports. The agency's acting chief has requested an independent investigation of the approval, including whether all contacts between employees of the FDA and Biogen, the manufacturer of Aduhelm, were proper. Until that investigation is finished and the data on the drug are reviewed by another panel of experts, the Cleveland Clinic said Aduhelm will not be offered in its pharmacy, either. Its physicians are not barred from prescribing it, but it will have to be given to patients somewhere else.
Mount Sinai also said it will reconsider after the investigation, waiting to see if the FDA's approval is confirmed. The health care system also has its experts compiling use guidelines and conducting its usual review before adopting a new drug. "Only after all these are in place will we reconsider," a spokeswoman said. Biogen was not happy with the hospitals' decisions and suggested people who want the drug but lack access contact the company. "Medical decisions should be based on science and data, so it is disappointing that patients living with Alzheimer’s disease may reportedly not be able to access Aduhelm at some facilities," the spokeswoman said. The company reaffirmed its support of the drug and the validity of the clinical data provided to the FDA. Biogen shares fell 7% on Thursday, per Reuters, which an analyst attributed to the health systems' announcements. (More Aduhelm stories.)
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