https:\/\/apnews.com\/article\/politics-health-us-food-and-drug-administration-medication-dementia-8a4dea09ba183d7f047ee5eb10224289<\/p>\n
FILE – This image provided by Biogen on Monday, June 7, 2021 shows a vial and packaging for the drug Aduhelm. The Food and Drug Administration\u2019s contentious approval of a questionable Alzheimer\u2019s drug took another hit Thursday, Dec. 29, 2022, as congressional investigators called the process \u201crife with irregularities.\u201d (Biogen via AP, File)
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\nFILE – This image provided by Biogen on Monday, June 7, 2021 shows a vial and packaging for the drug Aduhelm. The Food and Drug Administration\u2019s contentious approval of a questionable Alzheimer\u2019s drug took another hit Thursday, Dec. 29, 2022, as congressional investigators called the process \u201crife with irregularities.\u201d (Biogen via AP, File)
\nWASHINGTON (AP) \u2014 The Food and Drug Administration\u2019s contentious approval of a questionable Alzheimer\u2019s drug took another hit Thursday as congressional investigators called the process \u201crife with irregularities.\u201d<\/p>\n
The 18-month investigation by two House committees detailed \u201catypical collaboration\u201d between FDA regulators and a company it\u2019s supposed to oversee — Aduhelm manufacturer Biogen. The probe also cited Biogen documents saying the company intended to \u201cmake history\u201d when it set what investigators called an \u201cunjustifiably high\u201d initial price of $56,000 a year for the drug.<\/p>\n
The criticism comes as the FDA is expected to decide whether to approve another new Alzheimer\u2019s drug in January. Thursday\u2019s report urged the agency to \u201ctake swift action\u201d to ensure that any future Alzheimer\u2019s approvals aren\u2019t met with \u201cthe same doubts about the integrity of FDA\u2019s review.\u201d<\/p>\n
The FDA and Biogen issued statements Thursday defending the Aduhelm approval process.<\/p>\n
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\nIn 2021, the FDA overruled its own independent scientific advisers when it approved Aduhelm even though research studies failed to prove it really helped patients. Biogen had halted two studies after disappointing results suggested the drug wasn\u2019t slowing Alzheimer\u2019s inevitable worsening — only to later contend that a new analysis of one study showed higher doses offered an incremental benefit.<\/p>\n
The FDA argued the drug\u2019s ability to reduce a hallmark of Alzheimer\u2019s, a buildup of plaque in the brain, suggested it was likely to slow the disease. Backlash was immediate as three FDA advisers resigned in protest and the agency\u2019s then-acting chief called for an internal investigation. Eventually Medicare refused to pay for the drug — even after the yearly price was dropped to $28,000 — unless patients enrolled in clinical trials to prove if it indeed slowed cognitive decline.<\/p>\n
Thursday\u2019s report said FDA and Biogen engaged in an unusually high volume of phone calls, meetings and emails, some of them not properly documented. In addition, the regulators and company spent months working together to prepare a briefing document for FDA\u2019s advisers that didn\u2019t adequately represent substantial disagreement within the FDA about how to handle Aduhelm, the report said.<\/p>\n
The investigators recommended that FDA take steps to restore trust in the approval process that include properly documenting interactions with drugmakers. They also urged manufacturers to take into account advice from patient groups and other outside experts on fair drug pricing.<\/p>\n
In a statement Thursday, FDA said the Aduhelm decision \u201cwas based on our scientific evaluation of the data\u201d and that the agency\u2019s own internal review found its interactions with Biogen were appropriate. But it said it plans to update guidance on Alzheimer\u2019s drug development and will review the investigation\u2019s findings.<\/p>\n
In its own statement, Biogen said: \u201cAlzheimer\u2019s is a highly complex disease and we have learned from the development and launch of Aduhelm\u201d but that it \u201cstands by the integrity of the actions we have taken.\u201d<\/p>\n