Key Democrat Manchin Bashes FDA Leader on Alzheimer’s Approval


Senator Joe Manchin, a moderate Democrat considered a crucial vote within the party’s slim Senate majority, said Janet Woodcock, the temporary head of the Food and Drug Administration, should be quickly replaced with a permanent leader.

Manchin blasted an FDA decision to approve the controversial Alzheimer’s therapy Aduhelm despite conflicting evidence that the Biogen Inc. drug works and an overwhelmingly negative vote against the therapy by agency advisers. The FDA ruling led three members of that panel to quit in protest.

Manchin said this brings into question Woodcock’s leadership and said the FDA should at least provide an explanation of its decision to go against its advisers. It’s an attack that could potentially dim Woodcock’s chances of permanently leading the agency.

“Having a permanent agency head in charge to answer patients and doctors questions on this approval, as well as assure the general public of the FDA’s commitment to public health, is imperative, and Dr. Woodcock is not the right person to lead the FDA,” the senator wrote in a letter Thursday.

The FDA didn’t immediately respond to a request for comment.

The Biden administration has already filled many crucial health-care roles and the lack of a nominee to lead the FDA has frustrated many in Washington, particularly given the FDA’s intense role in the nation’s Covid-19 response and its upcoming work around the pandemic, such as consideration of full approval of vaccines.

Some members of Congress have criticized the $56,000 a year price tag on Biogen’s Aduhelm, approved last week.

Manchin urged U.S. President Joe Biden to nominate “acceptable permanent leadership to ensure Americans are protected from harmful drugs and that scientific recommendations are considered when approving new medications.”

Opiod Epidemic

Manchin is from West Virginia, which has been particularly hard hit by the opioid epidemic. He has previously criticized the FDA’s role in approving opioids responsible for overdose deaths in the U.S.

Among other senators, Manchin wrote Biden a letter earlier this year ripping into the agency for its “long track record approving dangerous opioids without considering public health.” On Thursday, he wrote that Woodcock, who has been at the FDA for more than 30 years,“has been there for all of it.”

Woodcock has been popular among some Democrats and Republicans in the past, with deft maneuvering through numerous congressional hearings over the years. So there’s a chance Manchin’s vote wouldn’t be needed if Biden did nominate her for permanent commissioner.

But the administration is also unlikely to want to upset Manchin, whose vote is crucial for a variety of Biden priorities in a 50-50 U.S. Senate controlled by Democrats.

©2021 Bloomberg L.P.

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