Key Democrat Manchin Bashes FDA Leader on Alzheimer’s Approval (Bloomberg):
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 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.” … 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.”
Senator Manchin’s Letter to President Biden regarding the FDA:
Read the letter HERE (opens PDF)
I write today concerning the lack of permanent leadership at the Food and Drug Administration (FDA), and the continued tenure of Dr. Janet Woodcock as interim commissioner. Just last week, the FDA granted approval for Aduhelm (aducanumab), a treatment for Alzheimer’s, despite its advisory panel voting nearly unanimously against its approval, with no panel member voting in favor of approval…
In 2020, over 90,000 Americans died from drug related overdoses, which is the highest year of overdose deaths ever recorded, with over half of those likely involving an opioid or synthetic opioid. This epidemic is headed in the wrong direction. The FDA has played a critical role in this overdose epidemic by overseeing continuous approvals of stronger and more addictive opioids since the initial approval of OxyContin in 1995 – and Dr. Woodcock has been there for all of it. Dr. Woodcock has repeatedly ignored public health concerns and shown a dereliction of duty by not working to end this epidemic. It is blatantly clear that we must do more to address the drug epidemic that is impacting every American…
Almost five months into your Administration, we still lack acceptable permanent leadership, making this one of the longest delays in almost 100 years for a new President to nominate a commissioner. While industry has benefited from the status quo over the last 35 years of Dr. Woodcock’s tenure at the FDA, the people, patients and families suffering from the opioid epidemic have not. We need urgency as the world emerges from the COVID-19 pandemic. You need to nominate a commissioner suited to address our public health challenges immediately, to set your agenda at this crucial agency for your first year, and give the Senate time to consider your nominee.
News in Context:
- First, do no harm? Six reasons to approach anti-amyloid drug Aduhelm cautiously, if at all
- Growing backlash against the FDA approval of unproven Alzheimer’s treatment Aduhelm, by Biogen
- A critical appraisal of amyloid-B-targeting therapies for Alzheimer disease
The post US Senator Joe Manchin calls for a new FDA Commissioner to replace current (acting) one who “has repeatedly ignored public health concerns and shown a dereliction of duty” over opioids and aducanumab appeared first on SharpBrains.