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

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, d...
Source: SharpBrains - Category: Neuroscience Authors: Tags: Brain/ Mental Health aducanumab Aduhelm Alzheimer's treatments Alzheimer’s therapy Alzheimers-disease Biogen FDA Food and Drug Administration Joe Manchin opioids OxyContin public-health Source Type: blogs