The West Virginia Senator Joe Manchin III (D-W. Va) sent a letter to President Joe Biden expressing his dismay regarding the FDA’s approval of Aduhelm (aducanumab), the controversial Alzheimer’s treatment from Biogen (NSDQ:BIIB).
The nonprofit watchdog group Public Citizen sent a broadly similar letter to HHS Secretary Xavier Becerra to “express its outrage” over the approval and to demand the resignations from prominent FDA officials.
Manchin also voiced concerns about the ongoing lack of permanent leadership as Dr. Janet Woodcock continues to serve as acting commissioner of the agency. Woodcock began her tenure as acting commissioner after Biden’s inauguration. She has worked at the agency since 1986.
Manchin asked Biden to make the FDA explain why it chose to ignore the advice of an external advisory committee, which had recommended that the agency not approve the drug without additional data.
Three members of that advisory committee have since resigned.
The letter also concluded that “Dr. Woodcock is not the right person to lead the FDA.”
Manchin also argues that the agency needs a permanent leader to help the country battle the COVID-19 pandemic and opioid epidemic. “The FDA needs new leadership to be accountable for new drug approvals and to address the public health consequences of widely-available prescription opioids, as well as the numerous other health concerns facing our country,” he wrote.