Key senator calls for Woodcock's removal in FDA fallout from Biogen Alzheimer's approval

 The FDA’s fallout from its controversial approval of Biogen’s Alzheimer’s drug Aduhelm is rolling on with one pivotal Democratic lawmaker calling on the administration to dethrone the agency’s top decision-maker. 

Sen. Joe Manchin (D-W.Va.) called on President Joe Biden in a letter dated Thursday to oust the FDA’s interim commissioner Dr. Janet Woodcock and quickly nominate an “acceptable” permanent chief. The moderate Democrat took aim at the FDA’s decision last week to approve Biogen’s Aduhelm, also known as aducanumab, for Alzheimer’s patients despite intense controversy over whether the treatment actually helps with cognitive decline. 

While Biden has yet to name a permanent agency head—a delay that has garnered criticism amid the pandemic—agency veteran Woodcock has been widely considered a top contender. Any future FDA commissioner would need the thumbs up from the Senate, which Democrats narrowly control.

“This approval underscores the fact that more of the same leadership at the agency is not the answer,” Manchin wrote in the letter. 

To many, Aduhelm’s wide-ranging FDA label came as a surprise, with some analysts calling it “almost shockingly broad.” The FDA didn’t limit Aduhelm to the early-onset patients studied in clinical trials, but instead gave the medicine the go-ahead for all Alzheimer’s patients.

The FDA's move also went against a resounding no vote from the agency’s own independent advisors late last year. At the very least, the FDA should provide an explanation as to why it went against the advisory committee, which it has yet done, Manchin argued. 

Since the approval, three members of the agency’s independent committee have resigned. One of those resignees, Harvard’s Aaron Kesselheim, candidly said in his resignation letter that the Aduhelm nod is “probably the worst drug approval decision in recent U.S. history.”

“The decision to approve drugs without the extra level of scrutiny about their safety and impact on public health has had lasting public health consequences,” Manchin wrote, noting the same rigorous review process for COVID-19 vaccines. 

A spokesperson for the FDA and the White House weren’t immediately available for comment. 

To be sure, the Aduhelm approval isn’t the only issue the West Virginia senator has taken up with Woodcock. Manchin, along with six other Democrat and Independent senators, called on Biden earlier this year to institute new FDA leadership to address the ongoing opioid crisis. In Manchin’s Thursday letter, the senator said Woodcock has “shown a dereliction of duty by not working to end” the opioid epidemic.

Meanwhile, Manchin isn’t the only one calling for Woodcock, as well as other top FDA officials, to hit the exit. 

Earlier this week, consumer advocacy group Public Citizen said Woodcock, as well as CDER Director Patrizia Cavazzoni and Billy Dunn, director of the FDA’s neuroscience unit, should resign following the “indefensible” Aduhelm approval, according to a letter dated Wednesday and sent to the Department of Health and Human Services. 

https://www.fiercepharma.com/pharma/sen-manchin-calls-for-woodcock-s-removal-as-fda-fallout-from-biogen-alzheimer-s-approval