Sen. Joe Manchin (D-W.Va.) on Thursday called on President Biden to nominate a permanent Food and Drug Administration (FDA) commissioner following the agency’s controversial decision to approve a new Alzheimer’s drug.

In a letter, the West Virginia senator requested Biden move forward with selecting an official to obtain Senate confirmation and lead the FDA. 

Janet Woodcock has served as the acting commissioner since Biden's inauguration.

Manchin argued that a confirmed commissioner is needed as the agency reviews COVID-19 vaccine manufacturers’ applications for full approvals and strives to gain back public trust in the FDA. 

“We need urgency as the world emerges from the COVID-19 pandemic,” he wrote. “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.”

Manchin specifically cited the FDA’s decision to approve the drug Aduhelm as reasoning for Woodcock to be replaced. 

While the senator acknowledged that the approval gave hope to Alzheimer’s patients, he also pointed out that the FDA’s independent advisory panel overwhelmingly rejected Aduhelm, saying there was a lack of evidence to prove that it worked. 

The FDA’s approval led to backlash, including the resignations of at least three scientists from the advisory committee.  

“This brings into question the current interim leadership of Dr. Woodcock, at a time when strong, trusted leadership at our health agencies is most important,” Manchin wrote. 

“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 added. 

He also expressed concerns about the opioid crisis after the U.S. recorded a jump in overdose deaths last year, saying the epidemic is “headed in the wrong direction.” Manchin accused the FDA of playing “a critical role” in the opioid epidemic by approving drugs.

“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,” he said.  

With Biden’s budget requesting a nearly 8 percent increase in FDA funding, Manchin also said a confirmed commissioner was essential to make sure the funding is “spent wisely and provides the resources our nation needs to recover from the pandemic, combat the opioid crisis, and restore public trust in the agency.”

The White House and FDA did not immediately respond to a request for comment.