Aduhelm Approval Could Imperil Woodcock's Future as FDA Commissioner

Stefani Reynolds-Pool/Getty Images

Since the beginning of President Joe Biden's administration, Janet Woodcock, the longtime director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA), has served as acting commissioner. But a controversial approval of an Alzheimer’s medication could prevent her from dropping the “acting” from her title.

According to Bloomberg, Woodcock faces heavy opposition from an evenly divided U.S. Senate, particularly from West Virginia Sen. Joe Manchin, who has been critical of the approval process for Biogen’s Aduhelm, formerly known as aducanumab.

Aduhelm was approved by the FDA in June under accelerated approval. But the approval was highly controversial due to an overwhelming rejection of the medication by the agency’s advisory committee. Following the FDA decision to approve the medication, at least three members of that advisory committee resigned in protest.

Public Citizen, a watchdog group, called for additional resignations at the FDA, including Woodcock’s, due to what that group said is a lack of clinical data supporting approval. A U.S. House of Representatives committee has planned to investigate the approval process, as well as the pricing of the drug, which has a list price of $56,000 per year.

Manchin has been critical of the approval of Aduhelm and of Woodcock. Bloomberg cited a letter Manchin sent to the White House in June following the approval of Aduhelm, calling for a replacement to Woodcock. He argued that not having a commissioner in place impacts the response to the pandemic, as well as other regulatory concerns.

According to Bloomberg, Manchin wrote, “Without a permanent, confirmed commissioner in place to lead the FDA, important decisions that impact the country’s response to Covid-19 will be slowed and prevent additional work to combat the ongoing drug overdose epidemic.”

Woodcock, 72, first joined the FDA in 1986 and has served in CDER since 1994 in a variety of leadership roles. Like many in leadership in the FDA, Woodcock has shifted her focus from regulatory approvals to the ongoing COVID-19 crisis. In May 2020, she temporarily stepped away from her CDER duties to assist Operation Warp Speed, the pandemic response under the previous administration, and the federal government’s efforts to rapidly develop vaccines against the novel coronavirus.

Despite the mounting criticism, Biden has not indicated when he will announced a permanent commissioner. Under federal rules, Woodcock is able to serve as acting FDA commissioner until Nov. 15, unless the president nominates someone during that time who has yet to be confirmed by the Senate.

The White House, which is still managing the ongoing COVID-19 crisis amidst a resurgence of spread due to the Delta variant, has not publicly tipped its hand regarding a permanent commissioner. A spokesperson for the White House told Bloomberg that the FDA currently has “strong acting leadership in place” while the government responds to the pandemic. Spokesman Chris Meagher said the administration will share information regarding a nominee “with the requisite expertise and leadership for this job.”