Janet Woodcock reportedly out of the race for permanent FDA commissioner
Biden has until November 15, when Woodcock's term as acting commissioner expires, to nominate a permanent head.
Photo: Stefani Reynolds-Pool/Getty Images
Now seven months into Joe Biden's presidency, the administration is no closer to appointing a permanent head of the Food and Drug Administration, as Bloomberg reports that the White House has officially ruled out Dr. Janet Woodcock for the full-time gig.
Woodcock, who has served as acting commissioner for the FDA since January when former commissioner Dr. Stephen Hahn stepped down, began her career with the agency in 1986. She joined with the agency's Center for Biologics Evaluation and Research and held the position of Center for Drug Evaluation and Research director multiple times throughout her career.
Despite her history with the FDA, "officials have privately concluded that she won't be the nominee," according to Bloomberg.
Biden has until November 15, when Woodcock's term as acting commissioner expires, to nominate a permanent head.
Earlier this month, White House officials told CNN it could be "weeks" before Biden makes his nomination. According to White House press secretary Jen Psaki, the search remains a priority for the administration, but Biden is waiting to find "exactly the right person."
WHAT'S THE IMPACT?
The prospect of confirming a permanent commissioner appears to be a determining factor in the administration's nomination, as the Senate is currently evenly split across party lines.
Woodcock came under fire following the FDA's approval of the controversial Alzheimer's drug Aduhelm. The drug has shown effectiveness at reducing plaques that build up in the brains of people afflicted with the disease, but separate studies have disagreed on whether it slows the decline in memory and thinking typically associated with Alzheimer's.
Among her most vocal opponents is Democratic Senator Joe Manchin, a key swing vote from West Virginia. In June, he sent a letter to Biden calling into question Woodcock's leadership after the FDA deviated from its advisory council's recommendation against approving Aduhelm.
"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," Manchin said in the letter. "I hope the Biden Administration will examine the consequences of Dr. Woodcock's leadership and appoint someone more suited to lead our country out of this devastating pandemic."
THE LARGER TREND
Back in March, a group of former FDA commissioners sent Biden a letter urging him to nominate a permanent head, citing the ongoing COVID-19 pandemic as a reason to do so.
Yet the nomination process presses on at a time when the FDA oversees a number of the nation's pandemic responses, including the review of drug manufacturer applications, vaccine approvals and inspections.
Even without a fixed leader, the FDA today granted full approval to Pfizer and BioNTech's COVID-19 vaccine, which will now be marketed as Comirnaty. The vaccine has been approved for the prevention of COVID-19 for those 16 years old and older. It will continue to be available under emergency use authorization for those 12 to 15, and for the administration of a third dose in certain immunocompromised patients.
The FDA is also set to conduct an investigation into the safety and effectiveness of a third dose of Pfizer and Moderna's vaccines following the Biden Administration's announcement that Americans can get a booster shot eight months after a second dose.
Twitter: @HackettMallory
Email the writer: mhackett@himss.org
