FDA still without a permanent leader as clock ticks down on acting head

Janet Woodcock, acting commissioner of the US Food and Drug Administration, listens during a Senate Appropriations subcommittee hearing in June.

By Kristen Holmes, CNN

(CNN) -- The clock is ticking down on the time President Joe Biden has to appoint a permanent head to the US Food and Drug Administration -- an agency critical to fighting the coronavirus pandemic -- with no outward signs he has a candidate in mind.

Dr. Janet Woodcock is serving as the acting leader of the agency, but legally she can stay on as acting head only through November 15, unless a permanent commissioner is nominated.

Last month, the White House would not predict what the timeline was for nominating a permanent head.

"The role of the FDA commissioner is critically important, as you all know, especially during the Covid-19 pandemic," White House deputy press secretary Karine Jean-Pierre told reporters Tuesday. "We have strong acting leadership in place that is playing an important role in our Covid-19 response and beyond, and look forward to sharing a nominee with the required expertise and leadership for this job, so hopefully we have something soon to share."

When asked Tuesday if he has a nominee in mind, Biden said: "We'll be talking about that in a little bit."

While Woodcock was once considered a top contender for the permanent position, administration officials told CNN she was no longer in the running after she came under fire from several Senate Democrats over the agency's role in the opioid crisis. But with roughly 40 days until her time is up, the White House has not indicated who might be under consideration for the position.

The deadline comes as the White House has another key health leadership role to fill, with the decision of Dr. Francis Collins, the National Institutes of Health director, to step down by the end of the year. Collins has led the agency for more than a decade.

Sources close to the FDA nomination process said the administration has spent time over the last 10 months looking at recommendations for the role, including from former FDA commissioners, and even putting some candidates through a vetting process, only to come up short so far.

There has been an emphasis on looking for someone who understands the communication challenges of public health and the agency, rather than just focusing on an academic -- prompted by what some see as verbal missteps from Dr. Rochelle Walensky, who helms the US Centers for Disease Control and Prevention.

While the FDA granted full approval to Pfizer's coronavirus vaccine in August under Woodcock's leadership, health officials say having a permanent head is critical.

"The lack of an FDA commissioner now, nine months into the Biden administration, I think is something that a lot of people just do not understand," said Dr. Leana Wen, an emergency physician and professor of health policy and management at the George Washington University who's a CNN medical analyst. "Think about what's on the FDA's docket right now: boosters, vaccines for younger kids, treatments, tests even that are approved by the FDA ... it's long past time for President Biden to nominate a permanent director there."

Lawmakers have also expressed frustration.

"Frankly, this nomination is long overdue," said Sen. Richard Burr of North Carolina, the top Republican on the Senate Health, Education, Labor and Pensions Committee. "The FDA has played a vital role in leading our pandemic response ... and has largely performed that role well. But beyond the pandemic, it's going to be incumbent on the FDA, working with Congress, to start applying the lessons we've learned during this crisis, so we're better prepared for the next public health threat and the next generation of medical breakthroughs."

There's also a danger in Woodcock leading the FDA past the November deadline with no named nominee, as it could open the agency to challenges to her authority and any actions under her watch. During the Trump administration, which chronically kept people in acting positions, officials faced lawsuits that threatened to undo the policies they implemented while in office.

Complicating matters even more is some recent internal turmoil at the agency.

Last month, two senior leaders in the vaccine review office announced they were stepping down, even as the agency is working toward high-profile decisions around Covid-19 vaccine approvals, authorizations for younger children and booster shots. The retirements of Dr. Marion Gruber, director of the Office of Vaccines Research and Review at FDA's Center for Biologics Evaluation and Research, and Dr. Philip Krause, deputy director of the office, were announced in an internal agency email.

After the announcement, Woodcock told FDA staff that the agency was operating in "difficult times."

"Following today's announcement that Marion and Phil have decided to retire, I wanted to reach out to reiterate my full support and complete confidence in your ability to continue delivering on the agency's mandate to deliver safe, effective and high-quality vaccines to the American people," Woodcock said in a separate email to staff that was sent to CNN at the time.

And soon the White House will have Collins' leadership role to fill at the National Institutes of Health. The White House said Tuesday that it expects to nominate someone for the position before he leaves.

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