President Biden has yet to nominate a permanent head of the Food and Drug Administration (FDA) at a time when the government is navigating a surge in COVID-19 cases from the delta variant.

It’s unclear why the post remains vacant more than six months into Biden’s presidency, but some experts suggest politics may be getting in the way.

Some Democratic senators are pushing back on the prospects of acting Commissioner Janet Woodcock being named to the permanent role, but health care experts are warning that the administration needs to fill the position immediately.

The tensions come as the FDA is coming under increasing pressure to grant full approval for the COVID-19 vaccines to boost confidence in the shots and potentially the country’s vaccination rate, with just half of the population now fully vaccinated.

The White House has been adamant that it is taking its time so that Biden can nominate someone with the right expertise for the job.

“The role of FDA commissioner is critically important, especially during the COVID-19 pandemic. 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 requisite expertise and leadership for this job,” a White House official told The Hill when asked if the president is concerned about not having a FDA commissioner as the delta variant pushes case counts higher.

White House press secretary Jen Psaki said she didn’t have an update on timing when asked about the status of a permanent pick.

“Obviously, the president would love to have a permanent pick in place and wants to nominate the right person, but I don't have an update on the timeline for that,” she said this past week, adding that he “has not identified the right person to nominate quite yet.”

Biden selected Woodcock, a longtime FDA regulator, to serve as the acting commissioner in January but has since received pushback, including from senators and anti-opioid advocates on that move.

Several Democratic senators have voiced opposition to Woodcock, citing her time at the FDA when opioid painkillers were approved, later contributing to an epidemic that has left many Americans dead.

“I continue to have concerns about Dr. Woodcock as a potential permanent FDA Commissioner, especially given the role she played in approving and labeling opioid-based medications,” Sen. Maggie Hassan (D-N.H.), a member of the Senate Health, Education, Labor and Pensions Committee, said in a statement.

“That’s why I’ve called on President Biden to put forward an FDA commissioner who will act independently from the industry that he or she regulates.”

Sen. Joe Manchin (D-W.Va.), a centrist, has also called on the administration to prioritize nominating a different commissioner, citing concerns about the opioid epidemic and the FDA’s controversial approval of the Alzheimer’s drug Aduhelm.

“Dr. Woodcock is not the right person to lead the FDA,” he wrote in a June letter to Biden.
Two months earlier, Sen. Catherine Cortez Masto (D-Nev.) vowed to oppose a potential Woodcock nomination.

Her prospects have not improved over the summer.

In a statement, Sen. Ed Markey (D-Mass.) called for a “permanent, qualified, trusted” commissioner to address the pandemic and opioid epidemic. Without specifically mentioning Woodcock, he said, “The FDA needs a leader who will learn from the agency’s past mistakes to ensure it never makes them again.”

Other names floated for commissioner include Zeke Emanuel, former health policy adviser in the Obama administration and an architect of the 2010 Affordable Care Act; Michelle McMurry-Heath, CEO of the Biotechnology Innovation Organization; Katherine Luzuriaga, director of the University of Massachusetts Center for Clinical and Translational Science; and Florence Houn, who worked at the FDA during multiple administrations.

Experts said they are puzzled by the delay in nominating a commissioner amid a pandemic.

Scott Becker, CEO of the Association of Public Health Laboratories, called it “very odd” that there’s no permanent head or even a nomination in the pipeline, saying he would have expected “this would have been one of the first agencies” to get its confirmed leader.

“Now's the time to nominate someone. ... Three months ago I would have said the same thing,” he said.
Some experts emphasized that it’s more important to get the right nominee than to rush one through the Senate.

“It's taken the administration rather a long time to make a decision,” said Diana Zuckerman, president of the National Center for Health Research. “It makes it even more important that they make the right decision, not just be pushed into making a decision in the next X number of weeks or months.”

Zuckerman called for the Biden administration to prioritize choosing a nominee with a “very strong public health perspective,” noting that Woodcock has become an “untenable” candidate amid the opposition and “controversial” decisions at the agency during her tenure, which dates back to 1986.

Still, Anna Abram, a deputy commissioner at the FDA during the Trump administration, said the public pressure to nominate a permanent agency leader may be more limited because Woodcock is “a steady hand at the helm.”

“But that doesn’t change the fact that there is a clock running and this ... really significant outstanding question of what is the plan for FDA,” she said, noting that permanent positions at the Department of Health and Human Services have been filled.

“How do you square the tremendous significance and impact that this agency has and its importance within the fact that they haven’t put forward a nominee to lead the agency long term?” she said. “That’s a little difficult to reconcile.”

Amid the delay, the FDA is facing calls from the public to provide full approval for any of the three COVID-19 vaccines to reduce hesitancy among unvaccinated people and to authorize the shot for children under 12 years old as the school year approaches. Some experts are also requesting the FDA back booster shots for vulnerable populations.

The role of FDA commissioner is especially challenging at this time while the administration navigates the best messaging to boost confidence in the COVID-19 vaccine. Scott Gottlieb, who served as FDA commissioner under former President Trump, is constantly sharing his insight in the media on coronavirus, highlighting the demands of being commissioner.

Daniel Fabricant, director of the Division of Dietary Supplement Programs at the FDA under former President Obama, said having someone in the commissioner’s office “drives the dialogue. It puts the dialogue back in the place of science. They need someone to drive the conversation publicly and drive it outside maybe the political wills.”

“COVID is a very tall shadow that looms over the agency, and I think for someone, no matter whoever is the commissioner, will have to reconcile the COVID issues, and that’s a lot to ask,” Fabricant said. “It’s a blood sport right now.”
Source: The Hill
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