The FDA Has Been Without A Permanent Leader For 8 Months As COVID Cases Climb

President Biden's failure to name someone to lead the Food and Drug Administration, more than 10 months after the election, has flummoxed public health experts who say it's baffling for the agency to be without a permanent leader during a national health crisis.

The pandemic has taxed the FDA, an 18,000-person agency whose chiefs have traditionally received bipartisan backing during the Senate confirmation process. Many leaders in public health, industry and consumer groups agree that Biden's foot-dragging on finding a new director has demoralized the staff and sent the wrong message about the agency's importance, even as the toll of COVID-19 mounts, with a recent average of more than 130,000 new cases and 1,500 deaths daily, according to the Centers for Disease Control and Prevention.

It's a tough job in normal times, observers say, and at the moment may be the worst top job in Washington. At the heart of the tension is finding a nominee who balances the agency's dual responsibilities of protecting public health while also working with the drug, medical device and other industries to approve products and treatments for market. Meanwhile, the agency has been mired in controversies related to approvals for drugs and COVID-19 vaccines; the discord over decisions has spilled into public view.

Why it's a "difficult post to fill"

FDA commissioner is a "particularly rough job in wartime," said Steven Grossman, executive director of the Alliance for a Stronger FDA, an outside organization consisting of industry, research and other groups, which pushes for Congress to increase agency funding. "It is a much more difficult post to fill than it appears to the eye."

Dr. Janet Woodcock, an agency veteran of more than three decades, has for months led as acting commissioner. She commands broad respect. But her perceived closeness to the pharmaceutical industry, particularly with respect to the agency's role in the opioid crisis, has led some Senate Democrats to come out against her official assumption of the role. Biden would need all Democrats on board or some Republican senators to back his choice to get the votes for confirmation.

In December, Biden announced other top health appointees he hoped would lead his pandemic response, including Health and Human Services Secretary Xavier Becerra, Surgeon General Vivek Murthy and CDC Director Rochelle Walensky. HHS oversees the FDA — as it does the office of the surgeon general, the CDC and the National Institutes of Health.

Others considered for nomination by Biden's team

But eight months after Biden's inauguration, there's still no sign of an FDA nomination. Biden officials reportedly considered multiple potential candidates throughout the spring, including Woodcock, former top FDA official and Maryland Health Secretary Joshua Sharfstein (who declined to comment for this story), former FDA official Michelle McMurry-Heath and Scripps Research Translational Institute Director Dr. Eric Topol (who confirmed to Kaiser Health News he wasn't interested). Then the process seemed to deadlock.

"People are just flabbergasted," says Dr. John Whyte, chief medical officer of WebMD and a former FDA official. "We don't even have rumors of viable candidates."

Many of the agency's other critical responsibilities require sustained leadership even as the FDA urgently vets COVID-19 treatments, tests and vaccines, according to people in public health, the health care industry and consumer groups. The FDA oversees much of the nation's food supply and the regulation of tobacco products and reviews the use of everything from stents and catheters to cancer drugs.

Another hot-button issue: teen vaping

Long-term decisions on tobacco regulation can't wait, says Matthew Myers, president of the Campaign for Tobacco-Free Kids, a consumer advocacy group that has been pushing the FDA to move quickly to implement a ban on menthol cigarettes (a ban the agency announced in April) and to decide which electronic cigarettes can stay on the market. This month the agency punted on whether it would ban the sale of e-cigarettes from several major companies, including Juul, the largest maker of such products.

"What the FDA does over the next weeks or months with regard to e-cigarettes will determine whether we have a decades-long youth e-cigarette epidemic or whether we reverse it now," Myers says. "Waiting for a new commissioner is not an option."

He and others conceded that, regardless of Woodcock's qualifications, any acting commissioner's ability to set priorities is diminished. That adds to anxiety about a leadership vacuum, even though few doubt her expertise.

Instability at the top has been a "morale hit" to the FDA staff

"One significant disadvantage to being 'acting' is there is no time frame of how long that individual will be in that position," says Dr. Andrew von Eschenbach, FDA commissioner in the George W. Bush administration. As important work is executed, "there is no certainty" how long an acting leader is "going to be there" to see it through, von Eschenbach says. "That's an instability that is very, very difficult to deal with."

For agency staffers, it stings to see other physicians in the Biden administration speak publicly on issues squarely in the agency's purview, says Stacy Cline Amin, a partner at law firm Morrison & Foerster and former chief counsel of the agency.

"It's been a morale hit for FDA," she says.

Under federal law, Woodcock can serve as acting commissioner until mid-November unless Biden nominates a permanent commissioner, in which case she can remain until the Senate confirms that person.

"People are anxious," says Ellen Sigal, founder of the influential nonprofit Friends of Cancer Research, which receives funding from the pharmaceutical industry and supported Woodcock for the job. "Is it going to be someone that knows the agency? Is it going to be someone that people really respect and really want to work with?"

Controversial decisions on Alzheimer's drug and COVID-19 vaccine boosters

The FDA is overwhelmingly run by career scientists whose jobs don't depend on who wins the White House. Any Senate-confirmed leader largely defers to the scientists who run FDA divisions to make decisions regarding products, according to former officials and others with knowledge of the agency's inner workings. For example, an FDA spokesperson says Woodcock was not involved in the controversial decision to approve Aduhelm, a costly Alzheimer's drug manufactured by Biogen that some research neurologists and others say went to market despite little evidence it works.

But in July, the lingering controversy led Woodcock to ask the HHS Office of Inspector General to "conduct an independent review and assessment of interactions between representatives of Biogen and FDA during the process that led to the approval of Aduhelm."

A leader appointed by the president and confirmed by the Senate has clout in setting priorities, hiring staff and making long-term decisions.

"The commissioner has obviously tremendous influence ... not on a product-by-product basis but what the philosophy is" related to the regulatory process, says Scott Whitaker, president and CEO of AdvaMed, which lobbies for the medical device industry. That philosophy expressed by the head of the agency "can impact how you think about developing products," he says.

Others say Biden's speed in announcing a nominee is less important in the end than selecting the right person, a calculation that's especially fraught given the agency's recent controversies.

Chief among them recently was the criticism from several scientists after the Biden administration announced a plan in August for widespread COVID-19 booster shots beginning the week of Sept. 20 — an announcement that came well before agency scientists had finished necessary reviews. Woodcock had signed on to an HHS statement announcing the plan, but some critics said the proposal came too far ahead of the science and unfairly jammed her staff.

Two veteran FDA officials who have announced their retirements were part of an international group of scientists that published an essay in The Lancet questioning whether the general public needs additional vaccine doses at this time.

The FDA is expected this week to authorize booster shots for high-risk patients and those age 65 and older, following the recommendation Friday of an advisory panel to the agency. The panel overwhelmingly rejected the administration's initial plan to offer extra shots more widely — for the general population — citing a need for additional research.

The White House didn't respond to questions about why Biden hasn't nominated someone as FDA commissioner or set a timeline for doing so.

"If it takes a little longer to get the right person who's going to be more aligned in protecting public health and represent interests of the public, as opposed to the interest of industry, which is what the case has been for many years under Dr. Woodcock, then it may be worth the wait," says Dr. Michael Carome, director of the health research group at Public Citizen, a liberal advocacy group that opposed Woodcock's nomination. The FDA referred a request for comment to the White House, which didn't respond.

Sigal sees the question of who should lead the FDA differently.

"FDA approves drugs, and they have to work with industry," she says. "The fact that you work with industry on drug development or on diagnostics with developers, or you work with people that are manufacturing food, with manufacturers or whatever — it's what the agency does."

Kaiser Health News is a national, editorially independent newsroom and program of the Kaiser Family Foundation. KHN is not affiliated with Kaiser Permanente.

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