Public health experts surprised Biden didn’t pick FDA chief

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President Joe Biden’s failure to nominate someone to head the Food and Drug Administration, more than 10 months after the election, has baffled public health experts who say it is baffling for the agency not to have a permanent leader during a national health crisis.

The pandemic has taxed the FDA, an agency of 18,000 people whose heads have traditionally received bipartisan support during the Senate confirmation process. Many leaders in public health, industry, and consumer groups agree that dragging Biden’s feet to find a new director has demoralized staff and sent the wrong message about the agency’s importance, even as the covid-19 toll increases, with an average of 130,000 new cases and 1,500 deaths per day, according to the Centers for Disease Control and Prevention.

It’s hard work in normal times, observers say, and right now it is perhaps the worst high profile job in Washington. At the heart of the tension is the search for a candidate who balances the dual responsibilities of the public health protection agency while working with the drug, medical device and other industries to approve products and treatments for the market. Meanwhile, the agency has become mired in controversies over drug approvals and covid vaccines, and discord over the decisions has spread to the public.

The commissioner of the FDA is “a particularly difficult job in wartime,” said Steven Grossman, executive director of the Alliance for a Stronger FDA, an external organization made up of industry, research and other groups, which pushes Congress to increase agency funding. “This is a much more difficult position to fill than it looks.”

Dr Janet Woodcock, a three-decade veteran of the agency, headed the post of interim commissioner for months. It commands a wide respect. But his perceived closeness to the pharmaceutical industry, particularly with regard to the agency’s role in the opioid crisis, has led some Senate Democrats to speak out against his formal assumption of that role. Biden would need all the Democrats on board or some Republican senators to support his choice to get the votes for confirmation.

In December, Biden announced other senior health officials who would lead his response to the pandemic, including Health and Human Services Secretary Xavier Becerra, Surgeon General Vivek Murthy and CDC Director Rochelle Walensky. The HHS oversees the FDA, as does the Office of the Surgeon General, the CDC, and the National Institutes of Health.

But still no sign of an FDA appointment. Biden officials reportedly considered several potential candidates throughout the spring, including Woodcock; former senior FDA official and Maryland Health Secretary Joshua Sharfstein; former FDA official Michelle McMurry-Heath; and the director of the Scripps Research Translational Institute, Dr Eric Topol (who confirmed to KHN that he was not interested; Topol is the editor-in-chief of Medscape.)

Then the process seemed to be deadlocked.

“People are just flabbergasted,” said Dr. John Whyte, chief medical officer of WebMD and former head of the FDA. “We don’t even have any rumors of viable candidates.”

Many of the agency’s other critical responsibilities require sustained leadership, even as the FDA urgently controls covid treatments, tests, and vaccines, according to public health officials, the healthcare industry and officials. consumer groups. The FDA oversees much of the nation’s food supply and tobacco product regulation, and examines everything from stents and catheters to cancer drugs.

Long-term decisions on tobacco regulation can’t wait, said Matthew Myers, president of the Campaign for Tobacco-Free Kids, which has pushed the FDA to act quickly to implement a ban on menthol cigarettes – something that it announced in April – and decide which e-cigarettes can stay on the market. This month, the agency asked if it would ban the sale of e-cigarettes from several large companies, including Juul, the largest maker of these products.

“What the FDA does over the next few weeks or months with respect to e-cigarettes will determine whether we have a decades-long youth e-cigarette epidemic or whether we are reversing it now,” said Myers. “Waiting for a new commissioner is not an option.

He and others conceded that whatever their qualifications, an interim commissioner’s ability to set priorities is diminished. This adds to anxiety about a leadership vacuum, even though few doubt Woodcock’s expertise.

“A significant drawback of being ‘acting’ is that there is no time frame for how long that individual will be in that position,” said Dr. Andrew von Eschenbach, FDA commissioner in the George administration. W. Bush. While important work is being done, “there is no certainty” how long an interim leader “is going to be there” to carry it out, he said. “It’s instability that is very, very difficult to deal with.”

For agency staff, it is peculiar to see other doctors in the Biden administration speak out publicly on matters directly within the agency’s purview, said Stacy Cline Amin, partner at the firm of attorneys Morrison & Foerster and former agency senior advisor.

“It was a blow to the morale of the FDA,” she said.

Under federal law, Woodcock can serve as interim commissioner until mid-November, unless Biden appoints a permanent commissioner, in which case she may stay until that person is confirmed by the Senate.

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

The FDA is overwhelmingly run by career scientists whose jobs don’t depend on whoever wins the White House. Any leader confirmed by the Senate relies heavily on the scientists who run the FDA’s divisions to make product decisions, according to former officials and experts with knowledge of the agency’s inner workings.

For example, an FDA spokesperson said Woodcock was not involved in the controversial decision to approve Aduhelm, an expensive Alzheimer’s disease drug made by Biogen that hit the market even though experts say there is little evidence that it works. But in July, the lingering controversy led Woodcock to question the Office of the Inspector General of HHS to “conduct an independent review and assessment of the interactions between representatives of Biogen and the FDA during the process leading to Aduhelm’s approval.”

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 obviously has enormous influence … not on a product-by-product basis but on philosophy,” said Scott Whitaker, president and CEO of AdvaMed, which lobbies for the medical device industry. The expressed paradigm “may have an impact on how you view product development”.

Others said Biden’s speed in announcing a candidate is less important than selecting the right one, a particularly difficult calculation given the agency’s recent controversies.

Chief among these were criticisms from several scientists after the Biden administration announced a plan for widespread covid “booster” shots from September 20, long before the agency’s scientists completed the tests. necessary examinations. Woodcock had signed a statement from HHS announcing the plan, but some experts said the proposal was too far ahead of science and unfairly blocked his staff. Two FDA veterans who announced their retirement were part of an international group of scientists who published an essay in The Lancet wondering if the general public needs additional doses of the vaccine right now.

FDA was to clear booster shots for high-risk patients and people 65 and older, following a recommendation on Friday from an advisory group that overwhelmingly rejected the administration’s initial plan to offer additional injections to the general population, citing a need for further research.

The White House did not respond to questions about why Biden did not appoint someone as FDA commissioner or set a timeline for doing so.

“If it takes a little longer to find the right person who will be more aligned with protecting public health and representing the interests of the public, as opposed to the interests of industry, which has since been the case many years under Dr. Woodcock, so it might be worth the wait, ”said Dr. Michael Carome, director of the health research group at Public Citizen, a liberal rights advocacy group that works. opposed Woodcock’s appointment.The FDA returned a request for comment to the White House, which did not respond.

Sigal sees it differently.

“The FDA approves drugs, and they have to work with industry,” she said. “Whether you’re working with industry on drug development or on diagnostics with developers, or working with people who make food, manufacturers or whatever, that’s what the agency does. “



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