Public Health Experts ‘Flabbergasted’ That Biden Still Hasn’t Picked an FDA Chief

Lambert here: Meanwhile, Scott Gottlieb is swanning around, making TV appearances, writing a book, and making policy recommendations.

By Rachana Pradhan, KHN Correspondent, reports on a broad array of national health policy decisions and their effect on everyday Americans. Originally published at Kaiser Health News.

President Joe 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 an average of 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 drug approvals and covid vaccines, and discord over decisions has spilled into public view.

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 three decades, has for months led as acting commissioner. She commands broad respect. But her perceived closeness to the drug industry, particularly with respect to the agency’s role in the opioid crisis, 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 who would helm 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.

But 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; former FDA official Michelle McMurry-Heath; and Scripps Research Translational Institute director Dr. Eric Topol (who confirmed to KHN he wasn’t interested). Then the process seemed to deadlock.

“People are just flabbergasted,” said Dr. John Whyte, chief medical officer of WebMD and 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 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 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 move quickly to implement a ban on menthol cigarettes — something it announced in April — and decide which e-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 said. “Waiting for a new commissioner is not an option.”

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

“One significant disadvantage to being ‘acting’ is there is no time frame of how long that individual will be in that position,” said 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, he said. “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, said 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 said.

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 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 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?”

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 on products, 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, a costly Alzheimer’s drug manufactured by Biogen that went to market even though experts say there’s 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, said Scott Whitaker, president and CEO of AdvaMed, which lobbies for the medical device industry. The expressed paradigm “can impact how you think about developing products.”

Others said Biden’s speed in announcing a nominee is less important than selecting the right one, a calculation that’s especially fraught given the agency’s recent controversies.

Chief among them was the criticism from several scientists after the Biden administration announced a plan for widespread covid “booster” shots beginning Sept. 20, well before agency scientists had finished necessary reviews. Woodcock had signed onto an HHS statement announcing the plan, but some experts 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 needed additional vaccine doses at this time.

The FDA was expected to authorize booster shots for high-risk patients and those 65 and older, following the recommendation Friday of an advisory panel that overwhelmingly rejected the administration’s initial plan to offer extra shots 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,” said 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 it differently.

“FDA approves drugs, and they have to work with industry,” she said. “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.”

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About Lambert Strether

Readers, I have had a correspondent characterize my views as realistic cynical. Let me briefly explain them. I believe in universal programs that provide concrete material benefits, especially to the working class. Medicare for All is the prime example, but tuition-free college and a Post Office Bank also fall under this heading. So do a Jobs Guarantee and a Debt Jubilee. Clearly, neither liberal Democrats nor conservative Republicans can deliver on such programs, because the two are different flavors of neoliberalism (“Because markets”). I don’t much care about the “ism” that delivers the benefits, although whichever one does have to put common humanity first, as opposed to markets. Could be a second FDR saving capitalism, democratic socialism leashing and collaring it, or communism razing it. I don’t much care, as long as the benefits are delivered. To me, the key issue — and this is why Medicare for All is always first with me — is the tens of thousands of excess “deaths from despair,” as described by the Case-Deaton study, and other recent studies. That enormous body count makes Medicare for All, at the very least, a moral and strategic imperative. And that level of suffering and organic damage makes the concerns of identity politics — even the worthy fight to help the refugees Bush, Obama, and Clinton’s wars created — bright shiny objects by comparison. Hence my frustration with the news flow — currently in my view the swirling intersection of two, separate Shock Doctrine campaigns, one by the Administration, and the other by out-of-power liberals and their allies in the State and in the press — a news flow that constantly forces me to focus on matters that I regard as of secondary importance to the excess deaths. What kind of political economy is it that halts or even reverses the increases in life expectancy that civilized societies have achieved? I am also very hopeful that the continuing destruction of both party establishments will open the space for voices supporting programs similar to those I have listed; let’s call such voices “the left.” Volatility creates opportunity, especially if the Democrat establishment, which puts markets first and opposes all such programs, isn’t allowed to get back into the saddle. Eyes on the prize! I love the tactical level, and secretly love even the horse race, since I’ve been blogging about it daily for fourteen years, but everything I write has this perspective at the back of it.


    1. Michael Ismoe

      Louis DeJoy might be available. If he can do for the FDA what he did for the Post Office, we can start getting our mortars and pestles ready.

  1. The Rev Kev

    What if they are picking not so much a leader for the FDA but a fall-guy instead? The fact that they haven’t filled that post may indicate that people know already that that job is a ticking time-bomb.

    1. Michael Ismoe

      Are you serious? This is the grift of a lifetime. “FDA Commissioner” is just another way of say “millionaire” in another language. Let’s just say that no one has ever left the this job and had to move directly to BK court.

      1. Arakawa

        Evidently due to inflation, the millions will now only buy someone who is too transparently stupid and or venial to be an effective figurehead.

      2. drumlin woodchuckles

        I suspect The Rev Kev’s theory is better. Also, Biden is too weak and semi-senile to keep track of all these things.

    2. NotTimothyGeithner

      The number of “qualified” people without problematic records is too high. It’s why Shrub let judicial appointees sit. Even lawyers weren’t crooked enough.

      It’s Biden, so I’ll go with the simpler explanation. Anyone interviewed would likely bring up Marijuana and cannabis derived products, a no-no for non Biden family members. It’s a seemingly easy win. John Boehner is in the industry. I imagine would be applicants can’t comprehend how out to lunch Biden is as they likely get too much news from cable sources.

  2. Monte McKenzie

    bigger ?
    Why is line 3 tar sands pipeline not being trashed by EPA
    & others?
    could it be the money Biden raised to beat Trump?

  3. Paula McMinn

    Just read a book called Unsavory Truth about what studies get funded and what gets approved in the food industry. I’m sure it’s the same across industries. The Deep pockets influence the outcomes, good or bad for the rest of us or ecosystem health.

  4. jr

    ” “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.”

    Gee, the language here has a message all it’s own. I thought the FDA was supposed to monitor those industries against bad practices! I thought the FDA was a safeguarding agency. The FDA should be terrifying the industry, not spooning with them.

    Strange days when the hustlers feel free to blurt out the quiet part…thought that was Trumps gig.

  5. Jeremy Grimm

    Ellen Sigal, founder of Friends of Cancer Research: “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.”

    How very true, and how very appalling and sad. That is indeed what the agency does. That is how most Government agencies have operated in the last few decades. They work cooperatively with the industries they were supposed to regulate and control. ‘Agency'(?) — agency on whose behalf?

  6. Societal Illusions

    18,000? i’m unclear how this many can seemingly accomplish so little. Why is it that we can only have double blind research studies done by large corporations with profit motives, again?

  7. Tom Stone

    I wonder how hot the bidding is for this job?
    It’s only a mid size rice bowl, but as has been mentioned it opens up a lot of career possibilities and income streams.
    There’s no shortage of people willing to service the public so perhaps this is as much about not helping a political rival as anything else.

  8. Susan the other

    Rock and a hard place for the democrats and Biden. Both Biden and Pelosi are on the record firmly against medicare for all or anything that looks like “socialized” medicine. The USA will become “Denmark” over their dead bodies. They undoubtedly are on the take; big donors from Pharma and the medical profession. Both of them spew nonsense propaganda like “health care is a human right” but neither one of them believes human rights should even slightly interfere with exorbitant profiteering – like the obscene profits now going on for American Medicine at its finest. It doesn’t flabbergast me that Biden has not chosen an FDA director – just about anybody he might choose is either a blatant criminal on the side of Biden and Pelosi or a sane, concerned professional fully against current American Medicine at its finest which Biden and Pelosi sanctimoniously promote. Biden really has no choices available. This is why our government doesn’t actually work.

  9. redleg

    The position is still up for bid. Be patient! They can’t possibly find the right person until bidding is complete.

  10. LarryMotuz

    It must be said that expecting Biden (or the Democratic Party elite) to search for an honest person for the job of the Commissioner– like Diogenes’s search, even if only apocryphally — goes somewhat against the grain of the party since Clinton was President. Or, perhaps they are searching for someone who has the appearance of an honest man, the problem being that finding even that where they are searching is a time-consuming, likely fruitless activity which must be seen to be being done for appearances sake.

  11. drumlin woodchuckles

    Here is an article from Tony Wikrent’s weekly roundup as re-printed every Sunday by Ian Welsh.–I-need-help-Michigan-county-health-director-pleads-for-help-after-almost-being-run-off-the-road

    Here is a paragraph from out of that article.
    ” As people resort to violence across the country, health officials are pleading for help. In one horrific incident, a Michigan County health director pleaded with county commissioners for help after almost being run off the road following the issuance of a mask mandate for preschool through sixth-grade school buildings, Michigan Advance reported.”

    The people doing this sort of thing are vile subhuman filth, sh*t, and garbage. They have no human feeling and they deserve no human sympathy. Only someone with Stockholm Syndrome regarding the Typhoid MAGA militant plague spreaders could feel otherwise. They seek to destroy public health for the rest of us. Only someone with PMC Derangement Syndrome could believe that public health employees deserve to be run off the road because ” they are PMC.”

    These so-called “people” deserve to have Life-LongTail Covid for the rest of their lives. They deserve to live with it till 120 years old. And in all sincerity, I hope they get it because they deserve it.

    They are not my fellow Americans. They are not my fellow anything.

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