A big day for boosters

By Adam Cancryn and Sarah Owermohle

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— An FDA advisory panel will debate the merits of distributing additional Covid-19 vaccines, in a key test for the Biden administration's booster plan.

— Florida Gov. Ron DeSantis is attacking HHS for limiting access to Covid-19 antibody treatments, amid the state's heavy reliance on the drugs.

— Former FDA Commissioner Scott Gottlieb writes in his new book that the CDC's culture — and the nation's pandemic planning — need an overhaul.

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A BIG DAY FOR BOOSTERS — The Biden administration could take its first shaky step into the booster era today, as an FDA vaccine advisory panel meets to debate the merits of giving Americans an additional dose.

The all-day discussion is likely to be weedy and technical, with drug experts and regulators paging through reams of data and deliberating over the finer points of statistics spelling out the safety and effectiveness of a third Covid-19 shot.

But the stakes couldn’t be clearer: The panel is the first test the Biden administration must pass to keep its promise to start doling out boosters next week – a high-profile and controversial strategy that’s divided health experts and government officials alike.

The panel’s blessing could go a long way toward smoothing the path for Covid-19 boosters, lending scientific credibility to the plan and clearing the way for the FDA to give it the official green light.

Prominent health officials, including chief medical adviser Anthony Fauci, have already thrown their weight behind the immediate need for boosters. And while the CDC would still need to weigh in, it would be largely a formality by that point.

Yet if there’s disagreement, it could further bog down the White House in a mess of its own making. Biden officials last month insisted on setting a firm deadline for booster distribution, betting that their scientific agencies would fall in line.

That didn’t quite come to pass. First, the FDA and CDC told the White House it wouldn’t be able to authorize boosters for all three vaccines. Then, two top FDA vaccine regulators overseeing the process announced their resignations – later co-authoring an article published this week in The Lancet arguing against the booster plan. The process has sparked accusations of political pressure and deepened divisions within the administration.

“It’s in the realm where reasonable people might differ on what the recommendation might be,” former FDA Commissioner Mark McClellan told PULSE. “I’m not sure if there’s going to be a unanimous vote on authorization.”

If there’s drama, it’ll happen early. Top vaccine regulator Peter Marks is scheduled to open the meeting at 9 a.m. Speaking next will be Marion Gruber, one of the outgoing officials who signed onto the scathing critique of the booster plan just days ago.

The meeting agenda | Livestream

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FLORIDA FEUDS OVER COVID TREATMENT CUT — GOP Gov. Ron DeSantis is opening a new front in his war with the Biden administration , this time over the government’s decision to seize control of the distribution of Covid-19 antibody drugs.

DeSantis blasted President Joe Biden’s health department on Thursday, accusing it of withholding critical therapies and punishing Florida for taking advantage of the federal supply to ramp up antibody treatments for its coronavirus patients.

The attack follows HHS’ announcement earlier this week that it would reinstitute a more rigid allocation system, citing the potential for shortages and need to more evenly distribute the drug. Just seven southern states — including Florida — accounted for 70 percent of all antibody treatment orders in early September.

“Our role as the government overseeing the entire country is to be equitable in how we distribute,” White House Press Secretary Jen Psaki said. “We’re not going to give a greater percentage to Florida over Oklahoma.”

That’s likely to scramble Florida’s pandemic strategy. DeSantis and other red-state governors have rejected mask requirements and other public health measures in favor of relying heavily on the antibody treatments.

But under HHS’ new distribution model, Florida is set to get fewer than 28,000 doses this week. That’s still the most in the country, but it’s well below the 72,000 that DeSantis’ office said they averaged in prior weeks.

Overall, the seven states that accounted for 70 percent of the federal supply originally are now set to receive closer to 55 percent – with the rest allocated among the remaining states, districts and territories.

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UNCONTROLLED SPREAD: GOTTLIEB ON COVID AND THE CDC — Health officials made several missteps early in the pandemic that set the course for calamity – but also offer lessons for the inevitable next outbreak, former FDA Commissioner Scott Gottlieb writes in his new book, “Uncontrolled Spread,” which is out next week.

PULSE got an early peek, and then chatted with Gottlieb about his main takeaways:

— CDC needs a culture shift. The book lays bare Gottlieb’s frustrations with what he’s long seen as a slow-moving and opaque public health agency (a sentiment now permeating parts of the Biden administration) – highlighting early failures on testing and tracking the virus.

“It’s just not their culture” to put out real-time, actionable data, he told PULSE. That led to some early Trump administration errors, like insisting there wasn’t community spread, that decimated White House trust in the CDC.

“Unfortunately, the early mistakes and the overconfidence ended up empowering the wrong policy people in the White House,” Gottlieb said. “They were able to use that against the public health officials and public health establishment.”

— Pressure on FDA had a ripple effect. “The agency … is at its best when they’re able to exercise their discretion, when they can make decisions based on scientific data that they’re reviewing but they don’t have to make a decision in advance of actually seeing the data,” Gottlieb, who sits on the board of Pfizer, said.

The book recounts controversies over hydroxychloroquine and convalescent plasma that he argues had a direct impact on FDA setting a higher bar for Covid-19 vaccines and delaying the authorization timeline.

— The pandemic playbook needs to be rewritten. Gottlieb makes the case for focusing on “core capabilities” like quick-pivoting manufacturing capacity, data revamps and better diagnostic tests, and public-private communication that isn’t reliant on preparing for one scenario.

“That’s not preparation for Covid or Ebola or influenza, that’s just preparation,” he said. “We can’t go back to the old approach where we make a list of pathogens and decide what we’re going to need for each.”

A message from PhRMA:

Proponents of government price setting often misrepresent voter opinion on support for allowing the federal government to “negotiate” drug prices. While nine out of 10 Americans said in a recent Kaiser Family Foundation poll that they support drug price negotiation, opposition to the approach soared to 65% when respondents were told negotiation could limit people’s access to medicines or result in fewer new treatments and cures.

Non-partisan, independent public polls have repeatedly demonstrated that once Americans understand what government negotiation is, and what the tradeoffs are, support drops dramatically.

76% of Americans oppose H.R.3-style “negotiation” if it causes delays in access to new prescription drugs, and 72% oppose it if it results in fewer new medicines developed in the future.

62% agree we should keep the current law that prohibits government interference in Medicare plan negotiations because it protects seniors and people with disabilities from losing access to their medicines.

JUDGE REJECTS CDC ORDER JUSTIFYING MIGRANT EXPULSIONS — A federal judge is blocking the Biden administration from using an emergency health order to justify expelling migrants at the southern border, POLITICO’s Sabrina Rodriguez reports.

The Trump-era order – known as Title 42 – does not authorize the government to expel migrants, U.S. District Court Judge Emmet Sullivan wrote in a ruling on Thursday. And as a result, it doesn’t allow those removed to be denied the opportunity to seek asylum.

The decision represents a major victory for human rights organizations and immigrant advocates who have argued for months that Title 42 is illegal and not justified by public health. Biden had come under fire for keeping it in place, most recently extending its use through a CDC update issued last month.

The judge’s order only applies to families, meaning the government can continue to kick out single adults. It also will not go into effect for another two weeks.

ICYMI: EPIC TO OFFER VACCINE CREDENTIAL — The health records giant will give people the option to carry vaccine passports containing their Covid-19 testing and inoculation statuses, POLITICO’s Darius Tahir and Rebecca Rainey report.

The initiative rolling out this week draws on Epic’s database of medical records for roughly 50 million Americans, and will allow users to access their vaccination information through a smartphone app or by printing it out.

The credentials could prove increasingly useful as the Biden administration crafts regulations requiring large employers to check their workers’ vaccination status. Bars and other public venues have also begun to institute requirements that people show proof of vaccination.

CALIFORNIA HEALTH EXCHANGE CHIEF TO RESIGN — Covered California Executive Director Peter V. Lee will step down early next year after a decade running the state’s Obamacare exchange, POLITICO’s Victoria Colliver reports.

Lee took the helm of Covered California just a year after Obamacare was signed into law, weathering the turbulent initial rollout and GOP efforts as late as 2017 to dismantle it. His resignation comes as the law is more secure than ever, and after 2.8 million people signed up for Obamacare coverage during a special enrollment period.

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Biden has nominated Robert Otto Valdez to be HHS’ assistant secretary for planning and evaluation. Valdez worked at HHS during the Clinton era, as well as serving as the White House’s special senior adviser on health care reform. He’s currently a professor emeritus at the University of New Mexico.

Judith Robb-McCord is joining the March of Dimes as its vice president of global impact. She was previously the vice president of technical leadership and support at Project Concern International and Global Communities.

The Justice Department is trying to block a bankruptcy plan that would grant broad legal immunity to Purdue Pharma, which has been accused of fueling the opioid epidemic, The New York Times’ Katie Benner reports.

The University of North Carolina school system is resisting pressure from faculty and students to mandate Covid-19 vaccinations, The News & Observer’s Kate Murphy reports.

An elite group within the NIH had been preparing since February for the possibility of Covid-19 booster shots, Kaiser Health News’ Sarah Jane Tribble and Arthur Allen report.

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