News: Biden taps Becerra to run HHS — And chooses Walensky for CDC

Monday, December 7, 2020

Biden taps Becerra to run HHS — And chooses Walensky for CDC — FDA hits back on criticism of vax timing

Dec 07, 2020

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By Dan Diamond and Adam Cancryn

Presented by

With Rachel Roubein and Dan Goldberg

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Quick Fix

— California Attorney General Xavier Becerra is Joe Biden's pick to run HHS.

— Infectious-disease expert Rochelle Walensky will also be tapped to run the CDC.

— FDA hit back at claims that its scientists slow-walked Covid-19 vaccine authorization.

IT's MONDAY PULSE — And welcome to the Becerra-era? We'll have to see how the next few weeks unfold before it's official.

In the meantime, we're watching to see who fills out Biden's health team, including at CMS and FDA. Tips to ddiamond@politico.com and acancryn@politico.com.

A message from PhRMA:

Today, there are several promising vaccine candidates in stage three clinical trials. These trials have tens of thousands of participants, from every walk of life. From development to robust clinical trials, and throughout manufacturing, these vaccine candidates follow the same rigorous process of other vaccines that have saved millions of lives. More.

Driving the Day

IT's BECERRA — The California attorney general is Biden's choice to lead HHS, capping a turbulent process that saw at least three other people named as front-runners by news organizations in the past week.

Biden offered Becerra the job on Friday, and if confirmed, he would be the first Latino to run the health department — a role that will thrust him into the middle of a high-stakes pandemic response, POLITICO's Tyler Pager, Adam Cancryn and Alice Miranda Ollstein write.

— Becerra's a familiar face in Washington, having spent nearly 25 years in the House of Representatives culminating in a stint as chair of the Democratic caucus. Becerra also sat on the powerful House Ways and Means subcommittee overseeing health issues.

And as California's top lawyer for the past four years, Becerra is intimately familiar with Trump-era health policies that he sought to defeat in court. Becerra notably has led blue states' defense against a GOP lawsuit aimed at eliminating Obamacare.

— But Becerra also has a thinner management resume than previous HHS secretaries like former governors Tommy Thompson, Mike Leavitt and Kathleen Sebelius. Meanwhile, Sylvia Mathews Burwell and Alex Azar had spent considerable time as high-level administration officials and in senior roles at large organizations before they were tapped to run HHS.

The California AG office isn't small — it employs thousands of people — but Becerra's resume may be closest to former HHS Secretary Tom Price, a prominent congressman who had to learn to navigate the department in what became a bumpy, seven-month tenure in 2017.

— The choice of Becerra brings to an end a circuitous process that pulled in two governors and a former surgeon general and dragged on days longer than expected.

While Rhode Island Gov. Gina Raimondo was favored by the Biden team for the role, she publicly announced on Thursday that she wouldn't take the job, further scrambling the selection. New Mexico Gov. Michelle Lujan Grisham also fell out of favor amid perceptions that she was publicly campaigning for the job, and former Surgeon General Vivek Murthy ended up taking what's expected to be a super-charged version of his old role.

— PULSE's question: Is Becerra confirmable? Progressive advocates and health care groups rushed to applaud Becerra, pointing to his track record on defending the Affordable Care Act and fighting the pandemic.

"As Attorney General of California, he fought the pandemic by putting key public health and safety workplace protections in place, pushed to make life saving drugs more affordable, and fought to secure local and state funding as part of the CARES Act," said Zac Petkanas of Protect Our Care. Becerra's pick also won kudos from the Congressional Hispanic Caucus, which had clashed with Biden's team over its handling of Lujan Grisham's candidacy.

But his support for Medicare for All and advocacy around abortion rights could emerge as major GOP targets, especially in a closely divided Senate that Democrats may not control.

Becerra "went all the way to the Supreme Court to try to force California's pro-life pregnancy centers to advertise and refer for abortion — a policy the Court rejected as unconstitutional," SBA List President Marjorie Dannenfelser said in a statement.

— Flashback: A young Becerra extolls the benefits of single-payer and lays out his health care vision in an April 1994 congressional hearing on health reform. See clip.

MEET ROCHELLE WALENSKY — The Massachusetts General infectious-disease chief is Biden's pick to rebuild the battered CDC, Tyler scooped. Importantly, the position doesn't require Senate confirmation.

Walensky, who is also a professor of medicine at Harvard Medical School and an expert on AIDS and HIV, has advised Massachusetts Gov. Charlie Baker's Covid-19 pandemic response and last month joined an op-ed praising Baker's restrictions.

Walensky's also a frequently published author, raising concerns about gender parity in clinical trials and emerging as more of a national voice on coronavirus this year.

— In the wake of the pandemic, Walensky's worried about the nation's infectious disease workforce, noting that the specialty had lost out on potential recruits to higher-revenue alternatives, leaving physicians strained by Covid-19.

"The current experience with an overextended ID workforce is a cautionary tale," Walensky and colleagues wrote this summer. "Our nation's health and future clearly depend on a long-term strategic ID workforce plan."

— Those who know her say they're thrilled by the choice. "This is fantastically good news for CDC, for public health, and for the country," tweeted Yale health professor Jason Schwartz, who recently co-authored a Health Affairs article with Walensky and others that examined efforts to devise and roll out Covid-19 vaccines.

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FDA CONTINUES TO TAKE HEAT ON VAX TIMING — Bahrain on Friday granted emergency authorization for Pfizer's Covid vaccine, ensuring that the United States — as Trump and some deputies groused more than a week ago — will lag multiple countries in the international vaccine race. The United Kingdom authorized the vaccine last week.

The FDA's advisory committee reviewing the Pfizer vaccine data meets this Thursday, about one month after the company first trumpeted its promising Phase III results.

— Some of the sharpest criticism of FDA yet came on Friday, in a widely circulated column by Marty Makary, a Johns Hopkins physician who's advised the Trump White House and is editor-in-chief of MedPage Today (although the piece was published at the conservative digital media organization The Dispatch).

Alleging that FDA staff "undermined the Trump administration and politicized science" by delaying the vaccine, Makary further asserted that FDA insiders told him the agency went "dark for the four-day Thanksgiving holiday," wasting valuable time. He also claimed that his own Johns Hopkins team could finish a review of the Pfizer vaccine study data in a single hour.

Asked by PULSE about his column's claims, whether he contacted the FDA for comment and why he didn't publish it at MedPage, Makary said the column "speaks for itself and I encourage people to read it."

"The bottom line is that the U.K. approved the same vaccine but the FDA has not as thousands of Americas [sic.] die each day," Makary added. "That should be unacceptable to all of us."

— The column angered and frustrated many at FDA, who told PULSE that Makary didn't check his assertions and that they're factually incorrect.

For instance, Makary's claim about FDA shutting down for Thanksgiving "is divorced from reality," FDA Commissioner Stephen Hahn and top vaccine regulator Peter Marks said in a joint statement. "Over a thousand person hours were logged during the holiday weekend on the review of the emergency use authorizations."

"The claim that that the massive amount of data that was submitted to FDA could be reviewed in a few hours and did not need to be verified by its own experts, is absolutely ludicrous and undermines what the public has come to expect from the world's premier regulatory organization," Hahn and Marks added.

— PULSE notes: Makary's echoing a complaint that's been rattling around the White House, even as many infectious disease experts have praised the FDA for taking care to get the science right (and some have insisted the agency's current timeline is already staggeringly fast).

FDA's handling of the vaccine also has sparked a notable divide in medical news publications, where Medscape editor Eric Topol has emerged as one of Hahn's staunchest defenders, even as MedPage editor Makary has vaulted up the list of agency critics.

HEALTH PROVIDERS GET LEEWAY TO DIVVY UP COVID SHOTS — States struggling to prioritize who should receive the initial doses are handing off those critical decisions to health care providers, giving them less than two weeks to decide how to ration the scarce vaccine among their own employees, POLITICO's Rachel Roubein and Dan Goldberg report.

A CDC advisory panel last week overwhelmingly recommended that the first doses go to health care workers and long-term care facilities. Those recommendations aren't binding — and the Trump administration has made clear the decision ultimately rests with the states.

But now, some states — including Kentucky, Mississippi and New York — have instructed hospitals to devise tiering systems to determine which employees should receive the first vaccinations. Others, like Arkansas and Minnesota, are waiting to make decisions until they receive guidance from their own advisory panels.

Some hospital leaders argue they're better prepared than state officials to determine which employees should get the vaccine first. Yet others worry this patchwork approach could undermine the effort to transparently and equitably distribute the vaccine.

Inside the Humphrey Building

FOUR SENIOR OFFICIALS DEPART CMS — A top deputy to CMS Administrator Seema Verma and three of her senior advisers announced their departures on Friday, POLITICO's Dan Diamond scooped, as turnover continues ahead of the next administration.

— KIM BRANDT, the principal deputy administrator for operations and policy, is departing soon to pursue multiple opportunities, including a role with private equity firm Enhanced Healthcare Partners. Before re-joining CMS as a political appointee in 2017 — having done earlier stints as a career official at the agency and HHS — Brandt was a top staffer for the Senate Finance Committee.

— MARK ATALLA, who advised Verma on drug pricing and innovation, in addition to serving as the agency's liaison to Operation Warp Speed, will be starting a new venture to address vulnerable populations with former CMS Innovation Center chief strategy officer Gary Bacher, he told POLITICO.

— MATT HITTLE, who managed the agency's innovation initiative and also focused on a range of quality issues, is taking a new role as senior policy adviser at law and lobbying firm Akin Gump.

— ALINA CZEKAI, who led the agency's external engagement on the Covid-19 response, will soon take a job as vice president of strategic partnerships at Cohere Health, a firm focused on patient-centered care.

HHS ESTABLISHES 'TAXPAYER ACCOUNTABILITY BOARD' — The department on Friday announced a new initiative, overseen by the chief of staff, to review its contracting processes and create a new, more rigorous "contract review culture."

"One of the most important responsibilities federal employees have is to be good stewards of the hard-earned taxes Americans send to Washington, and HHS's Taxpayer Accountability Board will save billions of dollars by eliminating and preventing wasteful spending on contracts," HHS Chief of Staff Brian Harrison said in a statement.

Some of the department's most eye-catching scandals during the Trump administration — like an unusual Covid-19 ad campaign and Verma's use of external PR consultants — have centered on contracting issues.

WATCHDOG's VERDICT: THE HHS PROTECT HOSPITALIZATION DATA IS GOOD — That's according to a team at the Covid-19 Tracking Project, which has emerged as a go-to resource for coronavirus trends and analyzed the federal data set for hospitalizations and admissions.

The HHS Protect data closely parallels state data, the Covid-19 Tracking Project team writes, adding that they have "no reason to believe that the federal data on current hospitalizations or hospital admissions are in any way manipulated by political concerns."

The HHS Protect project and a key vendor, TeleTracking, were targeted by critics who alleged it was a politically motivated effort to suppress federal data by shifting responsibility away from CDC.

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Around the Nation

COLORADO'S FIRST GENTLEMAN HOSPITALIZED — Gov. Jared Polis drove his partner Marlon Reis to the hospital Sunday night, POLITICO's Dan Goldberg writes. Reis and Polis both tested positive for coronavirus eight days ago. Reis on Sunday suffered shortness of breath and a worsening cough. Polis' symptoms remain mild.

A message from PhRMA:

America's biopharmaceutical companies are making great progress against a common enemy – COVID-19. They're learning from successful vaccines for other diseases, developing new treatments and collaborating like never before.

Today, there are several promising vaccine candidates in stage three clinical trials. These trials have tens of thousands of participants, from every walk of life. From development to robust clinical trials, and throughout manufacturing, these vaccine candidates follow the same rigorous process of other vaccines that have saved millions of lives.

America's biopharmaceutical companies are working day and night until they defeat COVID-19. Because science is how we get back to normal.

What We're Reading

In a CNN interview, top Operation Warp Speed adviser Moncef Slaoui praised Biden's plan to ask Americans to wear masks for 100 days.

How the top Covid vaccine candidates made it to the finish line: WaPo's Carolyn Johnson traces the sprint to develop new mRNA vaccines.

"Headlines don't capture the horror we saw": Anesthesiologist Kasey Grewe chronicled life inside her New York City hospital this spring in a piece for the Atlantic.

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