Wednesday, December 2, 2020

White House frustrated as 'Warp Speed' taps brakes — Health workers, vulnerable elderly could get vax first — Brad Parscale: Trump's covid blunders cost the election

Presented by PhRMA: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy.
Dec 02, 2020 View in browser
 
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By Dan Diamond and Adam Cancryn

Presented by

With Susannah Luthi

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Quick Fix

— President Donald Trump and his deputies are admonishing FDA for not moving faster on emergency vaccine authorizations, which remain days away.

— Health workers and people in long-term care facilities should get the vaccine first, a CDC expert panel advised on Tuesday.

— Trump's mishandling of the pandemic cost him the election, the president's former campaign manager said in an interview.

WELCOME TO WEDNESDAY PULSE — Where once again, an official was spotted dining out … after voting to ban dining out. (In her defense, perhaps she was testing the system?)

Send your favorite examples of Covid hypocrisy and other tips to acancryn@politico.com and ddiamond@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

WHITE HOUSE TO FDA: CAN'T THE VACCINE PROCESS MOVE ANY FASTER? — Administration officials have been frustrated that their "Warp Speed" effort has run into Washington regulations, with vaccine distribution still days away even though Pfizer and Moderna announced promising results weeks ago, POLITICO's Dan Diamond, Adam Cancryn and Sarah Owermohle report.

And they've lambasted FDA officials, saying that every day counts during a life-threatening pandemic. This week's news that the U.K. could authorize a vaccine on Dec. 7 — several days before the FDA is likely to greenlight one — further angered White House officials who view having the West's first authorized vaccine as a key element of Trump's legacy.

"It's crazy to imagine the European Union or U.K. may approve a vaccine developed in the United States before us though, right?" said a senior official involved in the process.

HHS Secretary Alex Azar and White House Chief of Staff Mark Meadows both held meetings with FDA Commissioner Stephen Hahn this week, seeking to clarify where the process stands and if anything can be done to move more quickly on vaccine rollout.

It's important to remember: FDA is moving historically fast. The first shots are expected to be authorized less than a year after the coronavirus' genetic sequence was first shared, and FDA reviews like the one underway would normally take up to 10 months.

"[W]e know we need to do our job…to make sure that any vaccine meets our high standard of safety and efficacy," Hahn told state governors on a call convened by the White House on Monday, according to notes from the call obtained by POLITICO.

Meanwhile, PULSE's European counterparts point out that the concern overseas is reversed: There's frustration that the United States and United Kingdom will likely be weeks ahead of the European Union, which may not sign off on a vaccine until early 2021.

But some public health experts lament the lost opportunity, such as the chance to move more quickly on emergency authorizations.

"Every day that goes by is 2,000 people dead," said Walid Gellad, the director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. "I don't know another circumstance where waiting on drug approval has such an impact on mortality."

CDC PANEL: HEALTH WORKERS, LONG-TERM CARE RESIDENTS SHOULD GET VACCINES FIRST — An expert panel advising the CDC overwhelmingly endorsed giving the first Covid-19 vaccine doses to health care workers and those in long-term care facilities, POLITICO's David Lim reports.

The 13-1 vote backing the recommendations is not binding, but could be influential for the states putting together their vaccination plans. Health care workers have accounted for at least 243,000 infections, while skilled nursing facilities alone have recorded nearly 70,000 deaths.

The panel, known as the Advisory Committee on Immunization Practices, is expected to refine and finalize fuller recommendations for vaccine distribution after the FDA authorizes its first shots and allows the committee to see late-stage trial data.

— A rare NANCY MESSONNIER sighting: The CDC official tweeted Tuesday about the advisory committee, her first post in eight months. Messonnier drew anger from Trump and his deputies in March after she warned — accurately — that Covid-19 would disrupt daily life in America.

COMING TODAY: THE COVID-19 VACCINE EDUCATION AND EQUITY PROJECTMore than 60 groups will announce a new effort to promote vaccines, increase vaccination rates and reach vulnerable communities. The Pfizer-funded project includes a new website and will convene a discussion among groups that are fighting Covid-19 on the frontlines, a spokesperson said.

— Among the participating organizations: The Alliance for Aging Research, HealthyWomen, the National Caucus and Center on Black Aging, and Research!America.

CDC REVISING COVID QUARANTINE GUIDANCE — The CDC is prepping new guidance recommending that people exposed to Covid-19 quarantine for 10 days, or seven days if they've obtained a negative test, POLITICO's Adam Cancryn reports.

That's down from the current 14 days, and comes months after White House officials like Vice President Mike Pence began encouraging the agency to revisit its guidelines.

The new CDC guidance is based on extensive data about the virus' behavior gathered over the last several weeks, an administration official said.

BRAD PARSCALE: TRUMP BLEW IT ON COVID — Former Trump campaign manager Brad Parscale criticized the president's approach to the pandemic in a Tuesday interview, calling his decision not to express public empathy the biggest "policy error" of his reelection campaign.

"People were scared and I think if he would've been publicly empathetic he would've won by a landslide," Parscale said on Fox News. "I think he could've leaned into it instead of run away from it."

Parscale, who was replaced as campaign manager in July, claimed that his polling had Trump winning more than 400 electoral votes before the virus hit – and that he believed all the president needed to do to win re-election was to be empathetic about the crisis' toll.

Instead, Trump chose to focus on quickly reopening the economy.

"A young family with a young child who are scared to take them back to school wanted to see an empathetic president and an empathetic Republican Party," he said. "And I said this multiple times and he chose a different path."

 

TRACK THE TRANSITION: President-elect Biden has started to form a Cabinet and announce his senior White House staff. The appointments and staffing decisions made in the coming days send clear-cut signals about Biden's priorities. Transition Playbook is the definitive guide to one of the most consequential transfers of power in American history. Written for political insiders, it tracks the appointments, people, and the emerging power centers of the new administration. Track the transition and the first 100 days of the incoming Biden administration. Subscribe today.

 
 


Biden World

ROB PORTMAN: NEERA TANDEN SHOULD GET A HEARING — The Ohio Republican and member of the Senate Finance Committee told reporters on Tuesday that he's concerned that Biden's pick to lead the White House budget office is too partisan, but doesn't want to rule her out.

"I just don't think it's a good fit for this job," Portman said on a conference call, the Columbus Dispatch reported. "If she's nominated I think she should get a hearing and we should hear her out."

Portman served as OMB director during the George W. Bush administration. Tanden, the head of the Center for American Progress and a longtime confidante of Hillary Clinton, has come under fire from Republicans for tweets that lashed out against the GOP, and her confirmation is expected to be a battle.

 

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In Congress

DEMOCRATS BLAST HHS FOR RULE REVIEW PLANKey leaders of the House Ways and Means Committee chastised the Trump administration for a new proposal to require that older rules be reviewed or else automatically expire, suggesting it's an effort to sabotage "effective governance" and hurt programs like Medicare

"This sweeping and improper change would waste resources, undermine smooth program operation, and force the next Administration to divert resources away from addressing the COVID-19 pandemic," Reps. Lloyd Doggett, Bill Pascrell and Danny Davis wrote to HHS Secretary Alex Azar. The three Democrats chair the Ways and Means subcommittees for health, oversight and worker and family support, respectively.

HHS estimates that nearly 2,500 rulemakings would need to be reviewed over the next two-year window or otherwise expire, the Democrats note.

"It's a thinly-veiled effort to put the Department in a procedural straight jacket … just in time for the onboarding of a new Administration," Georgetown's Andy Schneider writes, panning the hasty effort.

RICHARD BURR IN TALKS TO LEAD HELP COMMITTEE — The North Carolina Republican is in talks with Senate Majority Leader Mitch McConnell about taking over the HELP Committee chairmanship next Congress, he confirmed to POLITICO's Susannah Luthi. But when asked directly if he would take the post, Burr demurred.

"Listen, that's up to what the makeup of Congress is," Burr said, referring to the twin runoffs in Georgia that will determine the Senate majority. "We've got to wait until Jan. 5 for that."

— Burr is next in line for the top GOP slot on the committee. But with the FBI probing stock trades he made after an early intelligence briefing on the pandemic, there's been speculation that libertarian firebrand Sen. Rand Paul could get the post instead.

Paul told POLITICO he's open to accepting the chairmanship if offered, but hasn't talked with McConnell about it — and is preparing to head the Small Business Committee.

CONGRESS MAKES ANOTHER 'SURPRISE' BILLING PUSH — Pressure is building on precisely the people who don't want to make the call on a proposed ban on "surprise" medical bills: House Speaker Nancy Pelosi and McConnell, Susannah reports.

It's a fix that lawmakers largely agree should happen — but it's only possible if they first decide to cross powerful doctor and hospital groups.

— The state of play in the House: For the measure to have a chance this year, Pelosi would have to overrule Ways and Means Chair Richard Neal — the Massachusetts Democrat who played a central role in derailing work toward a surprise billing fix around this time last year.

Pelosi spokesperson Henry Connelly said the committees "have all been working in good faith" and they are hopeful about reaching a deal. But a Ways and Means spokesperson noted the panel still hasn't seen legislative text (which hasn't been released), and said "differences are more fundamental than technical edits."

— State of play in the Senate: McConnell has been reluctant to bring up a vote on the proposal, but would face pressure if Pelosi signs off. And the legislation is a legacy project for HELP Chair Lamar Alexander (R-Tenn.), who's retiring at the end of the year.

— Taxpayers Protection Alliance hits insurers over surprise billing. The group is out with a new ad criticizing the insurance industry and warning against surprise billing legislation that would limit the rates paid to providers. "The pandemic isn't the time to give big insurance the big handout it's been lobbying for," the new ad says.

 

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.

 
Names in the News

MILKEN INSTITUTE launches "Early Warning" initiative. The organization's FasterCures team is devising a global framework to monitor and track threats, an effort to stave off the next pandemic.

"COVID-19 caught the world by surprise, and it shouldn't have," said Esther Krofah, executive director of FasterCures.

— Among the initiative's advisers: Former FDA commissioner Mark McClellan, Africa CDC director John Nkengasong and Jennifer Nuzzo of the Johns Hopkins Center for Health Security.

SHARON PARROTT to lead the Center on Budget and Policy Priorities. Parrott, who served as a top adviser to former HHS Secretary Kathleen Sebelius and worked in the Obama administration's OMB, will take over the research and policy institute in January. Parrott is currently working on Biden's agency review team for HHS.

She'll follow Bob Greenstein, who founded the center 40 years ago and has served as its CEO ever since, overseeing its growth from four staff in year one to 150 staff now.

DAN BLACK joins Debbie Dingell's office. Black, who led communications for Rep. Joe Kennedy, is now communications director for the Michigan representative, staying within the House Energy and Commerce Committee.

 

NEXT WEEK - DON'T MISS THE MILKEN INSTITUTE FUTURE OF HEALTH SUMMIT 2020: POLITICO will feature a special edition Future Pulse newsletter at the Milken Institute Future of Health Summit. The newsletter takes readers inside one of the most influential gatherings of global health industry leaders and innovators determined to confront and conquer the most significant health challenges. Covid-19 has exposed weaknesses across our health systems, particularly in the treatment of our most vulnerable communities, driving the focus of the 2020 conference on the converging crises of public health, economic insecurity, and social justice. Sign up today to receive exclusive coverage from December 7–9.

 
 


What We're Reading

The Biden administration needs to strengthen the scientific review process over Medicare and Medicaid, MEDCAC chair Peter Bach argues in the New York Times.

At Health Affairs, Minnesota health official Nathan Chomilo explores how to build racial equity into policy and organizations.

Writing at Harvard's "Bill of Health" blog, Dorit Reiss digs into whether an HHS secretary can mandate that a firm's employees and customers get coronavirus vaccines authorized for emergency use.

"Vaccines aren't politics any more than masks are politics." Former Obama official Andy Slavitt explains why he plans to get a Covid-19 vaccine.

 

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