Why Biden’s FDA pick can’t win confirmation until 2022

From: POLITICO Pulse - Wednesday Nov 24,2021 03:01 pm
Presented by the Surgical Care Coalition: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy.
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By Adam Cancryn and Sarah Owermohle

Presented by

Surgical Care Coalition

With Darius Tahir and David Lim

PROGRAMMING NOTE: We’ll be off for Thanksgiving this Thursday and Friday but back to our normal schedule on Monday, Nov. 29.

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Quick Fix

— Senate Democrats’ bid to confirm FDA nominee Robert Califf next month was thwarted by a paperwork delay, meaning he likely won’t get a final vote until January.

— Millions of people got booster shots in recent weeks, surging amid the federal government’s green light for broad booster dosing.

— Veterans Affairs is resisting lawmakers’ efforts to install more nursing home oversight, writing to a top senator that it’s taking care of problems with new training.

WELCOME TO WEDNESDAY PULSE — and here’s wishing you a happy and healthy Thanksgiving.

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A message from the Surgical Care Coalition:

The Surgical Care Coalition urges Congress to stop impending Medicare cuts of nearly 9% that will threaten patient access to quality surgical care. The health care system is already under considerable stress from COVID-19. The proposed Medicare cuts will further weaken the system and jeopardize care for the most vulnerable. Learn more about the Surgical Care Coalition, which represents more than 150,000 surgeons across the country, and how you can take action against the cuts.

 
Driving the Day

CALIFF’s CONFIRMATION TIMELINE SLIPS — A plot to speed Robert Califf’s FDA nomination through the Senate next month fell apart after the Biden administration failed to submit the necessary paperwork to Congress in time, Adam scoops.

The delay means Califf won’t get a confirmation hearing until mid-December at the earliest. And with the Senate already facing several pressing issues and eager to get out of town for the holidays, there’s virtually no chance of a full floor vote on his appointment before the end of the year.

How it happened: Senate HELP Committee Democrats had initially hoped to schedule Califf’s hearing for the week of Dec. 6, a timeline that would’ve given the full chamber a narrow shot at voting to confirm him at some point the next week.

But the plan hinged on the administration submitting his nomination papers by Nov. 19 so the panel would have enough time to review all the materials. The administration blew past that deadline, pushing the earliest chance at a HELP hearing to the week of Dec. 13 and effectively ruling out a final confirmation vote until January.

A Democratic Senate HELP Committee aide said the panel received Califf’s paperwork Monday and was working to schedule a hearing as soon as possible.

But it’s the latest complication in a monthslong effort to install a permanent FDA chief. The process has already taken most of Biden’s first year, leaving the agency without a confirmed leader in the middle of a pandemic.

That’s frustrated FDA staff who felt left in the dark throughout the search, and puzzled those close to the agency who privately question why it took so long to find a nominee — only to pick one bound to face criticism within the party over his ties to the health care industry.

Still, the White House is counting on Califf winning bipartisan support when he does get time in front of the Senate. And, crucially, HELP Committee Chair Patty Murray (D-Wash.) has already endorsed his candidacy.

BOOSTER SHOTS SURGE — Federal health officials approved Covid-19 booster doses for all adults last Friday. So far, 36.1 million fully vaccinated Americans have received booster shots. That’s double the number from less than a month ago, POLITICO DataPoint’s Annette Choi reports.

VA DEFENDS OVERSIGHT OF VETS HOMESThe Department of Veterans Affairs doesn’t think it needs new authority to oversee state veterans homes, the agency told Iowa Sen. Chuck Grassley in a letter this month obtained by POLITICO’s Darius Tahir.

The letter emerged from POLITICO's ongoing coverage of state veterans homes, a type of state-run center for long-term and other care for veterans. The homes, which in many cases suffer from neglect, lack of resources and oversight, had higher rates of deaths than VA-run facilities.

The situation prompted fresh calls for oversight, with Grassley sending a letter in August asking for more details about agency oversight policy for the homes. In its reply, the department says it doesn’t need new authority and is implementing a strategy to improve quality and training at poorly performing state homes.

The department has also started disclosing more data under pressure from Congress and the press and released such information last week.

 

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Coronavirus

ICYMI: FEARS GROW OVER GLOBAL VAX SHORTFALLTop Biden administration officials and international health groups are searching for new ways to accelerate Covid-19 vaccine deliveries to the developing world amid fears the virus will outpace the global inoculation effort well into 2022, POLITICO’s Erin Banco, Adam and Carmen Paun report.

The scramble comes as COVAX — the central vaccine equity initiative — faces a vaccine shortfall because of a combination of delivery delays, regulatory setbacks and a ban in exporting doses from India. The White House in recent weeks has tried to finalize deals for new doses to help fill the gap, but they’re unlikely to generate significant new supply until the latter part of next year.

The U.S. is also dealing with one other problem: A partnership between Johnson & Johnson and Merck to accelerate production of J&J doses has hit delays and now may not generate usable doses until the spring.

That’s months later than the White House anticipated when it first announced the deal to much fanfare back in March. It represents just the latest slowdown for a J&J shot that was supposed to play a key role in vaccinating the world.

The risk facing the world is enormous. Thousands of people around the globe are dying each day from Covid-19, and many poorer countries have yet to widely distribute first doses — meaning the death toll will continue to mount. Those unvaccinated areas could also give rise to new, more dangerous variants.

Global health activists have urged the administration to take a more confrontational stance toward vaccine makers that have refused to share the recipe for their shots with manufacturers focused on supplying the world.

Yet so far, the White House has relied largely on donating excess doses — while trying to negotiate new deals with the companies that would devote more of their supply to low- and middle-income nations.

 

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On the Hill

HOUSE LAWMAKERS UP PRESSURE ON CMS OVER MCIT More than 60 lawmakers on Tuesday urged CMS Administrator Chiquita Brooks-LaSure to rapidly propose a replacement for the recently repealed Medicare Coverage of Innovative Technology rule.

“A permanent withdrawal of the MCIT rule may delay future innovative medical devices and diagnostic tools,” the bipartisan group wrote in a letter.

That includes Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.), whose Cures 2.0 draft legislation includes a tweaked MCIT section aimed at addressing CMS concerns with the original rule, POLITICO’s David Lim writes.

“Feels like this is now led by the Hill,” a medical device lobbyist said. “But have to believe at some point CMS/HHS realizes it needs to engage, otherwise they can’t take credit.”

DRUG PRICING REFORM COULD HIT PHARMA RATINGS — Pharmaceutical companies’ credit ratings are likely to fall if Democratic lawmakers’ proposal for government negotiation on drug prices becomes law, Fitch Ratings said Tuesday.

While the measure is narrower than progressives’ original vision, it still could deal a blow to manufacturers’ credit health, the Wall Street credit agency wrote. First up for credit revisions would be branded drugmakers with affected products. “Fitch believes there would be limited offsets to declining revenue, which could have some effects on sector profitability and cash flow,” the company said.

Inside the Humphrey Building

HHS ALLOCATES $35M FOR TITLE X TELEHEALTHThe health department is making $35 million available to Title X family planning providers to fund expansions of their telehealth services, it said Tuesday.

HHS will distribute the money through 60 one-time grants, in an effort to allow providers to reach more patients and boost access in areas that may have limited options for in-person care.

 

BECOME A GLOBAL INSIDER: The world is more connected than ever. It has never been more essential to identify, unpack and analyze important news, trends and decisions shaping our future — and we’ve got you covered! Every Monday, Wednesday and Friday, Global Insider author Ryan Heath navigates the global news maze and connects you to power players and events changing our world. Don’t miss out on this influential global community. Subscribe now.

 
 
Names in the News

Margaret-Mary Wilson will take over as UnitedHealth Group’s chief medical officer on Dec. 5, replacing longtime CMO Richard Migliori. Wilson previously worked as an associate professor of internal and geriatric medicine at St. Louis University in Missouri.

What We're Reading

A federal jury in Ohio ruled that CVS Health, Walmart and Walgreens substantially contributed to the opioid crisis in two counties, the first time pharmacy chains have been found accountable in court, The New York Times’ Jan Hoffman reports.

Massachusetts Gov. Charlie Baker again ordered hospitals with limited capacity to cut down on elective and nonessential procedures amid staffing shortages and the Covid surge, The Boston Herald’s Amy Sokolow writes.

The nation's Covid-19 testing system is so complicated partly because we're simply asking the tests to do too much, The Atlantic's Katherine Wu writes.

A message from the Surgical Care Coalition:

A nearly 9% Medicare cut could threaten patient access to quality surgical care. The Surgical Care Coalition, representing more than 150,000 surgeons across the country, is advocating for Congress to stop these harmful cuts to protect patients and ensure access to the care they need.

Health care systems and providers across the country continue to be strained, and COVID-19 has forced patients to delay routine, preventative care leading to delays in diagnosis and treatment. The proposed Medicare cuts will weaken the system even further and jeopardize access to care for the most vulnerable.

Learn more about the cuts and how you can protect patient care by watching this video or visiting surgicalcare.org.

 
 

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