HEALTH CARE BRIEFING: Biden Faces NIH, FDA Leadership Vacancies

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The retirement of longtime National Institutes of Health chief Francis S. Collins leaves the Biden administration with another health agency position to fill as the White House faces a looming deadline to find a permanent head of the FDA.

Collins, who has led the NIH since 2009, said yesterday he plans to retire by the end of the year after nearly three decades at the agency. President Joe Biden is expected to pick an NIH director before Collins steps down, White House spokeswoman Karine Jean-Pierre said during a press briefing.

But that leaves the White House on the hunt for two top health picks: Collins’s replacement and the president’s first nominee to run the Food and Drug Administration. Under the Vacancies Act, acting FDA Commissioner Janet Woodcock can’t serve past Nov. 15 unless Biden nominates someone to fill the job permanently. If there’s a nominee in place, Woodcock can continue to serve as the nominee moves through the confirmation process.

Leadership of both agencies will be critical in the coming months as the pandemic remains a top priority for the administration and the FDA must evaluate booster shots and vaccines in kids. The Biden administration also has plans for a sweeping $65 billion pandemic preparedness plan as well as a new entity at the NIH to develop biomedical breakthroughs.

The prospect of vacant roles at multiple federal health agencies is worrying lawmakers.

“In the face of the pandemic this is the wrong time to lack directors,” Sen. Richard M. Burr (R-N.C.), the top Republican on the committee that approves health nominees, said in an interview. Read more from Jeannie Baumann and Alex Ruoff.

Collins Talks About His Exit: Collins said he thought now was the right time to retire because the work toward making Covid-19 vaccines and other tools available put the agency in a “in a very solid place.”

“Not that we’re out of this pandemic, because we most certainly are not,” Collins quickly added yesterday in an interview with Bloomberg Law. But with three vaccines now available, in large part through NIH’s basic research and public-private partnerships, along with its “Shark Tank”-like program for testing, “it feels as if the need for my continued sort of hour-to-hour oversight has been appropriately waning over the time.”

The physician-geneticist is the second-longest-running director of all time—just a year shy of James A. Shannon’s 13 years—and he’s the only director to serve under three administrations.

He said this is the right time to leave not only because of where the agency’s role is during the pandemic, but also because it will put the White House in the best spot to find and nominate a new NIH director whom the Senate can confirm. He’s returning to his laboratory within the National Human Genome Research Institute, where he researches gene functions. Read more from Jeannie Baumann.

Tough Choices Loom for Democrats Paring $3.5 Trillion Wish List

Biden and Democrats are jockeying to trim their once-$3.5 trillion signature domestic policy package to as little as $1.9 trillion while staying united on passing the legislation. Some big ticket items may fall by the wayside while others may expire after a few years or be restricted to only the poorest Americans, lawmakers say.

The shrinking size of the package means lawmakers will need to find offsets for the spending, to come through a combination of tax increases and other revenue-raising measures such as letting Medicare negotiate directly with drugmakers on the prices of some medication.

Read a rundown of vulnerable provisions, such as expansions of Medicaid and Medicare, from Bloomberg Government here.

Related: Paid Family and Medical Leave Allies Mull Fallback Options as Cost Pressures Mount
Last night Biden also told reporters he’d sign a reconciliation bill with or without the controversial Hyde Amendment, which would restrict federal funding for most abortions. “I’d sign it either way,” Biden said of the reconciliation bill when asked about including the Hyde Amendment. “I want to get the bill passed.” The provision is a key sticking point between Sen. Joe Manchin (D-W.Va.), who says he won’t support the bill without it, and progressive Democrats led by House Democrat Pramilia Jayapal (D-Wash.), who say they won’t support the bill with it, Laura Curtis and Jennifer Jacobs report.
Meanwhile, Biden declared that politicians who oppose his economic agenda are undermining the country itself, calling on Congress to pass the pair of infrastructure and social-spending measures he said would cement U.S. competitiveness. Biden visited the political battle-ground of Michigan state to shore up support for his proposals among centrist lawmakers. Justin Sink and Jenny Leonard have more.

The Coronavirus Pandemic

Covid-19 Death Toll This Year to Top 2020 Level: The death toll from Covid-19 in the U.S. this year is poised to surpass the number of fatalities in 2020. The wave fueled by the delta strain is waning in the U.S., but daily cases are still hovering near 100,000 and over 1,800 people are dying per day. The U.S. has the world’s highest death toll at over 703,000, of which 351,985 occurred in 2020, according to Johns Hopkins University and Bloomberg data. The toll for 2021 crossed 351,000 as of yesterday morning.

Symptoms of anxiety and depression hit U.S. adults more frequently as the number of Covid-19 cases increased during the accelerating pandemic, according to a new CDC study. Mental health severity scores were highly correlated with the average number of daily infections, according to the study in the CDC Morbidity and Mortality Weekly Report. Concerns are mounting once again amid the delta strain’s surge and as the winter months approach. Fiona Rutherford has more.

U.S. Says Vaccine Incentives Are Legal: Employers can legally offer health-care premium discounts that require people to get Covid-19 vaccinations, the Biden administration said in guidance. The guidance from the departments of Labor, Health and Human Services, and Treasury is aimed at helping employers understand rules tied to crafting incentives for employees to get vaccinated, James Gelfand, an executive vice president for The ERISA Industry Committee, said, Sara Hansard reports.

U.S. Says Arizona Can’t Reward Mask-Free Schools: The Treasury Department warned Arizona that two state grant programs aren’t a permitted use of federal funds from the American Rescue Plan because they’re conditioned on schools not requiring face masks. The state’s grant programs “undermine evidence-based efforts to stop the spread of Covid-19,” Deputy Treasury Secretary Adewale Adeyemo told Gov. Doug Ducey (R), calling for details on a remedy in a month. Catherine Larkin has more.
Related: Florida Forgoes $2.3 Billion of School Aid on Covid-19 Relief Deadline Miss

Moderna Wants Court’s Help to Avoid Vaccine Patent Suits: Moderna subsidiary ModernaTX will ask the Federal Circuit at oral arguments tomorrow to invalidate two patents it says could make its Covid-19 vaccine vulnerable to infringement suits. The Patent Trial and Appeals Board upheld parts of Arbutus Biopharma’s patents on drug-delivery technology. Moderna will tell the U.S. Court of Appeals for the Federal Circuit that there is a substantial risk that Arbutus will sue, accusing various Moderna products of infringing the patents. Read more from Perry Cooper and Susan Decker.

More Headlines:

What Else to Know Today

Court Lets Six-Week Abortion Law Fight Wither: Planned Parenthood lost its bid to revive several Texas lawsuits against anti-abortion groups that are primed to enforce, through litigation of their own, the state’s strict ban on abortions after six weeks’ gestation. The Texas Supreme Court denied the provider’s emergency request to reverse an order by a multidistrict litigation panel that indefinitely blocked all lawsuits filed in state courts challenging S.B. 8. Mary Anne Pazanowski has more.

In Arizona, the state told a federal judge it will appeal an order preventing it from enforcing a law that bans abortions based on a woman’s reason for wanting one. The “reason” ban prohibits a doctor from performing an abortion when they know a woman wants one due to a “genetic abnormality” in the fetus. The U.S. District Court for the District of Arizona halted the law after saying it likely violates a woman’s right to end a pregnancy by imposing an undue burden on it. Pazanowski has more.

Homicide Rate Rise Sets Record: The homicide rate in the U.S. increased 30% from 2019 to 2020, the highest ever increase recorded in modern history, the Centers for Disease Control and Prevention confirmed today. The homicide rate in the U.S. increased from 6 homicides per 100,000 in 2019 to 7.8 per 100,000 in 2020, according to the new provisional data. This exceeds the previous largest jump of 20% recorded from 2000 to 2001, which stemmed from the Sept. 11 terror attacks, according to the CDC.

The new data don’t document all the various types of homicides, but show that the the provisional firearm injury death rate increased 14% between 2019 and 2020, from 11.9 firearm deaths per 100,000 in 2019 to 13.6 per 100,000 in 2020, Alex Ruoff reports.

Health-Care Cost Increases Returning, Employers Report: Health benefit costs are expected to increase by more than 5% in both 2021 and 2022, employee benefits advisory firm Willis Towers Watson reported yesterday. The Willis Towers Watson 2021 Best Practices in Health Care Survey of 378 U.S. companies employing 5.9 million workers, conducted in June and July, found that achieving affordable costs was a key priority for 90% of respondents. Read more from Sara Hansard.

Centene Facing Proposed Class Action Over Network: A proposed class action suit brought by Ohio residents who bought health insurance on an Obamacare marketplace can proceed with its breach-of-contract and fraud claims against Centene, a federal court said. The complaint sufficiently alleged Centene breached its insurance policies by not maintaining a network of providers sufficient to make sure all types of services are available, the Southern District of Ohio ruled. Pazanowski has more.

More from the Courts:

What Else to Know:

With assistance from Alex Ruoff

To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Zachary Sherwood at zsherwood@bgov.com; Giuseppe Macri at gmacri@bgov.com; Michaela Ross at mross@bgov.com

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