HEALTH CARE BRIEFING: Lawmaker Moves to Set Biden Biomed Agency

President Joe Biden’s proposal to create a biomedical innovation hub within the National Institutes of Health is getting another jumpstart after being held up in the annual appropriations process.

Rep. Anna Eshoo (D-Calif.), head of a key House health panel, introduced a bill Friday to authorize the Advanced Research Projects for Health—a new NIH entity designed to catalyze cutting-edge discoveries through a public-private partnership approach instead of the research grant process the agency has used for more than a century.

The bill introduction comes after the Senate dropped the ARPA-H provision from its social spending package. Congressional leaders are aiming to cut or reduce areas of the once-$3.5 trillion package to win the support of key moderates.

Eshoo’s bill sets up potentially competing bills for ARPA-H within the same committee. The architects of the landmark biomedical innovation law 21st Century Cures plan to introduce their follow-up bill, dubbed Cures 2.0, in the coming weeks. A draft version of Cures 2.0 included placeholder language to authorize ARPA-H, and a spokesperson for Rep. Fred Upton (R-Mich.) said he and Rep. Diana DeGette (D-Colo.) still plan to include that language in Cures 2.0.

“Our intent is to authorize it within Cures,” Upton spokesperson Billy Fuerst said.

Ellie Dehoney, vice president of policy and advocacy for Research!America, said she believes Eshoo and the DeGette/Upton team knew that each was going to try to advance legislation to authorize the innovation hub. “I don’t think it’s stalled,” she said in an email. “They may have different views on whether Cures 2.0 can pass this year, but I am confident they respect each other’s decision to move forward based on these differing perspectives.”

All three lawmakers sit on the House Energy and Commerce Committee, which oversees the NIH and a sea of other health programs. Eshoo heads the Commerce health subcommittee, while Degette oversees the oversight panel. It’s unclear whether the lawmakers’ legislative staff had coordinated on authorizing language for ARPA-H, but they all met with Biden last spring to discuss the proposal. Read more from Jeannie Baumann.

Latest on Democrats’ Economic Plans: Schumer, Democrats Have Dwindling Time to Make Good on Promises

This Week’s Hearings

Health Insurance: The Senate Finance Committee announced a panel tomorrow entitled “Health Insurance Coverage in America: Current and Future Role of Federal Programs.”

Public Health: The House Energy and Commerce Health Subcommittee scheduled a Wednesday hearing on enhancing public health for children and families, especially amid the pandemic.

The Coronavirus Pandemic

FDA Wants to Study Moderna Shot for Kids Longer: The FDA is being very careful and wants more time to study the risk of a rare inflammatory heart condition before approving the Moderna vaccine for adolescents, NIH Director Francis Collins said on MSNBC. Collins says myocarditis, which appears to be primarily a risk for younger males, is “very rare” and reversible. “This is not a reason to worry about getting your kids immunized if they’re adolescents,” Collins said. Read more from Laura Curtis.

J&J Booster Garners FDA Advisers’ Backing: Johnson & Johnson’s Covid-19 vaccine booster gained a key recommendation from advisers to U.S. regulators that brings the additional shot a step closer to clearance. The FDA’s vaccine advisory group voted unanimously Friday in favor of recommending the booster for people 18 and older who received their initial immunization at least two months earlier. The experts also indicated support for mixing and matching booster shots from different manufacturers, but didn’t vote on a recommendation. Read more from Riley Griffin, Jeannie Baumann and Robert Langreth.

• The best way to bolster antibodies in people who got J&J’s single-shot vaccine may be to give an additional full dose of a mRNA vaccine, if a federal government-sponsored trial is any indication. The FDA may consider authorization of using one of the U.S.-cleared vaccines to boost initial doses of another, Peter Marks, director of the agency’s Center for Biologics Evaluation and Research, told the panel of advisers. He didn’t give a timeline for when this might happen. Read more from Robert Langreth.
• Meanwhile, Biden’s chief medical adviser said he expects U.S. regulators to consider whether people who got the one-dose Johnson & Johnson vaccine should get an mRNA shot against Covid-19 as a booster. “If you boost people who have originally received J&J with either Moderna or Pfizer, the level of antibodies that you induce in them is much higher than if you boost them with the original J&J,” Anthony Fauci said on ABC’s “This Week” on Sunday. Read more from Ian Fisher.

U.S. Borders to Open Nov. 8 for Vaccinated: The U.S. will open its borders to vaccinated foreigners on Nov. 8, a White House official said Friday, granting access to millions of people who have been shut out of the country while closing it off to anyone who hasn’t had their shots. Under the new system, vaccinated people who have had a negative test in the previous 72 hours will be able to board a flight to the U.S. as long as they share contact tracing information. Unvaccinated foreigners will be generally barred from entry, while unvaccinated Americans will need a negative Covid-19 test. Read more from Josh Wingrove, Siddharth Philip and Christopher Jasper.

• Separately, United Airlines’ policy that mandates all its employees be vaccinated against Covid-19 and places those with religious exemptions on unpaid leave can go into effect, a federal court in Colorado said. The decision is at odds with a recent opinion by the U.S. District Court for the Northern District of Texas, which issued a temporary restraining order against the policy in a similar challenge. Read more from Bernie Pazanowski.

More Headlines:

• U.K. Covid Case Load Prompts Gottlieb Call for ‘Urgent Research’
• Premera Blue Cross Sues Over Lab’s ‘Sham’ $979 Covid-19 Test Costs
• U.S. Labor Unions Are Having a Moment, With Covid-19 to Thank

What Else to Know

DOJ Will Ask Top Court to Halt Texas Abortion Law: The Justice Department said it will ask the U.S. Supreme Court to lift Texas’s ban on abortion after the sixth week of pregnancy, setting up a showdown likely to determine whether the law stays in effect through the end of the year. A federal appeals court last week let the law stay in effect as the case goes forward, even though a trial judge ruled the measure was unconstitutional. DOJ will ask the Supreme Court to set aside the appeals court order, a spokesman said. Read more from Greg Stohr.

CFPB Rules Pose Test for Medical Debt: Debt collection firms are running into outdated billing procedures, particularly in student loans and medical debt, as they look to revamp their consumer communication practices as required by new federal rules. Beginning on Nov. 30, the Consumer Financial Protection Bureau’s rules, the first federal regulations for the industry, require debt collectors to provide consumers with a clear description of the amount of money they allegedly owe and whom they owe. Read more from Evan Weinberger.

HHS Outside Help for Migrant Children Program: The administration wants outside help to improve its programs for unaccompanied migrant children amid steady public scrutiny of how the federal government cares for them. The Health and Human Services Department this week announced it’s seeking a contractor to give it recommendations “about how best to structure its resources to meet the myriad needs” of its program for unaccompanied children. Read more from Ellen M. Gilmer.

NIH Won’t Confirm or Deny Cassava Probe: The National Institutes of Health’s National Institute on Aging is aware of the allegations made against Cassava Sciences, according to an email from a spokesman from the office of communications, but will neither confirm nor deny an investigation into the company after speculation of a probe showed up on a Twitter post of a redacted email on Thursday, Cristin Flanagan reports.

• Earlier: Cassava Plunges After Alzheimer’s Data Draws Scrutiny, Shorts

More Headlines:

• Holmes Hired Dermatologist to Run Theranos Lab Who Worked Little
• Big Pharma Backs Apple’s Bid for Redo of Patent Ownership Ruling
• FDA OKs Genentech’s Tecentriq as Adjuvant Treatment
• Arena Must Keep Facing Woman’s Belviq Diet Drug Cancer Suit
• Death Row Inmate Revives Challenge to Tennessee Lethal Injection
• Biogen Mulls Options After ALS Drug Trial Misses Endpoint

To contact the reporter on this story: Michaela Ross in Washington at mross@bgov.com

To contact the editors responsible for this story: Zachary Sherwood at zsherwood@bgov.com; Giuseppe Macri at gmacri@bgov.com; Brandon Lee at blee@bgov.com