BRIEFING ON HEALTH CARE: the legislator decides to create the Biden Biomed agency

President Joe Biden’s proposal to create a biomedical innovation hub within the National Institutes of Health is getting a fresh start after being stuck in the process of allocating annual funds.

representing Anna eshoo (D-Calif.), Head of a key House health panel, introduced a bill on Friday authorizing advanced health research projects, a new NIH entity designed to catalyze cutting-edge discoveries through to a public-private partnership approach instead of the research grant process the agency has used for over a century.

The bill’s introduction comes after the Senate removed the ARPA-H provision from its social spending program. Congressional leaders aim to shrink or shrink areas of the $ 3.5 trillion package to gain the support of major moderates.

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

“Our intention is to allow it within Cures,” Upton spokesperson Billy Fuerst said.

Ellie Dehoney, Vice President of Policy and Advocacy for Research! America, said she believed both Eshoo and the DeGette / Upton team knew each was going to try to push forward legislation to allow the innovation hub. “I don’t think it’s stalled,” she said in an email. “They may have different views on how successful Cures 2.0 will be this year, but I have no doubts that they respect everyone’s decision to move forward on the basis of these different perspectives.”

All three lawmakers sit on the House Energy and Commerce Committee, which oversees the NIH and a host of other health programs. Eshoo heads the commerce health subcommittee, while Degette oversees the oversight committee. It’s not clear whether the legislative staff of lawmakers coordinated to allow the language for ARPA-H, but they all met with Biden last spring to discuss the proposal. Read more about Jeannie Baumann.

Latest news on Democrats’ economic plans: Schumer and Democrats have little time to keep their promises

This week’s hearings

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

Public health: The House’s Health, Energy and Commerce subcommittee has scheduled a Wednesday audience on improving the public health of children and families, in particular during a pandemic.

The coronavirus pandemic

FDA wants to study Moderna Shot for children for longer: The FDA is very cautious and wants more time to study the risk of rare inflammatory heart disease 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 young men, is “very rare” and reversible. “This is no reason to worry about getting your children vaccinated if they are teenagers,” Collins said. Read more about Laura Curtis.

J&J Booster enjoys the support of FDA advisers: Johnson & Johnson’s Covid-19 vaccine booster got a key recommendation from U.S. regulatory advisers that brings the extra shot closer to clearance. The FDA’s vaccine advisory group voted unanimously on Friday to recommend the recall for people 18 years of age and older who received their initial immunizations at least two months earlier. Experts also indicated their support for mixing and pairing boosters from different manufacturers, but did not vote on a recommendation. Read more from Riley Griffin, Jeannie Baumann and Robert Langreth.

  • The best way to boost antibodies in people who have received J & J’s single injection vaccine may be to give an additional full dose of an mRNA vaccine, if a federally sponsored trial is any indication. The FDA may consider allowing the use of one of the vaccines approved by the United States to increase the starting doses of another, said Peter Marks, director of the agency’s Center for Biologics Evaluation and Research, to the advisory panel. He didn’t give a timeline for when this might happen. Read more about Robert Langreth.
  • Meanwhile, Biden’s chief medical adviser has said he expects US regulators to question whether people who have received the single-dose Johnson & Johnson vaccine should get mRNA vaccines against Covid-19 as a reminder. “If you boost people who initially received J&J with Moderna or Pfizer, the level of antibodies you induce in them is much higher than if you boost them with the original J&J,” Anthony Fauci said on ABC. Week “Sunday. Read more about Ian Fisher.

U.S. borders to open on November 8 for those vaccinated: The United States will open its borders to vaccinated foreigners on November 8, a White House official said on Friday, granting access to millions of people who have been excluded from the country while closing it to anyone who does not has not been vaccinated. Under the new system, vaccinated people who have tested negative within the previous 72 hours will be able to board a flight to the United States as long as they share contact tracing information. Unvaccinated foreigners will generally be 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 requires all of its employees to be vaccinated against Covid-19 and places those with religious exemptions on unpaid leave may come into effect, a Colorado federal court has ruled. The ruling contradicts a recent opinion from 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 about Bernie Pazanowski.

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What else to know

Justice Department to ask Supreme Court to suspend Texas abortion law: The Justice Department said it would ask the U.S. Supreme Court to lift Texas’ ban on abortion after sixth week of pregnancy, setting up a showdown that could determine whether the law remains in force until the end of the year. Last week, a federal appeals court left the law in effect as the case progressed, even though a trial judge ruled the measure unconstitutional. The DOJ will ask the Supreme Court to overturn the appeal court’s order, a spokesperson said. Read more about Greg Stohr.

The CFPB rules lay the test for medical debt: Collection companies are facing outdated billing procedures, especially for student loans and medical debts, as they seek to revamp their consumer communications practices, as required by new federal rules. As of November 30, the Consumer Financial Protection Bureau rules, the first federal regulation for the industry, requires debt collectors to provide consumers with a clear description how much money they claim to owe and to whom they owe. Read more about Evan Weinberger.

HHS Outsourcing Program for Migrant Children: The administration wants outside help to improve its programs for unaccompanied migrant children as part of an ongoing public review of how the federal government deals with them. The Department of Health and Social Services announced this week that it was looking for an entrepreneur to give it recommendations “on the best way to structure its resources to meet the myriad needs” of its program for unaccompanied children. Read more about Ellen M. Gilmer.

NIH Won’t Confirm or Deny Cassava Investigation: The National Institutes of Health’s National Institute on Aging is aware of the allegations against Cassava Sciences, according to an email from a spokesperson for the communications office, but will not confirm or deny an investigation into the company after the speculation from a survey showed on Twitter Publish an e-mail written on Thursday, Cristin Flanagan reports.

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To contact the reporter on this story: Michaela ross in Washington at [email protected]

To contact the editors responsible for this story: Zachary Sherwood at [email protected]; Giuseppe Macri at [email protected]; Brandon lee at [email protected]

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