HEALTH CARE BRIEFING: Little Time for Medical Innovation Bill
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A bipartisan duo in the House is nearing completion on their legislation meant to spur more medical innovations, but face a busy congressional calendar that threatens to push passage of their bill into next year, Alex Ruoff reports.
Rep. Fred Upton (R-Mich.) told Bloomberg Government he and Rep. Diana DeGette (D-Colo.) are now putting the final touches on their update to the 21st Century Cures law (Public Law 114-255)—dubbed Cures 2.0. That bill is slated to carry authorizing language for Biden’s proposed new biomedical research agency.
The duo was hoping to introduce their legislation back in the summer to help launch what the White House calls the Advanced Research Projects Agency for Health, or ARPA-H, modeled on similar research initiatives at the Pentagon and the Department of Energy, Upton said. Competing priorities kept staff from working on Cures 2.0 for months, he said. “None of us though it would take this long: we wanted to do this in June or July,” Upton said.
Now, Upton expects to introduce the bill in coming weeks with the goal of passing it sometime this year. However, lawmakers are largely focused on trying to pass Biden’s proposed roughly $2 trillion spending bill, then turning their attention to funding the government before current appropriations expire in early December. Either the spending bill or a government funding bill could include money for ARPA-H, but neither is a done deal.
Democrats and Republicans have yet to reach agreement on how the fund the government and could be headed toward simply extending current levels past December.
Happening on the Hill
Senators Rebuke J&J Talc Suit Maneuver: Senate Majority Whip Dick Durbin (D-Ill.) and other leading Democrats are calling for Johnson & Johnson to reverse course on a bid to shed billions of dollars in legal liabilities, alleging that the company is exploiting bankruptcy law to dodge accountability for its talc products. J&J is facing tens of thousands of lawsuits stemming from claims that its talc products cause cancer and other health problems in women. It’s trying to resolve the lawsuits via bankruptcy by putting a new unit that holds the claims in Chapter 11. Read more from Jeremy Hill.
- J&J Stuck With $29 Million Jury Award in Baby Powder Cancer Suit
- Why J&J Is in Bankruptcy Court Even Though It’s Not Bankrupt
More Nutrition Training in Medical School Sought: Lawmakers, seeking to promote Americans’ health and combat obesity, are seeking to expand nutrition training for doctors and medical students. Rep. Jim McGovern (D-Mass.), co-chairman of the House Hunger Caucus, and Rep. Mike Burgess (R-Texas) announced legislation directing medical schools, residency, and fellowship programs to expand nutrition curricula for physicians and students. “We’re going to pass this in the House,” McGovern said on Wednesday. Read more from Megan U. Boyanton.
The Coronavirus Pandemic
U.S. Says Texas Suit Over Vaccine Rule Fails to Show Harm: Federal government officials told a federal appeals court that Texas’ challenge to OSHA’s shot-or-test requirement for employees at large businesses fails to prove harm to companies that outweighs the risk to the public health from the spread of Covid-19. The response, filed Wednesday by the Labor and Justice departments to the U.S. Court of Appeals for the Fifth Circuit, comes in response to the state’s lawsuit seeking to put on hold, and then ultimately void, the emergency regulation issued last week. Erin Mulvaney has more.
- The American Medical Association told a federal appeals court that the Biden administration’s shot-or-test mandate for big businesses is needed to protect workers’ health and safety. “Workplace transmission has been a major factor in the spread of COVID-19,” attorneys for the biggest U.S. association of doctors and medical students said in a proposed friend-of-the-court brief submitted to the U.S. Court of Appeals for the Fifth Circuit. “The more workers who get vaccinated, the closer we are to slowing the spread of the virus and creating a safer environment.” The panel hasn’t yet accepted the submission for filing. Read more from Andrew Harris.
- Meanwhile, unions are challenging the vaccine-or-testing mandate for employers in three federal appeals courts, in an apparent effort to support the emergency rule, not block it. The union lawsuits were filed in two appeals courts that have a majority of Democratic-appointed judges, and one with a partisan split, improving chances the panels would look favorably upon the administration’s mandate. Read more from Ben Penn and Robert Iafolla.
- Twenty-six state attorneys general sued to block OSHA’s emergency standard for businesses with 100 or more employees to require Covid-19 vaccines or institute weekly testing and masks. More than two dozen business filed their own suit seeking to block the mandate, leading to the appeals court stay. BGOV analyst Christina Banoub delves into the new emergency rule and the lawsuits surrounding it in an OnPoint.
- Health-Care Worker Vaccine Mandate Challenged by 10 States
- Union Bargaining Duties for Shot-or-Test Rule Outlined by NLRB
- Trucking, Building, Retail Groups Fighting Shot-or-Test Rule
- LAPD Union’s Vaccine Mandate Challenge Rejected by Judge
Texas Loses Mask-Ban Fight Over Disabled School Kids: Texas Governor Greg Abbott’s (R) anti-mask crusade was dealt a serious blow by a federal judge, who permanently blocked Abbott’s edict banning school mask mandates as a violation of disabled students’ right to equally access educational facilities. U.S. District Judge Lee Yeakel sided Wednesday with some Texas parents who fear their medically vulnerable children will catch—and potentially die from—Covid-19 transmitted by unmasked classmates and teachers. Read more from Laurel Brubaker Calkins.
Biden Invests $785 Million to Fight Covid-19 Health Inequities: The Biden administration will invest $785 million of American Rescue Plan Funding to combat health inequities in communities hit hardest by the Covid-19 pandemic. The funds will support communities of color, rural areas, and lower-income populations, the administration said Wednesday. Covid-19 has highlighted that “a person’s ZIP code is a stronger driver of their health than their genetic code,” Marcella Nunez-Smith, chair of the White House’s Covid-19 Health Equity Task Force, said. Allie Reed has more.
- The White House also announced a deal to rush doses of the Johnson & Johnson vaccine against Covid-19 into conflict zones and other humanitarian settings around the world through the international COVAX vaccine distribution program. Previously the shots were available only through official government programs, adding hurdles to distribution in conflict areas. Read more from Josh Wingrove.
U.S. Spending $650 Million to Expand Rapid Testing: The U.S. will spend $650 million to increase production and access to rapid diagnostic tests that can confirm the results of at-home screening, part of an effort to quickly identify and treat people with Covid-19. People who buy over-the-counter rapid antigen tests at pharmacies may need confirmatory testing to verify the accuracy of the result, the Health and Human Services Department said Wednesday. The funds will help ensure the tests are readily available across the country and can provide results quickly, it said. Read more from Emma Court.
- Moderna Fight With NIH Heating Up Over Covid-19 Vaccine Credit
- Moderna Defends Covid Shot as Questions on Heart Risks Mount
- Two Million Ellume Covid-19 Tests Recalled on False Positive Risk
- At Least 900,000 U.S. Kids 5 to 11 Have Gotten One Vaccine Dose
- Texas Now Only U.S. State Where White People Aren’t Largest Vaccinated Group
- Covid Pills May Save Lives, But They Won’t End the Pandemic
- Autumn Covid Wave Puts ICU Beds Under Seige in U.S. West: Map
- Vaccine Holdouts May Need New Jobs Before Christmas, States Say
What Else to Know
Family Health Premiums Resume Fast Growth: Annual family premiums for employer-sponsored health insurance rose 4% to average $22,221 in 2021, the Kaiser Family Foundation reported. Workers contributed $5,969 toward the cost of family coverage with employers paying the rest, the KFF reported in its 2021 employer benefits survey of nearly 1,700 large and small companies. The premium changes roughly match the 5% year-to-year rise in workers’ wages. Inflation increased 1.9% over the same period, according to the data. Read more from Sara Hansard.
Drug Shortage Reporting Rules Prompt Questions: The meaning of a “life-saving” drug and how quickly supply chain data can become available are among the questions pharmaceutical companies are raising as they try to comply with expanded reporting rules aimed at fighting pandemic-fueled shortages. The goal of the updated rules is to bring efficiency to drug shortage reporting so the FDA can be better equipped to handle health crises in the future. But concerns persist that the scope of such requirements, along with the timelines for meeting them, are becoming too arduous. Celine Castronuovo has more.
Labor Official Defends Surprise Billing Rule: A Department of Labor official Wednesday defended a proposed rule pegging surprise billing payments to contract rates that has spawned lawsuits and complaints that it will result in inadequate payments to health-care providers. “Obviously we did take an approach in the interim final rule that wasn’t an accident. We’ve been thinking about this issue a lot, and it was a deliberate decision,” Ali Khawar, assistant secretary of the DOL’s Employee Benefits Security Administration, said in a webinar. Read more from Sara Hansard.
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- FTC Requiring ANI to Divest Pair of Generics for Novitium Deal
- Regeneron Patents on Eylea to Get Review on Mylan Challenge
- Novome, Genentech Enter Pact for Inflammatory Bowel Illness
- Drone Startup Plans Drug Deliveries to Homes in Salt Lake City
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