HEALTH CARE BRIEFING: Drug Talks Continue as Pelosi Presses Vote

House Speaker Nancy Pelosi (D-Calif.) aims to push forward with plans to vote this week on the two bills that comprise President Joe Biden’s economic agenda despite moderates echoing Sen. Joe Manchin’s (D-W.Va.) complaint about not knowing the full cost and economic impact.

None of the centrist Democrats have yet threatened to block a vote on a $1.75 trillion tax and spending plan that forms the biggest parts of Biden’s agenda. Yet it was another indication that Pelosi, Biden and other Democratic leaders haven’t fully sealed the deal to get the measure passed.

Pelosi is focused on the House voting on the tax and spending proposal and a separate $550 billion public works measure before she attends the United Nations climate summit in Glasgow, Budget Chair John Yarmuth (D-Ky.) said yesterday. Pelosi’s office has not announced when she is traveling to the summit, which lasts until Nov. 12.

“We’re on course to pass our bill,” Pelosi said last night of the larger package, which includes climate and social spending paid for by tax increases. Pelosi is trying to seal a last-minute deal on drug price cuts to add to the measure in order to allow a vote this week.

Senate Finance Chairman Ron Wyden (D-Ore.) said lawmakers made progress on negotiations to limit drug price hikes and allow Medicare to negotiate some prices, Steven T. Dennis reports. Democrats are still working on which drugs would be subject to price negotiations, but insulin products could be subject to negotiation under Part D. Read more from Erik Wasson and Emily Wilkins.

Group Takes Aim at Sinema: Patients For Affordable Drugs Now launched advertising in Arizona directed at Sen. Kyrsten Sinama (D-Ariz.) to push for inclusion of provisions to allow Medicare to negotiate lower drug prices in the package, the advocacy group said in a statement. The ad will run on Arizona cable television and digital platforms starting this week.

The Coronavirus Pandemic

Workplace Vaccine-or-Test Rule Clears White House Review: A federal Covid-19 vaccination and testing mandate for employers with 100 or more employees is close to being released after the White House’s regulatory office completed a three week review of the OSHA emergency rule. The analysis by the Office of Information and Regulatory Affairs is usually the last formal step before a final rule becomes public. In a notice yesterday, the regulatory office said it completed its review.

In a separate emailed statement yesterday, a Department of Labor spokesperson said the emergency temporary standard will be published in the Federal Register “in the coming days.” The standard will require covered employers to “develop, implement, and enforce a mandatory Covid-19 vaccination policy, unless they adopt a policy requiring employees to choose either to get vaccinated or to undergo regular Covid-19 testing and wear a face covering at work.” Read more from Bruce Rolfsen.

Health-Care Worker Vaccine Mandate Finalized: An interim final rule requiring Covid-19 vaccination for health-care workers at facilities paid by Medicare and Medicaid cleared White House review and can now publish at any time. The health-care sector has led the charge for vaccine mandates in work settings, with many hospitals and health systems requiring the jab for their staff before state and federal mandates. The rule will take effect as soon as it is published in the Federal Register. Allie Reed has more.

Millions of Kids’ Covid Vaccines Shipped Ahead of CDC Clearance: An estimated 15 million doses of kids’ vaccines will arrive at thousands of sites across the nation over the next week, as the White House readies for widespread inoculations if the CDC signs off. The Food and Drug Administration’s Friday authorization of the Pfizer vaccine for kids ages 5 to 11 was a “critical operational milestone” that allowed vaccines to ship, said Jeff Zients, Biden’s Covid-19 chief. Josh Wingrove and Jeannie Baumann have more.

WHO Calls for More Experts to Study Origins: The World Health Organization reopened a search for experts to join a committee to study the coronavirus’s origins to add more specialists in areas such as biosecurity. Applicants have until tomorrow to express interest, and the WHO said yesterday it’s looking for experts in social science, anthropology, ethics, political science and biosafety. The WHO’s proposal for 26 experts to lead a probe comes after an earlier bid was beset by controversy. Thomas Mulier has more.

More Headlines:

• Step Inside a Rehab Clinic in Manhattan for Long Covid Sufferers
• Moderna Plunges After FDA Setback on Teenage Covid Vaccines
• Union for Federal Prison Employees Sues Over Vaccine Mandate
• Novavax Rises in Premarket on Optimism Over Vaccine Approval

What Else to Know Today

Four Key Moments in Top Court’s Abortion Law Arguments: The Supreme Court yesterday heard arguments on Texas’ new abortion law, which has halted most procedures in the state, and the questioning offers some clues to the outcome. Four of the justices were already inclined to put a hold on the statute, which outlaws almost all abortions after about six weeks of pregnancy, months earlier than high court precedent. Justices Stephen Breyer, Elena Kagan and Sonia Sotomayor and Chief Justice John Roberts had all said they would have done so when abortion providers asked the court to pause the law before it went into effect on Sept. 1.

The other five thought it was too early for the court to step in at that stage. But now that it is considering the matter in depth, some of those justices signaled they might be in play. Kimberly Robinson offers four important moments from inside the courtroom.

• Related: Justices Grapple With Courts’ Powers to Stop Texas Abortion Law

J&J, Teva Beat $50 Billion Opioid Case in First Industry Win: Johnson & Johnson, Teva Pharmaceutical Industries, and other former opioid makers scored the pharmaceutical industry’s first win in the sprawling four-year litigation over the drugs, defeating a lawsuit by local governments in California that claimed they created a public-health crisis through misleading marketing.

Superior Court Judge Peter Wilson in Santa Ana yesterday rejected claims that units of J&J, Teva, Endo International and Abbvie’s Allergan duped doctors and patients about the addictiveness of opioid painkillers and created a so-called “public nuisance” tied to the medications. Officials in Los Angeles, Santa Clara and Orange counties and the city of Oakland sought as much as $50 billion to beef up policing and treatment budges depleted by the epidemic. Read more from Jef Feeley.

More Headlines:

• Horse-Trainer Drug Case Gets More Review After DOJ Admits Error
• Eli Lilly Defeats Agency’s Attempt to Enforce Drug Discount Policy
• Boston LGBTQ Health-Care Bias Rule Case Halted Until April 2022
• Kalanick-Backed Startup Kareo to Merge With Health-Care IT Firm
• Sun Pharma Profit Beats on Push Into Specialty Treatment

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