HEALTH CARE BRIEFING: Small Biotechs May Be Spared in Drug Bill

A Senate leader crafting a drug pricing proposal is trying to win the support of moderate Democrats by promising to carve out exceptions for small biotech companies. Those moderate senators are warning they won’t commit until they see all the details.

Senate Finance Chair Ron Wyden (D-Ore.) said he’s promised that pharmaceutical companies with limited access to capital or that invest heavily in research could be exempt from central parts of his drug pricing bill, which he has yet to unveil completely. He outlined the components of the measure in June but has yet to release legislative text.

The legislation would empower the government to negotiate with drugmakers for better prices and caps on drug price increases, Wyden said. “I’ve talked my colleagues and said, ‘You can protect the consumer from being clobbered by the cost of insulin and other drugs and be sensitive to innovation. That’s a space where we can land,” Wyden said.

Wyden needs to win over all 49 of his Senate Democratic colleagues and almost all House Democrats in order to see his vision turned into law.

As they wait for Wyden to make his plan public, House leaders have moved forward with their own legislation directing the federal government to negotiate lower drug prices and cap price increases. That package, pegged to the wide-sweeping domestic spending bill, has no carve-outs for small biotechnology companies similar to what Wyden has described.

However, at least four centrist Democrats in the House have pledged to vote against their party’s domestic policy package. That means the proposal would have to change in some fashion for it to pass on the House floor. All Republicans are expected to vote against the massive spending package, which could total as much as $3.5 trillion. Alex Ruoff has more.

House Readies Reconciliation Vote: House Democrats are heading toward a showdown this week over President Joe Biden’s economic agenda, with a planned vote on a $550 billion infrastructure package that has riven the caucus in two and still more negotiations on broader tax and spending plan.

Speaker Nancy Pelosi (D-Calif.) put the infrastructure bill on the schedule for today under pressure from moderates eager to get the bipartisan bill, which has already passed the Senate, enacted. But progressives—whose votes are likely vital—are insisting on progress first on the bigger social-spending bill.

Last night, she told House Democrats in a letter that the infrastructure legislation will be voted on Thursday. Party leaders are continuing to negotiate among factions on the second bill encompassing much of the rest of Biden’s plans. “We’re going to pass the bill this week,” Pelosi said of the public works legislation on ABC’s “This Week” program yesterday. “I’m never bringing a bill to the floor that doesn’t have the votes.” Read more on the legislation as well as the status of the stopgap measure from Erik Wasson and Laura Litvan.

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Happening on the Hill

Hearings on the Hill:

  • School Reopenings: The Senate Health, Education, Labor and Pensions Committee holds a hearing Thursday on school reopenings amid the Covid-19 pandemic. Health and Human Services Secretary Xavier Becerra and Education Secretary Michael Cardona are set to testify.
  • Virus Relief: The House Transportation and Infrastructure Committee will convene on Thursday to assess the federal government’s Covid-19 relief and response efforts.
  • State & Local Health: The House Select Subcommittee on the Coronavirus Crisis convenes Wednesday for a hearing on strengthening state and local health departments.
  • Virus Protection: The House Education and Labor Civil Rights and Human Services and Health, Employment, Labor, and Pensions Subcommittees plans a joint hearing on Tuesday to review successful models for protecting communities from Covid-19.

Fentanyl Report Deadline Vote: The House plans to vote on legislation (H.R. 4981) as early as today that would extend for an additional 120 days the due date for the final report of the Commission on Combating Synthetic Opioid Trafficking. The House Foreign Affairs Committee hasn’t acted on the measure, which Rep. David Trone (D-Md.), who is the Democratic cochairman of the commission, introduced on Aug. 6. The measure will be considered under suspension of the rules, an expedited procedure that indicates broad bipartisan support.

House Passes Abortion Bill in Wake of Texas Law: State restrictions on abortion services would be prohibited under legislation passed by the House Friday. The House voted 218-211 on a bill (H.R. 3755) that would give the Justice Department the power to bring civil actions against government officials or individuals who try to impose limitations on abortions, other than those that are deemed necessary.

Democratic leaders say protecting the right to access abortion services and providers’ right to offer such services is essential after Texas passed a law limiting abortion to before a fetal heartbeat is detected — generally six weeks, before many people even know they’re pregnant. A group of Senate leaders promised to vote on the bill “in the very near future,” although it’s unlikely to garner the 60 votes needed in that chamber to send it to Biden’s desk. Read more from Alex Ruoff.

  • Meanwhile, oral arguments on Georgia’s six-week abortion ban on Friday appeared to be over before they began, with Chief Judge William Pryor Jr. opening with a suggestion that the Eleventh Circuit just halt the case. The “prudent” course would be to wait for the U.S. Supreme Court to decide Dobbs v. Jackson Women’s Health Org., which presents the question of whether Mississippi’s ban on abortions after 15 weeks is constitutionally permissible. Mary Anne Pazanowski has more.

Drug Pricing Allies See Promise in Leahy Bill: A planned bill to make changes to how the Patent Trial and Appeal Board reviews patents includes a new validity challenge that supporters of lower drug prices believe could be useful in getting more generics on the market. The legislation, which Sen. Patrick Leahy (D.-Vt.) plans to introduce, would allow the Patent Trial and Appeal Board to examine a patent’s validity under the double-patenting doctrine during a review challenge. Matthew Butlman has more.

The Coronavirus Pandemic

Biden Touts Pfizer Boosters After CDC Chief Overrules Advisers: Biden said 60 million Americans who got the Pfizer-BioNTech Covid-19 vaccine will soon be able to get a booster shot, after one of his top health officials overruled an advisory panel to expand eligibility. “We took a key step in protecting the vaccinated with booster shots, which our top government doctors believe provides the highest level of protection available to date,” Biden said Friday at the White House.

Centers for Disease Control and Prevention Director Rochelle Walensky issued a statement advising that booster shots could be given to certain adults with the Pfizer vaccine 6 months after the second of their first two shots. Her statement broadened eligibility for the shots beyond the recommendations of a CDC advisory panel. But Biden said Walensky was in-line with medical science.

In particular, Walensky said that people age 18 to 64, who have no underlying medical conditions but who work in places with a high chance of Covid-19 exposure, would be able to get a Pfizer booster if they previously got the Pfizer vaccine. That overruled a vote earlier in the day by the CDC’s Advisory Committee on Immunization Practices, but was in line with recommendations from the Food and Drug Administration. Read more from Josh Wingrove and Jenny Leonard.

  • Walensky was particularly motivated by one factor: she believed that nurses and other health officials working in Covid-19 units, many of whom are now 8 months past their second shot, should be eligible for third shots, according to one of the people familiar with the matter. Read more from Josh Wingrove.
  • Meanwhile, though clearance of the booster falls short of the Biden administration’s goal to get most immunized Americans an extra jab, it still amplifies calls for sending more shots to poorer nations. The decisions come amid a debate that’s gaining momentum among wealthy countries over whether the U.S. should prioritize third doses nationally or do more to help get first doses to regions that are far from widespread immunization. Read more from Ian Lopez.

Medicare, Medicaid to Pick Up Tab for Boosters: Medicare, Medicaid, and the Children’s Health Insurance program will pay the full cost of boosters with no cost-sharing for nearly all beneficiaries, the White House said on Friday. “CMS is ensuring that cost is not a barrier to access, including for boosters,” said Chiquita Brooks-LaSure, head of the U.S. Centers for Medicare and Medicaid Services. Beneficiaries in the program already pay nothing for the Covid-19 vaccines or their administration. Tony Pugh has more.

U.S. Contractors Must Get Vaccine by Dec. 8: Federal contractor employees must be fully vaccinated against Covid-19 by Dec. 8 unless they are granted a legal accommodation, under White House guidance released Friday. The guidance from the Safer Federal Workforce Task Force—which also includes masking and physical distancing requirements—was required under Biden’s Sept. 9 executive order on coronavirus safety protocols for companies that employ government contracts. Paige Smith has more.

  • Meanwhile, dozens of industry lobbying groups are urging the Labor Department’s workplace safety agency to accept their input as regulators write an emergency rule to implement Biden‘s call for an employer vaccination mandate. The Coalition for Workplace Safety—led by groups such as the U.S. Chamber of Commerce—wrote to the Occupational Safety and Health Administration’s top official on Friday. Read more from Ben Penn.

Walensky Warns of ‘Dire Straits’: Parts of the U.S. health system “are in dire straits,” as the spread of the Covid-19 delta variant forces some states to prepare for rationed medical care, Walensky said. “That means that we are talking about who is going to get a ventilator, who is going to get an ICU bed,” Walensky said on CBS’s “Face the Nation” yesterday. “Those are not easy discussions to have, and that is not a place we want our health care system to ever be.” Idaho, among the U.S.’s least-vaccinated states, and Alaska have said that hospitals can begin to ration medical care if needed. A major hospital in Montana also implemented so-called “crisis of care standards” to prioritize who is treated. Health officials warned the measure could be widened across the state. Read more from Ian Fisher.

Providers Want More Time to Spend Relief Money: Medical groups and health lawyers are calling on the government to give hospitals more time and clarity as they hustle to report how they spent pandemic assistance funds by an approaching deadline. The delta variant has hit an already overburdened health-care workforce hard, with hospitals losing money and staff. And rules from HHS around how the funds would be spent and accounted for have changed several times. Allie Reed has more.

More Pandemic Headlines:

What Else to Know Today:

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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