Health legislative train might have left the station

By Katherine Ellen Foley, David Lim and Lauren Gardner

PROGRAMMING NOTE: We’ll be off for Thanksgiving this Friday but back to our normal schedule on Tues., Nov. 28.

Rep. Brett Guthrie says it's unlikely there will be a year-end omnibus spending package that would include health legislation. | Francis Chung/E&E News

WHAT END-OF-THE-YEAR PACKAGE? Congress’ recent agreement to temporarily fund the government has Washington emptying out for Thanksgiving and lobbyists, congressional staffers and at least one key lawmaker confronting the reality that there could be no more legislative vehicles for health policy priorities this year.

Rep. Brett Guthrie (R-Ky.), chair of the House Energy and Commerce health subcommittee, told Prescription Pulse the short-term government funding deal likely prevents a typical year-end omnibus spending package to which health legislation could be attached.

“It would be tough to do before the end of this calendar year,” Guthrie said. “We’ve got to do offsets, we gotta do full committee markup, and then you’ve got to get it across the floor.”

The House and Senate have worked to pass health care priorities out of committee, such as transparency requirements for pharmacy benefit managers and tweaks to Medicare physician pay reimbursement. But other efforts, such as reaching a bipartisan agreement in the House on legislation to address generic drug shortages, have yet to be hashed out in committee.

Lobbyists are eyeing a few potential year-end legislative vehicles, such as congressional action on a supplemental package with funding for Israel or Ukraine or the National Defense Authorization Act. But none of those are certainties.

One lobbyist with knowledge of the situation granted anonymity to discuss the year-end legislative outlook said the “million-dollar question for every health care entity” is whether a standalone health package could be moved.

“Optimists would say the [Medicare Physician Fee Schedule] ‘fix’ could be the basis of a health package that could move alone,” said another lobbyist with knowledge of the conversations granted anonymity to discuss the situation. “I’m skeptical.”

The most likely path for health care legislation comes early next year: the Jan. 19 deadline for the so-called laddered continuing resolution that includes FDA funding.

IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Your host has already baked a pecan pie for Thanksgiving and foresees at least one more and possibly a pumpkin pie.

Send news, tips and pie recipes to Lauren Gardner (lgardner@politico.com or @Gardner_LM), David Lim (dlim@politico.com or @davidalim) and Katherine Ellen Foley (kfoley@politico.com or @katherineefoley).

TODAY ON OUR PULSE CHECK PODCAST, host Ben Leonard talks with POLITICO health care reporter Ashleigh Furlong, who explains the Lancet Countdown's report that warns of the dire consequences of rising temperatures and increasing energy emission — and the potential catastrophic threats climate change poses to human health.

Novartis is one of several challengers to Medicare's drug price negotiation program. | Fabrice Coffrini/AFP via Getty Images

SETTING THE IRA CHALLENGE TABLE — DOJ and pharma industry lawyers face a slew of deadlines heading into the holidays as briefing on several Inflation Reduction Act lawsuits progresses.

Here’s a status update on some challenges to Medicare’s drug price negotiations authority:

Merck: The government must file a reply in support of its cross-motion for summary judgment today in federal district court in the District of Columbia. A judge last month granted a motion by Merck, which makes the diabetes drug Januvia, to allow subsidiary Merck Sharp & Dohme to join the lawsuit without any more changes to the briefing schedule. The DOJ had argued that the wrong “Merck” was challenging the program, a charge relevant to the question of legal standing.

Novo Nordisk: The insulin manufacturer’s case was reassigned earlier this month to Judge Zahid N. Quraishi in U.S. district court for New Jersey at the DOJ’s request since he’s presiding over three other IRA challenges: Bristol Myers Squibb, Janssen and Novartis. Briefing has yet to be scheduled.

Novartis: The maker of Entresto, a heart failure drug, is due to file its motion for summary judgment Wednesday in New Jersey.

Bristol Myers Squibb and Janssen: The DOJ must file its last reply supporting its cross-motion for summary judgment by Dec. 8. Briefing for the companies’ cases was combined due to the similarity of their arguments and their common jurisdiction in New Jersey.

AstraZeneca: The company, which makes diabetes drug Farxiga, must respond to the DOJ’s opposition by Dec. 1 in Delaware.

Boehringer Ingelheim: The government must file its response to BI’s motion for summary judgment by Dec. 6 in Connecticut. The firm makes Jardiance, a diabetes and heart failure medication.

U.S. Chamber of Commerce: The government’s opposition to the group’s motion for summary judgment is due Dec. 15. An Ohio district court judge previously denied an effort by the Chamber to obtain a preliminary injunction to block implementation of the negotiations program.

PhRMA: The trade lobby is waiting for the judge in the Western District of Texas to rule on the government’s motion to dismiss the case.

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FDA: DRUG ADS SHOULD BE CLEAR — The regulator issued a final rule Monday that supplements its rules of the road for prescription drug advertisements by setting standards for how side effects and contraindications should be communicated.

"This rule seeks to help ensure that [direct-to-consumer] ads communicate risk information in a manner that helps consumers notice, attend to, and understand the drug’s risks," the final rule states.

COPS WARY OF MENTHOL BAN — The Federal Law Enforcement Officers Foundation will meet with the Office of Management and Budget next week to discuss the forthcoming rule banning menthol cigarettes — or what the officers see as “another unfunded federal mandate,” according to the foundation’s president, Jon Adler.

“We’re concerned that because this wasn’t thought out and planned properly, local [police] departments don’t have the law enforcement assets to implement what the FDA wrote in their plan, which is in effect robust enforcement,” Adler, former director of the Bureau of Justice Assistance in the DOJ, told Prescription Pulse.

He fears the rule would either require the government to appropriate federal funds for state and local police departments or force local police departments to reallocate resources to focus on keeping menthol cigarettes off store shelves.

The FDA’s proposed rule would criminalize the sale and distribution of menthol cigarettes but not consumer possession. However, several civil rights activists, including the Rev. Al Sharpton, have raised concerns that the ban on menthol cigarettes could lead to dangerous interactions between law enforcement and people of color. Most Black smokers prefer menthol cigarettes.

Adler’s group has received funds from tobacco companies, but Adler said the money was spent on wellness programs for law enforcement officers.

What’s next: The rules banning menthol cigarettes and flavored cigars are under final White House review and could be issued as soon as the end of this year.  

NHS, PHARMA REACH DRUG PRICING DEAL — The U.K. government and the British pharmaceutical lobby agreed Monday on a five-year spending cap on brand-name medicines.

The agreement limits the maximum annual growth in sales for brand-name drugs from 2 percent in 2024 to 4 percent in 2027. Any additional revenue will be paid back to the U.K.’s National Health System via a levy.

AI CLINICAL TRIAL COMPANY LAUNCHED — The British-Swedish pharma giant AstraZeneca said Monday it is launching Evinova, a business that will assist other drugmakers with artificial intelligence clinical trial design and management. Evinova said it will also provide technical support and tools for using AI to collect clinical data and track trials over time.

FDA chief of staff Julie Tierney will transition into the role of the Center for Biologics Evaluation and Research’s deputy center director for strategy, policy and legislation.

Fees layered on top of monthly rent make assisted living homes unaffordable for many Americans, Jordan Rau reports for KFF Health News.

The FDA cautioned health care providers on Monday not to use Cardinal Health Monoject syringes with syringe pumps and patient-controlled analgesia pumps while the agency evaluates a potential risk of incompatibility that might not be fully mitigated by a recent recall.

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David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley

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