Dems run back IRA wish list

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Jul 28, 2023 View in browser   By David Lim, Lauren Gardner and Katherine Ellen Foley Presented by Driving the Day House Ways and Means Committee ranking member Richard Neal says that House Democrats "won't be deterred by Republican threats" in their quest to lower drug prices. | Francis Chung/POLITICO via AP Images MEDICARE DRUG PRICES FOR PRIVATE PLANS? Washington got a glimpse this week of Democrats’ desired drug-pricing legislative agenda if they win a supermajority. The strategy? Giving private insurance plans access to the price Medicare negotiates for drugs. Democratic committee leaders in the House introduced the Lowering Drug Costs for American Families Act, a bill that codifies the current wish list of drug-pricing policies: extending the inflation rebate caps to those with private health insurance and increasing the number of drugs annually selected for Medicare negotiation from 20 to 50 starting in 2029. Larry Levitt, executive vice president for health policy at KFF, told POLITICO the new push gives Democrats a health care policy messaging bill to run on during the 2024 election. But he noted that Democrats had already tried to pass similar expansive drug-pricing policies in the Inflation Reduction Act , which contained a narrower set of measures than championed by former House Speaker Nancy Pelosi (D-Calif.) at the start of the Biden administration. “Giving the government authority to negotiate drug prices in Medicare was certainly monumental and the biggest political loss pharma has probably ever suffered,” Levitt said. “But extending price negotiation to the private sector would create an unprecedented role for the federal government in curbing health care prices.” Drugmakers are already challenging the legality of the Biden administration’s implementation of such negotiations, and any expansion to the private sector is nearly guaranteed to draw additional lawsuits. “Lowering health care costs is key to finishing the job for the American people, and House Democrats won’t be deterred by Republican threats or big pharma’s lawsuits,” Ways and Means Committee ranking member Richard Neal (D-Mass.) said. Wall Street offered a gut check on the bill’s chances in the current Congress, where Republican control of the House makes it certain to be dead on arrival. “The bill has no chance of moving or even getting a vote in the House,” TD Cowen Washington Research Group’s Rick Weissenstein wrote Thursday in a research note. “It is likely to become the bill of choice for the liberal wing of the party heading into the next election as Democrats look to retake the House.”   YOUR TICKET INSIDE THE GOLDEN STATE POLITICAL ARENA: California Playbook delivers the latest intel, buzzy scoops and exclusive coverage from Sacramento and Los Angeles to Silicon Valley and across the state. Don't miss out on the daily must-read for political aficionados and professionals with an outsized interest in California politics, policy and power. Subscribe today.     IT’S FRIDAY. WELCOME TO PRESCRIPTION PULSE. Did you know condoms are medical devices? This FDA contract solicitation for two automated condom air burst machines for testing condoms caught our eye, hat tip to our colleagues at AgencyIQ. Send news and tips to Katherine Ellen Foley (kfoley@politico.com or @katherineefoley), Lauren Gardner (lgardner@politico.com or @Gardner_LM or @gardnerlm19) and David Lim (dlim@politico.com or @davidalim or @david.a.lim). TODAY ON OUR PULSE CHECK PODCAST, host Alice Miranda Ollstein talks with Lauren, who reports on recent tuberculosis cases in the U.S. linked to recalled bone graft materials, bringing the total cases to five, including one death, and what's being done about the latest contamination concerns. Listen to today’s Pulse Check podcast   A message from PBM Accountability Project: PBM profits are tied to the cost of drugs. That means that PBMs make more money if drug prices are higher. Let’s end the PBM shell game once and for all. Learn more.   In Congress House Speaker Kevin McCarthy and his leadership team punted an FDA funding bill until after August recess. | J. Scott Applewhite/AP Photos HOUSE PUNTS FDA APPROPS VOTE — House GOP leadership abandoned plans Thursday to hold a floor vote on a bill to fund the FDA and the Agriculture Department before August recess amid intraparty divisions over spending and policy, POLITICO’s Meredith Lee Hill reports. The House Rules Committee had already postponed a meeting Wednesday night to set floor debate parameters for the fiscal 2024 legislation. The conservative House Freedom Caucus has sought tens of billions of dollars in extra cuts to spending measures that leaders have already finalized, angering Republican subcommittee “cardinals” whose votes Speaker Kevin McCarthy also needs. Democrats have lined up against the bill over deep cuts to nutrition programs and a policy provision nixing mail delivery of abortion pills, an issue that’s also been met with resistance by some moderate Republicans. SENATE PANEL ADVANCES NIH BILL — The Senate Appropriations Committee approved a bill Thursday to fund HHS at $117 billion in fiscal 2024, POLITICO’s Ben Leonard writes, setting up a showdown with the House over spending levels once lawmakers return this fall. The chambers are particularly far apart on funding for the NIH and the Advanced Research Projects Agency for Health.   HITTING YOUR INBOX AUGUST 14—CALIFORNIA CLIMATE: Climate change isn’t just about the weather. It's also about how we do business and create new policies, especially in California. So we have something cool for you: A brand-new California Climate newsletter. It's not just climate or science chat, it's your daily cheat sheet to understanding how the legislative landscape around climate change is shaking up industries across the Golden State. Cut through the jargon and get the latest developments in California as lawmakers and industry leaders adapt to the changing climate. Subscribe now to California Climate to keep up with the changes.     Around the Agencies FTC, SURESCRIPTS REACH PROPOSED SETTLEMENT — Surescripts, the health information and e-prescribing giant, and the FTC on Thursday agreed on a proposed settlement that resolves FTC charges that the company “used anti-competitive tactics to illegally monopolize two e-prescription drug markets.” The settlement prevents Surescripts from “engaging in exclusionary conduct and executing or enforcing non-compete agreements with current and former employees.” The company said it was pleased the settlement was reached but argued the FTC challenge relied on “significant factual errors” about its business. ARPA-H INVESTMENT — The White House is touting a new ARPA-H program that aims to improve cancer surgery outcomes by seeking proposals to assist tumor-edge and critical anatomy visualization, POLITICO’s Erin Schumaker reports. The new agency charged with funding high-risk, high-reward research believes that if surgeons can see tumors' edges more clearly, they'll have a better shot at removing them and avoiding damage to healthy tissue. ARPA-H will begin taking proposals on Sept. 7. Eye on the FDA THE PRICE IS RIGHT — The FDA published a slate of new fiscal 2024 user fee rates Thursday for biosimilars, generic drugs, medical devices, prescription drugs, outsourcing facilities and more in the Federal Register.   A message from PBM Accountability Project:   Industry Intel LATE-STAGE CANCER VACCINE TRIAL BEGINS — A Phase III clinical trial began this week for a combination of Merck’s immunotherapy Keytruda and a personalized mRNA vaccine candidate from Moderna geared at preventing cancer recurrence for patients with high-risk, retracted melanoma. Earlier this year, the companies reported that the combination of treatments prevented recurrence better than immunotherapy alone in a Phase II trial. Tobacco ILLEGAL VAPE DISTRIBUTORS WARNED — The FDA issued warning letters Thursday to three companies still selling unauthorized flavored e-cigarettes. According to the agency, Easy Wholesale, ABS Distribution and EC Supply were found to be selling vapes, including Elf Bars and Esco Bars, without marketing authorizations. Third time’s the charm? The agency issued warning letters in June to retailers selling the products and, in May, issued an import alert with Customs and Border Protection to detain shipments containing those products coming from China, South Korea and some ports in the U.S. So far, FDA’s enforcement hasn’t been enough in the eyes of leading health experts. A group of 24 city health commissioners wrote to Center for Tobacco Products Director Brian King, asking his agency to take additional action to keep the flavored vapes off shelves. Pharma Moves Chris Boshoff will become Pfizer’s chief oncology research and development officer and executive vice president. Mikael Dolsten will step into a broader role there as chief scientific officer and president of research and development. William Pao, the chief development officer, is departing the company in the month ahead. Angus Grant is joining Teva Pharmaceutical Industries on Aug. 1 as an executive vice president of business development. What We're Reading Six months after launching sales, Missississippi’s medical marijuana operations are outpacing demand, POLITICO’s Paul Demko reports. Ivermectin may have a role in stopping disease-carrying ticks, Maryn McKenna reports for Undark. Document Drawer The FDA published draft guidance outlining clinical considerations for medical device makers developing studies for devices intended to treat opioid use disorder. HHS Secretary Xavier Becerra and Ashish Jha, former White House Covid-19 Response Coordinator, make the case in The New England Journal of Medicine that government investment into improved Covid-19 vaccines and monoclonal antibodies is needed to prepare for current and future respiratory viruses. The FDA sent a proposed rule that is likely to float stricter regulation of laboratory-developed tests for review to the White House Office of Information and Regulatory Affairs.   A message from PBM Accountability Project: Every time you go to the pharmacy counter, health insurance middlemen called pharmacy benefit managers – or PBMs – increase their already high profits. Last year alone, the top 3 PBMs recorded more than $27 billion in profits. It’s time to end the PBM shell game. There is growing, bipartisan agreement in Congress to break the link between the price of medicine and PBM revenues to help Americans afford and access their medications. Voters agree. More than 80% of voters want to stop PBMs from directly profiting off drug prices. We need actionable reforms to hold PBMs accountable and to address the games they play that drive up out-of-pocket costs at the pharmacy counter. Decisive action is needed by Congress today. Learn more.     Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

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