First-round loss for PhRMA

Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Feb 13, 2024 View in browser   By David Lim and Lauren Gardner With Ben Leonard Driving the Day HHS Secretary Xavier Becerra applauded a court ruling to dismiss a challenge to Medicare drug price negotiations Monday. | Greg Nash-Pool/Getty Images PhRMA TAKES AN L — The pharmaceutical industry suffered a blow in court Monday when a federal judge dismissed a lawsuit challenging Medicare drug price negotiations backed by the Pharmaceutical Research and Manufacturers of America without a hearing. "It may tell you something about whether the judge thought that PhRMA had even half a leg to stand on," said Nicholas Bagley, a law professor at the University of Michigan. “Even among the lawsuits that have been filed, which are all weak, this is the weakest.” Senior U.S. District Judge David Alan Ezra ruled that the National Infusion Center Association, the Global Colon Cancer Association and PhRMA did not have standing to file the lawsuit in the U.S. District Court Western District of Texas. “We are disappointed with the court’s decision, which does not address the merits of our lawsuit, and we are weighing our next legal steps,” PhRMA spokesperson Nicole Longo said. If the lawsuit is appealed, it will head to the Fifth Circuit Court of Appeals in New Orleans. HHS Secretary Xavier Becerra said the ruling “offers more reason for optimism” about the first Medicare drug price negotiations. “We will continue to implement the President’s historic prescription drug price law,” Becerra said. But Lawrence Gostin, faculty director of the O’Neill Institute for National and Global Health Law at Georgetown University, said it remains to be seen if the decision foreshadows what happens with the eight other lawsuits challenging the Inflation Reduction Act. “It's way too early for the Biden administration to declare victory,” Gostin said. “The Fifth Circuit is the most conservative circuit in the country. I often say it’s the place where all good public health regulation goes to die.” IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. We saw the pharma commercials during the Super Bowl, but let’s give a round of applause to the spot that promoted our favorite cup of Joe. Send news and tips to Lauren Gardner (lgardner@politico.com or @Gardner_LM) or David Lim (dlim@politico.com or @davidalim).   CONGRESS OVERDRIVE: Since day one, POLITICO has been laser-focused on Capitol Hill, serving up the juiciest Congress coverage. Now, we’re upping our game to ensure you’re up to speed and in the know on every tasty morsel and newsy nugget from inside the Capitol Dome, around the clock. Wake up, read Playbook AM, get up to speed at midday with our Playbook PM halftime report, and fuel your nightly conversations with Inside Congress in the evening. Plus, never miss a beat with buzzy, real-time updates throughout the day via our Inside Congress Live feature. Learn more and subscribe here.     Coronavirus Dr. Paul Offit (seen here in a 2015 photo) dissects the U.S. response to Covid-19 and explores how to navigate the next pandemic in his new book. | Matt Rourke/AP OFFIT DOWNLOADS COVID LESSONS — Dr. Paul Offit — director of the Vaccine Education Center at Children's Hospital of Philadelphia — is no stranger to Covid-19 commentary. The rotavirus vaccine inventor — or, as he would call himself, “a boring guy who inoculated mice in a small, windowless room” — wrote his latest book chronicling the past, present and future of the pandemic as “a catharsis,” he told Lauren Monday. “I pretty much had a front-row view of the way we did all this.” “Tell Me When It’s Over: An Insider’s Guide to Deciphering Covid Myths and Navigating Our Post-Pandemic World” is out today. Here are excerpts of his conversation with Lauren, edited for length and clarity: In your new book, you wrote that “countering misinformation at a national or statewide level is virtually impossible” but is “possible at a local level.” What role should the federal government play in combating misinformation that doesn’t play into furthering it? The more you try to debunk it, the more a story it becomes. The trick is finding people in a community who are influential. For example, when the Somali-American community in Minnesota was visited by anti-vaccine advocates, the Minnesota Department of Health tried to work with local religious leaders to explain the importance of the vaccine and the danger of the disease. So working through state or local health departments to identify people who have knowledge and influence locally and give them the information and resources they need to go into their communities and make a difference. You recount how CDC and FDA advisory committees were sometimes bypassed on certain Covid vaccine policy decisions. The FDA has signaled an interest in shifting those expert panels away from making formal recommendations and instead focusing on the substance of their discussions. What’s your take? It’s a terrible idea. Look at what happened with the bivalent vaccine [developed as a booster]. The immunological data were completely unimpressive, so I voted no. The day after [the advisory committee] met, the government bought 105 million doses of the Pfizer vaccine. For me, the crystallizing moment was: I called people — [then-director of the National Institute of Allergy and Infectious Diseases Dr. Anthony Fauci, White House Covid-19 response coordinator Dr. Ashish Jha, then-CDC Director Rochelle Walensky]. They’re great. They really care. And I just said, “Don’t say it’s better [than the original vaccine formulation] because it’s not better.” When you say it’s better, you’re not being fair to the science. What can government and public health officials do to communicate more clearly about science? There’s always an evolution to knowledge, and that’s always going to be disconcerting. That’s what the public health community is going up against. That’s what this book is about. The answer is, you just be honest, knowing that you do learn as you go. Around the Agencies CMS TO RESEARCHERS: NO PAPER FOR YOU — The Centers for Medicare and Medicaid Services announced changes to its research protocols Monday, sparking some criticism. CMS will stop shipping researchers physical copies of data extracts, citing a surge in data breaches and security concerns. Instead, researchers — save for those from excepted federal and state agencies — will be directed to a virtual center where they can access data starting Aug. 19. The agency has said the site is more cost-efficient than sending physical copies. But many academics raise concerns that this will mean increased costs for researchers and could impede high-quality and timely analysis. CMS data on millions of Medicare and Medicaid beneficiaries is often used in health care policy research. Adam Sacarny, an assistant professor of health policy at Columbia University's Mailman School of Public Health, said the move was a “shock.” The cost varies significantly by project for physical versus digital data extracts, he said. “For some projects, it’s great. For some projects, it's off the table because it's too expensive,” Sacarny told our colleague Ben. William Schpero, an assistant professor of health policy at the Weill Medical College of Cornell University, said the move is like “throwing the baby out with the bathwater” and added that it could disproportionately hurt students at institutions with fewer resources. CMS didn’t respond to a request for comment. Industry Intel GILEAD BUYS CYMABAY — Gilead Sciences said Monday it agreed to buy CymaBay Therapeutics and its drug candidate seladelpar for $4.3 billion. The drug is used for primary biliary cholangitis, a chronic and debilitating inflammation of the liver’s bile ducts. WHAT WE'RE READING Quality control issues identified by the FDA at a plant in India have led to generic drugmaker Aurobindo halting some production, STAT's Ed Silverman reports. Document Drawer The FDA released draft guidance on Monday recommending when and how data-monitoring committees should be used for clinical trials.   DON’T MISS POLITICO’S GOVERNORS SUMMIT: Join POLITICO on Feb. 22 to dive into how Governors are wielding immense power. While Washington remains gridlocked, governors are at the center of landmark decisions in AI and tech, economic development, infrastructure, housing, reproductive health and energy. How are they setting the stage for the future of American politics, policies and priorities? How are they confronting major challenges? Explore these questions and more at the 2024 Governors Summit. REGISTER HERE.       Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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