Sanders, Cassidy game out drug pricing package

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

Apr 07, 2023 View in browser   By David Lim and Katherine Ellen Foley With Megan R. Wilson Driving The Day Senate HELP Committee Chair Bernie Sanders (right) and ranking member Sen. Bill Cassidy are preparing to mark up a bipartisan bill that focuses on changing pharmacy benefit managers and generic drug policies. | J. Scott Applewhite/AP Photo DRUG LOBBYISTS, MARK YOUR CALENDARS — April 19 is the day Senate HELP Chair Bernie Sanders (I-Vt.) wants to mark up a yet-to-be-seen bipartisan bill focused on policies related to generic drugs and pharmacy benefit managers, more than a half-dozen lobbyists tell Megan and David. That means the rush is on for committee staff to write the legislation with details still in flux, said the lobbyists, who were granted anonymity to discuss private committee deliberations. The committee meeting is slated to come just weeks after top HELP staffers for Sanders and ranking member Sen. Bill Cassidy (R-La.) sent an email to other committee members about a markup “focusing on bipartisan policies” and encouraging staffers to highlight priorities their bosses might have on changing PBM and generic policies, according to a March 16 email obtained by POLITICO. “When the committee has scheduling announcements to make, we will make them,” said Mike Casca, Sanders’ spokesperson and deputy chief of staff. Ty Bofferding, a spokesperson for Cassidy, referred questions to Sanders’ office, noting: “The majority sets the schedule.” Lobbyists are busy determining what’s in and what’s out of the legislation, but the committee could pull language from previously introduced bills, most of which were bipartisan. Sanders, a vocal critic of large drugmakers, hasn’t said much about PBMs throughout his 32-year tenure in Congress. Cassidy is interested in expanding access to generic drugs, which are cheaper than their brand-name counterparts. He’s also been critical of PBMs and talked about the need for industry transparency. IT'S FRIDAY. WELCOME TO PRESCRIPTION PULSE. We take note of our colleague Lauren Gardner’s enthusiasm that the FDA has granted De Novo approval to Happiest Baby’s SNOO Smart Sleeper — now a Class II medical device. Send news and tips to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Ben Leonard talks with Daniel Payne about how the pandemic has negatively impacted kids’ mental health and the legislation being proposed to help combat Covid’s effect. Plus, Katherine provides a dispatch from this week’s World Vaccine Congress in Washington. Listen to today’s Pulse Check podcast Eye on the FDA Peter Marks, director of the FDA Center for Biologics Evaluation and Research, says the U.S. needs a national infectious disease surveillance system that can collect real-time data. | Susan Walsh/AP Photo QUICKER APPROVALS FOR GENE THERAPIES? Peter Marks, the director of the FDA Center for Biologics Evaluation and Research, said the agency must more clearly define how it will use accelerated approval to advance the gene therapy field. The agency is using some funding from last year’s user fee reauthorization package to expand the number of staff assigned to cell and gene therapies, advance manufacturing technologies, study concurrent submission and review alongside other regulatory authorities and pilot an enhanced communication program for rare diseases, Marks told the Alliance for a Stronger FDA this week. “The hope is that with the combination of these different initiatives, we’ll be able to salvage some of what has happened in the small population gene therapy world with the downturn in the stock market and venture investment in this area,” Marks said. “A number of programs in industry that originally were looking at small populations have now been either given back to academics or just dropped entirely.” The goal, he said, is to reverse those trends and work toward a “commercially viable ecosystem.” But the agency competes with tech companies and the biopharmaceutical industry to hire reviewers, statisticians and epidemiologists — a challenge Marks says will be especially difficult this year. On the Covid-19 front: The agency’s top vaccine regulator said moving toward a simplified annual schedule for Covid vaccines should boost Americans’ vaccine confidence. “Part of that is probably communicating what [vaccines] can do — which is help save lives and prevent hospitalizations — and what they will not do, at least for this generation, which is prevent transmission or perhaps even prevent people from catching Covid-19,” Marks said. Looking ahead: If the U.S. does not implement a national infectious disease surveillance system capable of collecting real-time data on the spread of diseases like Covid, “we're going to be laughingstocks,” Marks added. PRETERM BIRTH DRUG PULLED — The FDA has formally withdrawn approval for Makena, a drug to help reduce the risk of preterm birth that had been on the market since 2011. Makena nor any of three generics can no longer be sold in the U.S., the agency said Thursday. The FDA had granted Makena accelerated approval, but in a post-marketing clinical trial that wrapped in 2019, the drug failed to prolong pregnancy in individuals susceptible to early labor nor did it benefit patients or babies. An independent advisory panel and an FDA official then recommended the drug be pulled from the market. Covis Pharma, Makena’s manufacturer, volunteered to pull the drug from the market in March. The FDA said it recognized that some supplies of the drug were already distributed and that patients should talk with their health care providers before taking the drug. “The touchstone of FDA drug approval is a favorable benefit-risk assessment; without that favorable assessment, the drug should not have the status of being FDA-approved,” FDA Commissioner Robert Califf said in a statement.   GO INSIDE THE 2023 MILKEN INSTITUTE GLOBAL CONFERENCE: POLITICO is proud to partner with the Milken Institute to produce a special edition "Global Insider" newsletter featuring exclusive coverage, insider nuggets and unparalleled insights from the 2023 Global Conference, which will convene leaders in health, finance, politics, philanthropy and entertainment from April 30-May 3. This year’s theme, Advancing a Thriving World, will challenge and inspire attendees to lean into building an optimistic coalition capable of tackling the issues and inequities we collectively face. Don’t miss a thing — subscribe today for a front row seat.     Around the Agencies CHANGES TO MEDICARE ADVANTAGE PLANS — CMS clarified that Medicare Advantage plans must comply with national, local and other coverage requirements included in traditional Medicare. Insurers offering MA plans will also be mandated to create a committee tasked with annually reviewing whether their policies are consistent with Medicare requirements, according to a final rule issued this week. “Where there is not a national coverage determination or local coverage determination, then a Medicare Advantage plan can establish [its] own clinical coverage criteria, and it must follow widely accepted available clinical guidelines,” CMS Deputy Administrator Meena Seshamani told reporters. Other changes in the rule apply to MA ads, mental health, Star ratings and an expanded low-income Medicare Part D subsidy benefit. Quick Hits Johnson & Johnson reached a proposed $8.9 billion settlement with tens of thousands of consumers who alleged its talc products caused cancer, The New York Times’ Tiffany Hsu reports. GSK and Moderna are racing for a share of the potential $10 billion market for RSV vaccines, Andrew Dunn reports for Endpoints. Pharma Moves Madeleine Russak joined Signal Group as a vice president. She previously worked as communications director for Sen. Mazie Hirono (D-Hawaii) and deputy communications director for the HELP Committee under Sen. Patty Murray (D-Wash.). Document Drawer The FDA added quinacrine hydrochloride to the 503B list, which dictates the bulk active pharmaceutical ingredients that can be compounded. The FDA issued draft guidance on incorporating clinical outcome assessments as endpoints in patient-focused drug development. The FDA issued draft guidance on notifying the agency of a discontinuation or an interruption of an active pharmaceutical ingredient or finished product.   STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today.       Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

To change your alert settings, please log in at https://www.politico.com/_login?base=https%3A%2F%2Fwww.politico.com/settings This email was sent to rouf@idiot.cloudns.cc by: POLITICO, LLC 1000 Wilson Blvd. Arlington, VA, 22209, USA Please click here and follow the steps to unsubscribe.