FDA preps — again — for government shutdown

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

Feb 27, 2024 View in browser   By David Lim With Ben Leonard  Driving The Day The FDA funding clock is ticking as Congress debates spending packages, with one that includes banning mail delivery of abortion pills. | Kena Betancur/AFP via Getty Images TICK TOCK, ONCE MORE — The FDA is in a familiar position: If Congress doesn’t take action by Friday, the nation’s food and drug watchdog will have its government funding cut off. Over the weekend, efforts by top lawmakers and appropriators to unveil a small spending package fell apart. Sparring included disagreements over longstanding policy core to the Agriculture-FDA spending bill, such as a Republican effort to ban mail delivery of abortion pills, cuts to agriculture programs and USDA funding allocations. The top four congressional leaders are slated to meet today with President Joe Biden to discuss funding negotiations and stalled money for Ukraine, Israel and other nations. Not FDA’s first rodeo: FDA spokesperson Michael Felberbaum referred to remarks FDA Commissioner Robert Califf made last month to the Alliance for a Stronger FDA when asked Monday about a potential agency shutdown. “Uncertainty is going to be excruciating,” Califf said to the nonprofit that advocates for agency funding. “We have a veteran staff at FDA that has been through this many times before; it’s almost become an expectation that we will end up in this situation for some period of time.” During a shutdown, 74 percent of FDA staffers considered essential would continue to work, according to the agency’s fiscal 2024 contingency plan. Industry raising alarm: The medical device industry said many companies with products awaiting FDA or CMS decisions on approvals and other issues would face longer review times if a shutdown occurs. “[That] in turn could force small medtech innovators to close their doors,” AdvaMed CEO Scott Whitaker said, regarding the trade group that represents device makers. IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Fool’s Spring is upon D.C. Enjoy it while you can. Send news and tips to Lauren Gardner (lgardner@politico.com or @Gardner_LM) or David Lim (dlim@politico.com or @davidalim). Lawmakers haven't been able to agree on legislation to reform PBM practices, an impasse that Sen. Bill Cassidy blames on House members. | Mariam Zuhaib/AP PBM REFORM PUSH PAUSED — Bipartisan legislation to overhaul how pharmacy benefit managers operate is in flux after talks broke down over the scope of the reforms, according to seven lobbyists and two congressional aides granted anonymity to discuss negotiations candidly. Multiple committees in both chambers have advanced legislation to reform PBM practices, but lawmakers have not been able to reconcile the varying approaches in time for the government funding deadline later this week. The discord has some lobbyists and policymakers blaming the House — including Democratic lawmakers who are reportedly rejecting the Senate Finance Committee’s more aggressive reforms and Republicans who don’t want to mandate any changes to PBM practices in the commercial, or private-sector, market. “The House appears unwilling to entertain significant Senate provisions not already included in the House package,” said a spokesperson for Sen. Bill Cassidy (R-La.), ranking member of the Health, Education, Labor and Pensions Committee, who authored some proposed rules for PBMs. “Cassidy is committed to negotiations and getting the most robust package that can pass both chambers and be signed into law.” A source with knowledge of the negotiations pushed back against those claims, saying Cassidy wanted to go beyond consensus in Congress and ban “spread pricing” in the commercial market. That’s a practice in which PBMs charge insurers more for drugs than what they’re reimbursed by pharmacies. The path forward: Lawmakers are eyeing a smaller package that would address extenders like securing funding for community health centers, paying doctors under Medicare and averting cuts to disproportionate-share hospitals, according to three of the lobbyists. That’s similar to what Congress has done during previous spending battles. Prospects of future PBM reform aren’t dead though, with a potential lame-duck session coming post-election — but some are skeptical about how much can happen for a year-end package, which also bumps up against the expiration of the debt ceiling.   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 COVID VACCINE UPDATE MEETING SET — The FDA will convene its outside panel of vaccine experts on May 16 to discuss and recommend which variants the 2024-2025 Covid-19 vaccine should target. “The FDA anticipates that changes to the vaccine composition may need to be made based on the currently circulating strains of the virus that causes COVID-19,” the agency said Monday. “As the agency has previously stated, barring any new major changes to circulating virus, the FDA expects that the composition of COVID-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine.” Eye on the FDA FDA PULLS AN APPROVAL — The FDA deployed its expanded powers Friday to speed the withdrawal of products granted accelerated approval for the first time. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research who signed the withdrawal decision for Oncopeptides’ Pepaxto, said follow-up study of the multiple myeloma drug didn’t confirm it benefits patients or is safe and effective based on available evidence. “I recognize that the decision to withdraw Pepaxto might be upsetting for patients who have exhausted all their options among drugs approved for their condition, and for their loved ones and providers,” he wrote. “However, I believe that patients deserve FDA-approved treatments that are safe and effective.” Artificial Intelligence ESHOO TALKS AI — Rep. Anna Eshoo (D-Calif.) will be a key member of a recently announced bipartisan 24-member AI task force, and she’s pushing for some legislative action before the end of the year, she told Ben in an interview. House Speaker Mike Johnson and Minority Leader Hakeem Jeffries asked the task force for recommendations on new artificial intelligence regulations, and while that appears to be a “long-term view,” Eshoo said, she’s pushing for a “shorter-term view” of what can happen. Eshoo, who chairs the House Energy and Commerce Health Subcommittee, is not seeking reelection. What she wants: Addressing how AI might impact biosecurity is a top priority for her, as is legislation she’s working on to bolster AI transparency about whether FDA-cleared AI is suitable for pediatric care. “There are very few products that indicate whether they’ve been tested or validated in children,” Eshoo said. WHAT WE'RE READING NIH Director Monica Bertagnolli worries her agency might have to reduce medical research grants to investigators if Congress keeps her agency’s budget flat for the rest of this fiscal year, POLITICO’s Erin Schumaker reports. On Friday, a prescription drug affordability board in Colorado voted to consider a payment limit for Amgen’s autoimmune disease drug Enbrel, Inside Health Policy’s Luke Zarzecki reports. House Energy and Commerce Health Subcommittee Chair Brett Guthrie (R-Ky.) took to The Hill in an op-ed to decry the effects of the Inflation Reduction Act on the U.S. drug industry. Document Drawer The Pew Research Center published a survey on Monday examining Americans’ views of weight-loss drugs like Ozempic and Wegovy. Sen. Chuck Grassley (R-Iowa) released on Monday the FTC’s response to his and his colleague Maria Cantwell’s (D-Mass.) inquiry into the status of the antitrust agency’s PBM investigation.   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.       Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

To change your alert settings, please log in at https://login.politico.com/?redirect=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 Unsubscribe | Privacy Policy | Terms of Service