ACIP LEGAL FALLOUT — The Trump administration’s delay of what was supposed to be this week’s regularly scheduled meeting of the CDC’s vaccine advisers — and its anticipated overhaul of the panel — raised questions about what legal recourse drug companies and others might have. As we’ve reported since now-HHS Secretary Robert F. Kennedy Jr.’s star rose with President Donald Trump’s electoral win, the department head has vast discretion to remake the Advisory Committee on Immunization Practices — and Kennedy plans to replace at least some of them because of perceived conflicts of interest. But it may not be so simple. The CDC typically adopts the ACIP’s recommendations, which have become an integral step in ensuring both clinical use and insurance coverage of newly approved vaccines. References to the committee and its expected actions have been baked into federal and state laws — 2016’s 21st Century Cures Act directs the panel to consider any new vaccines or indications at its next meeting following FDA approval, and 2022’s Inflation Reduction Act requires ACIP-recommended shots covered under Medicare Part D to be offered at no cost to beneficiaries. ACIP also votes on whether a pediatric vaccine should be added to the Vaccines for Children program, which offers shots at no cost to low-income kids. “A court should most certainly look at the history and the context in addressing any action” that affects the committee’s work, said Richard Hughes IV, a lawyer at Epstein Becker Green and a former Moderna executive. Who has standing? While the FDA licenses new vaccines for the U.S. market, insurance coverage policies are usually tied to the ACIP’s recommendations for their use. That means any delay to committee votes can have a material impact on uptake. “How many doctors would consider recommending a $100 vaccine without professional [CDC] recommendation?” said Dorit Reiss, a vaccine law expert at the University of California College of the Law. A spokesperson for GSK, which had two products slated for ACIP votes this week, didn’t comment on whether the company would consider legal action over the meeting delay. Is that your final answer? Any groups itching to get litigious would have to argue that the scrapping of the ACIP meeting is a “final agency action.” HHS’ statement asserted that the cancellation is a “postponement” to ensure the public has adequate time to comment before the meeting. While that likely buys the administration some time, drugmakers and others who want to see ACIP continue to make recommendations might have to decide at some point that the delay has morphed from temporary to indefinite — and thus a “final” action. “It’s really hard to sue against nonaction, which is what this is,” Reiss said. Reiss noted that the ACIP’s next meeting is scheduled for June. “How far can you postpone it without actually canceling it?” she asked. “There’s only a limited time they can claim this.” IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Finally, some nice weather in the nation’s capital. Send your tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).
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