HHS defends IRA as anniversary nears

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Aug 15, 2023 View in browser   By Lauren Gardner, Katherine Ellen Foley and David Lim Driving the Day HHS has filed a motion to dismiss a lawsuit involving its authority to negotiate prescription drug prices for Medicare. | Uriel Sinai/Getty Images HHS LAUNCHES DEFENSE AGAINST IRA SUITS — The Department of Health and Human Services has filed a motion to dismiss one of the six lawsuits challenging its authority to negotiate prescription drug prices for Medicare beneficiaries. The filing in the U.S. Chamber of Commerce case — which counts the Dayton Area, Ohio and Michigan chambers of commerce among the plaintiffs — in the federal Sixth Circuit is the first that outlines the major points of the Biden administration’s defense of the Inflation Reduction Act, whose first birthday is Wednesday. The chambers argue that the law violates the First, Fifth and Eighth amendments of the Constitution. Your host unpacks the takeaways from HHS’ arguments here: — It’s too soon. No prices have been set yet, much less the drugs that have been chosen for negotiation. HHS argues the Chamber and its members can’t show imminent harm from the program and they’re speculating as to who might be subject to negotiation. — Relief for whom? The Chamber hasn’t demonstrated that any of its members would have standing to sue the government, HHS says in its motion. In its suit, the group identified AbbVie, which markets the blockbuster cancer drug Imbruvica, as a member that could be asked to negotiate based on Medicare Part D spending in 2021. But HHS says only a drug’s “primary manufacturer” — the company granted FDA approval — would be invited to negotiate. In this case, that would be Pharmacyclics, which isn’t a party to the litigation, though AbbVie owns the company. The department also argued that the group lacks standing because of other pending lawsuits in multiple courts by drug manufacturers. Note that Merck, a Chamber member, has filed its own challenge to the law in U.S. District Court for D.C. “Different courts might reach different conclusions regarding the merits of the same constitutional claims,” HHS wrote. “If such a conflict arose, drug manufacturers who are also members of one of the association Plaintiffs here would seek to follow the more favorable ruling, while refusing to accept the adverse judgment.” — Medicare participation is voluntary. The Chamber has argued that it’s “impossible” for most drug companies to opt out of federal health markets because of their size. But, in an accompanying HHS motion opposing the group’s request for a preliminary injunction, the department says sufficient legal precedent confirms “that imposing voluntary conditions on federal health-care spending is Congress’s prerogative and does not implicate property interests protected by the Fifth Amendment.” The Chamber has asked the court to rule on its request to stop implementation of the program by Oct. 1, when drugmakers would either have to agree to participate in the price negotiations or choose between withdrawing from Medicare or facing potentially steep excise taxes. IT’S TUESDAY. WELCOME TO PRESCRIPTION PULSE. Did you know that the FDA can still issue Covid-19 emergency use authorizations under Section 564 of the Federal Food, Drug, and Cosmetic Act? Send news and tips to Lauren Gardner (lgardner@politico.com or @Gardner_LM), David Lim (dlim@politico.com or @davidalim) and Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Ben Leonard talks with Madison Fernandez, author of POLITICO’s Weekly Score, about the momentum building among Virginia Democrats, who are betting that defending abortion rights will lead to wins in the state’s fall elections despite their 2021 losses on the issue in the state. Listen to today’s Pulse Check podcast   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.     MEDICAL DEVICES The FDA has proposed that some laboratory developed tests be subject to the agency's review. | Getty Images LABS, Dx MAKERS MEET WITH OIRA — A pending FDA proposal at the White House is drawing the attention of laboratory, diagnostic manufacturer and pathologist trade lobbies that want to influence a proposed rule likely to explicitly define laboratory developed tests as medical devices. The potential change may subject some tests, which are created and used within a single laboratory, to FDA review. Some groups argue that FDA review would hinder innovation and rapid deployment of tests, while others say more oversight would protect patients and ensure that important tests perform well clinically. The White House Office of Information and Regulatory Affairs recently met, or is scheduled to meet, with the Association for Molecular Pathology, American Clinical Laboratory Association, Advanced Medical Technology Association, Friends of Cancer Research and a group that includes the Center for Science in the Public Interest. Friends of Cancer Research CEO Jeff Allen told POLITICO that FDA tracking is important if an LDT is significantly different or underperforming compared to another test or diagnostic. “There’s just essentially a blind spot around the performance of certain tests because [labs are] not necessarily required to share this information,” Allen said. Eye on the FDA CALIFF: SUPPLEMENT PROGRAM A ‘CRITICAL PRIORITY’ — In a blog post Monday, FDA Commissioner Robert Califf commented on the agency’s plan to update its dietary supplement surveillance program, which it plans to integrate into the agency’s Human Food Program. The FDA announced plans to restructure the agency’s food division under a single Human Food Program in January following the infant formula crisis that unveiled years of regulatory dysfunction. Califf said that within the forthcoming Human Foods Program, the Office of Dietary Supplement Programs will report to the Office of Food Chemical Safety, Dietary Supplements and Innovation — a program that Califf said will be strengthened to better assess chemicals and ingredients that appear in dietary supplements. Califf added that there are “no plans to reduce ODSP’s resources or capabilities” and the agency plans to modernize the oversight of dietary supplements — though he didn’t provide specific details. The reorganization will streamline the hierarchy of organizations, which Califf said is crucial to expedite decision-making. Currently, the ODSP director reports to the head of the Center for Food Safety and Applied Nutrition, and OFCSDSI reports to a deputy commissioner at the agency. The final proposal for the restructuring will be ready later this year. Industry Intel CHIKUNGUNYA VACCINE DECISION DATE DELAYED — Valneva, a European vaccine company, said Monday that the FDA has postponed making an approval decision on the company’s chikungunya virus vaccine. The mosquito-borne virus has already infected at least 300,000 people worldwide and led to 300 deaths, according to the European Centre for Disease Prevention and Control. The FDA had been slated to make a decision in August, but the company said the date has been pushed to November so the agency and the company can agree on plans for a Phase IV trial.   DON’T MISS POLITICO’S TECH & AI SUMMIT: America’s ability to lead and champion emerging innovations in technology like generative AI will shape our industries, manufacturing base and future economy. Do we have the right policies in place to secure that future? How will the U.S. retain its status as the global tech leader? Join POLITICO on Sept. 27 for our Tech & AI Summit to hear what the public and private sectors need to do to sharpen our competitive edge amidst rising global competitors and rapidly evolving disruptive technologies. REGISTER HERE.     Research Corner COVID SHOTS DURING PREGNANCY HELP MOM, BABY — Receiving a Covid-19 vaccine during pregnancy can benefit pregnant people and their newborns, according to a new NIH study. Researchers found that vaccinated pregnant people generated antibodies against different coronavirus variants and antibodies crossed into the placenta, likely offering some protection to newborns who aren’t yet eligible for the shots. Pharma Moves James Ryan joins BioNTech’s management board as chief legal officer. Previously, he was the company’s general counsel and senior vice president of Legal & IP. Kenvue, the consumer health brand spun off from Johnson & Johnson, has retained the Washington Tax & Public Policy Group as its first federal lobbyist, POLITICO Influence reports. What We're Reading Some private insurers are opting not to cover the recently approved Alzheimer’s drug Leqembi because they consider the drug “experimental,” Tom Murphy writes for The Associated Press. Patients are pressuring the FDA to approve the first treatment for a rare, fatal disease that leads to inappropriate bone growth amid dubious data from late-stage clinical trials, Andrew Joseph and Damian Garde write for STAT. Document Drawer The FDA on Monday requested comments on implementing voluntary consensus standards for regenerative medicine therapies and on information collection pertaining to the registration of human drug compounding outsourcing facilities.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

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