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.
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