Drugmakers, trade groups push back against Medicare drug price negotiations

Plaintiffs filed a motion for a preliminary injunction on July 12 to halt implementation of the drug price negotiations by Oct. 1, when drugmakers are due to sign agreements with CMS to negotiate over the first 10 drugs selected. The Justice Department moved on Aug. 11 to dismiss both the case and the preliminary injunction request.

The chambers must reply to the government motions by Aug. 25, with a final DOJ response due Sept. 8.

National Infusion Center Association v. Becerra, U.S. District Court for the Western District of Texas (Fifth Circuit)
Filed: June 21

PhRMA, the drug industry’s major lobbying group, brought this lawsuit with infusion providers and a colon cancer patient advocacy group.

They argue the law violates the due process clause of the Fifth Amendment and excessive fines clause of the Eighth Amendment by constraining drugmakers’ ability to seek review of pricing decisions and imposing a large excise tax if they decline to participate. They also maintain that the government program “violates the separation of powers and the nondelegation doctrines” of the Constitution, which says Congress can’t delegate its powers to other entities.

PhRMA and the groups filed a motion for summary judgment on Aug. 10. DOJ must file its opposition and cross-motion for summary judgment by Sept. 29. Replies from plaintiffs and the government are due Oct. 26 and Nov. 17, respectively.

Bristol Myers Squibb v. Becerra, U.S. District Court for the District of New Jersey (Third Circuit)
Filed: June 16

The company behind the blockbuster blood thinner Eliquis, which analysts expect to appear on CMS’ initial list of drugs subject to negotiations, argues the program violates the First and Fifth amendments.

BMS maintains the deals they’d have to sign with Medicare infringe upon free speech by “compelling” drugmakers to echo the government’s “political messages.” The company also argues the program’s goal of prodding manufacturers to sell their products to the government below fair market value amounts to an illegal grab under the Fifth Amendment’s “takings” clause.

BMS filed a motion for summary judgment on Aug. 16. DOJ must file its opposition and cross-motion for summary judgment by Oct. 16. Replies from BMS and DOJ are then due on Nov. 10 and Dec. 8, respectively.

Janssen Pharmaceuticals v. Becerra, U.S. District Court for the District of New Jersey (Third Circuit)
Filed: July 18

The J&J company’s lawsuit echoes many of BMS’ arguments — so much so that the drugmakers agreed with the Justice Department to follow a combined briefing schedule to streamline the process.

The drugmaker also argues that the IRA illegally conditions Medicare and Medicaid participation with acquiescence to price negotiations. The company expects its blood thinner Xarelto to be included on CMS’ list.

Merck v. Becerra, U.S. District Court for the District of Columbia
Filed: June 6

The manufacturer claims the program violates the First Amendment and the Fifth Amendment’s “takings” clause, echoing fellow drugmakers’ arguments. It expects CMS to name its diabetes drug Januvia as one of the first products subject to negotiation.

Merck filed a motion for summary judgment on July 11. DOJ must file its opposition and cross-motion for summary judgment by Sept. 11. Replies from Merck and DOJ are then due on Oct. 19 and Nov. 21, respectively.

Astellas Pharma v. HHS, U.S. District Court for the Northern District of Illinois (Seventh Circuit)
Filed: July 14

The Japanese drugmaker’s U.S. affiliate argues the IRA violates the First Amendment and the Fifth Amendment’s “takings” and due process clauses. It expects its prostate cancer drug Xtandi will be subject to the first round of negotiations and surmises its overactive bladder drug Myrbetriq could also be included.

Boehringer Ingelheim v. HHS, U.S. District Court for the District of Connecticut (Second Circuit)
Filed: Aug. 18

The German pharma company echoes many of the same legal arguments made by other manufacturers — that the program violates the First, Fifth and Eighth amendments’ protections for free speech, takings and excessive fines, as well as due process and the separation of powers.

The company makes the diabetes drug Jardiance, which it believes could be included on CMS’ list.

AstraZeneca Pharmaceuticals v. Becerra, U.S. District Court for the District of Delaware (Third Circuit)
Filed: Aug. 25

The British drugmaker argues that CMS violated the Administrative Procedures Act because guidance implementing the program “impermissibly” redefines a “qualifying single source drug” to cover all dosage forms and strengths of a drug marketed with the same active ingredient. It also argues that the IRA is unconstitutional because it violates the Fifth Amendment’s due process clause by eschewing notice-and-comment rulemaking.

Source:Politico