Pharma, Medical Groups Rebut Motion to Toss Drug Pricing Suit

Infusion therapy providers would be harmed if a federal judge dismisses a lawsuit challenging Medicare’s new drug price negotiation program, attorneys for a coalition of trade associations wrote in a filing Monday.

The Inflation Reduction Act’s drug pricing provisions will result in lower Part D reimbursements to centers administering medicines subject to Medicare negotiations, attorneys representing the National Infusion Center Association said. NICA is joined in its lawsuit by drug industry group the Pharmaceutical Research and Manufacturers of America, as well as the Global Colon Cancer Association.

The groups have demonstrated they will suffer an immediate and direct injury from the program’s implementation, the attorneys wrote. Therefore, they request Judge David A. Ezra of the US District Court for the Western District of Texas reject the Biden administration’s motion to toss their lawsuit against the program.

The groups are seeking an early ruling on their lawsuit claiming the drug price negotiation program violates the separation of powers and nondelegation doctrine, the Fifth Amendment’s due process clause, and the Eighth Amendment’s prohibition on excessive fines.

Department of Justice attorneys say the case should be dismissed because NICA is the only one out of the three plaintiffs that’s located within Texas. NICA also lacks standing because it “does not even represent members who manufacture or sell prescription drugs,” government attorneys have argued.

The filing from PhRMA and its fellow plaintiffs comes as a federal judge in Ohio is expected to rule this week on the US Chamber of Commerce’s motion to pause the negotiation program. The Chamber, along with several state and local affiliates, have asked Judge Michael J. Newman to enjoin the Centers for Medicare & Medicaid Services from implementing the negotiation provisions, and to do so before Oct. 1—the deadline for manufacturers of the first 10 drugs up for negotiations to sign agreements entering price talks.

All of this is running alongside the growing threat of a government shutdown, which Health and Human Services Secretary Xavier Becerra warned last week could throw off the negotiation timeline.

After signing agreements, drugmakers have until Oct. 2 to submit manufacturer-specific data to the CMS to help the agency make a proposal on a product’s maximum fair price. Under the IRA, the CMS must send by Feb. 1 of next year an initial offer on each product’s maximum fair price.

Judge Robert Pitman, who previously was handling PhRMA’s case, ruled Sept. 12 that the court would toss a previous filing schedule and rule first on the federal government’s motion to dismiss PhRMA’s lawsuit. Pitman reassigned the case to Ezra on Sept. 21, though the reason for this wasn’t clear from Pitman’s order.

The case is Nat’l Infusion Ctr. v. Becerra, W.D. Tex., No. 1:23-cv-00707, reply to motion to dismiss filed 9/25/23.