Four drugmakers to face government together in IRA oral arguments next month


Four drugmakers to face government together in IRA oral arguments next month

Published: Feb 21, 2024

By Tristan Manalac


A federal judge in New Jersey has ruled that four major pharmaceutical companies can present their oral arguments against the Inflation Reduction Act’s drug price negotiation provisions in one hearing, Endpoints News reported on Tuesday.

Judge Zahid Quraishi has agreed to let the drugmakers—Bristol Myers Squibb, Johnson & Johnson’s Janssen Pharmaceuticals, Novartis and Novo Nordisk—lay out their legal challenges to the Medicare Drug Price Negotiation Program under the Inflation Reduction Act (IRA) over four hours on March 7, 2024.

Quraishi’s decision follows a letter that the parties submitted on Friday regarding the hearing’s schedule. In their electronic filing, the drugmakers proposed that the court hear their arguments on a single date “given the overlapping nature of the claims asserted and certain common defenses to those claims,” the letter read.

“Hearing all of the cases together on the same day would maximize the efficiency of the oral argument,” the companies argued.

The plaintiffs proposed a four-hour hearing—from 10:00 AM to 2:00 PM, split in half by a short break. The companies contend that a longer hearing is “warranted” because arguments will involve four separate cases which together present “at least seven constitutional and statutory challenges” to the IRA.

The federal government disagreed with the companies’ proposal, pointing out that the summary-judgment briefings have yet to be completed in the Novartis and Novo Nordisk cases. The companies are set to submit their summary-judgment response briefs on Feb. 23, and the government has until March 22 to file a reply for the Novo case and March 27 for Novartis.

“Given the significance of these cases and the nature of plaintiffs’ claims, defendants believe they would be prejudiced by being deprived of an opportunity to submit replies in support of their cross-motions for summary judgment,” the government argued in the electronic filing.

The government said that it would be available to present arguments for the BMS and Janssen cases.

The four pharma companies are seeking to block the IRA’s Drug Price Negotiation Program, arguing that it violates several rights guaranteed in the U.S. Constitution, including the Fifth Amendment right to just compensation and the First Amendment right to freedom of speech. They allege that the program forces them to agree that the negotiated prices are fair, which they vehemently disagree with.

Several other companies have also filed legal challenges to the IRA’s Drug Price Negotiation Program, including Merck and AstraZeneca.

Last week, a Texas court tossed out a similar lawsuit filed by industry groups Pharmaceutical Research and Manufacturers of America, National Infusion Center Association and Global Colon Cancer Association. The ruling cited the case’s improper venue and was not focused on the merits of the arguments against the IRA.

Source: BioSpace