Merck calls for summary judgment in IRA drug price negotiation case
Merck calls for summary judgment in IRA drug price negotiation case
Published: Jul 13, 2023
By Tristan Manalac
BioSpace
Merck has filed a motion for summary judgment asking a federal judge to rule on its case against the U.S. government over the Inflation Reduction Act without going to trial.
In its 59-page document, filed Tuesday in the U.S. District Court for the District of Columbia, Merck argued that the Inflation Reduction Act’s Drug Price Negotiation Program “involves no genuine negotiations and no voluntary agreements.” Instead, the IRA provision threatens pharmaceuticals companies with “enormous monetary penalties,” compelling them to provide access to their drugs at discounted prices that the government determines, according to the filing.
“It is tantamount to extortion,” Merck wrote.
Merck also contends that the IRA price negotiation program is unconstitutional as it violates the Fifth Amendment stipulation that the state needs to provide just compensation for any private property taken for public use.
The company makes the case that the IRA program also violates the First Amendment by forcing drugmakers to agree that the discounted prices, as dictated by the Department of Health and Human Services, are fair.
“[C]onscripting companies to conceal unpopular price-setting is exactly the parroted orthodoxy that the First Amendment’s compelled-speech doctrine is meant to forbid,” Merck argued in its motion.
Tuesday’s filing follows Merck’s initial lawsuit, filed last month, seeking an injunction against the newly enacted IRA.
“Because this statute unlawfully impairs our core purpose of engaging in innovative research that saves and improves lives, Merck intends to litigate this matter all the way to the U.S. Supreme Court if necessary,” Robert Josephson, the company’s spokesperson, told Politico at the time.
The industry followed suit soon after the filing of Merck’s lawsuit. Bristol Myers Squibb filed its own legal challenge against the IRA, making the same arguments as Merck and moving to have its negotiation struck down as unconstitutional. Lobbying group Pharmaceutical Research and Manufacturers of America (PhRMA) has backed both Merck and BMS in these cases.
President Joe Biden signed the IRA into law in August 2022, which immediately sparked resistance from the biopharma industry. PhRMA CEO Stephen Ubl called the legislation “a tragic loss for patients” because it stifles innovation in the pharmaceuticals industry.
Merck CEO Robert Davis agreed and said, during the company’s second quarter 2022 earnings call, that the new pricing negotiation program would be “highly chilling on innovation.”
Source: BioSpace
