Judge Michael Newman of the Southern District of Ohio issued a ruling denying a preliminary injunction sought by the Chamber of Commerce.
Michael Newman, U.S. District Court Judge OhioThe Chamber's lawsuit argues that the program violates drugmakers' due process rights under the Fifth Amendment by giving the government the power to effectively dictate prices for their medicines.
The Chamber said an appeals court established a precedent that when the government sets prices, it must provide procedural safeguards to ensure a company receives a reasonable rate and fair return on investment. ItThe Medicare negotiations do not provide these safeguards and impose price caps that are well below a drug's market value, the Chamber argued.
"There is a very, very high risk, maybe a guarantee, but certainly a very, very high risk, that this regime will result in prices that are unfair," Jeffrey Bucholtz, an attorney for the Chamber, told judge Newman during a hearing earlier this month.price the government sets, or face an excise tax of up to 1,900% of U.S. sales of the drug.
But lawyers for the DOJ said during the hearing that the program was far from compulsory. Drugmakers can choose the alternative to those two options: Withdraw their voluntary participation in the Medicare and Medicaid programs, according to attorney Brian Netter. "The measure of relief here is for manufacturers to decide whether they want to stay in the program under the terms that are on offer," Netter said. "If they choose not to, that's their prerogative."Legal experts say the pharmaceutical industry hopes to
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