
A sign in front of the Centers for Medicare & Medicaid Services building in Woodlawn, Md., on March 19, 2025. Kayla Bartkowski/Getty Images
A lobbying group that represents pharmaceutical manufacturers sued the federal government on Oct. 7 over a program aimed at reducing the prices of drugs.
The Pharmaceutical Research and Manufacturers of America (PhRMA) said in a legal complaint in federal court in Washington that the Most Favored Nation policy, planned for Medicare by the Center for Medicare & Medicaid Services (CMS), illegally imposes foreign price controls.
The program “is unlawful and clearly exceeds CMS’ authority,” Stephen Ubl, president and CEO of the lobbying organization, said in a statement.
“The policy doesn’t make medicines more affordable for most beneficiaries, while putting future medical innovation and patient access at risk. We share the administration’s goal of ensuring Americans can access and afford their medicines, but CMS cannot rewrite the law and bypass Congress to impose foreign price controls. Patients need more choices and more breakthroughs—not government price-setting schemes that undermine both.”
The Department of Health and Human Services, the parent agency of CMS and one of the defendants named in the suit, did not return a request for comment by publication time. CMS has said in notices that it has statutory authority to implement changes to drug pricing, including from portions of the Social Security Act.
Government officials have also pointed to part of the act saying there shall be no judicial review of certain changes to pricing.
PhRMA, which represents 34 manufacturers including Pfizer and Sanofi, sued the government during the first Trump administration over an earlier iteration of the pricing rule. A federal judge entered a temporary restraining order, ruling in favor of the group.
The rule was withdrawn after Joe Biden became president.
President Donald Trump in 2025 announced a new most-favored-nation pricing effort, and has since unveiled agreements with dozens of manufacturers, including Pfizer, Merck, and GlaxoSmithKline.
“Americans—who have for decades paid, by far, the highest prices of any nation anywhere in the world for prescription drugs—will now pay the lowest price anywhere in the world for drugs,” Trump said in a speech in February.
One of the components is an update to Medicare’s drug pricing model, basing pricing on the average sales price across a number of nations. The rule, due to take effect on Jan. 1, 2027, “would untether Medicare pricing from the statute and the American market, instead importing foreign price controls from 19 countries,” the new lawsuit says.
Officials do not have a statutory basis to implement the program, PhRMA said in the complaint. “CMS relies on an obscure statutory provision,” it said, which does not give it “carte blanche to rewrite the Medicare program to fit policy priorities that Congress has not authorized.”
Market-based pricing is critical for ensuring that Americans can access vital medicines, the lobbying group said, and keeping the program in place would “upend … stability and predictability, harming seniors and imperiling our nation’s global pharmaceutical leadership.”
The group is asking the court to declare the program illegal and prohibit government officials from enforcing it.









