AbbVie Sues HHS Over Selection of Botox for Medicare Price Cuts

AbbVie Inc. is challenging the Trump administration’s decision to select its Botox drug for a government program that slashes the cost of certain medicines through price negotiations with manufacturers.

The Centers for Medicare & Medicaid Services exceeded its statutory authority under the Inflation Reduction Act when it selected Botox for the Medicare Drug Price Negotiation Program because the drug is a plasma-derived product, which disqualifies from the plan, AbbVie said in complaint filed Wednesday in the US District Court for the District of Columbia.

Botox is a drug commonly known for its cosmetic uses but also treats chronic migraines and eye-and-neck movement disorders. It was one of the 15 drugs selected for the third cycle of negotiations over prices that will go into effect in 2028.

“Unlike previous challenges related to the IRA, this lawsuit is the first that arises from CMS’s violation of one of those express statutory exclusions established by Congress: namely, the IRA’s exclusion of ‘plasma-derived products’ from price controls,” AbbVie said.

The CMS excludes certain drugs from negotiations, including biological products that come from human whole blood or plasma, also known as plasma-derived products. Botox has an ingredient that is collected from human blood plasma, according to the company.

Botox “undoubtedly falls within that exclusion,” the drugmaker added.

The company alleges the selection of Botox violates the Administrative Procedure Act, forces it to turn over the product to Medicare beneficiaries without just compensation in violation of the takings clause, and requires it to express an “untrue statement” that it has acceded to a fair price in violation of the First Amendment.

The suit joins other lawsuits from manufacturers challenging the negotiation program in recent years, which have largely been rejected by federal courts.

Some pharmaceutical giants including AstraZeneca Plc, Boehringer Ingelheim Pharmaceuticals, and Bristol Myers Squibb Co. are urging the US Supreme Court to review the program.

Paul, Weiss, Rifkind, Wharton & Garrison LLP represents AbbVie.

The case is AbbVie Inc. v. US Department of Health and Human Services, D.D.C., No. 1:26-cv-00431, 2/11/26.