AbbVie has filed a federal lawsuit against the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) challenging the inclusion of Botox (onabotulinumtoxinA) in Medicare’s drug price negotiation program under the Inflation Reduction Act (IRA). The complaint, filed February 11 in the U.S. District Court for the District of Columbia, argues that CMS exceeded its statutory authority and violated multiple constitutional protections.

AbbVie asserts that Botox qualifies as a plasma‑derived product, because approximately one‑third of its formulation consists of human serum albumin, a protein extracted from donated human plasma. The IRA specifically excludes plasma‑derived products from Medicare price negotiations, and CMS’s fact sheet reiterates this exemption. AbbVie argues that Botox falls within that exclusion.

AbbVie’s lawsuit includes several challenges: 

• The company alleges the IRA compels it to endorse the negotiated “maximum fair price” as fair, constituting compelled speech.
• AbbVie argues that forcing below‑market pricing amounts to an unlawful taking of property without just compensation.
• The complaint states that refusal to comply subjects manufacturers to “ruinous” tax liability and potential exclusion from federal programs.

The suit names HHS Secretary Robert F. Kennedy Jr. and CMS Administrator Mehmet Oz as defendants.

Botox remains one of AbbVie’s most important products, generating over 10% of the company’s $61.16 billion in annual revenue. AbbVie has stated it anticipated pricing pressure and incorporated it into long‑term forecasts.

Botox is one of 15 drugs selected for the 2028 IRA negotiation cycle. AbbVie called its lawsuit the first arising from CMS's alleged violation of a statutory product exclusion. Drugmaker AstraZeneca has also asked the Supreme Court ot review the constitutionality of the drug pricing program.