On February 12, 2026, AbbVie filed a lawsuit against the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) to challenge the government’s decision to impose price controls on Botox.
The key points of this lawsuit include the following.
- The Plasma Exemption: AbbVie argues that Botox is a “plasma-derived product” because it contains human serum albumin (a protein extracted from blood plasma). Under the Inflation Reduction Act (IRA) of 2022, Congress specifically excluded plasma-derived products from Medicare price negotiations.
- Constitutional Challenges: The lawsuit alleges several constitutional violations:
- First Amendment: AbbVie claims the government is forcing it to “falsely admit” that the regulated price is “fair,” which it argues is a violation of free speech.
- Fifth Amendment: The company argues the price caps constitute an illegal “taking” of property without due process.
- Financial Impact: Botox is a critical asset for AbbVie, accounting for over 10% of its $61.16 billion annual revenue. While famous for cosmetic use, Botox is also heavily used for medical treatments like migraines and incontinence.
- Key Figures: The lawsuit names HHS Secretary Robert F. Kennedy Jr. and CMS Administrator Mehmet Oz as defendants. The case has been assigned to U.S. District Judge Carl Nichols.
- Legal Precedent: This is the first lawsuit specifically challenging the government for allegedly violating a product exclusion within the drug pricing program. Other drugmakers, such as AstraZeneca, are also challenging the program’s constitutionality in higher courts.
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