AbbVie has filed a lawsuit against the U.S. Department of Health and Human Services (HHS), challenging the decision to include Botox in the Medicare Drug Price Negotiation Program created under the Inflation Reduction Act (IRA) of 2022. The complaint was filed in the U.S. District Court for the District of Columbia.
The company argues that Botox qualifies as a plasma-derived product and therefore should have been excluded from the negotiation process. According to the complaint, Botox contains human serum albumin (HSA), a protein extracted from human blood plasma that AbbVie describes as essential to the drug’s safety and efficacy. AbbVie states that one-third of Botox consists of HSA.
In the filing, the company states: “Because HSA is sourced from plasma collected from human donors, Botox is a ‘plasma-derived product’ that Congress excluded from the price-control program.” AbbVie maintains that the Centers for Medicare & Medicaid Services (CMS) exceeded its authority by selecting Botox for the third cycle of negotiations despite that exclusion.
A CMS fact sheet issued last month, in which the agency selected Botox for the third cycle of negotiations, noted that certain medicines, including those derived from plasma, were excluded from the drugs nominated for negotiations. AbbVie contends that Botox falls within that exclusion.
The lawsuit names HHS, CMS, CMS Administrator Mehmet Oz, and Health Secretary Robert F. Kennedy Jr. as defendants. The case was assigned to U.S. District Judge Carl Nichols, an appointee of President Donald Trump.
Beyond the statutory exemption argument, AbbVie raises constitutional claims. The company alleges that capping the price of Botox constitutes an unlawful taking without just compensation under the Fifth Amendment and violates due process protections.
It also argues that the negotiation framework infringes on its First Amendment rights by compelling it to state that a government-set price is “fair.” AbbVie further states that it is being forced to sell Botox at confiscatory prices to Medicare beneficiaries or face ruinous tax liability and potential exclusion from federal government programs. The lawsuit seeks to end the application of the negotiated pricing to Botox.
HHS said Thursday that it does not discuss pending litigation.
Botox is known for its cosmetic use in smoothing facial wrinkles, but it is also approved for therapeutic purposes, including the treatment of eye- and neck-movement disorders, neck spasms, incontinence, and migraines. AbbVie reports Botox revenue in two segments: Therapeutic and Cosmetic. In 2025, Therapeutic sales reached nearly $3.77 billion worldwide, while Cosmetic revenue totaled $2.6 billion. Botox accounted for just over 10% of AbbVie’s $61.16 billion in revenue last year, with therapeutic uses representing about 6%.
During the company’s fourth-quarter earnings call, Chief Executive Officer Robert Michael addressed Botox’s selection for negotiation. He said the company was disappointed, given that it considers the product plasma-derived and stated that AbbVie had anticipated CMS’s move and incorporated potential pricing challenges into its long-term growth forecasts.
Legal challenges to the IRA’s drug pricing provisions began in the months following the law’s passage in 2022, with companies including AstraZeneca, Novo Nordisk, and Bristol Myers Squibb filing suits that questioned the program’s constitutionality. AstraZeneca has asked the U.S. Supreme Court to review the program. AbbVie has described its complaint as the first lawsuit arising from CMS allegedly violating an exclusion under the negotiation framework.
AbbVie shares rose 1% to $223.10 in morning trading on Thursday.
Why AbbVie Is Challenging the CMS Decision
According to AbbVie, Botox contains human serum albumin — a protein derived from blood plasma — which the Inflation Reduction Act (IRA) expressly excludes from Medicare price negotiations. AbbVie asserts that CMS exceeded its statutory authority under the IRA by including Botox for negotiation instead of applying the written exclusion.
