AbbVie Sues HHS Over Botox Inclusion in Medicare Drug Price Negotiation Program

AbbVie filed a lawsuit Feb. 11 challenging the federal government's decision to include Botox in Medicare's drug price negotiation program. The company argues that Botox should be exempt under current federal legislation governing Medicare pricing.

In the complaint filed in the U.S. District Court for the District of Columbia, the drugmaker alleged CMS exceeded its authority under the Inflation Reduction Act by selecting Botox for price negotiations. AbbVie argues the drug qualifies as a "plasma-derived product," which is excluded from the program under federal law.

Botox has been approved by the FDA since 1989 and contains three ingredients, including human serum albumin — a protein derived from human blood plasma that makes up roughly one-third of the drug's formulation, according to the lawsuit. Because of that composition, AbbVie contends Botox meets the statutory definition of a plasma-derived product and should not have been selected.

The complaint also challenges the structure of the negotiation program itself. AbbVie alleges the price-setting process could amount to unconstitutional takings, compelled speech and violations of due process. The company said CMS' negotiated price ceilings have produced discounts exceeding 70% in some instances and argued that manufacturers that refuse to participate face steep penalties or potential exclusion from federal healthcare programs.

CMS included Botox on a list of 15 drugs selected for the 2028 negotiation cycle — the first year the program will apply to Medicare Part B medications. Botox accounted for $1.1 billion in Medicare spending from November 2024 to October 2025.

The IRA authorizes CMS to negotiate a "maximum fair price" for certain high-cost drugs. The program began with 10 Medicare Part D drugs for 2026 and expanded to 15 drugs in 2027 and 2028, and 20 drugs in each year thereafter.

The legal challenge adds to a broader wave of industry pushback against U.S. government drug pricing policies. AbbVie is a large biopharmaceutical company with a portfolio that spans immunology, oncology, neuroscience, and aesthetics, where Botox is a flagship product. The outcome could influence how other branded therapies are treated under Medicare rules, potentially shaping how large drugmakers think about pricing and contract structures with public payers.