AbbVie has sued the Department of Health and Human Services (HHS), challenging the agency’s decision to select its blockbuster anti-wrinkle therapy Botox for the next round of Medicare price negotiation.
In January, the Centers for Medicare & Medicaid Services (CMS) announced 15 Medicare Part D drugs, including Botox, selected for its third round of pricing negotiations, a provision introduced by the Inflation Reduction Act in 2022.
In a lawsuit filed on Wednesday, AbbVie (ABBV) argued that the CMS exceeded its authority when it selected Botox for pricing negotiations, as the drug, which is also used to treat conditions such as migraines, is a plasma-derived product.
AbbVie (ABBV) added that Botox, which generated $4.7B in net U.S. sales for the company in 2025, includes a component derived from human plasma, even though the IRA excludes that drug class from pricing negotiations.
Botox “undoubtedly falls within that exclusion,” Bloomberg reported, quoting the pharma giant as saying in the lawsuit filed in the U.S. District Court for the District of Columbia.
“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,” it said.
The lawsuit marked the latest challenge for the program, which got underway in 2023 with the selection of 10 Medicare Part D drugs for the first round of pricing talks.
The top pharmaceutical lobby group, PhRMA, and leading drugmakers such as Merck (MRK) and Bristol Myers (BMY) have previously filed lawsuits challenging the constitutionality of the program, albeit with limited success.