AbbVie Sues HHS, CMS for Including Botox in Drug Price Negotiation Program

 

AbbVie contends that Botox should have been excluded from the IRA drug price negotiation program because it is a plasma-derived product.

AbbVie has filed a lawsuit against the Department of Health and Human Services alleging that the agency overstepped its authority when it selected the company’s aesthetics blockbuster Botox for inclusion in the drug price negotiation program of the Inflation Reduction Act.

In its complaint, filed Wednesday with the U.S. District Court for the District of Columbia, AbbVie contended that because Botox is a plasma-derived product, it should be exempt from the price setting program, according to a report from Bloomberg Law.

Indeed, the Center for Medicare and Medicaid Services’ own fact sheet last month—the same one in which the agency selects Botox for the third cycle of the drug negotiation scheme—notes that in its selection of drugs nominated for negotiations, the CMS excluded certain medicines, including those that are derived from plasma.

Botox “undoubtedly falls within that exclusion,” the complaint contended, according to Bloomberg.

AbbVie addressed Botox’s inclusion in the negotiations during its fourth-quarter earnings call. “We’re obviously disappointed that it was selected given that it’s a plasma-derived product and should have been excluded,” CEO Robert Michael said in response to an analyst question.

Still, Michael continued, the company had anticipated CMS’ move and baked potential pricing challenges into its long-term growth forecasts. The pharma divides its sales figures for Botox into Therapeutic and Cosmetic revenue. In 2025, Therapeutic earnings hit almost $3.77 billion worldwide, while Cosmetic revenue reached $2.6 billion.

AbbVie’s lawsuit also named as defendants CMS, which falls under the Department of Health and Human Services, and CMS administrator Mehmet Oz.

Aside from the exemptions for plasma-derived products, AbbVie also alleged that the drug negotiation constitutes a taking of its product without just compensation that also forces it to agree, in violation of the First Amendment, that it has agreed to CMS’ price, as per Bloomberg.

These are all familiar refrains. In the months following the IRA’s passage into law in 2022, it was met with lawsuits from industry giants including AstraZeneca, Novo Nordisk and Bristol Myers Squibb. Arguments against the drug price negotiation targeted its constitutionality, raising similar concerns as AbbVie’s Wednesday suit. They have had limited success.

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