A federal judge in the U.S. District Court for the District of Columbia ruled Oct. 29 that AbbVie’s Botox must be excluded from Medicare’s Drug Price Negotiation Program, according to court documents.
On Feb. 11, AbbVie challenged HHS’ decision to include Botox in Medicare’s drug price negotiations, arguing the drug qualifies as a “plasma-derived product” exempt under the law and that CMS exceeded its authority by selecting it.
Botox, first approved by the FDA in 1989, 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.
On Oct. 29, the court found that HHS’ decision to include botox in the program violates the Inflation Reduction Act of 2022. It found that one of Botox’s core components is derived from human plasma, and should be excluded from the drug price program. It also barred the agency from publishing a negotiated “maximum fair price” for the drug.
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