Pharmaceutical research and development company AbbVie has won a legal challenge against the US Department of Health and Human Services (HHS).
According to court documents, a federal judge ruled that Botox must be excluded from Medicare’s Drug Price Negotiation Program under the Inflation Reduction Act (IRA) of 2022. The ruling, issued on October 29, followed AbbVie’s argument that Botox qualifies for an exemption as a plasma-derived biological product, because its formulation contains human serum albumin, a protein sourced from human blood plasma.
The court agreed that this ingredient constitutes a significant and necessary component of the product, concluding that the Government had misinterpreted the statutory exemption. Consequently, HHS is prohibited from publishing a negotiated maximum fair price for Botox under the programme.