AbbVie files lawsuit against US health agency over Botox price controls

AbbVie sued the U.S. Department of Health and Human Services on Wednesday, questioning the decision of the Centers for Medicare and Medicaid Services to implement price controls on botulinum toxin in medical insurance and assistance services. In the complaint filed in the federal court in Washington D.C., AbbVie stated that botulinum toxin is a medical insurance drug explicitly excluded from price controls when Congress passed the 2022 Inflation Reduction Act. The pharmaceutical company, based in North Chicago, Illinois, said its lawsuit is the first to be filed against CMS for allegedly violating one of the exclusion clauses, particularly excluding "plasma derivative products" from price controls. HHS did not immediately respond to a request for comment. The lawsuit also names Health Secretary Robert Kennedy, CMS, and CMS Administrator Mehmood Ozzreh as defendants. Botulinum toxin injections are commonly used to smooth facial wrinkles, but can also be used to treat various conditions including eye and neck movement disorders, neck spasms, urinary incontinence, and migraines. The complaint stated, "As botulinum toxin is derived from human plasma collected from human donors, it is considered a 'plasma derivative product,' which Congress has excluded from price control programs." AbbVie claimed that price controls force them to sell botulinum toxin to Medicare beneficiaries at a "confiscatory price," or else risk facing "devastating tax liabilities and exclusion from federal programs," and falsely acknowledging that the price they charge is "fair."