In a complaint filed in the Washington, D.C., federal court, AbbVie said Botox is among the medications covered under Medicare that Congress specifically excluded from price controls when that body passed the Inflation Reduction Act of 2022.
The North Chicago, Illinois-based drugmaker called its lawsuit the first arising from CMS' allegedly violating one of those exclusions, specifically the exclusion of "plasma-derived products" from price controls.
HHS did not immediately respond to a request for comment. The lawsuit also names Health Secretary Robert F. Kennedy Jr., CMS and CMS administrator Mehmet Oz as defendants.
Botox injections are often used to smooth facial wrinkles, but can also be used to treat several medical conditions including eye- and neck-movement disorders, neck spasms, incontinence and migraines.
AbbVie said one-third of Botox is human serum albumin, a protein extracted from human blood plasma and essential to the product's safety and efficacy.
"Because HSA is sourced from plasma collected from human donors, Botox is a 'plasma-derived product' that Congress excluded from the price-control program," the complaint said.
AbbVie said the price controls force it to sell Botox at "confiscatory prices" to Medicare beneficiaries, or risk "ruinous" tax liability and exclusion from federal government programs, and falsely admit that the price it charged was "fair."
The drugmaker said CMS violated its free speech rights under the U.S. Constitution's First Amendment by telling it what to say about the price. It also said CMS' actions amounted to a due process violation and illegal "taking" under the Fifth Amendment. Its lawsuit seeks to end the price controls.
Botox accounted for just over 10% of AbbVie's $61.16 billion of revenue last year, with purchases for therapeutic uses accounting for about 6%.
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