Health Affairs September 13, 2023
Andrew Twinamatsiko, Zachary Baron

As we have covered in previous articles here, the new authority Congress provided to the Department of Health and Human Services (HHS) under the Inflation Reduction Act (IRA) to directly negotiate the price Medicare pays for a few high-cost drugs is facing a concerted legal attack by drug manufacturers and their allies.

Nine lawsuits challenging the IRA’s negotiation program have so far been filed across the country. Many of the ongoing lawsuits, by Merck, Bristol Myers Squibb, Janssen, Novartis, AstraZeneca, and Boehringer Ingelheim are largely identical, mostly pursuing claims under the First, Fifth, and Eight Amendments and the Takings Clause of the Fifth Amendment. One manufacturer, Astellas, chose to drop their lawsuit after HHS did not select its drug for...

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