Legal Challenges to the Inflation Reduction Act: An Update on Pending Challenges and Reactions to Oral Argument in Dayton Area Chamber Of Commerce et al. v. Becerra et al.

Two weeks ago, HHS announced the first 10 drugs that will be subject to the new Drug Price Negotiation Program under the Inflation Reduction Act (“IRA”). Six of the manufacturers whose drugs are on the list and several other interested groups have filed lawsuits challenging the legality of the Program. In one of those cases, filed by various Chambers of Commerce, the parties have completed briefing on the Plaintiffs’ Motion for a Preliminary Injunction to stop administration of the Drug Price Negotiation Program and on the Government’s Motion to Dismiss the case. The federal district court for the Southern District of Ohio has scheduled oral argument on those motions for September 15, 2023. This will mark the first time a judge engages with the merits of a legal challenge to the Drug Price Negotiation Program. Join Life Sciences Regulatory & Compliance partner and co-chair of Goodwin’s Late-Stage Drug Development practice Matt Wetzel, Appellate and Supreme Court partner and co-chair of Goodwin’s FDA litigation practice Brian Burgess, and IP Litigation partner Alex Lu for a discussion of the oral argument and a review of the other pending challenges to the IRA’s Drug Price Negotiation Program.