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 Program. In one of those cases, filed by various regional Chambers of Commerce as well as the U.S. Chamber 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.
On September 19, 2023, Appellate and Supreme Court partner and co-chair of Goodwin's FDA litigation practice, Brian Burgess, IP Litigation partner and Big Molecule Watch editor, Alex Lu, and Life Sciences Regulatory & Compliance partner and co-chair of Goodwin's Late-Stage Drug Development practice, Matt Wetzel, will lead a webinar to discuss the oral argument and provide a review of the other pending challenges to the IRA's Drug Price Negotiation Program.
Click here to register for the webinar.