Updates on the Drug Price Negotiation Program of the Inflation Reduction Act: An Overview of Recent Court Decisions, the Status of Remaining Challenges, and the Status of “Negotiations”

Six months into the first year of the Inflation Reduction Act’s Drug Price Negotiation Program, the “negotiations” and legal challenges thereto continue to play out. Since our last webinar several months ago, courts have dismissed two lawsuits challenging the Drug Price Negotiation Program, the parties in the remaining lawsuits have completed briefing on dispositive motions in their cases, and a district court has recently held oral argument on the dispositive motions in four of the remaining challenges. On the “negotiation” front, manufacturers of selected drugs have exchanged “counteroffers” with CMS in response to CMS’s initial “maximum fair price” offer, and negotiations will close August 1st.

Join Brian Burgess (Appellate and Supreme Court Litigation partner and co-chair of Goodwin’s FDA litigation practice), Alex Lu (IP Litigation partner and Big Molecule Watch editor), and Matt Wetzel (Life Sciences Regulatory & Compliance partner and co-chair of Goodwin’s Late-Stage Drug Development practice) for an update on the various legal challenges to the Inflation Reduction Act’s Drug Price Negotiation Program and the status of the ongoing “negotiations” for the first ten drugs selected into the Program.

CLE credit will be offered for California, Minnesota, New Jersey, New York, and Pennsylvania.