Recorded Webinar—The IRA’s Drug Price Program: What You Need to Know as the “Negotiation” and Litigation Heat Up

Webinar

Materials:

Panelists:
Stacy Cline Amin, Partner, Morrison & Foerster LLP; Former FDA Chief Counsel & HHS Deputy General Counsel
Dan Troy, Managing Director, Berkeley Research Group; Former FDA Chief Counsel
Matt Wetzel, Partner, Goodwin Procter LLP

Description:
The government’s implementation of the Inflation Reduction Act’s (IRA) Drug Price Negotiation Program is in full swing. Eight constitutional and statutory challenges to the Program are proceeding, with one court refusing four business associations’ request to preliminarily enjoin the process. Our panel of experts will discuss where things stand on the “negotiation” side and identify developments to watch for, while also discussing the lawsuits’ status and the strength of their claims.

Speakers' Biographies

Stacy Cline Amin

Stacy is a partner in the Washington, DC office of Morrison & Foerster LLP. She leads the FDA + Healthcare Regulatory and Compliance practice within the firm’s Global Life Sciences + Healthcare Group. Stacy previously served as Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), and held senior positions within the White House Counsel’s Office and health committees in both the House and Senate.

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Dan Troy

Dan is Managing Director with Berkeley Research Group (BRG) in Washington, DC. Prior to joining BGR, Dan served as Executive Vice President and General Counsel of Valo Health LLC and General Counsel of GlaxoSmithKline PLC. He is a highly sought thought leader, having served as chief counsel of the FDA, chaired the US Chamber Litigation Center, and led influential committees and sections within organizations such as the American Bar Association and the American Law Institute. Dan is also a member of WLF's Legal Policy Advisory Board.

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Matt Wetzel

Matt is a partner in the Washington, DC office of Goodwin Procter LLP. He co-leads the firm’s Medtech practice and co-chairs the firm’s Late Stage Drug Development practice. Prior to joining the firm, Matt served as Chief Compliance Officer of a Silicon Valley diagnostic start-up; was the Vice President & Deputy General Counsel of medical technology trade association AdvaMed; and he held an executive legal and compliance role at a multinational medical device maker.

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