Public Law 115-92: DOD-FDA Enhanced Engagement to Accelerate the Development of Medical Products for Military Personnel

Since its enactment in 2017, Public Law No. 115-92 has significantly boosted the availability of medical products that protect and treat military personnel. This webinar will provide an overview of PL 115-92, which amended the Federal Food, Drug, and Cosmetic Act to increase collaboration between the U.S. Department of Defense (DOD) and the FDA with a goal of more rapidly fielding DOD’s medical product priorities (MPPs) necessary to meet military emergencies. Participants will walk away with a practical understanding of how PL 115-92 enables enhanced regulatory engagement, expedited reviews, and other flexibilities that can greatly accelerate the regulatory review process; how the DOD Priority List and Medical Product Acceleration Committee (MPAC) operate; and how medical product developers can engage with the DOD to explore partnership opportunities that could lead to inclusion on the DOD Priority List. The presenters discussed real-world examples of products that have benefited from the law, including freeze-dried plasma, treatments for chemical nerve agent poisoning, battlefield pain management, malaria prevention, and traumatic brain injury diagnostics.

Speakers: Justin A. Coen, Partner, Faegre Drinker Biddle & Reath LLP, justin.coen@faegredrinker.com; Jeremiah J. Kelly, Partner, Faegre Drinker Biddle & Reath LLP, jeremiah.kelly@faegredrinker.com