FDA Commissioner Speech Suggests New Vision for Agency

AGG Litigation partner Gabe Scannapieco and Food & Drug attorneys Alan Minsk and Laura Dona published an article in Law360 sharing their analysis on FDA Commissioner Dr. Marty Makary’s first major public address since taking office — an ambitious and reform-driven blueprint for the future of the U.S. agency.

Delivered during a fireside chat at the Food and Drug Law Institute Annual Conference, Dr. Makary signaled significant shifts ahead for FDA policy, enforcement, and public health strategy. Gabe, Alan, and Laura outline the commissioner’s proposed restoration of the agency, a reorientation toward scientific integrity and regulatory flexibility, and a strong emphasis on real-world data and selective modernization — including the rollout of AI-supported review systems by mid-2025.

The article explores the commissioner’s commentary on food safety, pediatric health, tobacco regulation, and drug approval standards, with the AGG team offering insight into how these themes could impact companies in life sciences, food and drug, and consumer products sectors.

To read the full article, please click here (subscription required).