New Rules, New Risks: Inside the Changing World of Federal Inspections

Hyman, Phelps & McNamara, P.C. (“HPM”) Director Larry Houck will moderate “New Rules, New Risks: Inside the Changing World of Federal Inspections” at the Food and Drug Law Institute’s Enforcement, Litigation, and Compliance Conference in Washington, D.C., December 4-5, 2025.  The session will explore the ever-evolving landscape of federal inspections, including the Food and Drug Enforcement’s use of unannounced foreign inspections, changes in domestic inspection priorities, and the effects of reduced staffing.  The session will explore how the Drug Enforcement Administration’s regulatory oversight and inspection activity impacts manufacturers, distributors, pharmacies, practitioners and other registrants amid growing scrutiny of controlled substances.  Panelists will also examine how federal agencies are rebalancing inspection strategies across borders, sectors, and products.  The session will occur Friday, December 5th.

Mr. Houck was a diversion investigator with DEA in the field and at agency headquarters for 15 years prior to joining HPM in 2001.

Some of the topics in other conference sessions will include:

• FDA’s Compliance Challenges and Enforcement Priorities
• Criminal Liability and Enforcement Trends
• AI in Industry and at FDA
• Dietary Supplements and Labeling
• Significant Class Action Trends Impacting Food, Dietary Supplements and Drug Manufacturers
• FDA Tobacco Enforcement
• Drug Shortages
• False Claims
• Medical Device Enforcement
• State-Level Challenges and Initiatives
• Compounding Litigation and Enforcement
• Recent Court Decisions Impacting FDA’s Authority

Further conference information, including registration, can be found here.