Stephanie Trunk and Darshan Kulkarni discuss the evolving landscape of the pharmaceutical industry under the Trump Administration in 2025. They highlight the uncertainty surrounding regulatory changes, particularly with new leadership at the FDA, CMS, and HHS (with RFK confirmed). There is concern over shifting prosecutorial priorities, overturned FDA diversity initiatives, and potential scrutiny of diversity efforts in private companies.

A major focus is the changing environment of off-label marketing, where reliance on FDA guidances is being replaced by stricter adherence to statutory regulations due to court rulings like Coronia and Loper Bright. This shift creates uncertainty for regulated industries, as enforcement becomes less predictable.

Key Topics Discussed:

Off-Label Promotion & Enforcement:

• Off-label use is legal, but off-label promotion remains a complex issue.
• Enforcement is increasingly driven by the False Claims Act, with oversight from multiple agencies (FDA, FTC, DOJ, OIG, CMS).
• The blurring of lines between medical and sales functions is a growing concern, especially with AI chatbots playing a role in medical communications.

Compounding & the GLP-1 Market:

• The discussion explores drug compounding, particularly regarding GLP-1 weight loss medications.
• Regulatory challenges stem from drug shortages, compounding rules, and market competition, with potential Lanham Act violations and unfair competition claims.
• The Inflation Reduction Act and its implications for drug shortages and penalties are also considered.

Key Compliance Considerations:

• Maintaining clear separation between sales and medical functions.
• Ensuring compliance with FDA promotional material regulations.
• Managing risks related to AI chatbots and speaker programs.
• Implementing robust compliance programs in line with DOJ, OIG, and FDA guidelines.
• Understanding the growing role of state attorneys general and competitor-driven enforcement actions.

The overall sentiment reflects industry uncertainty as pharmaceutical companies navigate regulatory and legal shifts in this new landscape.

Support the show