FDA Under Pressure: Enforcement, DOGE & Global Supply Chains
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What is happening inside the FDA, and how are regulatory shifts impacting pharmaceutical, medical device, and food companies? In this episode of the KLF Deep Dive, host Darshan Kulkarni sits down with veteran Food and Drug lawyer Alan Minsk (Partner and Chair of the Food & Drug Practice at Arnall Golden Gregory LLP) to discuss the evolving enforcement climate, agency turnover, and global supply chain challenges.
Together, they break down the structural impact of government efficiency initiatives (DOGE) on FDA staff morale and resources, the surge in direct-to-consumer (DTC) advertising enforcement, and shifting focus toward food safety, dietary supplements, and alternative treatments. Alan and Darshan also unpack offshore manufacturing scrutiny, virtual inspections, and how emerging trade dynamic policies like the BIOSECURE Act affect cross-border IP and pharmacovigilance.
What You'll Learn in This Episode:
Agency Morale & Resources: How leadership turnover and budget cuts affect review times, reviewer retention, and day-to-day regulatory interactions.
DTC & Promotional Enforcement: Why the FDA is leveraging AI and data tools to rapidly issue untitled and warning letters targeting prescription drug advertising.
Manufacturing Scrutiny & Virtual Auditing: How FDA holds ex-US manufacturing plants accountable through email-based virtual inquiries and border holds.
Reshoring vs. Offshore Risk: The decision matrix for large versus small pharma companies when considering US-based manufacturing footprint expansion.
Cross-Border Dynamics & Biosecure Rules: Navigating pharmacovigilance data sharing and licensing agreements with overseas partners, particularly in China and Japan.
Support the show
www.kulkarnilawfirm.com
What is happening inside the FDA, and how are regulatory shifts impacting pharmaceutical, medical device, and food companies? In this episode of the KLF Deep Dive, host Darshan Kulkarni sits down with veteran Food and Drug lawyer Alan Minsk (Partner and Chair of the Food & Drug Practice at Arnall Golden Gregory LLP) to discuss the evolving enforcement climate, agency turnover, and global supply chain challenges.
Together, they break down the structural impact of government efficiency initiatives (DOGE) on FDA staff morale and resources, the surge in direct-to-consumer (DTC) advertising enforcement, and shifting focus toward food safety, dietary supplements, and alternative treatments. Alan and Darshan also unpack offshore manufacturing scrutiny, virtual inspections, and how emerging trade dynamic policies like the BIOSECURE Act affect cross-border IP and pharmacovigilance.
What You'll Learn in This Episode:
Agency Morale & Resources: How leadership turnover and budget cuts affect review times, reviewer retention, and day-to-day regulatory interactions.
DTC & Promotional Enforcement: Why the FDA is leveraging AI and data tools to rapidly issue untitled and warning letters targeting prescription drug advertising.
Manufacturing Scrutiny & Virtual Auditing: How FDA holds ex-US manufacturing plants accountable through email-based virtual inquiries and border holds.
Reshoring vs. Offshore Risk: The decision matrix for large versus small pharma companies when considering US-based manufacturing footprint expansion.
Cross-Border Dynamics & Biosecure Rules: Navigating pharmacovigilance data sharing and licensing agreements with overseas partners, particularly in China and Japan.
Support the show
www.kulkarnilawfirm.com
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