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Navigating an FDA in Chaos During Turbulent Times
Manage episode 480763651 series 3648675
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Mookie Spitz welcomes Dale Cooke, one of the most trusted names in FDA regulatory compliance, who shares a survival guide for healthcare marketing professionals during this historic time of sweeping upheaval. Against the backdrop of Trump’s second-term administration, which has eliminated thousands of FDA and HHS positions and ushered in unpredictable deregulation, Dale shares urgent insights from inside the storm.
Packed with real-world examples, biting humor, and a touch of Philly cheesesteak vs Chicago deep-dish banter, their wide ranging conversation explores the traumatizing impact of today's uncertainty on public health oversight. Acknowledging the importance of reducing bureaucracy. Dale explains why the pharmaceutical industry isn't asking for less regulation, but predictable regulation—and how the administration’s chaotic approach is making instability the norm.
Whether you're a pharmaceutical exec, agency lead, marketing and advertising pro, legal advisor, or just fascinated by the intersection of AI, health, communications, and politics, this episode delivers clarity in a time of confusion—and proves why, whenever in doubt, the industry has for decades grabbed the batphone and shouted "Let's call Dale!"
The Guest
Dale Cooke is the president of PhillyCooke Consulting and FDA Ad Law. He helps companies communicate about FDA-regulated products using 21st century tools, while remaining compliant with regulations written in the 1960s. Dale has worked with more than 50 pharmaceutical and medical device clients and more than 30 advertising agencies around the world. His insights have been featured in Politico, The Pink Sheet, Stat News, Law360, and other publications. Dale is an active member of the Food and Drug Law Institute (FDLI), the Alliance for a Stronger FDA, and the Digital Health Coalition.
Dale teaches in the Temple University School of Pharmacy RAQA program.
Dale is the author of Effective Review and Approval of Digital Promotional Tactics, which is now in its second edition in FDLI’s Topics in Food and Drug Law series. He is regularly invited to speak at industry conferences on topics including FDA enforcement trends, best practices for review processes, global review practices, and life sciences use of social media.
Dale earned his B.A. in Philosophy from Southern Methodist University, an M.A. in Philosophy from the University of Arizona, studied Epidemiology and Biostatistics at Drexel University’s School of Public Health, received a graduate certificate in Healthcare Compliance from Seton Hall University’s School of Law, and his J.D. at Drexel University’s Kline School of Law.
https://www.linkedin.com/in/daleacooke/
www.PhillyCooke.com
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