Is Your Off-Label Use Now a Federal Crime? episode artwork

EPISODE · Mar 2, 2026 · 5 MIN

Is Your Off-Label Use Now a Federal Crime?

from DarshanTalks Podcast · host Darshan Kulkarni

Send us Fan MailFor decades, a "clean mental line" existed: Doctors prescribe, and companies don't promote off-label. That line just got a lot messier. In this episode, Darshan Kulkarni breaks down the Hsaio Declaration—a seismic shift in DOJ enforcement that aims to turn independent medical judgment into evidence of a federal crime.We dive into the University of Pittsburgh Medical Center (UPMC) subpoena battle, the fallout of Executive Order 14187, and why "Scientific Exchange" may no longer be a safe harbor for Medical Affairs. If you are a physician, a compliance officer, or a pharma marketer, the blast radius of this new theory is larger than you think. Is your prescribing pattern being "engineered" by marketing? The DOJ thinks so.Support the showwww.kulkarnilawfirm.com

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Send us Fan Mail For decades, a "clean mental line" existed: Doctors prescribe, and companies don't promote off-label. That line just got a lot messier. In this episode, Darshan Kulkarni breaks down the Hsaio Declaration—a seismic shift in DOJ enforcement that aims to turn independent medical judgment into evidence of a federal crime. We dive into the University of Pittsburgh Medical Center (UPMC) subpoena battle, the fallout of Executive Order 14187, and why "Scientific Exchange" may no long...

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Is Your Off-Label Use Now a Federal Crime?

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