DarshanTalks Podcast

The FDA’s New Political Enforcement Strategy


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In this episode, Darshan Kulkarni exposes a massive legal shift that is quietly dismantling the "Practice of Medicine" defense. We track the whiplash from the 2021 Ivermectin court victories to the DOJ’s aggressive 2025 memorandum targeting gender-affirming care.

Is "Intended Use" being weaponized as a high-tech surveillance tool? If the government can criminalize the intent behind a legal hormone, what does that mean for every manufacturer and physician operating in the off-label space? Darshan breaks down the April 2025 DOJ Memo and why your compliance strategy is likely outdated. This isn't just a policy change; it’s a precedent that puts every drug in the market at risk.

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DarshanTalks PodcastBy Darshan Kulkarni

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