When the FDA Plays Politics

In this episode of KLF Deep Dive, we examine a chilling shift in regulatory enforcement: the weaponization of "Intended Use." If the science hasn't changed and the law hasn't changed, why is the FDA pivoting from "advice-giving" to "subpoena-swinging"?

Host Darshan Kulkarni breaks down the legal whiplash between the Ivermectin era and the current crackdown on gender-affirming care. We explore why the "Practice of Medicine" shield is disappearing and what this "Rule of the Mood" means for pharmaceutical executives trying to navigate an increasingly political landscape. This is about the survival of the rule of law in life sciences.

Transcript

SPEAKER_01 0:00

Imagine that you're a doctor, you have two patients. One wants a drug for use that the FDA has not officially approved, but it's been around for decades. Case A, the FDA says, we don't practice medicine. That's between you and your patient. But in case B, suddenly that same FDA is knocking on the door with a subpoena, claiming you've reintended the drug. The science hasn't changed. The law hasn't changed. So what did? Politics. I'm Darshan Kilcarney, this is Darshan Talks. Before you dive into the detail of two intended uses, do me a favor, hit that subscribe button and ring the bell. You don't want to miss the compliance updates that actually keep you out of handcuffs. Let's talk about a story about something called intended use. A few years ago, the world went crazy over ivermectin. People were using it for COVID-19, and regardless of what you think about the efficacy, the legal reality is what was fascinating. FDA launched a massive social media campaign. Remember the whole you're not a horse tweet? When they got hauled into court by the doctors, the FDA's lawyers didn't say the use was illegal. What they said is we're just giving advice, we don't interfere with the doctor-patient relationship. They hid behind the practice of medicine shield to avoid liability. Fast forward to today, we're seeing a 180-degree pivot. Now the FDA and DOJ are looking at gender-affirming care, specifically the off-label use of testosterone or puberty blockers. But they aren't saying that's between you and your doctor. This time what they're doing is they're going after intended use.

SPEAKER_00 1:41

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SPEAKER_01 2:16

With gender care, off-label use is a regulatory violation, and we don't like the intent. If you're a pharmaceutical executive, how do you sleep? You're looking at a moving target. If the FDA can choose when intended use applies based on the social controversy of the week, then the rule of law has been replaced by the rule of the mood. The fact is that this is going to keep happening from one administration to the other, and that's not okay. You can't operate a business long term with that. We're watching the FDA transform from a science-based gatekeeper into a political enforcement agency. And that transition, pun intended, is going to cost the industry billions in legal fees. This is the story of a regulatory whiplash, and we're in the first act. We're going to keep pulling this thread to see who else gets caught in this tangle. Thanks for joining us. Share this with your compliance team. If you would like me to break down the specific legal filings from the recent Fifth Circuit court case that force the FDA to admit that they can't stop off-label prescribing, reach out. Until then, remember, the law's only as good as its last application. Called click or email.