When the FDA Plays Politics

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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.

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Episode Transcript

SPEAKER_01 (00:00):
Imagine that you're a doctor, you have two patients.
One wants a drug for use thatthe FDA has not officially
approved, but it's been aroundfor decades.
Case A, the FDA says, we don'tpractice medicine.
That's between you and yourpatient.
But in case B, suddenly thatsame FDA is knocking on the door
with a subpoena, claiming you'vereintended the drug.

(00:22):
The science hasn't changed.
The law hasn't changed.
So what did?
Politics.
I'm Darshan Kilcarney, this isDarshan Talks.
Before you dive into the detailof two intended uses, do me a
favor, hit that subscribe buttonand ring the bell.
You don't want to miss thecompliance updates that actually
keep you out of handcuffs.
Let's talk about a story aboutsomething called intended use.

(00:45):
A few years ago, the world wentcrazy over ivermectin.
People were using it forCOVID-19, and regardless of what
you think about the efficacy,the legal reality is what was
fascinating.
FDA launched a massive socialmedia campaign.
Remember the whole you're not ahorse tweet?
When they got hauled into courtby the doctors, the FDA's

(01:06):
lawyers didn't say the use wasillegal.
What they said is we're justgiving advice, we don't
interfere with thedoctor-patient relationship.
They hid behind the practice ofmedicine shield to avoid
liability.
Fast forward to today, we'reseeing a 180-degree pivot.
Now the FDA and DOJ are lookingat gender-affirming care,

(01:28):
specifically the off-label useof testosterone or puberty
blockers.
But they aren't saying that'sbetween you and your doctor.
This time what they're doing isthey're going after intended
use.

SPEAKER_00 (01:41):
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SPEAKER_01 (02:16):
With gender care, off-label use is a regulatory
violation, and we don't like theintent.
If you're a pharmaceuticalexecutive, how do you sleep?
You're looking at a movingtarget.
If the FDA can choose whenintended use applies based on
the social controversy of theweek, then the rule of law has
been replaced by the rule of themood.
The fact is that this is goingto keep happening from one

(02:39):
administration to the other, andthat's not okay.
You can't operate a businesslong term with that.
We're watching the FDA transformfrom a science-based gatekeeper
into a political enforcementagency.
And that transition, punintended, is going to cost the
industry billions in legal fees.
This is the story of aregulatory whiplash, and we're

(03:00):
in the first act.
We're going to keep pulling thisthread to see who else gets
caught in this tangle.
Thanks for joining us.
Share this with your complianceteam.
If you would like me to breakdown the specific legal filings
from the recent Fifth Circuitcourt case that force the FDA to
admit that they can't stopoff-label prescribing, reach
out.
Until then, remember, the law'sonly as good as its last

(03:21):
application.
Called click or email.