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 Darshan breaks down the April 2025 DOJ Memo and why your compliance strategy is likely outdated.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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Episode Transcript

Darshan (00:00):
So let's think about this.

(00:01):
You're in a room with yourdoctor, the doors closed, you're
discussing a treatment thatmight save your life.
Or at least change it for thebetter.
You think that that conversationis private.
You think that the law protectsyour doctor's right to treat
you.
That's not true in 2026 anymore.
This privacy now dependsentirely on which drug is on the

(00:23):
prescription pad.
I'm Darshan Kilcarney, this isDarshan Talks.
Today we're pulling back thecurtain on a massive legal
double standard, one that'sturning the FDA into a political
weapon.
Before we start, hit thatsubscribe button, ring the bell
so you never miss a deep diveinto this intersection of law
and life sciences.

(00:43):
Let's talk about duplicity.
Remember 2021?
The hype of the Ivermagnoncraze.
Lawmakers were shouting from therooftops.
They were discussing thesanctity of the doctor-patient
relationship.
They argued that the FDA had nobusiness telling a doctor that
they couldn't prescribe anapproved drug for an off-label

(01:04):
use, in this case COVID-19.
They even sued and won a majorvictory in the Fifth Circuit.
They claimed that the FDA wasoverstepping its authority by
interfering in the practice ofmedicine.
In this case, the case ofIvormeckin, the data was at best
terrible.
Nevertheless, the fact remainsthat that is a choice a

(01:24):
physician and a patient canmake.
The message was clear.
The government stays out of theexam room.
Let's be clear.
They were right.
Now it's 2026, and that sanctityhas evaporated.
When the drug has been for pressstone for an abortion or
hormones for gender-affirmingcare, we know that in both these
cases they work.

(01:46):
Practice of medicine defense hasvanished.
Instead of protecting yourprivacy, we're seeing the DOJ
and Attorney Generals use thisintended use rule as a new
high-tech surveillance tool.
And that's where it getsdangerous.
The DOJ's recent April 2025memorandum is a game changer.
They're now saying that if adrug is used for gender

(02:08):
transition, even if it's anoff-label use of a perfectly
legal hormone, the manufacturerand the doctor can both be
investigated from misbranding.

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Darshan (02:28):
Why?
Why?
Because they claim that theintent of the use makes it a new
drug that has not been approved.
And they aren't stopping at thepharmacy counter.
We've seen the administrationtake zero action to defend
privacy regulations.
They're allowing states tosubpoena the private medical
records of patients who travelacross state lines of care.

(02:50):
Wait, wait, wait, wait.
What happened to this wholedecision between the patient and
the doctor?
For Ivermectin, this was afundamental right to try an
unproven treatment.
In this case, we know it works,but it's a regulatory violation
that warrants a federalinvestigation and a breach of
patient records.
During the life sciences, thisduplicity is a legal minefield.

(03:11):
We're moving towards a worldwhere the FDA's enforcement
priorities are not dictated byclinical data, but by the poison
pill provisions in the latestappropriations bill.
Let me be clear.
I've always known the FDA is apolitical organization.
There is definitely a certainamount of politics that
happened.
I've interviewed Rob Tailiff.
He admits that that's a thing.

(03:33):
The question is, those politicaldecisions have usually been
contained through the concept ofapprovals.
We've never seen regulatoryaction occur, at least not that
I'm aware of.
Occur where you're fundamentallytargeting both manufacturers and
physicians for taking things anddoing things that were within

(03:53):
the actual practice of medicine.
Here's your problem.
When the law treats the sameaction, off-label prescribing in
this case, as a protectivefreedom one day and a criminal
action the next, the industryloses its North Star.
So we're watching the slow deathof medical privacy, and I'm not
even sure how slow it is, in thename of regulatory intent.

(04:15):
This isn't just abouthealthcare.
It's about precedent.
We're setting this precedent forevery drug in the market.
If you want to keep your companyand your patients protected, you
need to stay ahead of theseshifts.
If you'd like me to do a deeperdive into specific intended use
evidence, as the DOJ is nowusing it to target and trigger
audits, reach out now.

(04:36):
Until then, remember the law isonly as good as its last
application.
Call, click, or email.