Is Your Off-Label Use Now a Federal Crime?

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 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 show

www.kulkarnilawfirm.com

Episode Transcript

Darshan (00:00):
So for decades we've all lived with this clean mental
line.
Doctors can prescribe off-label,but drug companies cannot
promote off-label.
But that line just got a lotmessier.
The Department of Justice, underthe new SAW Declaration, is now
pushing a theory that off-labelprescribing itself by done by a

(00:20):
doctor can become evidence of aFood, Drugs, and Cosmetics Act
violation when the governmentthinks that the behavior was
shaped, nudged, or engineered bypharmaceutical marketing.
So here's what happened.
As we know, President Trumpissued Executive Order 14187
titled Protecting Children fromChemical and Surgical

(00:42):
Mutilation.
The Executive Order demanded anend to gender-affirming care.
In response, the AttorneyGeneral issued a memorandum in
April 2025 and it instructedU.S.
attorneys to investigate femalegenital mutilation.
The Consumer Protection Branchthen began investigating medical

(01:05):
providers and the pharmaceuticalcompanies for violations of the
Food, Drugs, and Cosmetics Actfor engaging in misbranding by
making false claims about theon-or-off-label use of puberty
blockers, sex hormones, or anyother drug used to facilitate a
child's so-called gendertransition.

(01:25):
They sent 20 subpoenas tohospitals and healthcare
providers, and they asked forany documents related to this
gender-affirming care.
They even wanted personalidentifying information such as
social security numbers, birthdates.
And obviously, for many reasons,including the fact that there's
many, many privacy issuesinvolved, there was pushback.
Parents of patients at theUniversity of Pittsburgh Medical

(01:47):
Center, UPMC, moved to quash thesubpoena and argued the
government is inappropriatelyusing the Food Drugs and
Cosmetics Act to criminalize orregulate medical practice.
Once a drug is approved,healthcare providers have always
been able to prescribe forunapproved uses when medically
appropriate.
We've seen this in the contextof cancer treatments,
antibiotics, and many, manyother treatment offices.

(02:10):
The pharmacists have seen thisall the time.
The DOJ's position, on the otherhand, detailed in a declaration
with the acting director, LisaSao, signals a significant shift
in DOJ policies and aroundenforcement involving drug
treatments.
Sao asserts that healthcareproviders who prescribe certain
drugs off-label may be subjectto Food, Drugs, and Cosmetics

(02:32):
Act liability.
She asserts that providers ofgender-affirming care are
failing to provide adequatelabeling for off-label uses and
are actively deceiving patientsand parents with false claims
and statements regarding thedrugs' effectiveness or
alternatives and thereforemisrepresented risks.
We've seen versions of theseclaims from plaintiffs'

(02:54):
attorneys in the past, but neverthe government, and never under
the Food Drugs and CosmeticsAct.

SPEAKER_00 (03:01):
Enjoying our content, we'd love to hear more.
Please like, comment, share, andfind more.

Darshan (03:09):
So let that sink in.
This is not about rogue repshanding out sketchy slides.
This is about actual scientificexchange, medical education, and
the way influence actually worksin real life.
So here's the DOJ's angle inplain English.
If the company designsmessaging, education, or
scientific discussions, knowingthat they will drive off-label

(03:30):
use, the DOJ may argue that theprescribing decision is no
longer independent medicaljudgment.
I.e., it becomes the endpoint ofan unlawful promotional scheme.
That is terrifying.
So if you frame it this way,physicians stop looking like a
neutral actor and they look likepart of that causal chain.

(03:51):
And that's new.
And it should make prescribers,whether it's your doctor,
whether it's your nursepractitioner, whether it's your
PA, extremely uncomfortable.
For physicians, this is a realrisk shift.
You're still allowed toprescribe off label.
That part hasn't changed.
Because again, that's regulatedby the state laws.
What has changed is that it cannow be Monday morning

(04:12):
quarterbacking.
To see how your decision can beinterpreted after the fact.
Emails, speaker programs,advisory boards, repeated
exposure to educationalmessages.
If the DOJ believes that thoseinteractions were structured to
produce off-label use, yourprescribing patterns are
suddenly evidenced.
Look at pharma marketers.

(04:33):
This theory blows up that oldcompliance comfort zone.
The one that said, as long as westay scientific, we're safe.
What the DOJ is saying is thatintent matters more than labels.
If scientific exchange functionslike promotion, they will treat
it like promotion.
And now we're back to intendeduse.
This means that marketers, MSLs,medical affairs, and brand teams

(04:57):
are all in that blast radius.
Bottom line, off-labelprescribing is still legal, but
it's not invisible.
If you prescribe, ask yourself,who shaped the information you
relied on?
I'm not even sure you can answerthat, but they're asking you to
ask that.
If you market, assume that theDOJ is reading your strategy
deck, not just your disclaimer.

(05:19):
This gap between science andpromotion just got narrower.
And ignoring that reality is howpeople get subpoenaed.
Call, click, or email.