February 16, 2026 • 15 mins
In this episode of DarshanTalks, host and attorney-pharmacist Darshan Kulkarni deconstructs the legal "scorched-earth" offensive currently reshaping the weight loss drug industry. Following the February 2026 announcement that the GLP-1 shortage is officially resolved, the "Golden Age" for compounders has vanished overnight, leaving companies like Hims & Hers in the crosshairs of both the FDA and Novo Nordisk.
Darshan takes us from the tragic "ghost" of the 2012 NECC fungal meningitis outbreak to the modern-day "Compounding Wild West." We explore the crucial differences between Section 503A and 503B pharmacies and why adding Vitamin B12 to a patented molecule isn't the "customization" compounders claim it is.
Key topics include:
- The NECC Legacy: How a 2012 tragedy created the Drug Quality and Security Act (DQSA) and why the FDA is using it to end the mass-marketing of copycat drugs.
- The Science of the "Bluff": Why "not adulterated" does not mean "safe and effective" under the FD&C Act.
- Novo Nordisk vs. Hims & Hers: The billion-dollar patent battle and why the DOJ is now getting involved.
- The Shortage Shield: What happens to telehealth platforms the moment the FDA "Shortage" flag disappears.
Don't let your healthcare be decided by an Instagram ad. Understand the intersection of biochemistry and federal law to protect your health and your practice.
www.kulkarnilawfirm.com
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Darshan (00:00):
Welcome to Darshan Talks.
To learn about healthcare,you're actually allowed to
understand.
I'm your host, DarshanKulcarney.
Today we're tackling the biggestlegal and medical collision of
the decade.
The war over weight lossmedications.
We're going to talk about whythe FDA, the very agency meant
to protect you, sometimes causesthe shortages that put you at
(00:20):
risk.
We're going to talk about thecompounding wild, wild west.
And most importantly, we'regoing to talk about the tragedy
from before 2012 that changedthe law forever.
And why that coast is the reasoncompanies like him and hers are
suddenly running for cover whileNova Nordisk is going onto the
offensive and launching ascorched earth offensive, if you
(00:43):
will.
The fact is that healthcare sitsat the intersection of two of
the most complex languages onearth: biochemistry, federal
law.
My life has been spent living atthat intersection.
I started as a doctor pharmacy,I stood at the counter, I talked
to patients, I wondered how themolecular structure of drugs
would uniquely interact with apatient's personal biology.
(01:06):
And I quickly learned thatchemistry is only half the
answer.
It's the law.
So I went back and amongst a fewother degrees, I also became an
attorney.
I've spent 20 years navigatingthe FDA, the Department of
Health and Human Services, andthe halls of Congress.
When you subscribe to thispodcast, and I hope you do, you
aren't just getting aninfluencer's opinion on the
(01:26):
latest health trend.
You're getting the dual lensview from someone who knows the
signs and the court transcripts.
So if you want to understand whya local compounding pharmacist
is currently in legal panic, wehave to go back to about 2009.
And let's talk about a dirtylittle secret from the industry.
The FDA often causes the veryshortages it's trying to fix.
(01:48):
Now we all want the FDA to bestrict.
We want them to walk into afactory and say, this floor
isn't clean enough.
Shut it down.
But here's the paradox.
When you do this to a majorplant for compliance issue,
maybe it's just a paperworkerror, maybe it's a cooling fan
that isn't up the spec, maybeit's multiple companies.
Either way, you're raisingexpectations, and the shortage
(02:09):
of that drug stops instantly andpossibly forever.
So in 2009, when the FDAunilaterally declared that
they're going to startregulating and insisting that
there's a higher quality thandrug manufacturers of meat,
several drug manufacturers saidthat it was simply not worth it
for them to keep making thedrug.
They had incredibly thinmargins, and these new
(02:31):
requirements would push theminto unprofitability.
So suddenly you had massive drugshortages.
I remember I was working as apharmacist, and we had 200, 300
of them at a time.
Patients who had cancer couldn'tget their medications.
Pharmacies were the savinggrace.
Compounding pharmacies came inand tried to fix that problem.
(02:51):
Before 2012, compoundingpharmacies were largely just the
neighborhood apothecary.
It mixed a little bit of creamfor a rash, liquid version for a
child who couldn't swallow,something for your vets, so that
you can give it to horses or toyour pet.
They were all regulated by thestate boards of pharmacy, but
not the FDA.
With these shortages, theneighborhood apothecaries
(03:13):
suddenly became high-volume drugmanufacturers with none of the
oversight that the FDA provided.
So inevitably, we became due fora tragedy.
That tragedy was the New EnglandCompounding Center with the
NECC.
The NECC wasn't acting like aneighborhood pharmacy.
They were acting like a massivedrug manufacturer, but without
(03:34):
any of the FDA's goodmanufacturing practices
oversight.
They were mass-producing vialsof a drug called
metalprenicillin acetate.
It's used for back pain, butit's also just a simple steroid.
There's nothing exotic about it.
But they wanted to move fast.
Since they had high volumes,they were making loads of money,
they had orders to fill.
And hopefully because they alsowanted to just help patients.
(03:55):
But they skipped things thatwere essential, like sterility
testing.
Let me be clear, sterilitytesting possibly wasn't even
required at this point.
We just didn't have the rules atthat point.
But it should have beenexpected.
And if you're a pharmacistmaking that high volume of
drugs, we should have known.
And the result was horrific.
The vials were contaminated withblack mold.
Doctors across the countryinjected that mold directly into
(04:18):
the spines of the patients, andit caused a fungal meningitis
outbreak that killed 64 peopleand sickened nearly 800 more.
I remember where I was when thenews broke.
Every pharmacist in the countryfelt a pit in their stomach.
We knew that the world was aboutto change, and we knew that
certain pharmacists, the onesfrom NECC, they were looking at
(04:38):
jail time and they did go tojail.
In response, Congress passed theDrug Quality and Safety Act, the
DQSA of 2013.
This law created a great wall.
It created two new classes ofpharmacies, the 503A and the
503B.
503A are your traditionalpharmacies.
You can only make a drug if theyhave a specific prescription for
(05:00):
a specific patient.
There has to be customization.
And we're going to talk aboutthis because that's where we are
right now.
Then there are 503Bs.
These are the outsourcingfacilities.
They can mass produce.
You have to follow much stricterFDA rules like a mini Pfizer,
and you can only compound what'son the FDA shortage list.
But when the drug hits the FDAshortage list, it triggers a
(05:21):
legal loophole of the Food,Drugs, and Cosmetics Act.
The law says if the big guyscan't make it, we will let the
compounders step in so thatpatients don't die or suffer.
This was the golden age forcompounders, and went on until
possibly right about now.
This is when compounders werelegally allowed to copy the most
profitable drugs in the worldbecause the FDA's own oversight
(05:44):
had contributed to the shortage.
What if that golden age has justended and why does it matter
today?
Well, it matters because for thelast two years, these
compounders have been trying toblur the lines between the two
sections that sell you theseweight loss drugs.
And the FDA is finally saying,remember the NECC, we aren't
(06:04):
letting that happen again.
This is the part of the podcastwhere I tell you to put on your
science hats.
When you see a telehealth ad forcompounded semaglutide, you
always use words like safe andFDA approved.
As a pharmacist and a lawyer, Ineed you to know that these
words are being used as a legalshield.
Quite bluntly, in many cases,they're a lie.
And they have been called out.
The FDA has cited them becausethey do not represent a
(06:27):
scientific reality.
In the world of the FDA, thereare three distinct pillars of a
drug.
There's efficacy, there'ssafety, and there's
adulteration.
There's also misbranding.
We aren't going to talk about itright now.
Let's talk about efficacy.
Speaking of a drug like RegoviaProof, Novanordis has to spend
billions of dollars on efficacystudies.
They had to prove to the FDAthat this specific molecule in
(06:50):
this specific concentration,manufactured in a specific way,
delivered in this specific way,actually makes people lose
weight or addresses diabetesover five years.
But safety is a little bit morecomplicated.
Lawyers for compounders and thecompounders themselves are
saying, we've done the testing,we can show that our product is
(07:11):
made in a clean environment,therefore it's safe.
That's a fundamentalmisunderstanding of how the word
safety is used under the FederalFood, Drugs, and Cosmetics Act.
Specifically, safety is definedfor the product.
You need to show that a productmade in a specific concentration
in a specific way delivers thespecific format.
That if there's harm, that levelof harm is acceptable.
(07:34):
In this specific scenario for aspecific disease state, we don't
actually know the answer.
We might know that the facilityin which it comes from is clean
and makes the product in anacceptable way, but we don't
know enough about the productitself.
That product has not beenevaluated.
And that's the differencebetween, say, RC colo and coke.
(07:55):
They may both have similaringredients, but they're not the
same.
And when there's a drugshortage, that may be good
enough, but when there isn't,there's a vast difference
between the two.
Compounders have zero safety andefficacy studies.
They're just assuming thatbecause the product is similar
enough to Novo's product, itwill work the same way.
In the eyes of the law, thatproduct is an unapproved drug.
(08:19):
So what about adulteration?
This is what compounders focuson.
They'll show you a piece ofpaper, this fancy piece of paper
with a big title on it calledcertificate of analysis.
It shows that the rawingredients are not adulterated.
It means that there's no lead,there's no mold, there's no
poison, it's not a safety issue.
That's the assertion thatthey're gonna make.
They're going to say it's theexact same ingredient as the
(08:40):
original approved drug.
They might say it's FDAapproved, but that's not true.
It's not going to be theoriginal approved drug because
that would be a patentviolation.
And there's no evidence thatthis similar product is good
enough or that the differencesare meaningless.
And without that evidence, thecompounded drug is effectively
snake oil being made in a cleanenvironment.
(09:02):
Essentially, compounders aremixing two concepts.
They want you to believe thatbecause the product is not
adulterated, it is thereforesafe and effective.
And those two things arecompletely different.
It's a massive leap that the lawsimply does not support.
So, how did we get to a pointwhere everyone is buying these
copycat drugs?
For that, we have to blame orthank COVID.
(09:25):
Before 2020, telemedicine was aniche service.
But during the pandemic, with noway to access medications of
physicians, the governmentloosened the rules.
Doctors could prescribe almostanything over video call.
When the weight loss craze hit,companies like Him's and Hers,
Roe, and Noom realized that theyhad a built-in delivery system.
They paired a five-minute onlineconsultation with a compounding
(09:48):
partner.
Let's be honest, it was abrilliant business move.
They didn't have to buy theexpensive brand name drug.
They could mark up the cheapcompounded version by 500% if
they wanted to.
And they could hide behind theFDA shortage list as their legal
justification.
And for a while they were thedarlings of Wall Street.
They were disrupting healthcare.
But disruption in tech is fine.
Disruption in the Food, Drugsand Cosmetics Act may be a
(10:10):
felony.
Nova Nordis sued multiple times,but they lost.
They were told by the judge orby the court that the Food Drugs
and Cosmetics Act allowscompounding pharmacies to make
these drugs, and to the extentthey don't, only the FDA can
enforce the FDNC Act.
And since Novo Nordis is not theFDA, they don't have the right
to enforce.
(10:31):
There was no patenting issuebecause they were making copies
that were similar but not thesame.
And then the marketing issues.
And we'll talk about it a littlebit further, but as long as they
were not showing specific harmto Novo Nordis, those claims
were allowed.
The compounders are smart enoughto avoid or at least cloud the
issue.
So let's get to today.
(10:51):
Why did Hymns and Hers, acompany worth billions, suddenly
pull that compounded Wigovi pillafter only four days in the
market?
Hymns and Hers and Roe, inFebruary 2026, it was announced
that they're going to startmaking a compounded pill.
There was no shortage.
They tried to assert that it wasthe personalization for
patients, but there's no patientcare whose pill needs to be
(11:13):
personalized.
Furthermore, is it reallypersonalization if you've got a
literal ton of them sitting inyour pharmacy waiting for the
next patient to come in?
In the past, the DEA has saidthat, you know what, unique
decisions that need to be madefor the patient to decide
whether a medication isappropriate.
If you give the prescriberpre-printed forms, that's not
unique anymore.
In the same way, if you have aliteral pile of medications and
(11:38):
you're just saying use one ofthese, is that really
personalization?
How is this any different?
So what we have now is where theFDA has stopped being polite.
In 2026, the FDA and theDepartment of Health and Human
Services issued a jointstatement.
They said that the compounderswere no longer just filling a
gap.
They were trying to replace theregulated pharmaceutical
(11:58):
industry entirely, and that'snot okay.
The FDA began bringing lawsuitsunder the Food, Drugs and
Cosmetics Act.
They began essentially targetingthe quote unquote essentially a
copy rule.
That rule says that even duringa shortage, a pharmacy cannot
make a drug that is essentiallya copy of a commercially
available product unless there'sa change that produces a
(12:19):
clinical difference for anindividual patient.
Now, compounders start to getcute.
They start adding vitamin andthey said, look, it's not a
copy, it's a customized wellnessblend.
And the FDA's response, nicetry.
Adding a vitamin to a patenteddrug does not make it a new
drug.
It makes it an unapproved,misbranded, and adulterated
(12:41):
version of a patented drug.
We're already seeing versions ofthis with some of the rectile
dysfunction drugs as well, wherethey're combining products that
no one has really asked for andsaying, come buy these.
So the FDA commissioner isreferring these cases to the
Department of Justice forcriminal investigation.
These disruptors are going torealize that the game is over.
(13:01):
This is why Hims and Hers tookthe backseat.
The legal team seems to haverealized that the shortage
shield is gone.
Now, personally, I don't thinkit's over.
I do think there will be otherclaims made, and quite bluntly,
the market is simply too big andtoo profitable to ignore.
Now, while the FD is attackingfrom the regulatory side, Novo
(13:22):
Nordisk, the maker of Ozempikand Wigovi, is attacking on the
civil side.
Since last year, Novo has been ascorched earth campaign.
They aren't just suing formoney, they're suing for
trademark infringement and falseadvertising.
And they've won some and they'velost some, but in this specific
case, it's very clear that Novoowns the molecule.
Novo's also going after thetelehealth platforms themselves.
(13:42):
They're arguing that bymarketing compound or
semaglutide, these companies areconfusing the public into
thinking that they're gettingthe FDA approved one.
In fact, if you look at thewarning letters, you're going to
see that they claim that theproduct is FDA approved when
it's not.
Here's the kicker.
Novo has finally fixed thesupply chain.
They've notified the FDA thatthe shortage is officially over.
(14:05):
The moment that shortage flagdisappeared from the FDA
website, every compounder stillmaking the drug became a
lawbreaker overnight.
And let me be clear, compounderssued.
They said the shortage was notover, and yet the FDA said, no,
no, it's done.
We've covered a lot today.
We went from the tragicmold-filled vials of the NECC to
(14:26):
the boardroom battles of himsand hers and Nova Nordis.
And you may be asking, Darshan,why do I need to know this?
I just want to lose 20 pounds.
You need to know this becauseyour health has been used as a
pawn in a multi-billion dollarlegal chess match.
If you're taking a compoundeddrug, you need to know if that
pharmacy is a 503 or a 503B.
(14:46):
You need to know if they've donestability testings, or if
they're just hoping that thedrug doesn't spoil in your
mailbox.
When you subscribe to DarshanTalks, you get the truth behind
the marketing.
You get healthcare you canunderstand, backed by the
expertise of a pharmacist whoknows the signs and an attorney
who knows the rules.
Don't let your healthcare bedecided by an Instagram ad.
(15:06):
Let's look at the law, thescience, and the reality
together.
So thank you for joining me onthis on this deep dive.
The story is moving fast andliterally by the hour, so by the
time this comes out, it's maybealready out of date.
Hit subscribe, leave a review,and remember in the world of
healthcare, the most powerfulmedicine is knowledge, and
you're allowed to understand it.
I'm Darshan Kulkarney, and thisis Darshan Talks.
Welcome to Darshan Talks.
To learn about healthcare,you're actually allowed to
understand.
I'm your host, DarshanKulcarney.
Today we're tackling the biggestlegal and medical collision of
the decade.
The war over weight lossmedications.
We're going to talk about whythe FDA, the very agency meant
to protect you, sometimes causesthe shortages that put you at
(00:20):
risk.
We're going to talk about thecompounding wild, wild west.
And most importantly, we'regoing to talk about the tragedy
from before 2012 that changedthe law forever.
And why that coast is the reasoncompanies like him and hers are
suddenly running for cover whileNova Nordisk is going onto the
offensive and launching ascorched earth offensive, if you
(00:43):
will.
The fact is that healthcare sitsat the intersection of two of
the most complex languages onearth: biochemistry, federal
law.
My life has been spent living atthat intersection.
I started as a doctor pharmacy,I stood at the counter, I talked
to patients, I wondered how themolecular structure of drugs
would uniquely interact with apatient's personal biology.
(01:06):
And I quickly learned thatchemistry is only half the
answer.
It's the law.
So I went back and amongst a fewother degrees, I also became an
attorney.
I've spent 20 years navigatingthe FDA, the Department of
Health and Human Services, andthe halls of Congress.
When you subscribe to thispodcast, and I hope you do, you
aren't just getting aninfluencer's opinion on the
(01:26):
latest health trend.
You're getting the dual lensview from someone who knows the
signs and the court transcripts.
So if you want to understand whya local compounding pharmacist
is currently in legal panic, wehave to go back to about 2009.
And let's talk about a dirtylittle secret from the industry.
The FDA often causes the veryshortages it's trying to fix.
(01:48):
Now we all want the FDA to bestrict.
We want them to walk into afactory and say, this floor
isn't clean enough.
Shut it down.
But here's the paradox.
When you do this to a majorplant for compliance issue,
maybe it's just a paperworkerror, maybe it's a cooling fan
that isn't up the spec, maybeit's multiple companies.
Either way, you're raisingexpectations, and the shortage
(02:09):
of that drug stops instantly andpossibly forever.
So in 2009, when the FDAunilaterally declared that
they're going to startregulating and insisting that
there's a higher quality thandrug manufacturers of meat,
several drug manufacturers saidthat it was simply not worth it
for them to keep making thedrug.
They had incredibly thinmargins, and these new
(02:31):
requirements would push theminto unprofitability.
So suddenly you had massive drugshortages.
I remember I was working as apharmacist, and we had 200, 300
of them at a time.
Patients who had cancer couldn'tget their medications.
Pharmacies were the savinggrace.
Compounding pharmacies came inand tried to fix that problem.
(02:51):
Before 2012, compoundingpharmacies were largely just the
neighborhood apothecary.
It mixed a little bit of creamfor a rash, liquid version for a
child who couldn't swallow,something for your vets, so that
you can give it to horses or toyour pet.
They were all regulated by thestate boards of pharmacy, but
not the FDA.
With these shortages, theneighborhood apothecaries
(03:13):
suddenly became high-volume drugmanufacturers with none of the
oversight that the FDA provided.
So inevitably, we became due fora tragedy.
That tragedy was the New EnglandCompounding Center with the
NECC.
The NECC wasn't acting like aneighborhood pharmacy.
They were acting like a massivedrug manufacturer, but without
(03:34):
any of the FDA's goodmanufacturing practices
oversight.
They were mass-producing vialsof a drug called
metalprenicillin acetate.
It's used for back pain, butit's also just a simple steroid.
There's nothing exotic about it.
But they wanted to move fast.
Since they had high volumes,they were making loads of money,
they had orders to fill.
And hopefully because they alsowanted to just help patients.
(03:55):
But they skipped things thatwere essential, like sterility
testing.
Let me be clear, sterilitytesting possibly wasn't even
required at this point.
We just didn't have the rules atthat point.
But it should have beenexpected.
And if you're a pharmacistmaking that high volume of
drugs, we should have known.
And the result was horrific.
The vials were contaminated withblack mold.
Doctors across the countryinjected that mold directly into
(04:18):
the spines of the patients, andit caused a fungal meningitis
outbreak that killed 64 peopleand sickened nearly 800 more.
I remember where I was when thenews broke.
Every pharmacist in the countryfelt a pit in their stomach.
We knew that the world was aboutto change, and we knew that
certain pharmacists, the onesfrom NECC, they were looking at
(04:38):
jail time and they did go tojail.
In response, Congress passed theDrug Quality and Safety Act, the
DQSA of 2013.
This law created a great wall.
It created two new classes ofpharmacies, the 503A and the
503B.
503A are your traditionalpharmacies.
You can only make a drug if theyhave a specific prescription for
(05:00):
a specific patient.
There has to be customization.
And we're going to talk aboutthis because that's where we are
right now.
Then there are 503Bs.
These are the outsourcingfacilities.
They can mass produce.
You have to follow much stricterFDA rules like a mini Pfizer,
and you can only compound what'son the FDA shortage list.
But when the drug hits the FDAshortage list, it triggers a
(05:21):
legal loophole of the Food,Drugs, and Cosmetics Act.
The law says if the big guyscan't make it, we will let the
compounders step in so thatpatients don't die or suffer.
This was the golden age forcompounders, and went on until
possibly right about now.
This is when compounders werelegally allowed to copy the most
profitable drugs in the worldbecause the FDA's own oversight
(05:44):
had contributed to the shortage.
What if that golden age has justended and why does it matter
today?
Well, it matters because for thelast two years, these
compounders have been trying toblur the lines between the two
sections that sell you theseweight loss drugs.
And the FDA is finally saying,remember the NECC, we aren't
(06:04):
letting that happen again.
This is the part of the podcastwhere I tell you to put on your
science hats.
When you see a telehealth ad forcompounded semaglutide, you
always use words like safe andFDA approved.
As a pharmacist and a lawyer, Ineed you to know that these
words are being used as a legalshield.
Quite bluntly, in many cases,they're a lie.
And they have been called out.
The FDA has cited them becausethey do not represent a
(06:27):
scientific reality.
In the world of the FDA, thereare three distinct pillars of a
drug.
There's efficacy, there'ssafety, and there's
adulteration.
There's also misbranding.
We aren't going to talk about itright now.
Let's talk about efficacy.
Speaking of a drug like RegoviaProof, Novanordis has to spend
billions of dollars on efficacystudies.
They had to prove to the FDAthat this specific molecule in
(06:50):
this specific concentration,manufactured in a specific way,
delivered in this specific way,actually makes people lose
weight or addresses diabetesover five years.
But safety is a little bit morecomplicated.
Lawyers for compounders and thecompounders themselves are
saying, we've done the testing,we can show that our product is
(07:11):
made in a clean environment,therefore it's safe.
That's a fundamentalmisunderstanding of how the word
safety is used under the FederalFood, Drugs, and Cosmetics Act.
Specifically, safety is definedfor the product.
You need to show that a productmade in a specific concentration
in a specific way delivers thespecific format.
That if there's harm, that levelof harm is acceptable.
(07:34):
In this specific scenario for aspecific disease state, we don't
actually know the answer.
We might know that the facilityin which it comes from is clean
and makes the product in anacceptable way, but we don't
know enough about the productitself.
That product has not beenevaluated.
And that's the differencebetween, say, RC colo and coke.
(07:55):
They may both have similaringredients, but they're not the
same.
And when there's a drugshortage, that may be good
enough, but when there isn't,there's a vast difference
between the two.
Compounders have zero safety andefficacy studies.
They're just assuming thatbecause the product is similar
enough to Novo's product, itwill work the same way.
In the eyes of the law, thatproduct is an unapproved drug.
(08:19):
So what about adulteration?
This is what compounders focuson.
They'll show you a piece ofpaper, this fancy piece of paper
with a big title on it calledcertificate of analysis.
It shows that the rawingredients are not adulterated.
It means that there's no lead,there's no mold, there's no
poison, it's not a safety issue.
That's the assertion thatthey're gonna make.
They're going to say it's theexact same ingredient as the
(08:40):
original approved drug.
They might say it's FDAapproved, but that's not true.
It's not going to be theoriginal approved drug because
that would be a patentviolation.
And there's no evidence thatthis similar product is good
enough or that the differencesare meaningless.
And without that evidence, thecompounded drug is effectively
snake oil being made in a cleanenvironment.
(09:02):
Essentially, compounders aremixing two concepts.
They want you to believe thatbecause the product is not
adulterated, it is thereforesafe and effective.
And those two things arecompletely different.
It's a massive leap that the lawsimply does not support.
So, how did we get to a pointwhere everyone is buying these
copycat drugs?
For that, we have to blame orthank COVID.
(09:25):
Before 2020, telemedicine was aniche service.
But during the pandemic, with noway to access medications of
physicians, the governmentloosened the rules.
Doctors could prescribe almostanything over video call.
When the weight loss craze hit,companies like Him's and Hers,
Roe, and Noom realized that theyhad a built-in delivery system.
They paired a five-minute onlineconsultation with a compounding
(09:48):
partner.
Let's be honest, it was abrilliant business move.
They didn't have to buy theexpensive brand name drug.
They could mark up the cheapcompounded version by 500% if
they wanted to.
And they could hide behind theFDA shortage list as their legal
justification.
And for a while they were thedarlings of Wall Street.
They were disrupting healthcare.
But disruption in tech is fine.
Disruption in the Food, Drugsand Cosmetics Act may be a
(10:10):
felony.
Nova Nordis sued multiple times,but they lost.
They were told by the judge orby the court that the Food Drugs
and Cosmetics Act allowscompounding pharmacies to make
these drugs, and to the extentthey don't, only the FDA can
enforce the FDNC Act.
And since Novo Nordis is not theFDA, they don't have the right
to enforce.
(10:31):
There was no patenting issuebecause they were making copies
that were similar but not thesame.
And then the marketing issues.
And we'll talk about it a littlebit further, but as long as they
were not showing specific harmto Novo Nordis, those claims
were allowed.
The compounders are smart enoughto avoid or at least cloud the
issue.
So let's get to today.
(10:51):
Why did Hymns and Hers, acompany worth billions, suddenly
pull that compounded Wigovi pillafter only four days in the
market?
Hymns and Hers and Roe, inFebruary 2026, it was announced
that they're going to startmaking a compounded pill.
There was no shortage.
They tried to assert that it wasthe personalization for
patients, but there's no patientcare whose pill needs to be
(11:13):
personalized.
Furthermore, is it reallypersonalization if you've got a
literal ton of them sitting inyour pharmacy waiting for the
next patient to come in?
In the past, the DEA has saidthat, you know what, unique
decisions that need to be madefor the patient to decide
whether a medication isappropriate.
If you give the prescriberpre-printed forms, that's not
unique anymore.
In the same way, if you have aliteral pile of medications and
(11:38):
you're just saying use one ofthese, is that really
personalization?
How is this any different?
So what we have now is where theFDA has stopped being polite.
In 2026, the FDA and theDepartment of Health and Human
Services issued a jointstatement.
They said that the compounderswere no longer just filling a
gap.
They were trying to replace theregulated pharmaceutical
(11:58):
industry entirely, and that'snot okay.
The FDA began bringing lawsuitsunder the Food, Drugs and
Cosmetics Act.
They began essentially targetingthe quote unquote essentially a
copy rule.
That rule says that even duringa shortage, a pharmacy cannot
make a drug that is essentiallya copy of a commercially
available product unless there'sa change that produces a
(12:19):
clinical difference for anindividual patient.
Now, compounders start to getcute.
They start adding vitamin andthey said, look, it's not a
copy, it's a customized wellnessblend.
And the FDA's response, nicetry.
Adding a vitamin to a patenteddrug does not make it a new
drug.
It makes it an unapproved,misbranded, and adulterated
(12:41):
version of a patented drug.
We're already seeing versions ofthis with some of the rectile
dysfunction drugs as well, wherethey're combining products that
no one has really asked for andsaying, come buy these.
So the FDA commissioner isreferring these cases to the
Department of Justice forcriminal investigation.
These disruptors are going torealize that the game is over.
(13:01):
This is why Hims and Hers tookthe backseat.
The legal team seems to haverealized that the shortage
shield is gone.
Now, personally, I don't thinkit's over.
I do think there will be otherclaims made, and quite bluntly,
the market is simply too big andtoo profitable to ignore.
Now, while the FD is attackingfrom the regulatory side, Novo
(13:22):
Nordisk, the maker of Ozempikand Wigovi, is attacking on the
civil side.
Since last year, Novo has been ascorched earth campaign.
They aren't just suing formoney, they're suing for
trademark infringement and falseadvertising.
And they've won some and they'velost some, but in this specific
case, it's very clear that Novoowns the molecule.
Novo's also going after thetelehealth platforms themselves.
(13:42):
They're arguing that bymarketing compound or
semaglutide, these companies areconfusing the public into
thinking that they're gettingthe FDA approved one.
In fact, if you look at thewarning letters, you're going to
see that they claim that theproduct is FDA approved when
it's not.
Here's the kicker.
Novo has finally fixed thesupply chain.
They've notified the FDA thatthe shortage is officially over.
(14:05):
The moment that shortage flagdisappeared from the FDA
website, every compounder stillmaking the drug became a
lawbreaker overnight.
And let me be clear, compounderssued.
They said the shortage was notover, and yet the FDA said, no,
no, it's done.
We've covered a lot today.
We went from the tragicmold-filled vials of the NECC to
(14:26):
the boardroom battles of himsand hers and Nova Nordis.
And you may be asking, Darshan,why do I need to know this?
I just want to lose 20 pounds.
You need to know this becauseyour health has been used as a
pawn in a multi-billion dollarlegal chess match.
If you're taking a compoundeddrug, you need to know if that
pharmacy is a 503 or a 503B.
(14:46):
You need to know if they've donestability testings, or if
they're just hoping that thedrug doesn't spoil in your
mailbox.
When you subscribe to DarshanTalks, you get the truth behind
the marketing.
You get healthcare you canunderstand, backed by the
expertise of a pharmacist whoknows the signs and an attorney
who knows the rules.
Don't let your healthcare bedecided by an Instagram ad.
(15:06):
Let's look at the law, thescience, and the reality
together.
So thank you for joining me onthis on this deep dive.
The story is moving fast andliterally by the hour, so by the
time this comes out, it's maybealready out of date.
Hit subscribe, leave a review,and remember in the world of
healthcare, the most powerfulmedicine is knowledge, and
you're allowed to understand it.
I'm Darshan Kulkarney, and thisis Darshan Talks.
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