September 10, 2025 • 15 mins
A seismic shift is underway in pharmaceutical marketing regulation. Yesterday, the FDA fired a warning shot heard across the industry, announcing a massive crackdown on what they're calling misleading pharmaceutical advertising. With over 3,500 letters sent to manufacturers, this unprecedented enforcement action targets violations across all channels—traditional media, digital platforms, and especially social media influencer marketing.
For decades, we've watched regulatory oversight steadily decline. The numbers tell the story: from 120 warning letters in 2002 to just one in 2023. This created a perfect storm when combined with the rise of social media as patients' default health information source. A recent study found 88% of pharma-related social posts fail to meet fair balance standards—emphasizing benefits while minimizing risks. Even more concerning, algorithms amplify this imbalance by favoring positive content that drives engagement.
The implications reach across pharmaceutical organizations. While most brand teams already maintain strict compliance processes for official communications, the challenge lies in controlling third-party messaging, particularly from influencers who may genuinely love a product but fail to mention side effects or proper usage guidelines. For digital innovators, patient support teams, IT security experts, procurement officers, and executives, this enforcement wave demands immediate attention—not just to avoid penalties, but to restore and maintain public trust.
This moment presents an opportunity to reimagine pharmaceutical marketing through a lens of transparency. What if companies redirected even a fraction of their advertising budgets (reportedly up to 25% of total operating expenses) toward digital therapeutics, financial support solutions, and evidence-based patient education? The path forward requires greater transparency in partnerships, improved risk-benefit balance in all media, and an industry-wide recommitment to both the letter and spirit of FDA guidelines.
Subscribe to Postscripts for more insights at the intersection of pharma, technology, and patient impact as we continue exploring what happens after that first prescription is written.
PostScripts Rx is not intended to constitute medical advice, nor is it intended to influence prescribing decisions or any other medical or clinical decision-making. All medical and clinical judgment and decision-making, prescribing decisions, and all related considerations remain exclusively the responsibility of providers and patients.
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Speaker 1 (00:01):
Welcome to Postscripts, the podcast
exploring what happens afterthat first prescription.
We cover the latest news andinnovations in patient access,
support, digital tools, hcpengagement and pharma marketing
that we all hope drive betteroutcomes for patients.
This podcast is forinformational purposes only and
does not constitute any medicaladvice, nor should it influence
any clinical decision making.
(00:21):
Patients should always consulttheir healthcare professionals.
Welcome to the podcast.
My name is Brian Carr.
I'm from the Medisave team,although any opinions expressed
here are my own and not those ofMedisave or its partners.
Hey, what's happened?
Here is a warning letter that'sbeing heard around the industry
today.
Over the past few decades, thelines between drug promotion,
education and influence havegrown increasingly blurred.
(00:42):
But today one of the mosturgent conversations is now
happening within the lifesciences industry centers in the
US around the FDA's recentcrackdown, announced yesterday,
on what they're callingmisleading pharmaceutical
advertising, both direct toconsumer and through emerging
digital channels, especiallysocial, and more on that in a
bit.
So for many years, the volumeof regulatory enforcement on
(01:04):
advertising practices by pharmacompanies has declined
dramatically, and I have thestats on that in a minute.
But in an unprecedented move,the FDA has announced a renewed
commitment to monitoring andpolicing pharmaceutical
promotions with the launch of amajor campaign involving
thousands of warning and letterssent to pharmaceutical
companies.
Commissioner of the FDAactually summed up the broader
(01:27):
concern in a statement saying,quote for far too long the FDA
has permitted misleading drugadvertisements, distorting the
doctor-patient relationship andcreating increased demand for
medications regardless ofclinical appropriateness.
Drug companies spend up to 25%of their budget on advertising.
Still quoting here, thosebillions of dollars would be
(01:47):
better spent on lowering drugprices for everyday Americans.
End quote.
So today, on PostScripts, we'reunpacking the scope and
implications of this crackdown,particularly for brand marketers
, innovation teams andcompliance leaders, patient
access support teams, hcps, evenIT and cybersecurity experts
and particularly procurementofficers and, of course, c-suite
(02:08):
overall in the industry.
So what's the scope of thecrackdown?
Well, the FDA announced asweeping new enforcement
initiative targeting deceptive,misleading or unbalanced, what
they call pharmaceuticaladvertising.
More than 3,500 letters,reportedly, were sent to
manufacturers that the agencyhas identified as being in
violation of fair balancingadvertising guidelines.
The letters were both formal,untitled notices generally and
(02:31):
then enforcement-packed warningletters pointing to violations,
they say, across multipleplatforms TV and radio
commercials.
Print advertisements inprofessional journals and
magazines.
Sponsored web content display.
Ads in professional journalsand magazines, sponsored web
content, display ads andparticularly paid social
promotion and influencermarketing content.
So, according to the FDA'srelease communication guidance,
(02:55):
the increase in violation reallydoes stem from a spike in
pharma advertising activity thatprioritizes promotion over
education or balancedinformation.
So let's just take a clear lookat what constitutes, in the
FDA's mind, a misleadingadvertising.
Under federal law, all drugadvertising must comply with the
following truth and advertisingprinciples One, present a fair
balance of risks and benefits.
Two, provide adequatedirections for use.
(03:17):
Three, avoid overstating thedrug's efficacy or scale of
benefit.
Four, disclose major sideeffects and any
contraindications.
Five, clearly communicate theapproved indications and usage.
And six, declare any financialties in third-party endorsements
or influencer promotions.
And that's key.
So, as the FDA and independentwatchdogs have found, a 2024
(03:40):
study in the Journal ofPharmaceutical Health Services
Research analyzed over athousand pharma-related social
media posts and they found 100%of the posts emphasized the drug
benefits, only 33% mentionedpotential harms or risks.
88% of them failed to meet FDAfair balance standards,
according to the study.
(04:01):
So the challenge there isunmasking that digital area of
influence right.
So one of the greatestchallenges to the truth in
advertising in 2024 and 2025 isthis rise of social media as
this default health informationsource.
Patients, increasingly, areturning to platforms like
Instagram, tiktok, youtube,reddit, facebook, not only for
community but for treatmentrecommendations, real patient
(04:22):
experiences and diseaseeducation.
Unfortunately, many of thespaces are also becoming prime
locales for unbalanced drugpromotion disguised as organic
or user-generated content frominfluencers.
Right so the use of influencerssometimes they're paid,
sometimes incentivized versionsof patients really has made it
incredibly difficult todistinguish some editorial
(04:43):
testimony from strategicmessages.
And here's the challenge Severalproblems can arise.
So there could be a lack ofclear disclosure of financial
relationships betweeninfluencers and their pharma
companies, unless it'sexplicitly mentioned.
Right, there may be personalanecdotes that may often
misrepresent the overallclinical evidence or approved
indications.
Right so when influencers arejust talking about how this
(05:04):
medication affected them may bevery compelling and true and
factual, but that does notnecessarily mean it's for the
entire population.
Right.
Posts by themselves are goingto selectively highlight
treatment successes whileignoring the risks or
eligibility criteria.
So you can imagine just, even ifthe most balanced two pieces of
social media content arereleased by an agency or a
pharma company, meaning whetherit's successes, both are
(05:27):
balanced, showing successes, andone else is also showing
successes and risk.
You know risk.
Both are the same, but thealgorithm.
May they step in and say, well,this ad talked about successes
a little bit more or moreprominently, or at the first
half of it.
Therefore it's getting moreengagement.
Therefore it's going to getshown more than one that may
have bounced it out but maybestarted showing risks first, or
et cetera, et cetera.
So you've got this not only athird-party vendor or influencer
(05:51):
influencing the content, butalso the fourth party we could
even say algorithm stepping inand saying, well, I'm going to
show this one more than theother one because it's just
getting more engagement.
Right, because it's morepositive and showing successes.
Right.
So that blurring of boundarieshas real-world impacts.
As social media increasinglydrives this public understanding
of treatment options, it'sreally imperative that the
pharma industry rises to theoccasion, builds greater
(06:12):
transparency, balance andcompliance into all digital
outreach.
So think of the advertisingbudget as an arms race.
That's happening, right.
So pharma companies are amongthe biggest spenders in the
United States in advertising.
Typically, they'll spend morethan $8 billion.
I've seen higher estimates, too, on direct-to-consumer
marketing in the United Statesalone.
Right, that actually comes fromKantar Research.
(06:32):
The figure amounts atapproximately 20 to 25 percent
of some companies' totaloperating budget, right, so
compare that to investments inpatient affordability and
adherence solutions,evidence-based patient education
campaigns.
That imbalance does becomeglaring in some cases, right.
So as the FDA had said, quotethese billions of dollars would
be better spent, in his mind, onlowering drug prices for
(06:54):
everyday Americans.
Right End, quote.
So later, on top of that, thatrecent history of declining
regulatory oversight.
So you have these perfectconditions for a boundary
pushing marketing strategiesthat some might consider
predatory some.
And how do we get here?
Well, let's look at a timelineof that advertising oversight,
and I promised you this.
So the FDA has a long-standingmechanism for enforcing drug
(07:14):
advertising standards, and fromthe 1990s through the early
2000s, the agency regularlyissued 100-plus more warning
letters per year, at least twoper week, to what they thought
were misleading drug advertising.
And this is all in their annualreports, right?
But in recent years theenforcement actions have seen a
decline.
So in 2002, again 120 warningissues a letter.
(07:35):
That's more than two a week.
In 2010, just eight years later, only 52 letters issued,
averaging one a week.
Right, so it's cut 50%.
2022, they go from 52 lettersin 2010 to a decade later.
In 2022, only four letters wereissued.
2023, one letter is issuedright 2024, no letters were
issued.
This is all from the FDAenforcement annual reports.
(07:57):
Now you could say that's becausethe compliance has stuck.
The pharma companies areadhering even more and they're
getting it right and they knowexactly what it takes and how to
get through, and that islargely the case that I've seen,
especially working with brandteams or brand marketers,
procurement teams across theboard.
There are strict compliance andadherence rules for here's what
the messaging has to be passes,medical, legal, regulatory
(08:18):
review all the way across theboard.
The challenge may be in some ofthe social media influencers
campaigns that frankly, they maybe given here's a product,
here's how to talk about it,here's what you can't say but
then they riff for five minutesabout a product or a solution
and how great it is for them,and it may be completely honest.
The challenge is it may beemphasizing the successes over
anything.
The person may not have had anyside effects.
(08:38):
Therefore, they don't getmentioned, right.
So this decline in lettersgoing out really does allow for
more creative interpretations ofadvertising rules, particularly
on some of the newer platformsand those technologies,
especially when the regulationsweren't even originally written
to govern them in the 90s right,such as the TikTok videos and
(08:59):
even hashtags, ephemeral content, ai-generated patient
testimonials right, those arecoming.
So there's legal and ethicalimplications for pharma teams.
Obviously, this new wave ofenforcement it's not just a
warning shot.
It has deep ramifications forevery department.
Consider this right.
Brand marketers must evendoubly ensure all their
promotional materials meet fairbalance guidelines, and I will
tell you they do.
On every brand that we'veimplemented and talked through
(09:20):
through the years, there aremajor reviews, legal regulatory
compliance for anything officialcoming out of the brand teams,
no question about it.
So I think you'll see thosestandards, you know.
I'd like to say not even beimpacted, because they're
already meeting those standardsand every indication I've ever
seen, right.
But patient support teams needto provide educational outreach
that helps patients understandrisks, eligibility, treatment
(09:40):
expectations.
We may need to train patientsthat say, listen, if you're not
seeing the mention of any how itis used, any mention of side
effects or anything like that inwhatever media you're consuming
, we may need to educate them.
That may not be approved by theFDA, right?
Or there may be medicationsthat, frankly, are over the
counters, supplements that don'tneed to go to the FDA and it
just says FDA has not approvedthese statements.
We've seen that little fineprint, right?
(10:02):
So it may need patient supportteams to really educate.
Hey, I've heard about this newmedication.
Well, was it FDA approved?
Are you seeing any indicationsof side effects being mentioned
or indications on what it's goodused for, et cetera, et cetera,
right?
Digital innovation leadersyou're going to have to be able
to evaluate any influence ofprograms you have in digital
campaigns for alignment withthose disclosure rules.
Again, I think the digitalcampaigns that I've all seen
(10:24):
very strict compliance withbrand innovation, brand teams,
innovation teams, legal teamsacross the board.
I think it's in environmentswhere the full control may not
always be there, just becausesomeone's taken it and gone on
their own in maybe agood-natured way.
They're not trying to violateany rules, but they're talking
about positives withoutmentioning, maybe, any of the
side effects, right?
(10:47):
So think of it that way.
It and security teams need toreview all those systems that
automate communications andensure compliance in real-time
personalization tools, targetedads that's true.
Procurement offices you'regoing to need to assess your
vendor partners, agencies,influencer platforms for
regulatory reliability.
Frankly, I can see procurementand legal teams just telling
marketing teams no moreinfluencers.
I can just see it happening.
Right.
Pharmacy suite carry executiveresponsibility, of course, for
(11:08):
the ethical commercial practicesand long-term reputational risk
they do already anyway, right.
So there will be a lot of trustthrough transparency.
There's opportunity here, right?
So when you're standing at acrossroads and drug
advertisements can really raisecondition awareness in a
positive way and supportdiscovery of life's changing
treatments, the ultimate missionmust always stay
patient-centered, which itlargely is, but restoring and
(11:29):
keeping that public trust and,frankly, market share is going
to require embracing thosefollowing shifts greater
transparency in the influencerpartnerships, if you're still
using them, and sponsoredcontent.
Improved risk-benefit balancein all media, especially social.
More education, fewerexaggerations, if there are any.
Industry-wide recommitment tothe spirit, not just a letter of
(11:49):
FDA guidelines.
Industry self-regulation, whendone comprehensively,
proactively, is one of the mostpowerful tools in preventing
future scrutiny and legalexposure.
So what's going to happen next?
Well, according to the FDA,there's a wave of initial
enforcement just at thebeginning.
Ongoing digital surveillancetools are being developed to
track violations in real time.
Companies found in repeatednoncompliance may face fines,
(12:10):
forced retractions, productreviews or even litigation.
What's also interesting to note,though, is in the US
administration's message.
This summer, you may recallthey sent out most favorite
nation message demands.
Remember there were letterswritten to 17 pharma companies
about how US prices for patients, particularly those in Medicare
, need to be no higher thanthose used at other developed
(12:32):
countries.
In that executive order was athird or fourth bullet point
which said by the way,direct-to-consumer medication
programs in the US can begreatly enhanced and negate the
rules for most favored nationpricing if it's going
direct-to-consumer.
So there would be someinfluence where the
administration would allow moredirect-to-consumer flexibility
(12:54):
on pricing if it's goingdirect-to-patients, right.
So they opened up sort of thatD2C market there, right from one
end of it as well.
So here we have more guidancethat well, even if you're going
D2C, you really have to trainyour teams, vet your conduct,
clarify your policies,especially if you're using any
influencers in emerging digitalformats, so you don't appear on
(13:14):
the FDA's radar for anyviolations or warnings or
anything like that which,frankly, could even come from
your competitors, as we all know, right.
Well, they're looking at whatyou're putting out there and if
they see someone step over theline it's not unheard of that
you may get reported in the FDAby some competitors.
So in today's digitallytransformed landscape, the world
sees and shares faster thanever before.
The regulatory lag, though, iscatching up.
(13:37):
Right, so they mentioned theuse of AI tools, for example in
the FDA, to really catch thingsmore in real time.
Right, so that industry'sresponse can't afford just to be
reactive.
There is a time here to beproactive and really reassess
and make sure everything is incompliance.
Right, so you know, we didbegin this conversation today
with a quote from the FDA quotedrug companies spend up to 25%
of their budget on advertising,end quote.
(13:58):
Well, what if it would mean youtake a fraction of that and
puts it towards digitaltherapeutics, financial support
solution, evidence-based patienteducation, after the script is
written, that then informs,obviously, reimbursement rates
and federal programs about theefficacy of medication claims?
Right, and as healthcaremarketers, brand leaders,
digital innovators, accesschampions, we all have the
(14:20):
opportunity and theresponsibility to shape a more
transparent and equitabletreatment landscape.
Let's have this wave of FDAenforcement be a catalyst, not
only to make sure all ourcompliances are elevated, but
the connection with patients andproviders really is rooted in
trust, accuracy and value.
I'll list the sources to allthis information in the show
notes.
Again, if you're into marketing, innovation, it, access,
(14:42):
procurement, leadership roles,it really is that moment to
re-examine the messages put intothe world.
Patients consuming them arereally listening more closely
than ever before in channelsthat maybe we haven't thought of
as deeply as you have in thepast with print materials.
So thank you for joining us onPostscripts.
If you found this conversationvaluable, please follow and
subscribe for more insights aswe talk about that intersection
(15:05):
of pharma tech and patientimpact.
Until next time, keep lookingforward.
The real work begins after thatscript is written.
Welcome to Postscripts, the podcast
exploring what happens afterthat first prescription.
We cover the latest news andinnovations in patient access,
support, digital tools, hcpengagement and pharma marketing
that we all hope drive betteroutcomes for patients.
This podcast is forinformational purposes only and
does not constitute any medicaladvice, nor should it influence
any clinical decision making.
(00:21):
Patients should always consulttheir healthcare professionals.
Welcome to the podcast.
My name is Brian Carr.
I'm from the Medisave team,although any opinions expressed
here are my own and not those ofMedisave or its partners.
Hey, what's happened?
Here is a warning letter that'sbeing heard around the industry
today.
Over the past few decades, thelines between drug promotion,
education and influence havegrown increasingly blurred.
(00:42):
But today one of the mosturgent conversations is now
happening within the lifesciences industry centers in the
US around the FDA's recentcrackdown, announced yesterday,
on what they're callingmisleading pharmaceutical
advertising, both direct toconsumer and through emerging
digital channels, especiallysocial, and more on that in a
bit.
So for many years, the volumeof regulatory enforcement on
(01:04):
advertising practices by pharmacompanies has declined
dramatically, and I have thestats on that in a minute.
But in an unprecedented move,the FDA has announced a renewed
commitment to monitoring andpolicing pharmaceutical
promotions with the launch of amajor campaign involving
thousands of warning and letterssent to pharmaceutical
companies.
Commissioner of the FDAactually summed up the broader
(01:27):
concern in a statement saying,quote for far too long the FDA
has permitted misleading drugadvertisements, distorting the
doctor-patient relationship andcreating increased demand for
medications regardless ofclinical appropriateness.
Drug companies spend up to 25%of their budget on advertising.
Still quoting here, thosebillions of dollars would be
(01:47):
better spent on lowering drugprices for everyday Americans.
End quote.
So today, on PostScripts, we'reunpacking the scope and
implications of this crackdown,particularly for brand marketers
, innovation teams andcompliance leaders, patient
access support teams, hcps, evenIT and cybersecurity experts
and particularly procurementofficers and, of course, c-suite
(02:08):
overall in the industry.
So what's the scope of thecrackdown?
Well, the FDA announced asweeping new enforcement
initiative targeting deceptive,misleading or unbalanced, what
they call pharmaceuticaladvertising.
More than 3,500 letters,reportedly, were sent to
manufacturers that the agencyhas identified as being in
violation of fair balancingadvertising guidelines.
The letters were both formal,untitled notices generally and
(02:31):
then enforcement-packed warningletters pointing to violations,
they say, across multipleplatforms TV and radio
commercials.
Print advertisements inprofessional journals and
magazines.
Sponsored web content display.
Ads in professional journalsand magazines, sponsored web
content, display ads andparticularly paid social
promotion and influencermarketing content.
So, according to the FDA'srelease communication guidance,
(02:55):
the increase in violation reallydoes stem from a spike in
pharma advertising activity thatprioritizes promotion over
education or balancedinformation.
So let's just take a clear lookat what constitutes, in the
FDA's mind, a misleadingadvertising.
Under federal law, all drugadvertising must comply with the
following truth and advertisingprinciples One, present a fair
balance of risks and benefits.
Two, provide adequatedirections for use.
(03:17):
Three, avoid overstating thedrug's efficacy or scale of
benefit.
Four, disclose major sideeffects and any
contraindications.
Five, clearly communicate theapproved indications and usage.
And six, declare any financialties in third-party endorsements
or influencer promotions.
And that's key.
So, as the FDA and independentwatchdogs have found, a 2024
(03:40):
study in the Journal ofPharmaceutical Health Services
Research analyzed over athousand pharma-related social
media posts and they found 100%of the posts emphasized the drug
benefits, only 33% mentionedpotential harms or risks.
88% of them failed to meet FDAfair balance standards,
according to the study.
(04:01):
So the challenge there isunmasking that digital area of
influence right.
So one of the greatestchallenges to the truth in
advertising in 2024 and 2025 isthis rise of social media as
this default health informationsource.
Patients, increasingly, areturning to platforms like
Instagram, tiktok, youtube,reddit, facebook, not only for
community but for treatmentrecommendations, real patient
(04:22):
experiences and diseaseeducation.
Unfortunately, many of thespaces are also becoming prime
locales for unbalanced drugpromotion disguised as organic
or user-generated content frominfluencers.
Right so the use of influencerssometimes they're paid,
sometimes incentivized versionsof patients really has made it
incredibly difficult todistinguish some editorial
(04:43):
testimony from strategicmessages.
And here's the challenge Severalproblems can arise.
So there could be a lack ofclear disclosure of financial
relationships betweeninfluencers and their pharma
companies, unless it'sexplicitly mentioned.
Right, there may be personalanecdotes that may often
misrepresent the overallclinical evidence or approved
indications.
Right so when influencers arejust talking about how this
(05:04):
medication affected them may bevery compelling and true and
factual, but that does notnecessarily mean it's for the
entire population.
Right.
Posts by themselves are goingto selectively highlight
treatment successes whileignoring the risks or
eligibility criteria.
So you can imagine just, even ifthe most balanced two pieces of
social media content arereleased by an agency or a
pharma company, meaning whetherit's successes, both are
(05:27):
balanced, showing successes, andone else is also showing
successes and risk.
You know risk.
Both are the same, but thealgorithm.
May they step in and say, well,this ad talked about successes
a little bit more or moreprominently, or at the first
half of it.
Therefore it's getting moreengagement.
Therefore it's going to getshown more than one that may
have bounced it out but maybestarted showing risks first, or
et cetera, et cetera.
So you've got this not only athird-party vendor or influencer
(05:51):
influencing the content, butalso the fourth party we could
even say algorithm stepping inand saying, well, I'm going to
show this one more than theother one because it's just
getting more engagement.
Right, because it's morepositive and showing successes.
Right.
So that blurring of boundarieshas real-world impacts.
As social media increasinglydrives this public understanding
of treatment options, it'sreally imperative that the
pharma industry rises to theoccasion, builds greater
(06:12):
transparency, balance andcompliance into all digital
outreach.
So think of the advertisingbudget as an arms race.
That's happening, right.
So pharma companies are amongthe biggest spenders in the
United States in advertising.
Typically, they'll spend morethan $8 billion.
I've seen higher estimates, too, on direct-to-consumer
marketing in the United Statesalone.
Right, that actually comes fromKantar Research.
(06:32):
The figure amounts atapproximately 20 to 25 percent
of some companies' totaloperating budget, right, so
compare that to investments inpatient affordability and
adherence solutions,evidence-based patient education
campaigns.
That imbalance does becomeglaring in some cases, right.
So as the FDA had said, quotethese billions of dollars would
be better spent, in his mind, onlowering drug prices for
(06:54):
everyday Americans.
Right End, quote.
So later, on top of that, thatrecent history of declining
regulatory oversight.
So you have these perfectconditions for a boundary
pushing marketing strategiesthat some might consider
predatory some.
And how do we get here?
Well, let's look at a timelineof that advertising oversight,
and I promised you this.
So the FDA has a long-standingmechanism for enforcing drug
(07:14):
advertising standards, and fromthe 1990s through the early
2000s, the agency regularlyissued 100-plus more warning
letters per year, at least twoper week, to what they thought
were misleading drug advertising.
And this is all in their annualreports, right?
But in recent years theenforcement actions have seen a
decline.
So in 2002, again 120 warningissues a letter.
(07:35):
That's more than two a week.
In 2010, just eight years later, only 52 letters issued,
averaging one a week.
Right, so it's cut 50%.
2022, they go from 52 lettersin 2010 to a decade later.
In 2022, only four letters wereissued.
2023, one letter is issuedright 2024, no letters were
issued.
This is all from the FDAenforcement annual reports.
(07:57):
Now you could say that's becausethe compliance has stuck.
The pharma companies areadhering even more and they're
getting it right and they knowexactly what it takes and how to
get through, and that islargely the case that I've seen,
especially working with brandteams or brand marketers,
procurement teams across theboard.
There are strict compliance andadherence rules for here's what
the messaging has to be passes,medical, legal, regulatory
(08:18):
review all the way across theboard.
The challenge may be in some ofthe social media influencers
campaigns that frankly, they maybe given here's a product,
here's how to talk about it,here's what you can't say but
then they riff for five minutesabout a product or a solution
and how great it is for them,and it may be completely honest.
The challenge is it may beemphasizing the successes over
anything.
The person may not have had anyside effects.
(08:38):
Therefore, they don't getmentioned, right.
So this decline in lettersgoing out really does allow for
more creative interpretations ofadvertising rules, particularly
on some of the newer platformsand those technologies,
especially when the regulationsweren't even originally written
to govern them in the 90s right,such as the TikTok videos and
(08:59):
even hashtags, ephemeral content, ai-generated patient
testimonials right, those arecoming.
So there's legal and ethicalimplications for pharma teams.
Obviously, this new wave ofenforcement it's not just a
warning shot.
It has deep ramifications forevery department.
Consider this right.
Brand marketers must evendoubly ensure all their
promotional materials meet fairbalance guidelines, and I will
tell you they do.
On every brand that we'veimplemented and talked through
(09:20):
through the years, there aremajor reviews, legal regulatory
compliance for anything officialcoming out of the brand teams,
no question about it.
So I think you'll see thosestandards, you know.
I'd like to say not even beimpacted, because they're
already meeting those standardsand every indication I've ever
seen, right.
But patient support teams needto provide educational outreach
that helps patients understandrisks, eligibility, treatment
(09:40):
expectations.
We may need to train patientsthat say, listen, if you're not
seeing the mention of any how itis used, any mention of side
effects or anything like that inwhatever media you're consuming
, we may need to educate them.
That may not be approved by theFDA, right?
Or there may be medicationsthat, frankly, are over the
counters, supplements that don'tneed to go to the FDA and it
just says FDA has not approvedthese statements.
We've seen that little fineprint, right?
(10:02):
So it may need patient supportteams to really educate.
Hey, I've heard about this newmedication.
Well, was it FDA approved?
Are you seeing any indicationsof side effects being mentioned
or indications on what it's goodused for, et cetera, et cetera,
right?
Digital innovation leadersyou're going to have to be able
to evaluate any influence ofprograms you have in digital
campaigns for alignment withthose disclosure rules.
Again, I think the digitalcampaigns that I've all seen
(10:24):
very strict compliance withbrand innovation, brand teams,
innovation teams, legal teamsacross the board.
I think it's in environmentswhere the full control may not
always be there, just becausesomeone's taken it and gone on
their own in maybe agood-natured way.
They're not trying to violateany rules, but they're talking
about positives withoutmentioning, maybe, any of the
side effects, right?
(10:47):
So think of it that way.
It and security teams need toreview all those systems that
automate communications andensure compliance in real-time
personalization tools, targetedads that's true.
Procurement offices you'regoing to need to assess your
vendor partners, agencies,influencer platforms for
regulatory reliability.
Frankly, I can see procurementand legal teams just telling
marketing teams no moreinfluencers.
I can just see it happening.
Right.
Pharmacy suite carry executiveresponsibility, of course, for
(11:08):
the ethical commercial practicesand long-term reputational risk
they do already anyway, right.
So there will be a lot of trustthrough transparency.
There's opportunity here, right?
So when you're standing at acrossroads and drug
advertisements can really raisecondition awareness in a
positive way and supportdiscovery of life's changing
treatments, the ultimate missionmust always stay
patient-centered, which itlargely is, but restoring and
(11:29):
keeping that public trust and,frankly, market share is going
to require embracing thosefollowing shifts greater
transparency in the influencerpartnerships, if you're still
using them, and sponsoredcontent.
Improved risk-benefit balancein all media, especially social.
More education, fewerexaggerations, if there are any.
Industry-wide recommitment tothe spirit, not just a letter of
(11:49):
FDA guidelines.
Industry self-regulation, whendone comprehensively,
proactively, is one of the mostpowerful tools in preventing
future scrutiny and legalexposure.
So what's going to happen next?
Well, according to the FDA,there's a wave of initial
enforcement just at thebeginning.
Ongoing digital surveillancetools are being developed to
track violations in real time.
Companies found in repeatednoncompliance may face fines,
(12:10):
forced retractions, productreviews or even litigation.
What's also interesting to note,though, is in the US
administration's message.
This summer, you may recallthey sent out most favorite
nation message demands.
Remember there were letterswritten to 17 pharma companies
about how US prices for patients, particularly those in Medicare
, need to be no higher thanthose used at other developed
(12:32):
countries.
In that executive order was athird or fourth bullet point
which said by the way,direct-to-consumer medication
programs in the US can begreatly enhanced and negate the
rules for most favored nationpricing if it's going
direct-to-consumer.
So there would be someinfluence where the
administration would allow moredirect-to-consumer flexibility
(12:54):
on pricing if it's goingdirect-to-patients, right.
So they opened up sort of thatD2C market there, right from one
end of it as well.
So here we have more guidancethat well, even if you're going
D2C, you really have to trainyour teams, vet your conduct,
clarify your policies,especially if you're using any
influencers in emerging digitalformats, so you don't appear on
(13:14):
the FDA's radar for anyviolations or warnings or
anything like that which,frankly, could even come from
your competitors, as we all know, right.
Well, they're looking at whatyou're putting out there and if
they see someone step over theline it's not unheard of that
you may get reported in the FDAby some competitors.
So in today's digitallytransformed landscape, the world
sees and shares faster thanever before.
The regulatory lag, though, iscatching up.
(13:37):
Right, so they mentioned theuse of AI tools, for example in
the FDA, to really catch thingsmore in real time.
Right, so that industry'sresponse can't afford just to be
reactive.
There is a time here to beproactive and really reassess
and make sure everything is incompliance.
Right, so you know, we didbegin this conversation today
with a quote from the FDA quotedrug companies spend up to 25%
of their budget on advertising,end quote.
(13:58):
Well, what if it would mean youtake a fraction of that and
puts it towards digitaltherapeutics, financial support
solution, evidence-based patienteducation, after the script is
written, that then informs,obviously, reimbursement rates
and federal programs about theefficacy of medication claims?
Right, and as healthcaremarketers, brand leaders,
digital innovators, accesschampions, we all have the
(14:20):
opportunity and theresponsibility to shape a more
transparent and equitabletreatment landscape.
Let's have this wave of FDAenforcement be a catalyst, not
only to make sure all ourcompliances are elevated, but
the connection with patients andproviders really is rooted in
trust, accuracy and value.
I'll list the sources to allthis information in the show
notes.
Again, if you're into marketing, innovation, it, access,
(14:42):
procurement, leadership roles,it really is that moment to
re-examine the messages put intothe world.
Patients consuming them arereally listening more closely
than ever before in channelsthat maybe we haven't thought of
as deeply as you have in thepast with print materials.
So thank you for joining us onPostscripts.
If you found this conversationvaluable, please follow and
subscribe for more insights aswe talk about that intersection
(15:05):
of pharma tech and patientimpact.
Until next time, keep lookingforward.
The real work begins after thatscript is written.
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