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September 11, 2025 13 mins

The pharmaceutical advertising landscape stands at a crossroads as bold new regulatory initiatives threaten to upend decades of established marketing practices. This week, the administration announced plans directing the FDA to reconsider the 30-year-old guidelines that have enabled the modern era of direct-to-consumer pharmaceutical advertising.

At stake is a 1997 policy change that revolutionized pharmaceutical marketing by allowing companies to provide abbreviated risk information during television advertisements while directing viewers elsewhere for comprehensive safety details. This seemingly small accommodation transformed pharmaceutical promotion, creating the familiar format of medication commercials that has dominated airwaves for decades. With industry spending reaching $8.1 billion in 2022, the potential impact of regulatory reversal cannot be overstated.

Yet the path to implementation remains fraught with obstacles. FDA regulatory changes follow strict procedural requirements that historically take years to complete. The pharmaceutical industry's robust legal resources and First Amendment protections provide formidable defense against aggressive regulation. Meanwhile, the promotional landscape has evolved beyond traditional oversight, with social media influencers and telehealth platforms creating regulatory gray areas. The most forward-thinking pharmaceutical marketers are already pivoting toward digital patient support tools that enhance medication adherence while generating valuable outcomes data that demonstrates measurable value to stakeholders.

Whether you're a pharmaceutical marketer navigating this uncertain landscape or simply curious about the forces shaping healthcare communication, this episode provides essential context for understanding what's at stake. Subscribe now and join our next conversation exploring how AI-driven personalization is transforming patient experiences in digital health.

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 0 (00:00):
Welcome to Post Trips , the podcast exploring what
happens after that firstprescription.
We cover the latest innovationsin patient access, support,
digital tools, hcp engagementand pharma marketing and
innovation that we all hopedrive better outcomes for
patients.
This podcast is forinformational purposes only and
does not constitute the givingout of any medical advice, or
nor should it be influencing anyclinical decision making.

(00:21):
Patients should always consulttheir healthcare professionals.
Welcome to the podcast.
My name is Brian Carr.
I'm from the Medisafe team,although any opinions expressed
here are my own and notnecessarily those of Medisafe or
its partners.
So what are we talking abouthere?
Yesterday's news that there'dbe a crackdown on pharma D to C,
direct to consumer ads Is thisa regulatory shift in sight?

(00:42):
Well, this week the USadministration under President
Trump announced a bold newinitiative targeting pharma
advertising specifically, inorder to the FDA to revisit,
potentially reverse, the currentdirect-to-consumer advertising
guidelines really, that havestood for nearly 30 years.
The announcement has triggeredboth curiosity and concern
across the pharma industry.

(01:02):
So, while regulatory proposalsthey've been floated before,
this development implies again asignificant group of
ramifications for how brandmarketers, innovation teams,
even patient engagementstrategists, operate in the
field, especially here in the US.
So in this episode we're goingto delve into what the
administration is proposing andthe legal and regulatory hurdles
it faces and what it reallymeans for pharma marketing teams

(01:25):
and that possibility ofoversight, and expanding to
social media influencers andtelehealth platforms.
We're also going to close theloop by highlighting
technologies enabling compliantpatient engagement, including
tools like Medisafe and othersthat really support patient
adherence, engagement beyond theprescription.
That can help with engagementand efficacy metrics that are
needed if pharma sometimes wantsto prove its case about

(01:47):
advertising being so beneficialto patients.
Here's the news you know therewas a presidential push to rein
in pharma ads.
That happened this week.
The US administration directedthe FDA to reconsider policies
that do allow, right now, forshort-term and short-form side
effect disclosures in televiseddrug ads.
Right, the aim, according tothe administration, is to shut

(02:09):
down what they or some peoplesay is a loophole exploited by
drug companies to gloss oversafety risks.
Right, they'll announce, forexample, and add some side
effects and for more information, go to Reader's Digest for more
things like that.
Well, this would reverse someof those regulatory challenges
made in 1907 that allowed thecompanies to really kind of
summarize the risk informationduring TV ads and direct
consumers to a website or amagazine ad or other written

(02:32):
material for a morecomprehensive explanation.
This is 30 years old.
Even so, the change was pivotalin making broadcast drug
marketing feasible, both interms of production logistics
and costs.
But now, as part of theadministration's drug pricing
reform strategies, reverting therule could substantially raise
the bar for what qualifies ascompliant direct-to-consumer

(02:53):
advertising, effectivelyreshaping that toolbox that
marketers have on the brandteams.
Right, you know the Associated.
After this was announced thisweek, the Associated Press
reported well, this is very mucha not so fast situation.
Why, and they actually said,the implementation of this may
be years away.
And here's why you know,reversing that three decade old
precedent is complex.

(03:15):
The FDA policymaking doesn'thappen overnight.
The agency has to follow formalprocedures for regulatory
changes.
Processes involves initiatingrulemaking procedures,
publishing proposals for publiccomment, allowing time for
industry challenges and, yes,court appeals and litigation.
So, for example, the FDArecently finalized updated
guidelines for more transparentlanguage in drug ads.

(03:37):
That process took 15 years.
So even the Associated Presssaid if the administration
attempts to accelerate theprocess or bypass those normal
procedural steps that have setprecedent, that could open the
door to legal challenges.
Right, so court rulings in turnrisk establishing precedents
that could narrow the FDA'sauthority even further.
Right, so legal challenges areprobably likely.

(03:59):
Historically, the FDA hasexercised caution in pursuing
aggressive ad reins.
There's reasons for that.
In several cases the agency hasdeferred enforcement rather
than risk unfavorable courtrulings that actually restrict
officially restrict itsinfluence.
Right?
So such caution usuallyreflects a strategic desire to
protect the FDA enforcementcapabilities, which could be

(04:19):
eroded if boundaries are thentested in the legal system.
So, moreover, the pharmaindustry is protected under the
First Amendment rights as longas its advertising remains quote
truthful and not misleading.
So that is the truthful or notmisleading DTC advertising is
protected under the FirstAmendment.
Has documented evidence ofadvancing patient awareness and

(04:39):
engagement.
This comes from the Pharmalobbyist group at Pharma, and
this was in April 2024.
So the challenge here is currentDTC trends.
Right, it's a differentlandscape from the 2000s of 30
years ago, former FDA officials.
They also point out the pharmaadvertising landscape has
already transformed in the past30 years, when the ads were loud
, fast-moving, often useddistracting imagery to obscure

(05:01):
critical safety text orvoiceovers.
Today, the drug companieslargely abandon those egregious
tactics to result as a moremeasured environment.
This mitigates some of theurgency around regulatory
changes, a fact that couldweaken the political will to
push change through.
There's data from Kantar Mediarecently showing that DTC pharma
advertising really sped, reallypeaked post-COVID in 2022 and

(05:23):
beyond it sort of plateaued.
There were over 8.1 billion inad buys in 2022.
And it's come pretty stabilizedthere as consumer media really
has habits, have shifted intodigital formats, and that's a
Kantar study that came out in2023.
Honestly, there's also beenstaffing cuts at the FDA,
particularly in the advertisingdivision.
You know there's staffing cutsat the division.

(05:45):
It's the very departmentresponsible for issuing the
warning letters to noncompliantadvertisers and following up.
So this means, even if newrestrictions are approved, the
actual human resources needed toexecute this widespread
enforcement just currentlyaren't in place the way they
were.
So, with fewer people on thebeat, the agency would likely
need to prioritize the majorinfractions which may embolden

(06:08):
some companies to continuecurrent advertising practices
until compelled otherwise.
Again, in their case, theycertainly are advertising
legally and transparently withthe campaigns they're doing.
Now I can tell you in ourexperience all the campaigns are
strictly enforced with medical,legal, regulatory reviews,
anything that talks about theproducts or mentions them in any
way.
You know brand marketers willsay we're already doing and

(06:29):
complying with all those rules.
There are no egregious thingsthat FDA people may point out
from 30 years ago, right?
So even the FDA commissioneralso raised concern about how
pharma products are increasinglypromoted on platforms that fall
outside the agency'sjurisdiction jurisdiction,
particularly social media andeven telehealth companies.
Right, so you've got Instagram,now TikTok, youtube.

(06:50):
They've become hotbeds forhealth related content.
You've got patient influencers,many of whom are paid or
incentivized by pharma brands,completely on the up and up, but
they often endorse products,but they may have insufficient
disclosure of risks or sideeffects and that may not be
intentional.
Maybe an influencer talkingabout I have this condition and
I take this medication.

(07:11):
It's working great for me,right, and if they're disclosing
, I am being compensated by thepharma company.
The challenge that some criticsare saying is well, that may
skew right the conversation tobe more about the success of the
medication and not being fullytransparent on what the side
effects may be.
If that influencer for moresuccess very successful in the
medication, it's upbeat, clickon that more, despite its very
nature, those algorithms forwhat's getting shown and clicked

(07:47):
on and watched more successstories, for example, as opposed
to negative stories on sideeffects.
They may, by its very nature,just be getting a skewing of the
fair and balanced approach.
So maybe, beyond the pharmamarketers and brand managers,
even the on the level ofinfluencers, it's just a nature
of what's happening out there.
And this question, when the FDAactually has any jurisdiction,

(08:07):
given the free speech rights andcommerce rights, to actually
curtail what's happening oninfluencer platforms?
Right, certainly they can giveguidelines and guidance, but to
actually take it to court, thatcould be something that may
actually reduce their footprintif a ruling goes against them on
ways that people want to talkabout their own medical
experiences.
So some influences, clearly,are paid directly by
pharmaceutical companies.
Others simply share positiveexperience, right, in the hopes

(08:30):
of drawing attention fromsponsors.
That may happen.
Meanwhile, newer entities liketelehealth platforms, specialty
pharmacies they sometimes claiman exemption from FDA guidelines
because they do not fit thetraditional definition of a drug
manufacturer, right?
So earlier this year, ahigh-profile Super Bowl ad
promoted a compound GLP-1'sweight loss medications,
showcasing benefits while,frankly, omitting some standard

(08:53):
risk information.
That could have been argued itwas a clear breach of FDA
advertising norms.
Yet action is still remainingpending, right.
So there's a legislativewildcard here, right,
recognizing the gap, a Senatebill was actually introduced in
2023, aimed at extending FDAoversight to include influencers
and non-traditional healthplatforms like telehealth
companies.
This could formally bringsocial media promotion under the

(09:15):
agency's scope.
However, the bill has stalled,hasn't received a hearing,
making it unlikely to influencestrategy.
Barring the bipartisan momentumahead of the next election
cycle, perhaps, but there may bebigger impacts ahead for pharma
.
You know communicationstrategies.
What's it all mean?
Well, tv definitely remainsinfluential, but regulatory
uncertainty may discourage largescale investments.

(09:36):
Social media promotions areoutpacing regulations, but risk
misalignment with FDArequirements may be risky, right
, so internal review teams areprobably going to be revisiting
evolving FTC disclosure rulesand they may consult legal
throughout campaign design.
Now, right.
Future advertising strategieswill likely balance mass market
reach with these hyperpersonalized support tools,

(09:58):
right, you know, I can imagine,for example, legal teams are
saying no more influencers.
Right, if it really gets to apoint where the FDA is cracking
down on influencer ads socialmedia beyond the control, it
could be simply.
Well, if patients want to talkabout it on their own and their
positive experiences, that'sfine.
It's pharma, it's just peopletalking as if they were in a
cafe If pharma is not part of itor officially compensating,

(10:19):
right, so they might be like.
Let's just reallocate thatsocial media influence and
budget elsewhere, right.
But there is opportunity here,right.
Digital support tools.
Regulatory changes arepercolating.
Brand teams can gain realtraction you know they are now
by investing in tools that buildtrust, guide treatment, provide
compliant patient journeys,especially those that sidestep
mass media risks.
You know.

(10:39):
Digital companions, medisafe,other platforms you know, gives
that robust patient engagementplatform with medication,
adherence reminders, two-waycommunication, educational
content.
Not only do they align with FDAcompliance expectations but
also can help those brand teamsdemonstrate measurable value to
payers and providers.
Why?
Because we have the data on theadherence rates, the efficacy

(11:00):
rates, right, the persistencerates on certain medications
that could help them evenqualify for better reimbursement
rates when it goes to thestate-sponsored and
federal-sponsored medicalprograms, right.
So you know the Trumpadministration's directive to
really tighten FDA drug rules.
It's significant, but it can befraught with legal and
operational, actual tacticalhurdles.
Historical precedent suggestsany reversal of advertising

(11:23):
policies could take many yearsand face likely industry
pushback.
We have FDA staffing cuts thatare limiting immediate
enforcement capacity.
I will say, though, theinfluence of marketing remains
sort of this wild west of pharmapromotion very personalized,
very effective.
The challenge there is you knowthe guidelines, or all you need
is one or two that become theexample and case study from an

(11:46):
FDA perspective on them claiminghey, not enough of side effects
were talked about in thistwo-minute influencer ad, which
is sponsored by Pharma.
Right, so you don't want to bethat example case.
So where do we go from here?
Well, the mission for Pharmabrand and innovation teams is
clear continue engaging patientsin ways that are evidence-based
, regulatory compliant andimpactful, right?

(12:06):
So the other thing is, you know, if it ever goes to a court
case or there's an appeal goingon, data is showing, by the way,
because of these ads or becauseof this marketing, people
subscribe to the medication.
They stayed on it longer.
We have data showing this,right, stay on it longer.
Therefore, it actually reduces,you know, it increases the
impact of medication, reducesbad things happening, and you
know, and the efficacy of themedication and the education

(12:29):
provided for patients can reallybe a benefit that actually
support.
This is why the education andthe ads spends are actually in
the nation and patient's bestinterest, right?
So while these political winscourt decisions may shape this
future landscape, the best hedgeis really to focus on efforts
with value-rich strategies,personalized platforms,
education-first communication,digital companions it's this

(12:51):
forward-looking go-to-marketmodel, regardless of how the DTC
ad reform plays out.
The next time we'll explore howAI-driven personalization in
digital health is transformingonboarding and titration
experiences for patients, so besure to tune in.
Thank you so much for joiningus here on Postscripts.
If you found this conversationvaluable, please follow or
subscribe for more insights atthe intersection of pharma tech,
patient impact and innovations.

(13:12):
Until next time, keep lookingforward.
The real work begins after thatscript is written.
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