October 1, 2025 • 13 mins
The pharmaceutical landscape is undergoing a seismic shift as the Trump administration drops a bombshell 100% tariff on imported branded and patented drugs, effective October 1st. This game-changing policy mandates that pharmaceutical companies build manufacturing plants on American soil or face potentially devastating market consequences.
We dive deep into the multifaceted implications of this dramatic policy shift that has already prompted nearly $20 billion in promised pharmaceutical manufacturing investments across the United States. The tariff represents a fundamental pivot toward economic nationalism in healthcare, framed around dual imperatives of national security and domestic job creation following the supply chain vulnerabilities exposed during the COVID pandemic.
For pharmaceutical brand marketers, this creates unprecedented communication challenges as companies navigate how to maintain brand value when prices may potentially double overnight. Patient access teams must rapidly scale copay assistance programs and develop new financial navigation resources to prevent affordability barriers. Meanwhile, innovation teams face profound questions about where research and development should physically occur, potentially fragmenting the collaborative global research model that has accelerated breakthrough therapies.
The operational dimensions cannot be understated—building FDA-compliant facilities requires substantial time and expertise, with procurement teams facing the complex task of securing U.S.-based contract manufacturers and redefining supply chains when 79% of active pharmaceutical ingredients are currently imported. This transition creates new cybersecurity concerns as domestic facilities handling sensitive biologic intellectual property become targets for industrial espionage.
Digital patient engagement platforms will become increasingly critical during this transition, offering pharmaceutical companies their most direct pathway to maintaining patient relationships while navigating affordability challenges. The administration has promised expedited regulatory approvals for new manufacturing facilities, potentially creating a new American era of biopharmaceutical independence—if executed thoughtfully and inclusively.
Subscribe to Postscripts for ongoing analysis at the intersection of pharmaceutical policy, technology and patient impact as this watershed moment continues to reshape the healthcare landscape.
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_00 (00:00):
Welcome to Postscripts, where we cover the
latest innovations in patientaccess, support, digital tools,
HTT engagement, and pharmamarketing that we all hope drive
better outcomes for patients.
This podcast is forinformational purposes only and
does not constitute medicaladvice, nor should it be used to
influence any clinical decisionmaking.
Patients should always consulttheir healthcare professionals.
Welcome to the podcast.
My name is Brian Carr.
(00:21):
I'm from the MetaSafe team,although any opinions expressed
here are my own and notnecessarily those of MetaSafe
and its partners.
Well, we all woke up thismorning to a game-changing
tariff hitting the industry asPresident Donald Trump announced
the sweeping policy change,sending ripples across the
global pharma industry.
Which, if you've been followingthe podcast, you know we've been
following this very, veryclosely for the past four or
(00:41):
five weeks here, that there'snow a hundred percent tariff on
imported, branded, and patenteddrugs that goes into effect on
Tuesday, October 1, actuallyWednesday next week, unless
pharmaceutical companies startbuilding plants in the United
States to manufacture theseproducts domestically.
So we've been talking about thison the podcast, all the almost
$20 billion or more ininvestment that pharma companies
(01:04):
have promised over the past twoor three weeks in building
plants, whether it's Virginia,Texas, California, that they're
promising to build by 2030, andhow that would probably get them
better terms when it came totariffs coming from medications
that are inbound to the U.S.,basically getting slapped with
the tariff.
And it is happening as we speak.
So the administration isactually falling through.
(01:24):
So it is a turning point, notjust in the U.S.
with trade policy, but in howthe pharma ecosystem is evolving
to address these shiftingeconomic pressures, regulatory
realities, and cost structures.
We're going to explore what thismeans for pharma brand
marketers, innovation teams,patient access and support
leaders, procurement, supplychain, IT, security
professionals, and then ofcourse the C-suite of pharma and
(01:45):
what they're doing about this.
So we we're gonna evaluate theripple effects across the market
dynamics, what happens withpatient pricing, manufacturing
strategy, global partnerships,and those implications for the
future state of pharmainnovation, clinical trials, for
example, in the United States.
So first, let's just do afoundational take here on what
is the policy and why now.
So the proposed tariff, it'spart of a broader push toward
(02:08):
economic nationalism we'reseeing in the U.S.
and reshoring in the U.S.
of manufacturing capabilities.
The argument from policymakersis twofold.
One, national security, uhespecially with some supply
chain challenges that we sawhappen through COVID, not only
in products and goods, butpharmaceuticals as well, and job
creation in the U.S.
So, according to theannouncement that was on uh
(02:28):
CNBC, I'll put all the sourcingin the in the show notes, the
drugs made overseas, especiallyin countries like China or
India, pose this dependencyrisk.
And reshoring manufacturingcould bring tens of thousands of
jobs back to the U.S.
facilities, increasing uhworkforce competitiveness.
Eli Lilly this week announced aTexas plant, and alongside that
was the potential for 1,500 newjobs in Texas, right?
(02:50):
So pharma isn't like textiles orsemiconductors, where we saw
those supply chain challengeshappening during COVID.
It's not just about the machinesand labor, it is about an
ecosystem of science, supplychain precision, clinical
partnerships, and dataintegrations.
So, what's the reality behindthe good intentions?
Well, for brand marketers, whathappens, what's gonna happen
when the price becomes taboo,right?
(03:11):
So for brand marketers, this100% tariff is gonna force a
massive recalibration ofpositioning, promotion, pricing
strategies, right?
Attention's gonna shift fromscientific innovation and
economic justification as U.S.
prices for branded importeddrugs may double overnight in
the absence of domesticmanufacturing moves.
So we've seen studies wherethere was one in uh health
(03:31):
affairs where 77% of Americansalready report that prescription
drugs are too expensive.
So introducing a tariff-relatedadditional spike is just going
to increase public scrutiny andlikely draw regulatory
attention.
So can consider you're a brandmarketer, the teams have to
prepare to communicate clearlyand ethically why branded drugs
are costing more withoutalienating those prescribers or
(03:54):
patients.
Reframe the brand straight,reframe those brand strategies
and stories to include supplychain transparency, domestic
commitment to job creation, forexample.
You're gonna see a lot more ofthat.
Align with the patient supportand access teams early to offset
affordability concerns, right?
So copay cards are gonna becomea bigger factor one can imagine,
(04:14):
right?
If to make sure those prices arestaying the same or helping
preserve market share, right?
So anticipate backlash frompayers and advocacy groups and
have some of that proactivemessaging already ready.
This is definitely a moment forbrand marketers to lead with
values and visibility and notjust benefits and efficacy.
Innovation teams, the domesticRD, or is it just for
manufacturing, right?
So the talent policy creates apotential fork in the road.
(04:37):
Will companies simply build U.S.
space factories or will theymove entire RD pipelines
stateside?
We're already seeing a RDinvestment in Thousand Oaks,
California from one of the majorpharma companies, for example,
right?
So innovation teams are gonna betasked with determining where in
the pipeline localization they'dsense, right?
So phase three manufacturingversus early discovery in the
(04:57):
phases, right?
How IP transfer laws and costsharing agreements will function
in the new regulatory space,that's gonna hit the procurement
teams as well.
How to qualify for US US-basedsuppliers so that they're in the
good manufacturing complianceprojects, right?
What about even applying for taxbreaks and making sure that the
all that is is coming to thefore to help to keep costs in
(05:20):
line or increase margin andprotect market share?
So whether the U.S.
has enough scientific andclinical trial infrastructure to
support pipeline continuity isgoing to be an interesting one,
although 47% of all clinicaltrial patients are in the U.S.
So you may not see the the theshortages in patients wanting to
do clinical trials, but are theygoing to be happier?
And the rollout strategies,right?
So if you've got domesticproduction happening here,
(05:42):
you've got clinical trial meds,you want to may want to roll
them out in countries whereyou're already producing the
meds.
You've already passed all theregulations, for example.
So you may see clinical trial,instead of having worldwide
launches or you know, regionallaunches, you may have to
readjust where those regionallaunches are in order, right?
So according to a report fromBiopharmadive, 60% of new drug
trials are conducted outside ofthe US.
(06:02):
Global RD partnerships aredriving the pipeline
acceleration.
So localizing this innovationwas requiring not just physical
infrastructure, but a mindsetshift, right?
And a supply chain shift thatthe raw materials have to be in
the US or have to be shipped inthe US or produced in the U.S.,
right?
Think about if you're on thepatient access and support
teams, you know, you get thisnew era of financial, and I'm
going to call it toxicity,right?
(06:24):
Perhaps the sharpest pain inthis policy would be felt not by
companies, but by patients.
Drug prices in the U.S., alreadythe highest globally, layering
in 100% tariff on brandedimports could push certain
specialty meds beyond the reacheven of the insured patients.
So patient access professionalsmust now architect expanded
co-pay assistance pipelines,emergency frameworks for
(06:45):
financial navigation andinsurance advocacy, longer
eligibility periods, perhaps forsupport programs, integrated
digital platforms, you know,like MetaSafe, like we have
here, deliver the adherence ofinformation and affordability
resources where they matter mostat the point of care.
So, for example, this theMetaSafe and other platforms,
again, they allow for tailoreddigital journeys, affordability
(07:05):
guidance, emotional supportresources that patients can
actively engage with duringtherapies, right?
As costs are rising, the digitaltools are going to be critical,
navigating these affordabilitychallenges in real time and
creating that one-to-one loyaltyand brand with patients, right?
Because especially there's otherfactors at play now for
direct-to-consumer advertising,may uh also be restricted.
(07:27):
So ads on television and thingslike that, because they can't
have the ISI, the informationstatements on a full television
ad, you may see uh betterengagement rates on digital
solutions where you end it toclick, here's the whole full
ISI, things like that.
So, you know, procurement andsupply chain, consider what's
happening there.
You're gonna be localizingwithout breaking the chain.
So procurement there, you've gotthe U.S.
(07:49):
policy is gonna set off ahigh-stakes game of chess,
right?
Where tariff avoidance requiresdomestic production, timelines,
and resources to stand up GMPcertified facilities are not
instantaneous.
Strategic sourcing will need toadapt on multiple fronts.
Key impact areas, securingU.S.-based C DMOs, contract
development and managementmanufacturing organizations,
prepared to expand capacity,redefining long-term contracts
(08:12):
of raw materials and APIproducers for U.S.
delivery and supply chainsecurity, right?
Managing parallel operationsboth domestically and globally
during a transition phase,right?
Rebuilding redundancy strategiesto avoid critical drug
shortages.
IQVI has reported that over 79%of active pharmaceutical
ingredients used in the US areimported, right?
(08:33):
So replicating that ecosystemdomestically where it's quickly,
affordably, and reliably done,it's not just about costs, it's
about survivability now.
Pharma IT and cybersecurity,consider that.
Guarding the criticalinfrastructure in tandem with
domestic plant building becomesimperative to secure them,
right?
So, you know, manufacturingfacilities, especially those
managing sensitive biologic IP,right, will become increasingly
(08:54):
attracted to cybercriminals,state actors, and industrial
espionage.
So IT and security leaders aregoing to really need to elevate
their security practices acrossthe plant level, Internet of
Thing, and SCADA systems, FDAinspection and validation data
pathways, cross-continental RDcollaborations via cloud
networks, coordination of thosethird-party logistics and
(09:15):
supplier portals, right?
Things like that.
So according to a 2024 cyber Mand MDX and Philips survey, 77%
of healthcare organizations haveexperienced cybersecurity
incidents in the last year, andFRAMA is not untouched.
Reshoring doesn't just meanlocal, it all means local
responsibility, right?
And regulations.
So if you're in the C-suite, youknow, you've got strategic
planning and politicalvolatility, you know, this
(09:38):
moment demands bold but balancedthinking.
CEOs, CFOs, COOs aresimultaneously managing investor
expectations, market stability,operational resource allocation
between short-term complianceand long-term sustainability,
lobbying and policy-makingengagement with trade
organizations.
International relations is alsokey with global partners who may
feel sideswiped now.
(09:59):
According to Delite's 2025Pharma CEO Outlook, over 64% of
CEOs say, quote, geopoliticalinstability, end quote, is now
their top operational risk.
I figure out from just 22% fiveyears ago.
So 22% five years ago, it's goneup threefold almost to 64%.
The tariff's not just going toreshape operations, it's going
to demand a recalibration ofglobal growth models that have
(10:20):
fueled pharma for the past fewdecades.
Is pharma at the risk of a tradewar, right?
So consider this.
Early hints suggest that globalmarkets could retaliate with
similar tariffs on U.S.-madediabetes, oncology, and
cardiovascular brand leaders.
The biopharma world may fracturefrom a harmonized global
marketplace into regionalfiefdoms, each with its own
price structures, manufacturinghubs, and regulatory
(10:42):
constraints.
The fragmentation will raisecosts, not reduce them, and slow
innovation that thrives in thefluid exchange of clinical,
scientific, and technologicalcapital.
So are tariffs solving for costsor creating new ones?
There are opportunities ahead.
Look at the silver linings andlong-term games.
So there, you know, tariffpressure could spark new
investment in American biotechclusters, create faster tech
(11:03):
translation from bench to benchside, and really encourage
companies to embed costefficiency into every layer of
the product lifecycle, not justpost-launch support.
So these scenarios are possibleif the policy is matched with
the robust government supportfor your GMP infrastructure
building.
So we have seen some of thatwith the U.S.
administration saying any newplants that are being built in
the U.S.
will almost get to the top ofthe line when it comes to
(11:25):
approvals from the EPA and theFDA.
And they've instructed EPA andFDA officials not to be
burdensome with theirregulations and their approvals
and to speed things along.
That was actually written intoan executive order on
paraphrasing.
Workforce developmentpartnerships between industry
and academia are going to beimportant.
Regulatory flexibility fromagencies, like I mentioned, from
FDA to speed these approvals isgoing to be key.
And it's already been broughtout by the administration that
(11:47):
they expect that.
You know, because Pharma went tothe administration as this was
being spoken about months agoand said, we'd love to build new
plants, but it takes five to tenyears.
We all heard this in the U.S.
It's going to take five to tenyears to build a new plant.
Well, the administration heardthat and said, no, we'll get you
the top list to get thoseapprovals within, you know, 18
months to two years, right, atthe most.
So when you're looking at, youknow, if they're done right,
(12:07):
this could catalyze a brand newAmerican era of
biopharmaceutical independence,but it's really going to be done
smartly, inclusively, and youknow, it's really adaption over
reaction, right?
So this October of one deadlineis fast approaching, and 100%
tariff declaration may or maynot be fully implemented or
scaled back due to political orlogistical pressures.
The intention is clear.
The U.S.
government wants a farmer toanchor more of its operations
(12:30):
domestically.
Farmer leaders across marketing,innovation, access, procurement,
and security, the clock isticking, you build new models,
test new messaging, and unitestakeholders across internal
silos to build solution firstresponses.
Digital tools like MetaSafe andothers, which really engage
directly with patients aroundboth access and experience, are
going to become even morecentral in the cost and
complexity rich environment.
(12:50):
Change is inevitable.
What matters now is how quicklyand collaboratively the industry
can adapt.
Well, thank you so much forjoining us in Postscripts.
If you found this conversationvaluable, follow or subscribe
for more insights at theIntersection of Pharma
Technology and Patient Impact.
We have other podcasts on the uhnew new guidelines for
direct-to-consumer advertisingthat are hitting as well, uh
(13:11):
definitely uh, which is inconjunction with this, and the
U.S.
administration um basicallygiving um most favored nation
status to those companies thatare trying to do direct to
consumer pricing, i.e., cuttingout middlemen and women.
And the administration actuallycalled that out in their
executive order that if you'redoing direct to consumer
advertising, maybe it didn'tactually say exempt, but it
would be looked upon differentlyby the administration when it
(13:32):
comes to tariffs and other uhreviews.
So all right.
Have a good day, everyone.
Thanks so much.
Welcome to Postscripts, where we cover the
latest innovations in patientaccess, support, digital tools,
HTT engagement, and pharmamarketing that we all hope drive
better outcomes for patients.
This podcast is forinformational purposes only and
does not constitute medicaladvice, nor should it be used to
influence any clinical decisionmaking.
Patients should always consulttheir healthcare professionals.
Welcome to the podcast.
My name is Brian Carr.
(00:21):
I'm from the MetaSafe team,although any opinions expressed
here are my own and notnecessarily those of MetaSafe
and its partners.
Well, we all woke up thismorning to a game-changing
tariff hitting the industry asPresident Donald Trump announced
the sweeping policy change,sending ripples across the
global pharma industry.
Which, if you've been followingthe podcast, you know we've been
following this very, veryclosely for the past four or
(00:41):
five weeks here, that there'snow a hundred percent tariff on
imported, branded, and patenteddrugs that goes into effect on
Tuesday, October 1, actuallyWednesday next week, unless
pharmaceutical companies startbuilding plants in the United
States to manufacture theseproducts domestically.
So we've been talking about thison the podcast, all the almost
$20 billion or more ininvestment that pharma companies
(01:04):
have promised over the past twoor three weeks in building
plants, whether it's Virginia,Texas, California, that they're
promising to build by 2030, andhow that would probably get them
better terms when it came totariffs coming from medications
that are inbound to the U.S.,basically getting slapped with
the tariff.
And it is happening as we speak.
So the administration isactually falling through.
(01:24):
So it is a turning point, notjust in the U.S.
with trade policy, but in howthe pharma ecosystem is evolving
to address these shiftingeconomic pressures, regulatory
realities, and cost structures.
We're going to explore what thismeans for pharma brand
marketers, innovation teams,patient access and support
leaders, procurement, supplychain, IT, security
professionals, and then ofcourse the C-suite of pharma and
(01:45):
what they're doing about this.
So we we're gonna evaluate theripple effects across the market
dynamics, what happens withpatient pricing, manufacturing
strategy, global partnerships,and those implications for the
future state of pharmainnovation, clinical trials, for
example, in the United States.
So first, let's just do afoundational take here on what
is the policy and why now.
So the proposed tariff, it'spart of a broader push toward
(02:08):
economic nationalism we'reseeing in the U.S.
and reshoring in the U.S.
of manufacturing capabilities.
The argument from policymakersis twofold.
One, national security, uhespecially with some supply
chain challenges that we sawhappen through COVID, not only
in products and goods, butpharmaceuticals as well, and job
creation in the U.S.
So, according to theannouncement that was on uh
(02:28):
CNBC, I'll put all the sourcingin the in the show notes, the
drugs made overseas, especiallyin countries like China or
India, pose this dependencyrisk.
And reshoring manufacturingcould bring tens of thousands of
jobs back to the U.S.
facilities, increasing uhworkforce competitiveness.
Eli Lilly this week announced aTexas plant, and alongside that
was the potential for 1,500 newjobs in Texas, right?
(02:50):
So pharma isn't like textiles orsemiconductors, where we saw
those supply chain challengeshappening during COVID.
It's not just about the machinesand labor, it is about an
ecosystem of science, supplychain precision, clinical
partnerships, and dataintegrations.
So, what's the reality behindthe good intentions?
Well, for brand marketers, whathappens, what's gonna happen
when the price becomes taboo,right?
(03:11):
So for brand marketers, this100% tariff is gonna force a
massive recalibration ofpositioning, promotion, pricing
strategies, right?
Attention's gonna shift fromscientific innovation and
economic justification as U.S.
prices for branded importeddrugs may double overnight in
the absence of domesticmanufacturing moves.
So we've seen studies wherethere was one in uh health
(03:31):
affairs where 77% of Americansalready report that prescription
drugs are too expensive.
So introducing a tariff-relatedadditional spike is just going
to increase public scrutiny andlikely draw regulatory
attention.
So can consider you're a brandmarketer, the teams have to
prepare to communicate clearlyand ethically why branded drugs
are costing more withoutalienating those prescribers or
(03:54):
patients.
Reframe the brand straight,reframe those brand strategies
and stories to include supplychain transparency, domestic
commitment to job creation, forexample.
You're gonna see a lot more ofthat.
Align with the patient supportand access teams early to offset
affordability concerns, right?
So copay cards are gonna becomea bigger factor one can imagine,
(04:14):
right?
If to make sure those prices arestaying the same or helping
preserve market share, right?
So anticipate backlash frompayers and advocacy groups and
have some of that proactivemessaging already ready.
This is definitely a moment forbrand marketers to lead with
values and visibility and notjust benefits and efficacy.
Innovation teams, the domesticRD, or is it just for
manufacturing, right?
So the talent policy creates apotential fork in the road.
(04:37):
Will companies simply build U.S.
space factories or will theymove entire RD pipelines
stateside?
We're already seeing a RDinvestment in Thousand Oaks,
California from one of the majorpharma companies, for example,
right?
So innovation teams are gonna betasked with determining where in
the pipeline localization they'dsense, right?
So phase three manufacturingversus early discovery in the
(04:57):
phases, right?
How IP transfer laws and costsharing agreements will function
in the new regulatory space,that's gonna hit the procurement
teams as well.
How to qualify for US US-basedsuppliers so that they're in the
good manufacturing complianceprojects, right?
What about even applying for taxbreaks and making sure that the
all that is is coming to thefore to help to keep costs in
(05:20):
line or increase margin andprotect market share?
So whether the U.S.
has enough scientific andclinical trial infrastructure to
support pipeline continuity isgoing to be an interesting one,
although 47% of all clinicaltrial patients are in the U.S.
So you may not see the the theshortages in patients wanting to
do clinical trials, but are theygoing to be happier?
And the rollout strategies,right?
So if you've got domesticproduction happening here,
(05:42):
you've got clinical trial meds,you want to may want to roll
them out in countries whereyou're already producing the
meds.
You've already passed all theregulations, for example.
So you may see clinical trial,instead of having worldwide
launches or you know, regionallaunches, you may have to
readjust where those regionallaunches are in order, right?
So according to a report fromBiopharmadive, 60% of new drug
trials are conducted outside ofthe US.
(06:02):
Global RD partnerships aredriving the pipeline
acceleration.
So localizing this innovationwas requiring not just physical
infrastructure, but a mindsetshift, right?
And a supply chain shift thatthe raw materials have to be in
the US or have to be shipped inthe US or produced in the U.S.,
right?
Think about if you're on thepatient access and support
teams, you know, you get thisnew era of financial, and I'm
going to call it toxicity,right?
(06:24):
Perhaps the sharpest pain inthis policy would be felt not by
companies, but by patients.
Drug prices in the U.S., alreadythe highest globally, layering
in 100% tariff on brandedimports could push certain
specialty meds beyond the reacheven of the insured patients.
So patient access professionalsmust now architect expanded
co-pay assistance pipelines,emergency frameworks for
(06:45):
financial navigation andinsurance advocacy, longer
eligibility periods, perhaps forsupport programs, integrated
digital platforms, you know,like MetaSafe, like we have
here, deliver the adherence ofinformation and affordability
resources where they matter mostat the point of care.
So, for example, this theMetaSafe and other platforms,
again, they allow for tailoreddigital journeys, affordability
(07:05):
guidance, emotional supportresources that patients can
actively engage with duringtherapies, right?
As costs are rising, the digitaltools are going to be critical,
navigating these affordabilitychallenges in real time and
creating that one-to-one loyaltyand brand with patients, right?
Because especially there's otherfactors at play now for
direct-to-consumer advertising,may uh also be restricted.
(07:27):
So ads on television and thingslike that, because they can't
have the ISI, the informationstatements on a full television
ad, you may see uh betterengagement rates on digital
solutions where you end it toclick, here's the whole full
ISI, things like that.
So, you know, procurement andsupply chain, consider what's
happening there.
You're gonna be localizingwithout breaking the chain.
So procurement there, you've gotthe U.S.
(07:49):
policy is gonna set off ahigh-stakes game of chess,
right?
Where tariff avoidance requiresdomestic production, timelines,
and resources to stand up GMPcertified facilities are not
instantaneous.
Strategic sourcing will need toadapt on multiple fronts.
Key impact areas, securingU.S.-based C DMOs, contract
development and managementmanufacturing organizations,
prepared to expand capacity,redefining long-term contracts
(08:12):
of raw materials and APIproducers for U.S.
delivery and supply chainsecurity, right?
Managing parallel operationsboth domestically and globally
during a transition phase,right?
Rebuilding redundancy strategiesto avoid critical drug
shortages.
IQVI has reported that over 79%of active pharmaceutical
ingredients used in the US areimported, right?
(08:33):
So replicating that ecosystemdomestically where it's quickly,
affordably, and reliably done,it's not just about costs, it's
about survivability now.
Pharma IT and cybersecurity,consider that.
Guarding the criticalinfrastructure in tandem with
domestic plant building becomesimperative to secure them,
right?
So, you know, manufacturingfacilities, especially those
managing sensitive biologic IP,right, will become increasingly
(08:54):
attracted to cybercriminals,state actors, and industrial
espionage.
So IT and security leaders aregoing to really need to elevate
their security practices acrossthe plant level, Internet of
Thing, and SCADA systems, FDAinspection and validation data
pathways, cross-continental RDcollaborations via cloud
networks, coordination of thosethird-party logistics and
(09:15):
supplier portals, right?
Things like that.
So according to a 2024 cyber Mand MDX and Philips survey, 77%
of healthcare organizations haveexperienced cybersecurity
incidents in the last year, andFRAMA is not untouched.
Reshoring doesn't just meanlocal, it all means local
responsibility, right?
And regulations.
So if you're in the C-suite, youknow, you've got strategic
planning and politicalvolatility, you know, this
(09:38):
moment demands bold but balancedthinking.
CEOs, CFOs, COOs aresimultaneously managing investor
expectations, market stability,operational resource allocation
between short-term complianceand long-term sustainability,
lobbying and policy-makingengagement with trade
organizations.
International relations is alsokey with global partners who may
feel sideswiped now.
(09:59):
According to Delite's 2025Pharma CEO Outlook, over 64% of
CEOs say, quote, geopoliticalinstability, end quote, is now
their top operational risk.
I figure out from just 22% fiveyears ago.
So 22% five years ago, it's goneup threefold almost to 64%.
The tariff's not just going toreshape operations, it's going
to demand a recalibration ofglobal growth models that have
(10:20):
fueled pharma for the past fewdecades.
Is pharma at the risk of a tradewar, right?
So consider this.
Early hints suggest that globalmarkets could retaliate with
similar tariffs on U.S.-madediabetes, oncology, and
cardiovascular brand leaders.
The biopharma world may fracturefrom a harmonized global
marketplace into regionalfiefdoms, each with its own
price structures, manufacturinghubs, and regulatory
(10:42):
constraints.
The fragmentation will raisecosts, not reduce them, and slow
innovation that thrives in thefluid exchange of clinical,
scientific, and technologicalcapital.
So are tariffs solving for costsor creating new ones?
There are opportunities ahead.
Look at the silver linings andlong-term games.
So there, you know, tariffpressure could spark new
investment in American biotechclusters, create faster tech
(11:03):
translation from bench to benchside, and really encourage
companies to embed costefficiency into every layer of
the product lifecycle, not justpost-launch support.
So these scenarios are possibleif the policy is matched with
the robust government supportfor your GMP infrastructure
building.
So we have seen some of thatwith the U.S.
administration saying any newplants that are being built in
the U.S.
will almost get to the top ofthe line when it comes to
(11:25):
approvals from the EPA and theFDA.
And they've instructed EPA andFDA officials not to be
burdensome with theirregulations and their approvals
and to speed things along.
That was actually written intoan executive order on
paraphrasing.
Workforce developmentpartnerships between industry
and academia are going to beimportant.
Regulatory flexibility fromagencies, like I mentioned, from
FDA to speed these approvals isgoing to be key.
And it's already been broughtout by the administration that
(11:47):
they expect that.
You know, because Pharma went tothe administration as this was
being spoken about months agoand said, we'd love to build new
plants, but it takes five to tenyears.
We all heard this in the U.S.
It's going to take five to tenyears to build a new plant.
Well, the administration heardthat and said, no, we'll get you
the top list to get thoseapprovals within, you know, 18
months to two years, right, atthe most.
So when you're looking at, youknow, if they're done right,
(12:07):
this could catalyze a brand newAmerican era of
biopharmaceutical independence,but it's really going to be done
smartly, inclusively, and youknow, it's really adaption over
reaction, right?
So this October of one deadlineis fast approaching, and 100%
tariff declaration may or maynot be fully implemented or
scaled back due to political orlogistical pressures.
The intention is clear.
The U.S.
government wants a farmer toanchor more of its operations
(12:30):
domestically.
Farmer leaders across marketing,innovation, access, procurement,
and security, the clock isticking, you build new models,
test new messaging, and unitestakeholders across internal
silos to build solution firstresponses.
Digital tools like MetaSafe andothers, which really engage
directly with patients aroundboth access and experience, are
going to become even morecentral in the cost and
complexity rich environment.
(12:50):
Change is inevitable.
What matters now is how quicklyand collaboratively the industry
can adapt.
Well, thank you so much forjoining us in Postscripts.
If you found this conversationvaluable, follow or subscribe
for more insights at theIntersection of Pharma
Technology and Patient Impact.
We have other podcasts on the uhnew new guidelines for
direct-to-consumer advertisingthat are hitting as well, uh
(13:11):
definitely uh, which is inconjunction with this, and the
U.S.
administration um basicallygiving um most favored nation
status to those companies thatare trying to do direct to
consumer pricing, i.e., cuttingout middlemen and women.
And the administration actuallycalled that out in their
executive order that if you'redoing direct to consumer
advertising, maybe it didn'tactually say exempt, but it
would be looked upon differentlyby the administration when it
(13:32):
comes to tariffs and other uhreviews.
So all right.
Have a good day, everyone.
Thanks so much.
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