Are You Ready When Your Drug Gets Approved Twice as Fast?

Regulatory timelines are changing dramatically, and pharmaceutical companies must adapt or risk being left behind. The Biden administration's pressure on the FDA is yielding concrete results - approval processes that once took 10-12 months are now being completed in about half the time through expedited review pathways.

This acceleration isn't hypothetical. A recent Reuters investigation revealed how the White House directly influenced faster reviews for nicotine alternatives, setting a precedent that's spreading throughout healthcare product approvals. The numbers tell a compelling story: 47% of novel drug approvals in 2023 used fast-track designation, 66% qualified for priority review, and 39% received breakthrough therapy status. For treatments addressing serious conditions with unmet needs, these accelerated pathways are becoming the rule rather than the exception.

The economic impact is substantial. Health Affairs analysis shows medications reaching Medicare beneficiaries just six months earlier could save $1.5 billion annually through reduced hospitalizations. For pharmaceutical marketers and access teams, this compressed timeline creates both challenges and opportunities. Brand strategies must become more agile, patient engagement must begin earlier, and real-world evidence collection needs to be ready at launch. Companies prepared to move as quickly as regulators stand to gain significant advantages in market positioning and payer relationships.

While critics raise legitimate concerns about balancing speed with safety, the FDA has increased post-market surveillance investments by 25% over five years. For pharmaceutical executives, the strategic imperatives are clear: track fast-track opportunities, frame products with strategic urgency, prepare for accelerated lifecycles, and build narratives that align with administration priorities around health equity and domestic manufacturing. As the landscape evolves, one question remains for every pharmaceutical leader: are you ready to move as fast as your regulators?

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.

Episode Transcript

Speaker 0 (00:00):
Welcome to Postscripts, the podcast
exploring what happens afterthat first prescription.
We cover the latest innovationsin patient access, support,
digital tools, HCP engagementand pharma marketing that we all
hope drive better outcomes forpatients.
This podcast is forinformational purposes only and
does not constitute any medicaladvice, nor should it be used
for any clinical decision-making.
Patients should always contacttheir healthcare professionals.

(00:23):
Welcome to the podcast.
My name is Brian Carr with theMedisave team, although any of
my opinions expressed here aremy own and not those of Medisave
or its partners.
Hey, what we're talking abouttoday is in this era of growing
public demand for faster access.
What's happened is the USadministration is following
through with faster FDAapprovals for products and
medications, and we have aconcrete example of it.

(00:44):
That happened this week.
So let's talk about it realquickly.
What we're seeing here is thatthe White House really is
pushing for aggressive work bythe FDA to expedite time to
market reviews, et cetera, etcetera, and what they're seeing
here is anywhere from what usedto take 10 months to 12 months
is almost cut in half with someof the approvals.
You know whether it's cancertherapies and these novel
nicotine alternatives, nicotinepouches we'll talk about that in

(01:05):
a second, the government reallyis pressuring and reshaping the
pace and pathway to get marketclearance, which can affect
patient access teams, supplychains, even marketing teams, as
their time to market may haveaccelerated by 50 percent in
some cases.
So it's not theoretical and thepoint of this podcast is it
really is happening.
Even as far back as the Bidenadministration had told the US

(01:26):
FDA to really have a more rapidreview process for really
certain health related productsand it really is influencing
product approvals at record pace.
You know, one of the unwrittenthings that came out of a lot of
the US administration'sexecutive orders this summer,
like the fourth bullet point wasthe FDA and the EPA are being
directed to expedite approvalsfor certain products that are

(01:49):
proposed by major pharmacompanies and actually
distribution plants and anyproduction facilities as they're
being built in the US need tobe expedited by the FDA and the
EPA.
That was the executive orderfrom one of the many things that
came out.
It was like a fourth bulletpoint, though didn't get
reported as much.
So we're digging into how thispressure is really materialized
into real regulatory outcomesthat changes really do matter to

(02:09):
our marketers.
Innovation leads access andeven execs.
So, according to the recentReuters investigation.
Reuters put out that the US FDAreally has been fast tracking
reviews of products likenicotine pouches in particular,
after direct pressure from theWhite House recently.
So the focus was initially onpublic health-centric,
non-combustible nicotinealternatives such as Zyn.

(02:30):
Z-y-n is the product.
It's a nicotine pouch asopposed to any tobacco smoke.
But the implications there onwhat they've fast-tracking for
nicotine pouches at the behestof pharma companies actually
does have implications to otherpharma companies.
No, I'm sorry, at the behest oftobacco companies can actually
be transitioned over to what'shappening for pharma companies
as well.
It's a broader governmentaleffort to really reduce

(02:51):
bureaucratic delays and gettingproducts that may serve public
health onto the market evenfaster.
Critics are going to questionthe balance between speed and
safety.
Industry leaders really do seean opportunity, especially in
the areas where some innovationrisks are getting lost in
lengthy, lengthy FDA reviewcycles.
So the usual FDA review processtypically spans 10 to 12 months

(03:13):
per phase and under pressure orwhen using expedited pathways
where they're seeing approvalsnow, can take closer to six
months, right Even less.
And what the agency has therights to do now is really
leverage some fast trackingmechanism, such as you know they
can give the medication or theproduct.
A fast track designation thatis intended for drugs and
products that really treatserious conditions, that fill an

(03:34):
unmet need.
They go to the front of theline, for example that's a more
colloquial way of saying it.
Or if it has a breakthroughtherapy designation for drugs
showing substantial improvementover available therapies already
on just their preliminaryevidence.
The priority review justshortens the review clock from
10 to 12 months down to aboutsix months, right.
So the use of these pathwayshas increased dramatically.

(03:57):
Since 2023 alone, 47% of the USnovel drug approvals used a
fast-track designation, 66%qualified for priority review
and 39% received a breakthroughdesignation and that comes from
the FDA itself in 2023, theirapprovals report.
So what's this mean for pharmastakeholders?
This really is an evolution,more than a regulatory trivia

(04:18):
here.
It's a shift that presentspotential acceleration in
go-to-market timelines,especially for treatments that
address public health needs orunderserved populations.
And you can imagine a scenariowhere, well, you know, hey, if
you're a pharma company andyou're building a new pharma
plant in Virginia, for example,or you've got a new R&D facility
that you've promised, thatyou're building in the San
Francisco area, that, oh, by theway, I've got some medications

(04:39):
that are also, we think, worthyof priority review or fast
tracking.
You can imagine where thegovernment would take a more
favorable review of those to getthem to the front of the line
than companies that may be suing, for example, the
administration over some oftheir tariffs or guidelines.
So I'm not saying that'shappening, but you can just
imagine those scenarios,especially if you've been in the
US for the past few months.
So let's look at a case study.

(05:00):
So these nicotine alternativeswhat's happening there is really
does signal a shift.
So you've got the Swedishcompany that has ZYN pouches.
It's a product design, it's anon-combustible nicotine
delivery system, so it's a pouchyou put between your lip and
gums, right.
So Reuters is reporting thatafter internal White House
meetings, the pace at which theFDA actually started reviewing

(05:22):
those pouches they call itsignificantly increased, and the
implication is theadministration is willing to
trade time for potential impact,a philosophy that could soon
bleed into approval strategies,like I said, for everything from
diabetes medications tobiosimilars.
So for pharma innovation teams,this sends a powerful signal.
Pairing robust clinical evidencewith urgent public health
framing may unlock a fast trackjourney through the regulatory

(05:46):
channels in the US, has economicand access implications right,
so faster approvals can producesignificant downstream savings
across the healthcare'secosystem.
So, for example, according toHealth Affairs did an analysis
that's showing that new Medicarenew medications reaching
Medicare beneficiaries just sixmonths earlier has the potential
to save one and a half billionbillion a year through decreased

(06:08):
hospitalizations and optimizeddisease management.
Even the Tufts Center for theStudy of Drug Development
estimates 15% savings can beachieved for every quarter
shaved off the average drugdevelopment timeline due to
decreased R&D burn rates andcommercialization drag.
So for patient access leaders,this represents two
opportunities.
Access leaders this representstwo opportunities.

(06:30):
One, improve health outcomesthrough early product unity and
demonstrate clear pharmaeconomic value to payers.
So when you support withadherence tools and wraparound
support programs, the net ROIstands to improve even more.
So what's in it for the pharmamarketer here?
So the angle is from launch tolift.
You see, expedited reviews canreshape the traditional launch
runway.
Earlier approval meansmarketers must really be ready

(06:50):
to accelerate their owntimelines for strategy
development, educationalinitiatives and stakeholder
engagement.
Brand teams in particularshould consider agile messaging
development as regulatorytimeframes.
Compress Campaigns must beflexible, fast iterating Earlier
patient engagement as well, sothat awareness isn't just
reactive to launch butproactively builds demand ahead

(07:11):
of launches we're seeing a lotof that where I am and then
real-world evidence readiness tosupport payer discussions at
the moment of launch.
If pricing and access decisionsneed to be made on a shorter
fuse, you're going to need moredata immediately once the launch
happens, from digital tools.
Digital platforms can give thaton real-world data coming back.
So an expedited approvaldoesn't just change when the
drug gets to market, it changesstrategies that need to land

(07:34):
across the provider, payer,patient ecosystems.
Some caveats here, though, too.
Right, so you're balancingspeed with safety.
Of course, no discussion iscomplete without acknowledging
those risks.
Right, the expedited pace ofapprovals.
Strong criticism of some publichealth advocates warning of
premature market entries withoutthe sufficient long-term data
right.
But the FDA counters that.

(07:54):
They insist that theaccelerated approvals doesn't
mean it's being reckless.
In fact they're saying theyhave bolstered their post-market
surveillance investmentsPost-launch.
It's out there.
They say they've increasedthose investments, you know, 25%
or more in the past five yearsto really monitor safety once
the products are in the realworld.
So that came from their budgetjustification last year.

(08:15):
So for pharma leaders, thisunderlines the undergoing
responsibility to engage aproactive pharmacovigilance and
transparency, particularly forbreakthrough drugs pushed
through under regulatorypressure for breakthrough drugs
pushed through under regulatorypressure.
So what are some of thestrategic takeaways for pharma
teams?
Well, if you're leading accessmarketing, commercial innovation
, there's four key strategies toconsider.
One, track those fast-trackopportunities.

(08:36):
Monitor where your pipeline canintersect with expedited review
pathways.
Align early, obviously, withthose FDA regulatory teams.
Two, frame with strategicurgency any of your collateral
and applications right.
Whether it's a rare disease,mental health, chronic illness.
Ensure your messaging reallydoes tie to that broader,
systematic and systemic impactthat matter to regulators right.

(08:57):
Three, prepare for thataccelerated life cycle right so.
Compress internal timelines forHCP education, field force
access support digitalonboarding and your launch
planning can be significantlycompressed up to 50%.
Right.
Build White House relevantnarratives right.
So, like it or not, policy andpublic health narratives matter,

(09:18):
right.
So make it easy for yourproduct to ride on these macro
trends we're seeing on healthequity, crisis response pricing
right.
So if you've got a plant that'sproducing it in the US, the
pricing can go down based on nothaving to pay tariffs that may
be coming on drugs that areimported to the US.
So all that can be part of, andexpected to become part of,
that messaging right Made in theUSA could be coming to your

(09:39):
pharma box and prescriptionssoon.
So the FDA is influenced bypolitical leadership, part of
public health demands.
They are really rewriting therules of speed and regulatory
affairs.
Products that could be trappedin red tape may now found
pathways to patientssignificantly faster, but only
if pharma is equally ready toact.
Think about the economicimpacts to patient access
commercialization timelines.

(10:00):
The trend really does offermore of the convenience.
It's an inflection point thatmay reshape how pharmaceuticals
bring innovation to life.
So the question for everypharma exec, brand, lead,
patient officer listening is areyou ready to move as fast as
your regulators?
Anyway, thank you for joiningus on Postscripts.
If you found this conversationvaluable, follow or subscribe
for more insights at theintersection of pharma tech

(10:22):
patient impact, access, supportand outcomes.