Transparency at Risk: FDA's Move Away from Advisory Committees

A seismic shift is underway at the FDA that could fundamentally alter how drugs reach American patients. Recent reporting reveals the agency is dramatically scaling back its use of independent advisory committees—consulting external experts on just 3% of medications this year, down from the historical 20-50%. This quiet revolution prioritizes efficiency but raises profound questions about transparency and public trust.

At stake is a decades-old system designed to provide objective external scrutiny of new medications before they enter the marketplace. These independent panels, comprising clinicians, researchers, and patient advocates, have traditionally offered crucial scientific perspectives beyond what FDA staff might present, created transparency through public meetings, and helped mitigate risks through peer review. Now, as the FDA increasingly bypasses these committees to streamline approvals, pharmaceutical companies face a complex new landscape.

For pharma executives, the implications are far-reaching. While faster approvals mean quicker time to market and potentially earlier revenue, they also create heavier post-marketing surveillance burdens when external scrutiny happens only after launch—if at all. Marketing teams may struggle with physician skepticism about drugs approved without traditional peer review, while patient access teams could face more challenging payer dialogues about comparative efficacy and value. Most concerning is the potential erosion of patient trust, as public hearings have historically provided rare windows into how approval decisions are made. With research showing that 74% of Americans support advisory committee use for novel drugs, pharmaceutical companies must now consider how to fill this transparency gap proactively—through open science initiatives, robust real-world evidence programs, and enhanced digital tools for monitoring outcomes and patient experiences post-prescription. 

The fundamental question facing our industry now becomes: how do we maintain credibility when regulatory review becomes less visible? Whether you're developing launch strategies, designing patient support programs, or building digital health solutions, addressing this challenge will be essential for success in this new regulatory era. Join us as we explore the profound implications of this regulatory shift and the opportunities it creates for innovation in patient-centered approaches to drug development and commercialization.

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 1 (00:01):
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 really
drive better outcomes forpatients.
We hope this podcast is forinformational purposes only and
does not constitute the givingout of any medical advice or it
should be used to influence anyclinical decision making.

(00:21):
Patients should always consulttheir healthcare professionals.
Hello, welcome to the podcast.
My name is Brian Carr for theMedisafe team, although any
opinions expressed here are myown and not those of Medisafe or
its partners.
So we're seeing a landscapeshift here.
Proposed FDA changes and whatmay happen to industry
implications.
This month came out of stat.
News actually broke the storythat the FDA is actively

(00:43):
considering significantreductions in its reliance on
independent advisory committeesin reviewing new drug
applications.
This is long considered acornerstone of transparency and
objectivity in US drugevaluation.
These independent panels.
Historically they play acritical role in deciding which
treatments go to market and whenright.
But now the FDA appears to bestepping back from this

(01:05):
decades-old model.
In the first half of this yearalone, the agency sought the
opinion of these externaladvisory committees and only 3%
of the medications it evaluated.
It's a sharp drop.
It's usually in previous years,and 20 to 50% of the new drugs
required such an advisory boardreview, and the implications of
the shift are pretty enormous,not just for regulatory

(01:26):
professionals or clinicalaffairs teams, but think about
pharma marketers, access teams,innovation execs, security and
IT and, ultimately, patientsthemselves.
So why did these committeesmatter until now, right?
Well, let's explore the changingand what it means.
First, let's understand whatadvisory committees are and the
role they traditionally playedin the FDA approval process.
They typically consisted ofindependent experts clinicians,

(01:49):
researchers, patient advocates,right who examined the data
supporting a particular drugapplication in their therapeutic
area and offered non-bindingrecommendations to the FDA.
Of this extra layer of scrutiny, credibility and transparency,
when a particularly complex orcontroversial drug was up for
review, the committees couldoffer one scientific perspective

(02:10):
beyond what the FDA staff maypresent.
Two transparency through publicmeetings and documentation, and
free risk mitigation in the end, right through peer review and
dissent when necessary.
Now, however, according to StatNews, this internal FDA
efficiency concerns now may beleading to reviewers just to
simply bypass the panels,particularly when drugs show

(02:31):
clear data.
Commissioner Robert Califf hasacknowledged public sentiment
about quote diminishing advisorycommittees.
End quote.
But he says the FDA is workingto rebuild trust in these events
selectively.
So now we're into thisefficiency versus transparency
debate, right?
So let's unpack that essentialquestion Are faster approvals
better if transparency suffers?

(02:53):
Right, so the accelerationmight be celebrated by
commercial teams.
Right, looking to rapidly bringproducts to market After all,
every day a drug is not in themarket represents theoretically
lost opportunity for bothrevenue and an unmet patient
need and impact.
That could help that patientright, and indeed the FDA has
increasingly prioritizedpathways such as the accelerated
approval and breakthroughtherapy designation to offer

(03:14):
quicker access.
So, for example, even between2012 and 2022 or so, 38% of the
drugs approved by the FDA usedthese expedited reviews pathways
, and that's according to theFDA itself.
And during this time, themedian FDA approval time across
all drugs fell to just about 10months, and that comes from a
study that Tufts did.
So in removing advisorycommittees for more of these

(03:37):
decisions, critics argue the FDAis risking, you know, eroding
public confidence, especiallywhen drugs are approved without
advisory input could later befound to be problematic or have
mounting safety concerns.
So what's this mean for pharmaexecs, right?
So if you're running a leadingpharma brand, or innovation
sprints, or designing patientsupport strategies, well.

(03:58):
One faster time to market.
From a purely operational lens,the proposed changes offer an
opportunity to really reduceunpredictable delays.
Advisory committees oftenextend application timelines by
one to three months, dependingon scheduling and feedback loops
.
Without those sessions,typically brand teams can set
earlier product launches andconcentrate their resources

(04:19):
accordingly.
Two higher risk profile, thoughright.
So, however, without all thatexternal scrutiny, the
post-marketing burden ofpharmacovigilance really becomes
heavier.
That places a little bitgreater ownership on medical
affairs, patient safety and thereal-world evidence teams to
monitor, track and reportongoing safety data.
So you know, you look at thisnew normal.

(04:41):
The post-approval surveillancetools and real-time patient
dashboards are going to becomeessential when the first exit
external review happens, youknow, only after launch.
Right, if at all.
Right Three trust and messagingchallenges.
Right.
So, from a brand marketing lens, introducing a drug approved
under a non-traditional reviewprocess can present a stigma in
the marketplace.
Theoretically right.

(05:01):
Even among HCPs and payersparticularly HCPs who typically
are all about what's the peerreview study say about it.
Right, teams may need tobolster their messaging strategy
to clearly define studyprotocols, endpoints, safety
narratives, since a public quotereview no longer reinforces
those points.
Right.
Four value demonstration inaccess pathways.

(05:24):
So for patient access andreimbursement teams.
The shift may impact payerdialogues about medical
necessity, comparative efficacyor uncertainty around long-term
benefits.
Payers and PBMs closely trackdrugs with limited advisory
oversight and may alter prior,off or step therapy design.
So being proactive withpharmacoeconomic and outcomes is

(05:45):
modeling and forecasting isgoing to be crucial the voice of
the patient.
So transparency and trust do gotogether.
From a patient standpoint,advisory committee hearings have
been one of those rare momentsthe public gets a window into
how drug approval decisions areactually made.
Many hearings include patienttestimonials or data presented
on patient-reported outcomes.
They've also historicallyprovided a stage for patient

(06:06):
advocacy groups to reallyendorse or challenge new
therapies and rare diseases orcomplex conditions.
So for many Americans,particularly those with chronic
illnesses or a few options,these hearings really do offer
hope and representation.
Skipping them risks turning youknow, arguably a drug approval
into a black box of, you know,of no transparency.
So there's a challenge there,right?

(06:27):
So, for example, surveysconducted by the Pew Research
team in 2022 found that 74percent of Americans supported
advisory committee use whendrugs are new or novel.
24% of Americans supportedadvisory committee use when
drugs are new or novel.
63% of respondents said thepublic hearings increased their
confidence in how the FDAevaluates treatments.
So for this reason, even if theFDA streamlines advisory

(06:48):
participation, pharma teamsshould consider maybe
voluntarily hosting open sciencedays or clinical data webinars
for patient groups, hcps andpolicymakers.
Such confidence building, youknow it really has to be
deliberate.
There may be legal, ethical andsecurity ramifications and for
those in pharma, it and securitythe shift is going to matter
because reduced advisoryoversight increases the

(07:08):
sensitivity of internal trialdata, especially if the external
review is skipped and someissues are only spotted
post-market.
So cybersecurity risk toclinical findings, trial
protocols and post-marketingsurveillance data is higher when
real-time feedback fromadvisory boards isn't factored
into the mitigation plans.
So security and regulatoryleaders really across pharma

(07:30):
must consider where patienttrust and internal control
systems intersect and whetherrobust data governance
frameworks can stand up to afaster, more insular FDA
workflow.
So you know, think oftechnology's role in this new
approval paradigm.
As the FDA repositions itsstrategies, these digital
therapeutics, patient supportplatforms, including Medisafe

(07:51):
and others, you know, becomeeven more critical when a drug
enters the market withoutexternal committee vetting.
Tools can really act asfrontline channels for real-time
adverse event tracking insights, adherence data as part of a
safety signal analysis, patienteducation tailored to therapy,
explanations and expectations.
Patient efficacy, ie they knowmore about their treatment and

(08:14):
their journey and they becomemore educated about it, as
opposed to simply knowing theyneed to take a medication.
So if fewer external eyes areon the front end, the
post-launch patient experiencereally needs to capture faster
signals, provide clarity andestablish a stronger
bi-directional communicationpath between brand provider and
patient.
And transparency doesn't stop atapproval and technology can

(08:34):
fill that gap right.
So, looking ahead, thestakeholder checklist regardless
of whether these FDA proposalsbecome policy, life science
leaders should really startpreparing their organizations
now.
Patient support leaders designonboarding and education
journeys that really anticipatesome skepticism or unknowns
around time to market Brandmarketers develop science-first
narratives.
Train field teams to articulatedata transparency teams to

(08:59):
articulate data transparency.
The access and market accessteams.
Get ahead with thecomprehensive HEOR models or
payer readiness and safetyconcerns.
Post-launch Medical affairsreal-world evidence teams.
Allocate more resources to thereal-world signal detection and
engage in ongoing dialogue withKOLs and advocacy groups.
Cybersecurity IT teams considerresilient strategies to protect
clinical and post-market datain a low oversight environment.

(09:21):
Conclusion here, at crossroadsfor FDA and pharma leadership,
this nature of drug evaluationis changing, with clear signals
that the FDA is moving toward aleaner, more internally driven
process.
While that gains in speed maycost in trust.
So unless pharma really stepsinto that transparency gap for
every brand, team, innovation,sprint or market access
initiative question now becomeshow do we prove credibility when

(09:44):
review is less visible?
Advisory committee usage may bereduced, but patient provider
and policymaker demand for openscience does remain constant.
It's up to industry leaders toadjust their launch strategies,
communications plans, patientsupport frameworks and
regulatory behaviors to reallybuild that trust proactively.
And when you have toolspost-prescription like Medisafe
and others that really areembedded in treatment juries,

(10:04):
there's an enormous opportunityto monitor the outcomes in a
rich patient experience, even inthis new decentralized future.
I've got plenty of stats andreview sources here from this
podcast, so thank you very much.
I'll put them in the show notes.
Thank you for joining us onPostscripts.
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