Why Federal Agencies Are Targeting Executives

Send us Fan Mail

Federal enforcement is changing. Regulators aren’t just going after companies anymore. They’re naming CEOs, CMOs, heads of clinical, quality, and operations in consent decrees and injunctions. Once your name is on that document, it follows you for years and shapes your career.

In this episode we unpack:

• Why enforcement has shifted toward individual accountability
• How repeated compliance failures trigger personal liability
• Data integrity and why it matters more than ever
• Why clinical research and telehealth are now in regulators’ crosshairs
• What personal obligations look like inside a consent decree
• What executives should be doing now to protect themselves

If you lead in an FDA-regulated space, this one matters.

Get show notes and resources at www.kulkarnilawfirm.com

Subscribe for weekly breakdowns of enforcement trends that actually affect you.

Support the show

www.kulkarnilawfirm.com

Episode Transcript

Darshan (00:00):
We're talking about a topic that absolutely every CEO,
CMO, head of clinical, andquality needs to hear.
What if a consent decree followsyou and not just your company?
Federal agencies have repeatedlyshown that when they lose
confidence in leadership, theylook to escalate beyond the

(00:20):
organization.
They want to attach obligationsto the actual people by name.
Let's talk about why thishappens, what it means, and how
you protect yourself.
Federal pattern, why areindividuals being named?
Recent injunction and consentdecree cases, courts didn't just
include the corporation.
They named the president, theexecutive in charge of your

(00:41):
operations, or the individualresponsible for compliance
oversight.
This shift didn't come out ofnowhere.
Federal agencies have spent thelast decade sending the same
message.
You can delegate tasks, youcannot delegate responsibility.

(01:18):
When those people get named, thedecree becomes part of the
professional life no matterwhere they go next.
So let's talk about when dataintegrity collapses and personal
liability rises.
Another major case that we justsaw involved widespread data
integrity issues spread acrossboth the US and Indian

(01:38):
operations.
Once again, enforcement didn'tjust fall on the corporation.
It included personal obligationslike oversight by independent
experts, mandated internalreorganization, accountability
for truthful submissions,ongoing reporting, and heavy
financial penalties.
This one was interesting becauseit actually established a new

(02:00):
office, an office of datareliability, something that we
may want to consider as weconsider going forward.
This will be led by a newexecutive, it will be supported
by a hotline, and by third-partyaudits.
When the government loses trustin the data, they stop
distinguishing between corporatefailures and leadership
failures, and that's when yourname can appear in decrees.

(02:22):
So why clinical research andtelehealth?
Why are these at risk now?
A lot of leaders believe thatconsent decrees only happen in
manufacturing.
They don't.
Not anymore.
Federal enforcement is lookingat systemic protocol violations,
investigators not beingsupervised, missing safety
reporting, inadequate vendoroversight, and this one's come

(02:43):
up a couple different times.
Telemedicine prescribing issues,poor audit trails and
decentralized trials,compounding activities outside
legal limits.
And again, we've seen multiplecases involving state attorney
generals in that case as well.
Any of these persist acrossinspections and audits,
leadership becomes fair game.
Think about telehealth companieswriting prescriptions at a scale

(03:05):
without proper documentation.
Think about decentralized trialcompanies with no verifiable
chain of custody.
Think about CROs runningprocesses that the sponsor never
verifies.
And this is what turns corporateviolations into leadership
accountability.
So what does personal liabilitylook like?

(03:25):
When your name is in the consentdecree, you're not dealing with
theoretical risk anymore.
It's a real life, day-to-dayresponsibility.

SPEAKER_00 (03:35):
Enjoying our content, we'd love to hear more.
Please like, comment, share, andfind more.

Darshan (03:43):
It can impact your restrictions on your ability to
run or supervised operationsbecause you may not be allowed
to oversee manufacturingclinical processes until
remediation is approved.
You may be looking at mandatorycertifications signed under
penalty of law, and youpersonally verify corrective
steps.
You may need to have directcommunication with the FDA and
you become a point of contactfor all oversight.

(04:05):
There may be personal financialexposure, and that may apply to
the executive and not just thecompany.
You may be looking at multi-yearfederal supervision, and these
decrees can last five years ormore and explicitly attach to
individuals.
And this can actually impactfuture job responsibilities in
an FDA regulated space.
And that's why proactivecompliance isn't just nice to

(04:27):
have, it's now becomingself-preservation.
Now nobody ever says, I hopetoday's the day I become
personally named in a federalinjunction.
And if they did, you know what?
I'd recommend therapy.
Maybe yoga, maybe KO.
I don't know.
But humor aside, that's exactlywhy compliance is something that
leadership has to activelychampion.
And it's not something that'sdelegated, then forgotten.

(04:49):
If the company fails repeatedly,federal agencies are going to
start looking at the person withthe authority to stop it.
So here's what you want to lookat.
This is straight from the KLFplaybook.
So treat every warning letterlike it's a final warning.
It's not a suggestion, it's nota friendly note, it's a warning.
You want to fix systemicproblems.
These are not symptoms.

(05:09):
You want to go after the rootcause of the problems
themselves.
So if something shows up inconsecutive inspections,
leadership gets the focus.
Strengthen data integrity.
We just saw that they'reactually naming new offices
based on this.
Whether it's manufacturing,research, telehealth,
compounding, you want an officeof data research, data
integrity.

(05:30):
Build true oversight into yourdecentralized and telehealth
models.
Audit trails matter.
If your data is not traceable,regulators will assume the
worst.
I did a podcast recently andeven had a newsletter about how
data chains need to startmattering and we need to start
tracking data.
Document leadership involvementand compliance.

(05:51):
You want a record that shows Ilooked, I acted, I funded, I
verified.
Validate vendors like they'repart of your company because
they mess up repeatedly, you'restill responsible.
This is where my team comes in.
We work with CEOs, CMOs, headsof clinical and operations to
help create compliancestructures that will stand up to
real inspection pressure.

(06:12):
It means executive-levelcompliance reviews, mock FDA
audits, and again, this mightalso include DOJ and HHS audits,
vendor qualification frameworks,clinical oversight, promotional
compliance guardrails,telehealth prescribing and
documentation, investigating andeliminating root causes before
regulators find them.
If you want to make sure thatyour name doesn't appear in a

(06:34):
consent decree, bring us inearly.
Visit www.clcarneylawfirm.com,schedule a consult.
As you can tell, complianceisn't just about legal, it's
operational.
It's data-driven, it'sdocumentation driven.
And that's where Ceres comes in.
Ceres gives your team acontrolled way to share
documents, to trackinteractions, to maintain audit
trails, to identify riskhotspots, and ensure that what

(06:57):
you think is happening isactually happening.
Whether you're running clinicalops, telehealth programs,
metaphors workflows, or vendormanagement, Ceres lets you see
the full picture.
If you don't have a structured,traceable compliant system,
that's the risk federal agencieslook for.
Saris helps eliminate thatuncertainty.

(07:19):
Follow our page on LinkedIn.
Consent decrees are evolving,they're becoming personal, and
federal agencies have shown thatthey're willing to name
individuals in leadership roles.
If this scares you a little,good.
It should.
That's exactly why theseagencies are going after
individuals.
Because the solution is withinyour control.

(07:40):
You want to support yourcompliance teams.
And the compliance teams, if youdon't have that support, you
have a problem.
You want to fix your problemsearly.
You want to use tools like SARSto keep everything auditable.
You want to work with KLF toensure that operations will
withstand scrutiny and then stayahead of the enforcement curve.
Call, click, or email.