April 28, 2025 • 30 mins
Community DC Host Dennis Glasgow speaks with the United States Drug Enforcement Administration's Matt Strait, who is a Deputy Assistant administrator in DEA’s diversion control division and Kerry Hamilton, who is also a Deputy Assistant administrator in DEA’s diversion control division, and covers policy about the DEA’s latest initiatives and some of the great success stories they have regarding regulatory drugs and medications with the millions of agencies that they work with to be compliant for the consumer and you at home.
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Episode Transcript
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Speaker 1 (00:07):
Good morning, and welcome to another edition of Community d C.
I'm your host Dennis Glasgow. This morning we get our
first ever opportunity to speak with the United States Drug
Enforcement Administration and guests Matt Strait, who is a Deputy
Assistant Administrator and DEA's Diversion Control Division, and Kerrie Hamilton,
who is also a Deputy Assistant Administrator in DEA's Diversion
(00:28):
Controlled Division and covers policy. We'll talk about the DEA's
latest initiatives and some of the great success stories they
have regarding regulatory drugs and medications with millions of agencies
that they work with to be compliant. For the consumer
and you at home. Here's my conversation with Matt and Cary.
I hope you enjoyed as much as I did. Matt
and Carrie, Good morning to both of you. Welcome to
Community DC. Mariti, well, I'm sure happy to have you guys.
(00:52):
This is my first opportunity to talk to the DEA,
and I'm obviously very intrigued to you know, being in
the media, sports and news, I hear about you. But
I think a great lesson for our listeners besides talking
about all the cool things that you and your team
do when it comes to Fenton all on drugs and
everything is to talk about exactly what the DEA does,
because I think everybody's heard of it, right, But when
(01:12):
it comes to Matt what you do? I know it's layered.
There's a lot of people there. Probably gets a little
complicated for layman like myself and some of our listeners.
But just if you were to give a thirty thousand
foot view overall what the DEA does, what would you tell? Yeah? Sure, Dennis.
Speaker 2 (01:24):
Well, first of all, we're about a nine thousand person organization.
We are fortunate enough to have a single mission, which
is to prevent the misuse or the abuse of all
sorts of substances that can be abused and that can
have devastating consequences on families nationwide and communities of course,
(01:46):
as we'll talk about at some point today. But within
DEA there's a couple of different components. Carrie and I
both work in our Diversion Control Division, And the Diversion
Control Division is actually the regulatory arm of the DEA,
and what we do is we regulate what is called
(02:08):
the drug supply chain. So these are all of the
folks from the manufacturers and importers and exporters of what
we call controlled substances. These are substances that can be
misused or abused. Wholesalers, distributors, pharmacies, hospitals, doctors, physicians, assistance
(02:30):
nurs practitioners. We regulate that entire supply chain, and we actually,
through the process of what's called registration, where we issue
a license to all of these entities, we create what
we call a closed system of drug distribution. That closed
system of drug distribution is what we really seek to regulate,
(02:51):
because what we're trying to do is to prevent the
diversion of these legitimately made, these lawfully obtained control old substances.
These are prescription drugs like oxycodone, OxyContin, things like vicodin,
things like xanax, valium, ADHD, medicines like concerted Riddlin. Well,
(03:15):
what we do is our goal is twofold. On the
first side, we seek to prevent, detect, and investigate instances
where those legitimately made substances leave that controlled system of
drug distribution.
Speaker 1 (03:33):
And then kind of.
Speaker 2 (03:34):
Most importantly, or at least in my opinion, very importantly,
is we also seek to ensure that there's an adequate
and uninterrupted supply of those substances that are necessary to
meet the legitimate medical scientific needs of the United States.
Speaker 1 (03:51):
Okay, and carry you want to expound on that a
little bit.
Speaker 3 (03:53):
Yes, I think a lot of times when the public
thinks of the Drug Enforcement Administration, they think about the
enforcement arm of the agency. As Matt said, we're more
of a regulatory arm. However, we do have some crossover
with the enforcement side. So under diversion control, as Matt said,
we have a closed system of distribution, and that's a
(04:14):
mechanism that allows us to track controlled substances from the
time they are produced until the time they reach the
end user. So we do conduct inspections of DEA registaurants
that would be manufacturers, distributors, pharmacies, hospitals, entities like that. However,
we also do cases that involve civil penalties and criminal
(04:39):
cases as well. So you might have a doctor shopper,
or you might have a drug trafficking organization that is
distributing oxycodone or drugs like that that are legitimately, legitimately
manufactured that go outside of that closed system of distribution,
(04:59):
and we are also responsible for handling those types of cases.
As well, So we do some of the same work
that the agents do, but our focus is primarily on
the regular story piece.
Speaker 1 (05:10):
Okay, well that makes a lot of sense, And this
is for either of you, I think, to give maybe
a little context to our listeners. I know that data
and knowledge's power is always a really big deal, and
you guys obviously work with so many different kind of
entities out there, so I imagine the numbers are big
of the different kind of types of entities that you
work with. But maybe for context, Matt, can you give
us some kind of data that you work with to
(05:31):
give us some context about how it works of what
you do.
Speaker 2 (05:33):
Well, first of all, fair to say we have two
point two million registrants and as a as a nine
thousand person organization, obviously making sure that we have data
to drive all of our decision making. It's just foundational
to the program. When you're regulating that many entities and
(05:55):
ensuring compliance across that entire supply chain, having data driven
solutions is absolutely key. So the Controlled Substances Act, which
is the law that we enforce, requires our registrants, based
on their specific business activity, to maintain certain records and
(06:18):
to submit certain types of reports to DEA, and it's
through the accumulation of that of those reporting obligations that
we are then able to really kind of understand how
these controlled substances are moving through the drug supply chain.
So kind of foundational to that system, that system is
(06:39):
a system by which manufacturers and distributors report their sales
and their purchases of all sorts of the most frequently
misused controlled substances.
Speaker 1 (06:51):
In the United States.
Speaker 2 (06:53):
And through that system of capturing like millions of transaction
level reports on sales and purchase of control substances from
manufacturers to distributors down to hospitals, we're actually able to
see how the drugs are moving through the supply chain.
But then other things we have obligations, like our suspicious
(07:16):
order reporting system, and this is where under the Controlled
Substances Act, our distributed all of our registrants are responsible
for developing systems that are used to identify suspicious activity.
And so when there is a suspicious activity which Congress
(07:38):
has defined by statute, they're obligated to report that.
Speaker 1 (07:41):
To the DEA.
Speaker 2 (07:43):
So in that way, I always like to talk about
the fact that our registrants are a force multiplier for
the DEA because their obligation if we're all in this
together and we're all partnering to really ensure the safety
of the American public, like, the only way we can
do that is by working together with our registrants. So
(08:05):
the suspicious order reporting system is foundational to that because
they're now basically eyes and ears on the ground identifying
suspicious activity reporting it to us, which could then turn
into some kind of investigative matter that we have to
then pursue.
Speaker 3 (08:22):
Okay, Kerry and I think oftentimes people have the misperception
that the relationship between the DEA and the registrant population
is adversarial, but that's not the case. As Matt said,
we want to work together to ensure the health and
safety of the American public, and to also ensure there's
(08:42):
an adequate supply of the medications that the public public
needs and that they have a legitimate need for as well.
Speaker 1 (08:49):
Sure, well that makes sense, guys, in my role, and
I'm a sports person, So there's two different kinds of
sports people with talk show host and then people that
cover the beat, and the person that covers the beat
will go out and search out a story on their
own and be very proactive about that, about the behind
the scenes of that person, what their family life is,
all those kind of cool things, and maybe we don't know.
(09:11):
And then there's the game that happens, and then I
react off of that game, and I've got my opinions.
So with that analogy, I'm curious because there's so many
moving parts of what you guys do. Do you guys
have to react more or are you more proactive of
what you do? Or is it both?
Speaker 2 (09:26):
Yeah, I think we have tried over the last decade
or so to really move away from being reactive to
a proactive stance. And I think that's the goal of
every regulator, probably in the federal government or in state
government for that matter, is to anticipate the challenge so
(09:48):
that you are not reacting to it. But I think
that just the nature of this business does require a
little bit of both. Like in some instances, and Carrie
is the kind of lifelong investigator, so I'll certainly defer
to her on this, But in many instances, you are
(10:09):
presented with information that you then have to react. But
I think if we're doing our jobs best and we're
utilizing our resources and the most efficient way possible, the
goal is to try to do things proactively rather than reactively.
Speaker 1 (10:25):
Right, Kerr, you want to expound on that a little
bit for us, great.
Speaker 3 (10:28):
We are both reactionary and we also try to be proactive.
On the reactionary side, we have to be nimble because
there are so many new substances that pop up all
the time. So there are new and emerging substances. We
have to be ready for those and be ready to
handle those new substances and things that we're seeing on
(10:48):
the street. On the proactive side, I think probably just
interviews like this and public outreach are a key tool
that we have to get the message out well.
Speaker 1 (11:00):
And I'm glad you're doing that because I think we'd
all agree knowledge is power, right, and when you kind
of have some context to what you guys do, I
think it's better for everybody. So, Matt, I'd like to
talk about the different kinds of drugs. I know you've
had twenty five years of experience, so I'm sure you've
seen just about everything this and I'm sure there's been
an evolution of drugs. But as I watch and read
and consume the news, fentanyl is always in the news.
(11:21):
I know, OPI it's been for the last couple of decades.
Those are the two big ones that I hear about.
What else is out there that you guys work on?
Speaker 2 (11:27):
So I think the opioid threat I think kind of
started in the two thousand and five two thousand and
six timeframe, really became an epidemic. I would say probably
around the twenty fifteen time maybe slightly before that. I
think that this nation has done a tremendous amount of
(11:49):
work at all levels, whether it's our registrant community and
doctors through their prescribing practices and through pharmacies and identifying,
you know, maybe illegitimate prescriptions and not filling them. I
think our registrant community has done a tremendous amount of
tremendous amount of great work trying to decrease the amount
(12:11):
of opioids that are here in the States which are
then potentially going to be misused. We have been absolutely
confronting the illicit fentanyl problem.
Speaker 1 (12:25):
Again.
Speaker 2 (12:25):
Another opioid analgesic, right, This one is a synthetic drug.
Whereas oxycodone and hydrocodone and morphine, these are what we
call semisynthetic opioids, but they're derived from a plant. But
I think the point is right now, on the opioid
side of the house, we're really concerned about illicit fentanyl.
(12:46):
But when we get beyond opioids, some of the other
drug classes that we are concerned about are going to
be anti anxiety medications, like some that I mentioned earlier,
which are going to be drugs like xanax, which is
the active ingredient is a drug called alpraisal lamb, and
then another drug called valium, which is another drug that
(13:08):
contains a drug called diezapan. These are benzodiazepines, the class
of drugs we're seeing a lot of a significant increase
in the prescribing of those medicines for anxiety type conditions.
And then, of course, another really important class of drugs
that we're monitoring are what we're seeing is a really
(13:29):
significant increase in the prescribing of stimulants. These are scheduled
to control substances containing drugs like amphetamine and methyl fenadate
and another drug called listex amphetamine, which are all widely
used in the United States and abroad in Europe and
in parts of Asia and South America to treat patients
(13:53):
with ADHD. But in the States we're seeing a specific
increase right now in new diagnoses of people with ADHD.
Speaker 1 (14:01):
Okay, well, I'm glad you brought that up. And this
is just a general question and probably some things you
can and cannot talk about. But once again, reading and
ingesting the news carry obviously our borders when it comes
to Mexico and Canada, we're keeping an eye on those
and that's where a lot of that is coming through,
but other countries too, and I'm curious when it comes
I'm sure the United States has its very own unique
(14:22):
system set up as compared to other countries. But when
it comes to what you two and your team do
for a living, and the thousands of men and women
that are doing out there to make sure everything is
regulated properly, how do we compare to the rest of
the world. Are we doing a great job? Are we
are we on an even even playing field? What can
you give us some context to the rest of the
world against the United States, either of you, there's something
(14:43):
there that we can compare it to.
Speaker 2 (14:44):
I would probably probably characterize our situation as I feel
like we're a bit unique compared to the rest of
the world. I think we are a large consumer country
when it comes to legitimate farm bmaceuticals. I do think
that our nation's focus on prescription opioids, we do have
(15:10):
a significant population of Americans with the disease of addiction
an opioid use disorder. And I think the point is
is that we see some of those who are not
accessing drug treatment drugs like you know, bubernorphine and methadone.
I think we do see them turning to the illicit market,
(15:32):
and we see a dea a significant amount of prescription
or I should say, pills that look like legitimate prescription pills,
which are actually what we call fake pills that are
coming across our southwest border into the States and then
being distributed to people who may or may not think
(15:54):
that they're getting a legitimately manufactured drug. That drug oftentimes
looks like oxycodone and then turns out having an active
ingredient in there, which is predominantly fentanyl.
Speaker 1 (16:06):
Right, So, Carrie, I'm worried and wondering about compliancy. I
imagine that once again we go back to that question
about you know, reacting and being proactive. I imagine that most
everybody is compliant, but when it comes to either you
getting a red flag about somebody out there or maybe
something you found. What's the process there? Just what you
(16:28):
can take us behind the scenes and of what you
do that if you find something that isn't the way
it should be. What does the team do with that point?
Speaker 3 (16:36):
Well, I think it's important to point out first that
out of those two point two million registaurants that we regulate,
a very small percentage of those are the focus of
our investigations. We try to ensure that those registrants are compliant.
It's not a gotcha moment where we go out there
and try and earnest to find something wrong. We want
(16:57):
to work with the registrant population and them into compliance.
When we register those entities, we explain to them the
record keeping and reporting requirements that they're required to follow
per the Code of Federal Regulations, and so it's our
job to educate and inform them so that they can
make informed decisions and so they can do the right thing.
(17:22):
When we conduct regulatory inspections, we go on site, we
take a look at the firm security, their record keeping,
We conduct an inventory of the controlled substances that are
on hand, and then we conduct what we call an
accountability audit. It's basically, for those of us who are
older like me, the equivalent of balancing a checkbook. We
(17:43):
see what they were supposed to have on hand initially,
then we take a look at their receipts and distributions,
and then we take account of what is on hand
on the day that we go out and we balance
the checkbook. We see if those receipts and distributions equal out.
If we do see an issue, there's a variety of
actions that we can take. We can start off with
(18:06):
administrative action. We might issue a letter of admonition to
the firm and ask them to respond in writing how
they're going to correct the situation. We have memorandums of
agreement that we've entered into with resistaurants. But if the
violations are severe enough, we can actually ask for an
order to show cause, where the firm has to go
(18:28):
before an administrative law judge and a hearing and explain
why they should be allowed to keep their DEA registration.
So we have a variety of actions that we can take.
We can also seek civil penalties or bring a criminal
case if necessary.
Speaker 1 (18:45):
Okay, well that makes sense, and guys, just from my knowledge,
because I don't know this is why I'm asking when
it comes to all the regulators, is everything under a
federal umbrella or when you go to each state, does
it complicate things a little bit? How does that part
of it work?
Speaker 3 (18:57):
So, depending upon what you're talking, there could be state
regulations that differ from the federal regulations. And what's important
to remember is the stricter of the two applies.
Speaker 1 (19:08):
Okay, Okay, that makes sense. So listen. The time that
this is airing, we're past the actual National take Back Day,
which was on Saturday, April twenty six. And the reason
that I bring that up, guys, I know that's an
important day. So Matt, if you could just get some
context of what it is, why you came up with
the idea, and what you're hoping to get out of it.
Speaker 2 (19:28):
Yeah, So, the National TakeBack Initiative, we are now doing
our twenty eighth bi annual event. We started in twenty ten.
Going back to the comment that I made earlier, back
in around twenty ten, we saw a lot of excess
prescriptions being written for opioids. Those opioids generally may have
(19:49):
been partially consumed by the patient but then found their
way in the home where they weren't being disposed. There
was not really clear guidance as to how they could
be sei and environmentally safely destroyed. And so the challenge is,
under the federal law that we enforce, the Control Substances Act,
(20:11):
a patient who is considered to be the ultimate user
under federal law is not authorized to actually distribute that
medicine themselves. And so the idea of actually getting that
substance out of the family's home and back to a
place where it could be destroyed is something that was
(20:32):
never contemplated under federal law, and it was actually something
that we went to Congress to ask force something I
had the benefit of being able to do back in
twenty ten, working with members of Congress to pass legislation
that would authorize, in a very unique circumstance, an ultimate user,
a patient, to be able to return that controlled substance
(20:52):
to that closed system of drug distribution for purposes of destruction.
And so what we did is that law passed in
around the twenty twelve time frame, twenty eleven time frame.
It took us a while to promulgate regulations that created
what today we know as our authorized collector program. We
(21:17):
brag extensively about the fact that we now have seventeen
thousand pharmacies and hospitals nationwide that are accepting unused, unwanted,
and expired medicines from patients three hundred and sixty five
days a year for purposes of destruction. We're now removing
those control substances out of the family medicine cabinet where
(21:40):
they could be misused by a friend or a family
member who happens to come upon them. But what's really
kind of neat is that during the pendency of that
regulatory drafting process, after we worked with Congress to pass
the law, the only accept that existed in the law
(22:01):
was for an ultimate user to return or to provide
a controlled substance to law enforcement. So from that exemption
that was built into the statute, our NTPI program was born.
And what we said is we think that this is
such a public health threat. Again in twenty ten, eleven, twelve, thirteen, fourteen,
(22:22):
that we said, during the time of this threat, we're
going to host these biannual events and we're going to
collect unused and unwanted medications. So our twenty eighth event
on Saturday, and we have collected nineteen point two million pounds. Wow,
across those across those last what fifteen or sixteen years?
Speaker 1 (22:44):
So could you give me some context? What was it
maybe when it started or last several years. I imagine
it's getting bigger and bigger and better in a more
positive range, But what kind of context and numbers are
we looking at.
Speaker 2 (22:54):
It's actually the exact opposite, which is what we're so
excited about. Okay, So before we had regulations in place,
or shortly after we had regulations in place, we didn't
have a robust number of partners in the pharmacy and
hospital space that was actually authorized collectors, and so as
a consequence, people really relied on the bi annual Dea
(23:18):
take Back Initiative as a means to get rid of
their unused and unwanted medications. But now with everyone recognizing
that they all have a role to play in addressing
our nation's opioid crisis, we've seen our pharmacies and our
hospital step up. They've implemented several thousand additional authorized collection
(23:40):
sites seventeen thousand to be exact. And the point is
is that now American citizens don't have to wait till
April or October to get rid of their meds. They
can go three hundred and sixty five days a year,
twenty four to seven to any one of these seventeen
thousand authorized collection sites. So we've actually seen our numbers
(24:02):
go down, and we actually think that rather than that
being a bad thing, we actually think that that's really.
Speaker 1 (24:08):
That makes sense. And I'm glad that you explain how
that works. But that's truly extraordinary that that many people
and pharmacies participate. I've had about five minutes left, so
I'd like to get the floor and some final thoughts
to both of you. So Carrie, I'd love to start
with you about what we've talked about, maybe what the
future looks like. But the floor is here, is Carrie
if you could start and kind of get some final
thoughts for everybody.
Speaker 3 (24:28):
Sure. So for the event that we've just had, we
had over forty three hundred law enforcement partners and sites
available to individuals to take their unused medication and dispose
of that. We use incinerators to dispose of the controlled substances,
and again I want to thank our law enforcement partners
for all they do to assist us with the National
(24:50):
Take Back Initiative. Those events collect a lot of medication.
But as Matt said, what we're seeing is that as
we increase the number of authorized collectors that are available
year round, individuals are turning in less drugs at the
national TakeBack initiative events, and that's what we want to
see happen to us. That's a measure of success. And
(25:13):
we also like to think that these take back initiatives
in these events or authorized collectors have also helped lead
to a decline in the overdose deaths that we've seen.
In the last few years, we've actually seen a decrease
in overdose deaths by twenty six point five percent.
Speaker 1 (25:36):
Wow, that's just extraordinary.
Speaker 2 (25:38):
Matt.
Speaker 1 (25:38):
You've got about two minutes left, so just some final
thoughts from you.
Speaker 2 (25:40):
I would want to leave the audience with that same
kind of, in my opinion, overwhelming statistic. For years, we've
been seeing this increase, this uptick in the number of
overdose deaths, and my god, we've been doing a ton
of work trying to decrease the number of overdose deaths,
whether it's been through expanding access to drugs like treatment
drugs like bubernorphine and methadone, and other overdose reversal drugs.
(26:05):
Like the loock zone and naltrexone. We've been doing a
tonnel work in that space. We have our NTBI event,
which seeks to remove kind of these excessive controlled substances
out of the family medicine cabinet. And you know, the
last year has just been remarkable, like Kerry said, at
twenty six and a half percent decline in overdose deaths.
(26:27):
And we recognize that we're not solely responsible for that.
We recognize that this is a whole of government approach.
This is beyond whole of government. This is also our
entire registrant community, which plays a big role and a
huge force multiplier for us. But we just can't be
happy enough with the debt, with the decline and overdose
(26:47):
deaths that we're starting to see, well.
Speaker 1 (26:48):
It's pretty extraordinary. And prep for the interview, I've been
on the website. It's easy to navigate. There is a
lot of information out there. But if you could, guys
could give the website to everybody to check it out,
because there's some really interesting data on there and I
learned a lot. So either of you can give the
website to everybody so they could check it out.
Speaker 2 (27:04):
Yeah, I would encourage everyone to go to www. Dot
dea TakeBack dot Com, which is all one word what's
great is there. You'll not only be able to see
the authorized collector program that we talked about, this is
the year round collection sites that are available and then
but bi annually, we also put on that website our
(27:25):
partner organizations and partner sites for the NTBI event, our
National take Back Initiative outstanding.
Speaker 1 (27:33):
Well, listen, guys, I could talk to you guys for
hours because we only hit the tip of the iceberg
about what do you actually do with your team of
incredible men and women out there? And I imagine at times,
just like any job, it seems thankless. But I want
to thank you guys and your team for all the
great work that you do behind the scenes that we
really don't know about that's happening out there to regulate
to make our country a lot better out there. So
I can't tell you how much I appreciate your valuable
(27:54):
time because I know both of you are busy. But
Madden Carrey, thank you so much for joining me on
Community DC. I really do appreciate it.
Speaker 3 (27:59):
Thanks having us.
Speaker 1 (28:00):
Thanks Dannis.
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Good morning, and welcome to another edition of Community d C.
I'm your host Dennis Glasgow. This morning we get our
first ever opportunity to speak with the United States Drug
Enforcement Administration and guests Matt Strait, who is a Deputy
Assistant Administrator and DEA's Diversion Control Division, and Kerrie Hamilton,
who is also a Deputy Assistant Administrator in DEA's Diversion
(00:28):
Controlled Division and covers policy. We'll talk about the DEA's
latest initiatives and some of the great success stories they
have regarding regulatory drugs and medications with millions of agencies
that they work with to be compliant. For the consumer
and you at home. Here's my conversation with Matt and Cary.
I hope you enjoyed as much as I did. Matt
and Carrie, Good morning to both of you. Welcome to
Community DC. Mariti, well, I'm sure happy to have you guys.
(00:52):
This is my first opportunity to talk to the DEA,
and I'm obviously very intrigued to you know, being in
the media, sports and news, I hear about you. But
I think a great lesson for our listeners besides talking
about all the cool things that you and your team
do when it comes to Fenton all on drugs and
everything is to talk about exactly what the DEA does,
because I think everybody's heard of it, right, But when
(01:12):
it comes to Matt what you do? I know it's layered.
There's a lot of people there. Probably gets a little
complicated for layman like myself and some of our listeners.
But just if you were to give a thirty thousand
foot view overall what the DEA does, what would you tell? Yeah? Sure, Dennis.
Speaker 2 (01:24):
Well, first of all, we're about a nine thousand person organization.
We are fortunate enough to have a single mission, which
is to prevent the misuse or the abuse of all
sorts of substances that can be abused and that can
have devastating consequences on families nationwide and communities of course,
(01:46):
as we'll talk about at some point today. But within
DEA there's a couple of different components. Carrie and I
both work in our Diversion Control Division, And the Diversion
Control Division is actually the regulatory arm of the DEA,
and what we do is we regulate what is called
(02:08):
the drug supply chain. So these are all of the
folks from the manufacturers and importers and exporters of what
we call controlled substances. These are substances that can be
misused or abused. Wholesalers, distributors, pharmacies, hospitals, doctors, physicians, assistance
(02:30):
nurs practitioners. We regulate that entire supply chain, and we actually,
through the process of what's called registration, where we issue
a license to all of these entities, we create what
we call a closed system of drug distribution. That closed
system of drug distribution is what we really seek to regulate,
(02:51):
because what we're trying to do is to prevent the
diversion of these legitimately made, these lawfully obtained control old substances.
These are prescription drugs like oxycodone, OxyContin, things like vicodin,
things like xanax, valium, ADHD, medicines like concerted Riddlin. Well,
(03:15):
what we do is our goal is twofold. On the
first side, we seek to prevent, detect, and investigate instances
where those legitimately made substances leave that controlled system of
drug distribution.
Speaker 1 (03:33):
And then kind of.
Speaker 2 (03:34):
Most importantly, or at least in my opinion, very importantly,
is we also seek to ensure that there's an adequate
and uninterrupted supply of those substances that are necessary to
meet the legitimate medical scientific needs of the United States.
Speaker 1 (03:51):
Okay, and carry you want to expound on that a
little bit.
Speaker 3 (03:53):
Yes, I think a lot of times when the public
thinks of the Drug Enforcement Administration, they think about the
enforcement arm of the agency. As Matt said, we're more
of a regulatory arm. However, we do have some crossover
with the enforcement side. So under diversion control, as Matt said,
we have a closed system of distribution, and that's a
(04:14):
mechanism that allows us to track controlled substances from the
time they are produced until the time they reach the
end user. So we do conduct inspections of DEA registaurants
that would be manufacturers, distributors, pharmacies, hospitals, entities like that. However,
we also do cases that involve civil penalties and criminal
(04:39):
cases as well. So you might have a doctor shopper,
or you might have a drug trafficking organization that is
distributing oxycodone or drugs like that that are legitimately, legitimately
manufactured that go outside of that closed system of distribution,
(04:59):
and we are also responsible for handling those types of cases.
As well, So we do some of the same work
that the agents do, but our focus is primarily on
the regular story piece.
Speaker 1 (05:10):
Okay, well that makes a lot of sense, And this
is for either of you, I think, to give maybe
a little context to our listeners. I know that data
and knowledge's power is always a really big deal, and
you guys obviously work with so many different kind of
entities out there, so I imagine the numbers are big
of the different kind of types of entities that you
work with. But maybe for context, Matt, can you give
us some kind of data that you work with to
(05:31):
give us some context about how it works of what
you do.
Speaker 2 (05:33):
Well, first of all, fair to say we have two
point two million registrants and as a as a nine
thousand person organization, obviously making sure that we have data
to drive all of our decision making. It's just foundational
to the program. When you're regulating that many entities and
(05:55):
ensuring compliance across that entire supply chain, having data driven
solutions is absolutely key. So the Controlled Substances Act, which
is the law that we enforce, requires our registrants, based
on their specific business activity, to maintain certain records and
(06:18):
to submit certain types of reports to DEA, and it's
through the accumulation of that of those reporting obligations that
we are then able to really kind of understand how
these controlled substances are moving through the drug supply chain.
So kind of foundational to that system, that system is
(06:39):
a system by which manufacturers and distributors report their sales
and their purchases of all sorts of the most frequently
misused controlled substances.
Speaker 1 (06:51):
In the United States.
Speaker 2 (06:53):
And through that system of capturing like millions of transaction
level reports on sales and purchase of control substances from
manufacturers to distributors down to hospitals, we're actually able to
see how the drugs are moving through the supply chain.
But then other things we have obligations, like our suspicious
(07:16):
order reporting system, and this is where under the Controlled
Substances Act, our distributed all of our registrants are responsible
for developing systems that are used to identify suspicious activity.
And so when there is a suspicious activity which Congress
(07:38):
has defined by statute, they're obligated to report that.
Speaker 1 (07:41):
To the DEA.
Speaker 2 (07:43):
So in that way, I always like to talk about
the fact that our registrants are a force multiplier for
the DEA because their obligation if we're all in this
together and we're all partnering to really ensure the safety
of the American public, like, the only way we can
do that is by working together with our registrants. So
(08:05):
the suspicious order reporting system is foundational to that because
they're now basically eyes and ears on the ground identifying
suspicious activity reporting it to us, which could then turn
into some kind of investigative matter that we have to
then pursue.
Speaker 3 (08:22):
Okay, Kerry and I think oftentimes people have the misperception
that the relationship between the DEA and the registrant population
is adversarial, but that's not the case. As Matt said,
we want to work together to ensure the health and
safety of the American public, and to also ensure there's
(08:42):
an adequate supply of the medications that the public public
needs and that they have a legitimate need for as well.
Speaker 1 (08:49):
Sure, well that makes sense, guys, in my role, and
I'm a sports person, So there's two different kinds of
sports people with talk show host and then people that
cover the beat, and the person that covers the beat
will go out and search out a story on their
own and be very proactive about that, about the behind
the scenes of that person, what their family life is,
all those kind of cool things, and maybe we don't know.
(09:11):
And then there's the game that happens, and then I
react off of that game, and I've got my opinions.
So with that analogy, I'm curious because there's so many
moving parts of what you guys do. Do you guys
have to react more or are you more proactive of
what you do? Or is it both?
Speaker 2 (09:26):
Yeah, I think we have tried over the last decade
or so to really move away from being reactive to
a proactive stance. And I think that's the goal of
every regulator, probably in the federal government or in state
government for that matter, is to anticipate the challenge so
(09:48):
that you are not reacting to it. But I think
that just the nature of this business does require a
little bit of both. Like in some instances, and Carrie
is the kind of lifelong investigator, so I'll certainly defer
to her on this, But in many instances, you are
(10:09):
presented with information that you then have to react. But
I think if we're doing our jobs best and we're
utilizing our resources and the most efficient way possible, the
goal is to try to do things proactively rather than reactively.
Speaker 1 (10:25):
Right, Kerr, you want to expound on that a little
bit for us, great.
Speaker 3 (10:28):
We are both reactionary and we also try to be proactive.
On the reactionary side, we have to be nimble because
there are so many new substances that pop up all
the time. So there are new and emerging substances. We
have to be ready for those and be ready to
handle those new substances and things that we're seeing on
(10:48):
the street. On the proactive side, I think probably just
interviews like this and public outreach are a key tool
that we have to get the message out well.
Speaker 1 (11:00):
And I'm glad you're doing that because I think we'd
all agree knowledge is power, right, and when you kind
of have some context to what you guys do, I
think it's better for everybody. So, Matt, I'd like to
talk about the different kinds of drugs. I know you've
had twenty five years of experience, so I'm sure you've
seen just about everything this and I'm sure there's been
an evolution of drugs. But as I watch and read
and consume the news, fentanyl is always in the news.
(11:21):
I know, OPI it's been for the last couple of decades.
Those are the two big ones that I hear about.
What else is out there that you guys work on?
Speaker 2 (11:27):
So I think the opioid threat I think kind of
started in the two thousand and five two thousand and
six timeframe, really became an epidemic. I would say probably
around the twenty fifteen time maybe slightly before that. I
think that this nation has done a tremendous amount of
(11:49):
work at all levels, whether it's our registrant community and
doctors through their prescribing practices and through pharmacies and identifying,
you know, maybe illegitimate prescriptions and not filling them. I
think our registrant community has done a tremendous amount of
tremendous amount of great work trying to decrease the amount
(12:11):
of opioids that are here in the States which are
then potentially going to be misused. We have been absolutely
confronting the illicit fentanyl problem.
Speaker 1 (12:25):
Again.
Speaker 2 (12:25):
Another opioid analgesic, right, This one is a synthetic drug.
Whereas oxycodone and hydrocodone and morphine, these are what we
call semisynthetic opioids, but they're derived from a plant. But
I think the point is right now, on the opioid
side of the house, we're really concerned about illicit fentanyl.
(12:46):
But when we get beyond opioids, some of the other
drug classes that we are concerned about are going to
be anti anxiety medications, like some that I mentioned earlier,
which are going to be drugs like xanax, which is
the active ingredient is a drug called alpraisal lamb, and
then another drug called valium, which is another drug that
(13:08):
contains a drug called diezapan. These are benzodiazepines, the class
of drugs we're seeing a lot of a significant increase
in the prescribing of those medicines for anxiety type conditions.
And then, of course, another really important class of drugs
that we're monitoring are what we're seeing is a really
(13:29):
significant increase in the prescribing of stimulants. These are scheduled
to control substances containing drugs like amphetamine and methyl fenadate
and another drug called listex amphetamine, which are all widely
used in the United States and abroad in Europe and
in parts of Asia and South America to treat patients
(13:53):
with ADHD. But in the States we're seeing a specific
increase right now in new diagnoses of people with ADHD.
Speaker 1 (14:01):
Okay, well, I'm glad you brought that up. And this
is just a general question and probably some things you
can and cannot talk about. But once again, reading and
ingesting the news carry obviously our borders when it comes
to Mexico and Canada, we're keeping an eye on those
and that's where a lot of that is coming through,
but other countries too, and I'm curious when it comes
I'm sure the United States has its very own unique
(14:22):
system set up as compared to other countries. But when
it comes to what you two and your team do
for a living, and the thousands of men and women
that are doing out there to make sure everything is
regulated properly, how do we compare to the rest of
the world. Are we doing a great job? Are we
are we on an even even playing field? What can
you give us some context to the rest of the
world against the United States, either of you, there's something
(14:43):
there that we can compare it to.
Speaker 2 (14:44):
I would probably probably characterize our situation as I feel
like we're a bit unique compared to the rest of
the world. I think we are a large consumer country
when it comes to legitimate farm bmaceuticals. I do think
that our nation's focus on prescription opioids, we do have
(15:10):
a significant population of Americans with the disease of addiction
an opioid use disorder. And I think the point is
is that we see some of those who are not
accessing drug treatment drugs like you know, bubernorphine and methadone.
I think we do see them turning to the illicit market,
(15:32):
and we see a dea a significant amount of prescription
or I should say, pills that look like legitimate prescription pills,
which are actually what we call fake pills that are
coming across our southwest border into the States and then
being distributed to people who may or may not think
(15:54):
that they're getting a legitimately manufactured drug. That drug oftentimes
looks like oxycodone and then turns out having an active
ingredient in there, which is predominantly fentanyl.
Speaker 1 (16:06):
Right, So, Carrie, I'm worried and wondering about compliancy. I
imagine that once again we go back to that question
about you know, reacting and being proactive. I imagine that most
everybody is compliant, but when it comes to either you
getting a red flag about somebody out there or maybe
something you found. What's the process there? Just what you
(16:28):
can take us behind the scenes and of what you
do that if you find something that isn't the way
it should be. What does the team do with that point?
Speaker 3 (16:36):
Well, I think it's important to point out first that
out of those two point two million registaurants that we regulate,
a very small percentage of those are the focus of
our investigations. We try to ensure that those registrants are compliant.
It's not a gotcha moment where we go out there
and try and earnest to find something wrong. We want
(16:57):
to work with the registrant population and them into compliance.
When we register those entities, we explain to them the
record keeping and reporting requirements that they're required to follow
per the Code of Federal Regulations, and so it's our
job to educate and inform them so that they can
make informed decisions and so they can do the right thing.
(17:22):
When we conduct regulatory inspections, we go on site, we
take a look at the firm security, their record keeping,
We conduct an inventory of the controlled substances that are
on hand, and then we conduct what we call an
accountability audit. It's basically, for those of us who are
older like me, the equivalent of balancing a checkbook. We
(17:43):
see what they were supposed to have on hand initially,
then we take a look at their receipts and distributions,
and then we take account of what is on hand
on the day that we go out and we balance
the checkbook. We see if those receipts and distributions equal out.
If we do see an issue, there's a variety of
actions that we can take. We can start off with
(18:06):
administrative action. We might issue a letter of admonition to
the firm and ask them to respond in writing how
they're going to correct the situation. We have memorandums of
agreement that we've entered into with resistaurants. But if the
violations are severe enough, we can actually ask for an
order to show cause, where the firm has to go
(18:28):
before an administrative law judge and a hearing and explain
why they should be allowed to keep their DEA registration.
So we have a variety of actions that we can take.
We can also seek civil penalties or bring a criminal
case if necessary.
Speaker 1 (18:45):
Okay, well that makes sense, and guys, just from my knowledge,
because I don't know this is why I'm asking when
it comes to all the regulators, is everything under a
federal umbrella or when you go to each state, does
it complicate things a little bit? How does that part
of it work?
Speaker 3 (18:57):
So, depending upon what you're talking, there could be state
regulations that differ from the federal regulations. And what's important
to remember is the stricter of the two applies.
Speaker 1 (19:08):
Okay, Okay, that makes sense. So listen. The time that
this is airing, we're past the actual National take Back Day,
which was on Saturday, April twenty six. And the reason
that I bring that up, guys, I know that's an
important day. So Matt, if you could just get some
context of what it is, why you came up with
the idea, and what you're hoping to get out of it.
Speaker 2 (19:28):
Yeah, So, the National TakeBack Initiative, we are now doing
our twenty eighth bi annual event. We started in twenty ten.
Going back to the comment that I made earlier, back
in around twenty ten, we saw a lot of excess
prescriptions being written for opioids. Those opioids generally may have
(19:49):
been partially consumed by the patient but then found their
way in the home where they weren't being disposed. There
was not really clear guidance as to how they could
be sei and environmentally safely destroyed. And so the challenge is,
under the federal law that we enforce, the Control Substances Act,
(20:11):
a patient who is considered to be the ultimate user
under federal law is not authorized to actually distribute that
medicine themselves. And so the idea of actually getting that
substance out of the family's home and back to a
place where it could be destroyed is something that was
(20:32):
never contemplated under federal law, and it was actually something
that we went to Congress to ask force something I
had the benefit of being able to do back in
twenty ten, working with members of Congress to pass legislation
that would authorize, in a very unique circumstance, an ultimate user,
a patient, to be able to return that controlled substance
(20:52):
to that closed system of drug distribution for purposes of destruction.
And so what we did is that law passed in
around the twenty twelve time frame, twenty eleven time frame.
It took us a while to promulgate regulations that created
what today we know as our authorized collector program. We
(21:17):
brag extensively about the fact that we now have seventeen
thousand pharmacies and hospitals nationwide that are accepting unused, unwanted,
and expired medicines from patients three hundred and sixty five
days a year for purposes of destruction. We're now removing
those control substances out of the family medicine cabinet where
(21:40):
they could be misused by a friend or a family
member who happens to come upon them. But what's really
kind of neat is that during the pendency of that
regulatory drafting process, after we worked with Congress to pass
the law, the only accept that existed in the law
(22:01):
was for an ultimate user to return or to provide
a controlled substance to law enforcement. So from that exemption
that was built into the statute, our NTPI program was born.
And what we said is we think that this is
such a public health threat. Again in twenty ten, eleven, twelve, thirteen, fourteen,
(22:22):
that we said, during the time of this threat, we're
going to host these biannual events and we're going to
collect unused and unwanted medications. So our twenty eighth event
on Saturday, and we have collected nineteen point two million pounds. Wow,
across those across those last what fifteen or sixteen years?
Speaker 1 (22:44):
So could you give me some context? What was it
maybe when it started or last several years. I imagine
it's getting bigger and bigger and better in a more
positive range, But what kind of context and numbers are
we looking at.
Speaker 2 (22:54):
It's actually the exact opposite, which is what we're so
excited about. Okay, So before we had regulations in place,
or shortly after we had regulations in place, we didn't
have a robust number of partners in the pharmacy and
hospital space that was actually authorized collectors, and so as
a consequence, people really relied on the bi annual Dea
(23:18):
take Back Initiative as a means to get rid of
their unused and unwanted medications. But now with everyone recognizing
that they all have a role to play in addressing
our nation's opioid crisis, we've seen our pharmacies and our
hospital step up. They've implemented several thousand additional authorized collection
(23:40):
sites seventeen thousand to be exact. And the point is
is that now American citizens don't have to wait till
April or October to get rid of their meds. They
can go three hundred and sixty five days a year,
twenty four to seven to any one of these seventeen
thousand authorized collection sites. So we've actually seen our numbers
(24:02):
go down, and we actually think that rather than that
being a bad thing, we actually think that that's really.
Speaker 1 (24:08):
That makes sense. And I'm glad that you explain how
that works. But that's truly extraordinary that that many people
and pharmacies participate. I've had about five minutes left, so
I'd like to get the floor and some final thoughts
to both of you. So Carrie, I'd love to start
with you about what we've talked about, maybe what the
future looks like. But the floor is here, is Carrie
if you could start and kind of get some final
thoughts for everybody.
Speaker 3 (24:28):
Sure. So for the event that we've just had, we
had over forty three hundred law enforcement partners and sites
available to individuals to take their unused medication and dispose
of that. We use incinerators to dispose of the controlled substances,
and again I want to thank our law enforcement partners
for all they do to assist us with the National
(24:50):
Take Back Initiative. Those events collect a lot of medication.
But as Matt said, what we're seeing is that as
we increase the number of authorized collectors that are available
year round, individuals are turning in less drugs at the
national TakeBack initiative events, and that's what we want to
see happen to us. That's a measure of success. And
(25:13):
we also like to think that these take back initiatives
in these events or authorized collectors have also helped lead
to a decline in the overdose deaths that we've seen.
In the last few years, we've actually seen a decrease
in overdose deaths by twenty six point five percent.
Speaker 1 (25:36):
Wow, that's just extraordinary.
Speaker 2 (25:38):
Matt.
Speaker 1 (25:38):
You've got about two minutes left, so just some final
thoughts from you.
Speaker 2 (25:40):
I would want to leave the audience with that same
kind of, in my opinion, overwhelming statistic. For years, we've
been seeing this increase, this uptick in the number of
overdose deaths, and my god, we've been doing a ton
of work trying to decrease the number of overdose deaths,
whether it's been through expanding access to drugs like treatment
drugs like bubernorphine and methadone, and other overdose reversal drugs.
(26:05):
Like the loock zone and naltrexone. We've been doing a
tonnel work in that space. We have our NTBI event,
which seeks to remove kind of these excessive controlled substances
out of the family medicine cabinet. And you know, the
last year has just been remarkable, like Kerry said, at
twenty six and a half percent decline in overdose deaths.
(26:27):
And we recognize that we're not solely responsible for that.
We recognize that this is a whole of government approach.
This is beyond whole of government. This is also our
entire registrant community, which plays a big role and a
huge force multiplier for us. But we just can't be
happy enough with the debt, with the decline and overdose
(26:47):
deaths that we're starting to see, well.
Speaker 1 (26:48):
It's pretty extraordinary. And prep for the interview, I've been
on the website. It's easy to navigate. There is a
lot of information out there. But if you could, guys
could give the website to everybody to check it out,
because there's some really interesting data on there and I
learned a lot. So either of you can give the
website to everybody so they could check it out.
Speaker 2 (27:04):
Yeah, I would encourage everyone to go to www. Dot
dea TakeBack dot Com, which is all one word what's
great is there. You'll not only be able to see
the authorized collector program that we talked about, this is
the year round collection sites that are available and then
but bi annually, we also put on that website our
(27:25):
partner organizations and partner sites for the NTBI event, our
National take Back Initiative outstanding.
Speaker 1 (27:33):
Well, listen, guys, I could talk to you guys for
hours because we only hit the tip of the iceberg
about what do you actually do with your team of
incredible men and women out there? And I imagine at times,
just like any job, it seems thankless. But I want
to thank you guys and your team for all the
great work that you do behind the scenes that we
really don't know about that's happening out there to regulate
to make our country a lot better out there. So
I can't tell you how much I appreciate your valuable
(27:54):
time because I know both of you are busy. But
Madden Carrey, thank you so much for joining me on
Community DC. I really do appreciate it.
Speaker 3 (27:59):
Thanks having us.
Speaker 1 (28:00):
Thanks Dannis.
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