[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]
THE DRUG ENFORCEMENT ADMINISTRATION'S ROLE IN COMBATING THE OPIOID
EPIDEMIC
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED FIFTEENTH CONGRESS
SECOND SESSION
__________
MARCH 20, 2018
__________
Serial No. 115-110
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
_________
U.S. GOVERNMENT PUBLISHING OFFICE
30-665 WASHINGTON : 2019
COMMITTEE ON ENERGY AND COMMERCE
GREG WALDEN, Oregon
Chairman
JOE BARTON, Texas FRANK PALLONE, Jr., New Jersey
Vice Chairman Ranking Member
FRED UPTON, Michigan BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois ANNA G. ESHOO, California
MICHAEL C. BURGESS, Texas ELIOT L. ENGEL, New York
MARSHA BLACKBURN, Tennessee GENE GREEN, Texas
STEVE SCALISE, Louisiana DIANA DeGETTE, Colorado
ROBERT E. LATTA, Ohio MICHAEL F. DOYLE, Pennsylvania
CATHY McMORRIS RODGERS, Washington JANICE D. SCHAKOWSKY, Illinois
GREGG HARPER, Mississippi G.K. BUTTERFIELD, North Carolina
LEONARD LANCE, New Jersey DORIS O. MATSUI, California
BRETT GUTHRIE, Kentucky KATHY CASTOR, Florida
PETE OLSON, Texas JOHN P. SARBANES, Maryland
DAVID B. McKINLEY, West Virginia JERRY McNERNEY, California
ADAM KINZINGER, Illinois PETER WELCH, Vermont
H. MORGAN GRIFFITH, Virginia BEN RAY LUJAN, New Mexico
GUS M. BILIRAKIS, Florida PAUL TONKO, New York
BILL JOHNSON, Ohio YVETTE D. CLARKE, New York
BILLY LONG, Missouri DAVID LOEBSACK, Iowa
LARRY BUCSHON, Indiana KURT SCHRADER, Oregon
BILL FLORES, Texas JOSEPH P. KENNEDY, III,
SUSAN W. BROOKS, Indiana Massachusetts
MARKWAYNE MULLIN, Oklahoma TONY CARDENAS, California
RICHARD HUDSON, North Carolina RAUL RUIZ, California
CHRIS COLLINS, New York SCOTT H. PETERS, California
KEVIN CRAMER, North Dakota DEBBIE DINGELL, Michigan
TIM WALBERG, Michigan
MIMI WALTERS, California
RYAN A. COSTELLO, Pennsylvania
EARL L. ``BUDDY'' CARTER, Georgia
JEFF DUNCAN, South Carolina
Subcommittee on Oversight and Investigations
GREGG HARPER, Mississippi
Chairman
H. MORGAN GRIFFITH, Virginia DIANA DeGETTE, Colorado
Vice Chairman Ranking Member
JOE BARTON, Texas JANICE D. SCHAKOWSKY, Illinois
MICHAEL C. BURGESS, Texas KATHY CASTOR, Florida
SUSAN W. BROOKS, Indiana PAUL TONKO, New York
CHRIS COLLINS, New York YVETTE D. CLARKE, New York
TIM WALBERG, Michigan RAUL RUIZ, California
MIMI WALTERS, California SCOTT H. PETERS, California
RYAN A. COSTELLO, Pennsylvania FRANK PALLONE, Jr., New Jersey (ex
EARL L. ``BUDDY'' CARTER, Georgia officio)
GREG WALDEN, Oregon (ex officio)
C O N T E N T S
----------
Page
Hon. Gregg Harper, a Representative in Congress from the State of
Mississippi, opening statement................................. 1
Prepared statement........................................... 3
Hon. Greg Walden, a Representative in Congress from the State of
Oregon, opening statement...................................... 6
Prepared statement........................................... 7
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 8
Prepared statement........................................... 10
Witnesses
Robert W. Patterson, Acting Administrator, Drug Enforcement
Administration................................................. 12
Prepared statement........................................... 15
Answers to submitted questions............................... 76
Submitted Material
Committee memorandum............................................. 67
DEA email dated May 6, 2011...................................... 72
DEA email dated August 20, 2013.................................. 74
THE DRUG ENFORCEMENT ADMINISTRATION'S ROLE IN COMBATING THE OPIOID
EPIDEMIC
----------
TUESDAY, MARCH 20, 2018
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:00 a.m., in
room 2322 Rayburn House Office Building, Hon. Gregg Harper
(chairman of the subcommittee) presiding.
Members present: Representatives Harper, Griffith, Burgess,
Brooks, Collins, Barton, Walberg, Walters, Costello, Carter,
Walden (ex officio), DeGette, Schakowsky, Castor, Tonko,
Clarke, Ruiz, Peters, and Pallone (ex officio).
Also present: Representative McKinley.
Staff present: Jennifer Barblan, Chief Counsel, Oversight
and Investigations; Mike Bloomquist, Staff Director; Ali
Fulling, Legislative Clerk, Oversight and Investigations,
Digital Commerce and Consumer Protection; Brittany Havens,
Professional Staff, Oversight and Investigations; Christopher
Santini, Counsel, Oversight and Investigations; Jennifer
Sherman, Press Secretary; Alan Slobodin, Chief Investigative
Counsel, Oversight and Investigations; Austin Stonebraker,
Press Assistant; Hamlin Wade, Special Advisor, External
Affairs; Christina Calce, Minority Counsel; Tiffany Guarascio,
Minority Deputy Staff Director and Chief Health Advisor; Chris
Knauer, Minority Oversight Staff Director; Miles Lichtman,
Minority Policy Analyst; Kevin McAloon, Minority Professional
Staff Member; and C.J. Young, Minority Press Secretary.
OPENING STATEMENT OF HON. GREGG HARPER, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MISSISSIPPI
Mr. Harper. We will call to order the hearing today on the
Drug Enforcement Administration's role in combating the opioid
epidemic.
Today, the Subcommittee on Oversight and Investigations
convenes a hearing on the DEA's role in combating the opioid
epidemic. This crisis is a top priority of the nation and
certainly of this committee and subcommittee. Opioid-related
overdoses killed more than 42,000 people in 2016. That's an
average of 115 deaths each day. An estimated 2.1 million people
have an opioid use disorder.
Since our earliest hearings in 2012, this subcommittee has
been investigating various aspects of this epidemic. In May
2017, the Committee opened a bipartisan investigation into
allegations of ``opioid-dumping,'' a term to describe
inordinate volumes of opioids shipped by wholesale drug
distributors to pharmacies located in rural communities, such
as those in West Virginia. From press reports and this
investigation, we have learned of opioid shipments in West
Virginia that shock the conscience.
Over 10 years, 20.8 million opioids were shipped to
pharmacies in the town of Williamson, home to approximately
3,000 people.
Another 9 million opioids were distributed in just 2 years
to a single pharmacy in Kermit, West Virginia, with a
population of 406.
Between 2007 and 2012, drug distributors shipped more than
780 million hydrocodone and oxycodone pills in West Virginia.
These troubling examples raise serious questions about
compliance with the Controlled Substances Act, administered by
the DEA.
The CSA was enacted through this committee in 1970. This
law established schedules of controlled substances and provided
the authority for the DEA to register entities engaged in the
manufacture, distribution, or dispensation of controlled
substances. The CSA was designed to combat diversion by
providing for a closed system of drug distribution in which all
legitimate handlers of controlled substances must maintain a
DEA registration, and as a condition of maintaining such
registration must take reasonable steps to ensure their
registration is not being used as a source of diversion. The
DEA regulations specifically require all distributors to report
suspicious orders of controlled substances in addition to the
statutory responsibility to exercise due diligence to avoid
filling suspicious orders.
This hearing has two goals. First, the subcommittee seeks
to determine how the DEA could have done better to detect and
investigate suspicious orders of opioids, such as the massive
amounts shipped to West Virginia. The DEA has acknowledged to
the committee that it could have done better in spotting and
investigating suspicious opioid shipments. What were the
deficiencies and has DEA addressed them? DEA has a
comprehensive electronic database containing specific
information at the pharmacy level. Could DEA use that database
more effectively to investigate diversion and to facilitate
compliance for the regulated industry?
The second goal is to find out whether the current DEA law
enforcement approach is adequately protecting public safety.
DEA statistics reveal a sharp decline since 2012 in certain DEA
enforcement actions, immediate suspension orders, or ISOs, and
orders to show cause. The number of ISOs issued by the DEA
plummeted from 65 in 2011 to just six last year. Former DEA
officials alleged in the Washington Post and on CBS' ``60
Minutes'' that the DEA's Office of Chief Counsel imposed
evidentiary obstacles and delays for ISO and for orders to show
cause submissions from the DEA field. The conflict between the
DEA lawyers and the DEA investigators allegedly resulted in
experienced DEA personnel leaving the agency and a loss of
morale.
The goal of laws regulating controlled substances is to
strike the right balance between the public interest in
legitimate patients obtaining medications in a timely manner
against another weighty public interest in preventing the
illegal diversion of prescription drugs, particularly given the
rampant and deadly opioid epidemic throughout the Nation. Our
investigation is intended to assist the committee's continuing
legislative effort to strike the right balance.
It is unfortunate that it's been a battle to get
information out of the DEA. We have made recent progress with
the DEA, but at this time our investigation still does not have
the full picture. DEA has made some commitments that should
hopefully help the committee gain the information it needs, and
we expect the DEA to honor those commitments.
And I welcome today's witness, DEA Acting Administrator
Robert Patterson. We have serious concerns about policy that we
need to discuss today. But we are steadfast in our support and
certainly want to salute the dedicated workforce at the DEA. We
need an effective DEA in this crisis.
I want to thank the minority for their participation and
hard work in this investigation, and I now yield to my friend,
the ranking member, Ms. DeGette.
[The prepared statement of Mr. Harper follows:]
Prepared statement of Hon. Gregg Harper
Today the Subcommittee on Oversight and Investigations
convenes a hearing on the Drug Enforcement Administration's
(DEA) role in combating the opioid epidemic. The opioid crisis
is a top priority of the nation and of this Committee. Opioid-
related overdoses killed more than 42,000 people in 2016--115
deaths each day. An estimated 2.1 million people have an opioid
use disorder.
Since our earliest hearings in 2012, this Subcommittee has
been investigating various aspects of the opioid epidemic. In
May 2017, the Committee opened a bipartisan investigation into
allegations of ``opioid-dumping,'' a term to describe
inordinate volumes of opioids shipped by wholesale drug
distributors to pharmacies located in rural communities, such
as those in West Virginia. From press reports and this
investigation, we have learned of opioid shipments in West
Virginia that shock the conscience:
Over 10 years, 20.8 million opioids were shipped
to pharmacies in the town of Williamson, home to approximately
3,000 people.
Another 9 million opioids were distributed in just
2 years to a single pharmacy in Kermit, West Virginia,
population 406.
Between 2007 and 2012, drug distributors shipped
more than 780 million hydrocodone and oxycodone pills in West
Virginia.
These troubling examples raise serious questions about
compliance with the Controlled Substances Act, administered by
the DEA.
The CSA was enacted through this Committee in 1970. This
law established schedules of controlled substances and provided
the authority for the DEA to register entities engaged in the
manufacture, distribution, or dispensation of controlled
substances. The CSA was designed to combat diversion by
providing for a closed system of drug distribution, in which
all legitimate handlers of controlled substances must obtain a
DEA registration, and as a condition of maintaining such
registration, must take reasonable steps to ensure their
registration is not being used as a source of diversion. The
DEA regulations specifically require all distributors to report
suspicious orders of controlled substances, in addition to the
statutory responsibility to exercise due diligence to avoid
filling suspicious orders.
This hearing has two goals. First, the Subcommittee seeks
to determine how the DEA could have done better to detect and
investigate suspicious orders of opioids, such as massive
amounts of opioids shipped to West Virginia. The DEA has
acknowledged to the Committee that it could have done better in
spotting and investigating suspicious opioid shipments. What
were the deficiencies, and has DEA addressed them? DEA has a
comprehensive electronic database containing specific
information at the pharmacy level. Could DEA use that database
more effectively to investigate diversion and to facilitate
compliance for the regulated industry?
The second goal is to find out whether the current DEA law
enforcement approach is adequately protecting public safety.
DEA statistics reveal a sharp decline since 2012 in certain DEA
enforcement actions, Immediate Suspension Orders (ISOs) and
Orders to Show Cause (OTSCs). The number of ISOs issued by the
DEA plummeted, from 65 in 2011 to just six last year. Former
DEA officials alleged in the Washington Post and on CBS ``60
Minutes,'' that the DEA's Office of Chief Counsel imposed
evidentiary obstacles and delays for ISO and OTSC submissions
from the DEA field. The conflict between the DEA lawyers and
the DEA investigators allegedly resulted in experienced DEA
personnel leaving the agency and a loss of morale.
The goal of laws regulating controlled substances is to
strike the right balance between the public interest in
legitimate patients obtaining medications in a timely manner
against another weighty public interest in preventing the
illegal diversion of prescription drugs, particularly given the
rampant and deadly opioid epidemic throughout the nation. Our
investigation is intended to assist the Committee's continuing
legislative effort to strike the right balance.
It is unfortunate that it's been a battle to get
information out of the DEA. We have made recent progress with
the DEA, but at this time our investigation still does not have
the full picture. DEA has made some commitments that should
hopefully help the Committee gain the information it needs, and
we expect the DEA to honor these commitments.
I welcome today's witness, DEA Acting Administrator Robert
Patterson. We have serious concerns about policy to discuss,
but we are steadfast in our support and salute the dedicated
workforce at the DEA. We need an effective DEA in this crisis.
I also want to thank the Minority for their partnership and
hard work in this investigation. I now yield to my friend, the
Ranking Member, Ms. DeGette.
Ms. DeGette. Thank you so much, Mr. Chairman.
And I am happy to kick off the whole series of hearings
with the Energy and Commerce Committee this week with this
Oversight and Investigations hearing.
Opioid overdose is now the number-one cause of
unintentional death in the United States. Every day we hear
reports of Americans dying and leaving loved ones, often
children, to pick up the pieces, and these reports are
heartbreaking.
The crisis has also had an economic toll. Estimates are
that it's cost this country a trillion dollars since 2001, and
here's the point at my opening statement where I show that
Congress can still be bipartisan because today I want to talk,
as the chairman did, about our committee investigation,
examining exactly how the opioid epidemic developed.
Our investigation, as the chairman said, focused on West
Virginia, which has the highest opioid death toll in the
Nation. The numbers that we are seeing coming out are simply
shocking. A major 2016 news investigation, for example,
reported that distributors shipped 780 million opioids to this
state between 2007 and 2012. Again, in 5 years, they shipped
780 million opioids to this small State of West Virginia. Now,
we focus on West Virginia but I am hoping that the lessons we
learned will apply nationwide, including in my home State of
Colorado.
Administrator Patterson, I join the Chairman in welcoming
you here. We have a lot of questions and we'd like to know what
you think failed us in West Virginia and, more importantly,
what we can do to avoid this again. We know something had to
have gone wrong. For example, in DEA's own court filings, in
2008 the distributor shipped one pharmacy in West Virginia
22,500 hydrocodone pills per month. But our investigation also
found that a number of pharmacies were sent even many times
more that amount. For example, the Chairman talked about
Kermit, West Virginia. We looked at one pharmacy in Kermit,
which has a few hundred people. Drug distributors supplied this
pharmacy with more than 4.3 million doses of opioids, more than
350,000 per month in a single year, and then the next year 4
million doses of opioids.
What on earth were people thinking? Now, when the DEA
finally shut down this pharmacy and took its owner to court,
the owner admitted at its height the pharmacy filled one
prescription per minute. Who could think that this was a
legitimate use?
News reports from the time describe pharmacy workers
throwing bags of opioids ``over a divider and onto a counter to
keep pace.'' One law enforcement agent noticed a cash drawer
``so full the clerk could not get it to close properly.'' And
this was not the only pharmacy to receive such massive
quantities of opioids. In another example, between 2006 and
2016, distributors shipped over 20 million doses of opioids to
two pharmacies in one town of 3,000 people.
I want to know if the DEA thinks that this amount of pills
sent to these pharmacies was excessive. In addition, the
Controlled Substances Act and applicable regulations required
the distributor to tell DEA how many pills that distributor
sold and to what pharmacies. DEA compiles this information into
a database called the Automation of Reports and Consolidated
Orders System. It's called ARCOS.
I want to know how the DEA made use of ARCOS data from 2006
on and whether it relied on that data to monitor the number of
pills that distributors sent to West Virginia. Did the DEA
perform analytic assessments of the pills the pharmacies
received? Did it look at how many pills distributors sent to a
town or region as a whole? And if so, I want to know why the
DEA didn't act to stop these shipments.
I want to know whether the distributors themselves
exercised appropriate due diligence before sending millions of
pills to pharmacies. For example, in a letter sent to all drug
distributors in 2006 and 2007, the DEA gave them a list of
circumstances that might be indicative of diversion, all of
which plainly require distributors to know their customers
before shipping them any opioids at all. I want to know if the
drug distributors met this standard when they shipped those
pills to tiny West Virginia and, similarly, did the
distributors comply with their obligations. And I want to know
also what the DEA is doing right now to stop painkillers from
flooding our communities today.
We have had a lot of hearings on this, Mr. Chairman, but
this is the first one to look in a hard way at this crisis
developed. We spend countless hours of law enforcement time
trying to stop illegal drugs from coming into this country and
here we are, sending millions of doses of opioids to tiny
little towns in West Virginia, all of this supposedly legally.
I think I can speak for the whole committee to say this
needs to stop, it needs to stop now, and we need to figure out
how we are going to protect our constituents and our citizens.
I yield back.
Mr. Harper. The gentlewoman yields back.
The chair will now recognize the chairman of the full
committee, Chairman Walden, for purposes of an opening
statement.
OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OREGON
Mr. Walden. Thank you, Mr. Chairman, and thank you for your
leadership on this very important issue to the people we
represent.
For nearly a year, this committee has been investigating
how inordinate numbers of pills were shipped to pharmacies in
rural West Virginia. The numbers that we have seen thus far, as
you've heard, Mr. Patterson, are nothing short of staggering--
more than 20 million prescription opioids shipped to a West
Virginia town with a population of fewer than 3,000 people.
Another West Virginia pharmacy, in a town with a population of
fewer than 2,000 people, received an average of 5,600
prescription opioids a day during a single year.
As part of our investigation, we have also looked at the
Sav-Rite pharmacies in Kermit, West Virginia, a town with a
population of about 400.
During last October's full committee hearing, I asked your
colleague at the DEA a very straightforward question: which
companies provided the Sav-Rite No. 1 pharmacy with so many
opioids that it ranked 22nd in the entire United States of
America for the number of hydrocodone pills received in 2006?
After an extended and unnecessary delay, we finally
received the DEA data and now know the answer to that question.
But this isn't the end of the matter, however.
We have learned that in 2008, a second Sav-Rite location
opened just 2 miles away from the original pharmacy. However,
the second Sav-Rite was forced to close and surrender its DEA
registration after it was raided by federal agents in March
2009. Now, in most instances, this would be a success story.
But in this case, the original Sav-Rite pharmacy--the one that
had received 9 million pills in just 2 years--stayed open for
another two years, and in those 2 years, Sav-Rite No. 1
dispensed about 1.5 million pills into the community. So the
question is, how did that happen? How is it possible?
The raid on Sav-Rite 2 was based on observations made
during undercover investigations conducted at both Sav-Rite
locations as well as a pill mill medical practice. As part of
the undercover operation, Federal investigators saw pharmacy
customers sharing drugs with one another in the parking lot,
and as you've heard, a cash drawer so full the clerk could not
close it, and learned that the owner of the Sav-Rite pharmacies
apparently developed a ``get-rich-quick scheme'' with a pill
mill medical practice. This scheme may have filled their cash
drawers, but it was devastating to the community.
It doesn't make any sense as to why the DEA did not shut
down both pharmacies at the same time. They were owned by the
same person. They were part of the same criminal scheme. DEA
has acknowledged that breakdowns occurred and lessons were
learned, in this case and in others.We need to make sure DEA
has fixed its own problems so that an effective DEA is part of
the many solutions needed to combat the opioid crisis.
As you know, people are dying. Lives are being ruined. We
must be united in our efforts to end this horrible epidemic.
That is why myself and this entire committee have been so
frustrated that it has taken so long to obtain DEA's full
cooperation in this investigation.
And while progress is being made in DEA's efforts--and I
appreciated our meeting on Friday--we still have plenty of
unanswered questions coming in to today's hearing. So I am
hopeful we can learn the answers to those questions today and I
am also pleased with the commitments DEA has made to fulfill
our remaining requests in this investigation. And I expect
those commitments to be honored, period. If they are not, we'll
be back talking again soon.
Our most pressing questions are intended to get DEA on a
better path. Every one of us on this dais and in this room
supports a strong and effective DEA. We know you have an
enormous and important job to do with dedicated agents and we
are grateful to all those in law enforcement personnel at your
agency. Quite simply, we want you to have the tools and the
resources you need to help us combat this epidemic, among the
other many duties you have at DEA.
So I want to thank you for again being with us today,
Acting Administrator Patterson, and we look forward to your
candor.
And I would like to yield the balance of my time to the
gentleman from Virginia, Mr. Griffith. Before I do that, I
would remind the committee we will have two full days of
hearings starting tomorrow and Thursday reviewing 25 pieces of
legislation on the opioids epidemic, and we hope and expect
everyone on the committee to attend those hearings.
With that, I yield to the gentleman from Virginia.
[The prepared statement of Mr. Walden follows:]
Prepared statement of Hon. Greg Walden
Thank you, Mr. Chairman, for holding this hearing on DEA's
role incombating the opioid epidemic, a top priority of this
committee.
For nearly a year, this committee has been investigating
how inordinate numbers of pills were shipped to pharmacies in
rural West Virginia. The numbers that we have seen thus far are
nothing short of staggering--more than 20 million prescription
opioids shipped to a West Virginia town with a population of
fewer than 3,000 people. Another West Virginia pharmacy, in a
town with a population of fewer than 2,000 people, received an
average of more than 5,600 prescription opioids a day during a
single year.
As part of our investigation, we have also looked at the
Sav-Rite pharmacies in Kermit, West Virginia, a town with a
population of approximately 400 people.
During last October's full committee hearing, I asked your
colleague at the DEA a very straightforward question: Which
companies provided the Sav-Rite #1 pharmacy with so many
opioids that it ranked 22nd in the entire country for the
number of hydrocodone pills received in 2006?
After extended delay, we received the DEA data and now know
the answer to that question. This is not the end of the matter,
however.
We have learned that in 2008, a second Sav-Rite location
opened, just two miles away from the original pharmacy.
However, the second Sav Rite was forced to close and surrender
its DEA registration after it was raided by federal agents in
March 2009. In most instances, this would be a success story.
But in this case, the original Sav-Rite pharmacy-the one that
received 9 million pills in just 2 years-stayed open for more
than two years. In those two years, Sav-Rite #1 dispensed about
1.5 million pills into the community. How is this possible?
The raid on Sav-Rite 2 was based on observations made
during undercover investigations conducted at both Sav-Rite
locations as well as a pill mill medical practice. As part of
the undercover operation, federal investigators saw pharmacy
customers sharing drugs with one another in the parking lot, a
cash drawer so full that the clerk could not close it, and
learned that the owner of the Sav-Rite pharmacies apparently
developed a ``get-rich quick scheme'' with a pill mill medical
practice. This scheme may have filled their cash drawers, but
it was devastating the community.
It doesn't make any sense as to why the DEA did not shut
down both pharmacies at the same time--they were owned by the
same person and were part of the same criminal scheme. DEA has
acknowledged that breakdowns occurred, and lessons were
learned-in this case and others. We need to make sure DEA has
fixed its own problems so that an effective DEA is part of the
many solutions needed to combat the opioid crisis.
People are dying. Lives are being ruined. We must be united
in our efforts to end this horrible epidemic. That is why
myself and this entire committee have been so frustrated that
it has taken this long to obtain DEA's full cooperation in this
investigation.
And while progress is being made in DEA's efforts, we still
have plenty of unanswered questions coming into today's
hearing. I am hopeful that we can learn the answers to those
questions today. I am also pleased with the commitments DEA has
made to fulfill our remaining requests in this investigation. I
expect those commitments to be honored. If they are not, we'll
be back here again soon.
Our most pressing questions are intended to get DEA on a
better path. Every one of us on this dais, and in this room,
supports a strong and effective DEA. We know you have an
enormous job to do and we are grateful to all of the dedicated
law enforcement personnel at the agency. Quite simply, we want
you to have the tools and the resources you need to combat this
epidemic, among the other many duties of the DEA.
So thank you again for being here with us today, Acting
Administrator Patterson. We look forward to your candor, and I
would like to yield the balance of my time to the gentleman
from Virginia, Mr. Griffith.
Mr. Griffith. Thank you, Mr. Chairman.
We have an implied constitutional responsibility to conduct
oversight and ensure that the Controlled Substances Act strikes
the correct balance between the public interest in legitimate
patients obtaining medications against the weighty public
interest in preventing the illegal diversion of prescription
drugs.
A key issue is whether the DEA is adequately protecting
public safety. DEA statistics reveal a sharp decline and
immediate suspension orders--ISOs--since 2012. ISOs are a DEA
administrative tool not to punish but to protect the public
from rogue doctors or pharmacists who would continue to provide
opioids to drug abusers unless their registration was
immediately suspended.
Former DEA officials alleged in the Washington Post and on
CBS ``60 Minutes'' that the DEA's office of chief counsel,
starting around 2013, changed its evidentiary requirements for
ISO submissions from the DEA field. DEA documents provided to
the Committee seem to substantiate this allegation.
Now, ISOs remind me of DUI cases in Virginia. When a police
officer gets a driver off the road who's been drinking, their
license to drive is administratively suspended in order to
protect the public.
Trial on the merits is delayed, but not public safety. It's
a similar principle here. Immediately suspend the rogue
operator and protect the public.
I yield back.
Mr. Harper. The gentleman yields back.
The chair will now recognize the ranking member of the full
committee, Mr. Pallone, for five minutes.
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you, Mr. Chairman.
The opioid epidemic continues to devastate communities and
families in every part of America, and every day 115 Americans
lose their lives in an opioid overdose.
We must do more to help those struggling with addiction,
and I am committed to working with all of my colleagues to
advance meaningful legislation and resources to help combat
this crisis. Families all across this nation are looking to us
for help, and it is my hope that DEA will work cooperatively
with us on this effort.
In addition to advancing efforts to respond to this crisis,
Congress also has a responsibility to figure out what went
wrong and how it went wrong and how to make sure something like
this never happens again. And that is why this committee has
been engaged in a bipartisan investigation into the role both
DEA and drug distributors have in addressing the ongoing opioid
crisis and what systems failed to protect the communities that
have been so overwhelmed by this epidemic.
So I hope that the lessons we learn will help us address
this urgent problem throughout the country, from New Jersey to
West Virginia and beyond.
Clearly, something went wrong. The safeguards designed to
prevent opioids from being diverted into the wrong hands simply
did not work and our committee's investigation has found that
drug distributors shipped millions of pills to multiple small-
town pharmacies in West Virginia every year. For example, a
pharmacy in a town of 2,000 people received 16.5 million doses
of opioids over a 10-year period and there were other
pharmacies in that area as well.
There is simply no way that there was an actual medical
need for this incredible volume of opioids in this rural
sparsely-populated area and I would hope that DEA can tell us
what broke down in the safeguards that should have protected
communities from these abusive practices. These include
failures by both the distributors and the DEA.
For example, I have questions about the data that DEA
collects and why they did not use it more aggressively to
prevent the oversupply of opioids in certain--in certain cases.
We know that distributors are required to tell DEA how many
pills they ship each month and where those pills go. It is not
clear, however, that DEA has used this data in the past, and if
DEA is using this data now to help it curtail excessive pill
distribution.
Distributors are also required to alert DEA when a pharmacy
places an order for what appears to be a suspiciously large
quantity of pills. It appears that distributors have not always
alerted DEA of those suspicious orders and may not even have
had adequate systems in place to identify inappropriately large
orders. But at the same time, it is also not clear that DEA has
always done enough with the suspicious orders they receive from
distributors to alert the agency to possible anomalous
shipments, and I hope we can get answers to both of these
questions.
And when multiple distributors ship to a single pharmacy,
possibly causing an oversupply, it is not clear that DEA has
had an adequate system to identify and flag to the distributors
that an oversupply problem may be unfolding. Unlike DEA, who
has access to comprehensive distribution data, distributors can
only see what they supply to an individual pharmacy. Yet, if
DEA is not flagging when multiple distributors are at risk of
collectively oversupplying a pharmacy, then the result is
another example of a system failure that can lead to diversion.
So it seems likely that failing to report suspicious orders
by distributors has hurt DEA's ability to monitor the
distribution of controlled substances and I hope that we will
hear that this is no longer an issue today, and if it is, I'd
like to know what tools DEA needs to help it to enforce this
requirement. At the same time, I do hope that DEA is making
full use of suspicious orders when they are reported to their
field offices.
Finally, Mr. Chairman, while our investigation has focused
on what went wrong in West Virginia, I also want to know how
DEA is monitoring distributors across the country now.
Addictive drugs are still abundant in our communities and now
new opioids are also being introduced to the market.
So I hope that DEA is actively or proactively analyzing
shipments of these pills and, where appropriate, stepping in
and stopping the over-distribution of these drugs.
So I just want to thank Administrator Patterson for
appearing before us. This issue is extraordinarily important
and no entity can address it alone. DEA and Congress must be
allies in combating the opioid crisis and only by understanding
what went wrong can we fix this system for the future.
So just, again, I know you're in the hot seat today but
this is something that we need to work on together.
Thank you, Mr. Chairman.
[The prepared statement of Mr. Pallone follows:]
Prepared statement of Hon. Frank Pallone, Jr.
Thank you, Mr. Chairman. The opioid epidemic continues to
devastate communities and families in every part of America.
Every day, 115 Americans lose their lives to an opioid
overdose.
We must do more to help those struggling with addiction,
and I am committed to working with my colleagues to advance
meaningful legislation and resources to help combat this
crisis. Families all across this nation are looking to us for
help, and it is my hope that DEA will work cooperatively with
us on this effort.
In addition to advancing efforts to respond to this crisis,
Congress also has a responsibility to figure out what went
wrong, how it went wrong, and how to make sure something like
this never happens again. That is why this Committee has been
engaged in a bipartisan investigation into the role both DEA
and drug distributors have in addressing the ongoing opioid
crisis, and what systems failed to protect the communities that
have been so overwhelmed by this epidemic.
I hope that the lessons we learn will help us address this
urgent problem throughout the country, from New Jersey to West
Virginia and beyond.
Clearly, something went wrong. The safeguards designed to
prevent opioids from being diverted into the wrong hands simply
did not work.
Our Committee's investigation has found that drug
distributors shipped millions of pills to multiple small-town
pharmacies in West Virginia every year. For example, a pharmacy
in a town of 2-thousand people received 16.5 million doses of
opioids over a 10-year period. And there were other pharmacies
in that area.
There is simply no way that there was an actual medical
need for this incredible volume of opioids in this rural,
sparsely populated area. I would hope that DEA can tell us what
broke down in the safeguards that should have protected
communities from these abusive practices. These include
failures by both the distributors and DEA.
For example, I have questions about the data that DEA
collects, and why they did not use it more aggressively prevent
the oversupply of opioids in certain cases. We know that
distributors are required to tell DEA how many pills they ship
each month, and where those pills go. It is not clear, however,
how DEA has used this data in the past, and if DEA is using
this data now to help it curtail excessive pill distribution.
Distributors are also required to alert DEA when a pharmacy
places an order for what appears to be a suspiciously large
quantity of pills. It appears that distributors have not always
alerted DEA of these suspicious orders, and may not even have
had adequate systems in place to identify inappropriately large
orders. But at the same time, it is also not clear that DEA has
always done enough with the suspicious orders they receive from
distributors to alert the agency to possibly anomalous
shipments. I hope we can get answers to both of these
questions.
And when multiple distributors ship to a single pharmacy,
possibly causing an oversupply, it is not clear that DEA has
had an adequate system to identify and flag to the distributors
that an oversupply problem may be unfolding. Unlike DEA who has
access to comprehensive distribution data, distributors can
only see what they supply to an individual pharmacy. Yet, if
DEA is not flagging when multiple distributors are at risk of
collectively oversupplying a pharmacy, then the result is
another example of a system failure that can lead to diversion.
It seems likely that failing to report suspicious orders by
distributors has hurt DEA's ability to monitor the distribution
of controlled substances. I hope that we will hear that this is
no longer an issue today, and if it is I'd like to know what
tools DEA needs to help it enforce this requirement. But at the
same time, I do hope that DEA is making full use of suspicious
orders when they are reported to their field offices.
Finally, while our investigation has focused on what went
wrong in West Virginia, I also want to know how DEA is
monitoring distributors across the country now. Addictive drugs
are still abundant in our communities, and now new opioids are
also being introduced to the market.
I hope that DEA is acting proactively to analyze shipments
of these pills and, where appropriate, stepping in and stopping
the over- distribution of these drugs.
I want to thank Administrator Patterson for appearing
before us today. This issue is extraordinarily important, and
no entity can address it alone. DEA and Congress must be allies
in combatting the opioid crisis, and only by understanding what
went wrong can we fix this system for the future.
Thank you.
Mr. Harper. The gentleman yields back.
I ask unanimous consent that the members' written opening
statements be made part of the record. Without objection, it
will be entered into the record.
Additionally, I ask unanimous consent that Energy and
Commerce members not on the Subcommittee on Oversight and
Investigations be permitted to participate in today's hearing.
Without objection, so ordered.
I would now like to introduce our witness for today's
hearing. Today, we have Mr. Robert Patterson, the Acting
Administrator for the Drug Enforcement Administration. We
appreciate you being here with us today, Mr. Patterson, and you
are aware that the committee is holding an investigative
hearing and when so doing it has been our practice of taking
testimony under oath.
Do you have any objection to testifying under oath?
Mr. Patterson. I do not.
Mr. Harper. Witness response is no.
The chair then advises you that under the rules of the
House and the rules of the committee, you're entitled to be
accompanied by counsel. Do you desire to be accompanied by
counsel during your testimony today?
Mr. Patterson. I do not.
Mr. Harper. Responds that he does not. In that case, I
would ask that you rise and please raise your right hand and I
will swear you in.
[Witness sworn.]
You are now under oath and subject to the penalties set
forth in Title 18 Section 1001 of the United States Code. You
may now give a 5-minute summary of your written statement.
You can hit the button on the mic and you have 5 minutes to
summarize your testimony.
Thank you again for being here, Mr. Patterson.
TESTIMONY OF ROBERT W. PATTERSON, ACTING ADMINISTRATOR, DRUG
ENFORCEMENT ADMINISTRATION
Mr. Patterson. Thank you, and good morning.
Committee Chairman Walden, Subcommittee Chairman Harper,
Ranking Members Pallone and DeGette, and distinguished members
of the subcommittee, thank you for the opportunity to be here
today to discuss the opioid epidemic and DEA's role in
combating this crisis.
Over the past 15 years, our nation has been increasingly
devastated by opioid abuse, an epidemic fueled for a
significant period of time by the overprescribing of potent
prescription opioids for acute and chronic pain. This
indiscriminate practice created a generation of opioid abusers,
presently estimated at more than 3 million Americans.
Over the past few years, we have begun to see a dramatic
and disturbing shift. As a result of the increased awareness of
the opioid epidemic, prescriptions for opioids have started to
decline--obviously, somewhat a success. But organizations, in
particular the well-positioned--in particular, the well-
positioned Mexican drug cartels have filled this void by
producing and distributing cheap powdered heroin, often mixed
with illicit fentanyl and other fentanyl-related substances and
selling it to users in both traditional powder form and, in
some cases, pressed into counterfeit pills made to resemble
illicit pharmaceuticals.
There are two central elements DEA is addressing as part of
this administration's collective efforts to turn this tide,
with a third piece that must also be addressed. First and
foremost is enforcement. Based on our investigations, actions
are undertaken every day using our criminal, civil, or
administrative tools to attack the traffic in illicit drugs and
the diversion of the licit supply.
Second is education. I strongly believe there is a real
value and a natural fit for the DEA in this space and look
whenever possible to partner with leaders in prevention and
education.
The third element is treatment. The DEA is committed to
doing what we can to improve access to drug treatment and
recovery services, working alongside our partners at the
Department of Health and Human Services, to utilize evidence-
based strategies that minimize the risk of diversion during
this public health emergency.
Ultimately, the only way to fundamentally change this
epidemic is to decrease demand for these substances and address
the global licit and illicit supply concerns through the
efforts of DEA and all of its partners. The action of DEA's
Diversion Control Division are critical with respect to
addressing the licit supply. Diversion of prescription opioids
by a few has a disproportionate impact on the availability of
prescription opioids. The fact remains that a majority of new
heroin users stated that they started their cycle of addiction
on prescription opioids. As a result, we are constantly
evaluating ways to improve our effectiveness to ensure that our
more than 1.7 million registrants comply with the law.
Our use of administrative tools and legislation that
changed our authorities in this area has been the subject of
numerous media reports. Let me address that issue up front. DEA
has continued to revoke approximately 1,000 registrations each
year through administrative tools such as orders to show cause,
immediate suspension orders, and surrenders for cause. We have
and will continue to use all of these tools to protect the
public from the very small percentage of registrants who
exploit human frailty for profit. Where a licensed revocation
is not necessary we have aggressively pursued civil actions and
MOUs designed to ensure compliance.
Over the last decade, DEA has levied fines totaling nearly
$390 million against opioid distributors nationwide and entered
into MOUs with each. DEA has also reprioritized a portion of
its criminal investigators and embedded them in with diversion
investigators and enforcement groups, referred to as tactical
diversion squads. We currently have 77 of these groups
nationwide who are solely dedicated to investigating,
disrupting, and dismantling individuals and organizations
involved in diversion schemes.
DEA's Diversion Control Division has simultaneously worked
to improve communication and cooperation with the registrant
community. As an example of this outreach, DEA offers year-
round training free of charge to pharmacists, distributors,
importers, and manufacturers. DEA just completed training more
than 13,000 pharmacists and pharmacy technicians on the
important role they play in ensuring they only fill valid
prescriptions.
In May, DEA will initiate a similar nationwide effort to
provide training on the vital role that prescribers play in
curbing this epidemic. This effort will start with specific
focus on States where we have seen little decrease or, in some
increases, an increase in opioid prescribing rates.
Administrative action, civil fines, and criminal cases are
all important steps. Where we have fallen short in the past it
is by not proactively leveraging the data that has been
available to us.
Although I am happy to discuss what happened in the past, I
focus my time on moving our agency forward and appreciate the
opportunity to update you on where we are today and where we
intend to go. For example, in January we utilized ARCOS data
overlaid with data from HHS and, when available, state PMP
programs. The result was approximately 400 targeted leads that
DEA was able to send to its 22 field divisions nationwide for
further investigation.
We are working all the Federal agencies in the space while
we continue to work well with our colleagues at ONDCP, CCD,
NIDA. The mutual issues that we face today have created
stronger and critical partnerships with FDA and HHS.
I'll finish up by saying I'd like to recognize the Health
Subcommittee's efforts to hold a legislative hearing starting
tomorrow on more than 25 pieces of legislation. That effort not
only underscores the unprecedented nature and complexity of the
opioid crisis but also demonstrates that we must all take
action to address this threat together.
Thank you for this opportunity and I look forward to your
questions.
[The prepared testimony of Mr. Patterson follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Harper. Thank you, Mr. Patterson. It'll now be the
opportunity for members to ask you questions regarding your
statement and look for solutions to the problems that we have
and I will begin by recognizing myself for 5 minutes for
questioning.
Over the past year, this committee has been investigating
opioid dumping and as part of this probe the Committee found
some disturbing examples, and I will share a couple of these,
some that we have touched on. A single pharmacy in Mount Gay-
Shamrock, West Virginia, population 1,779, received over 16.5
million hydrocodone and oxycodone pills between 2006 and 2016.
Distributors sent 20.8 million opioid pills to Williamson, West
Virginia, population 2,900, during the same period, and in 2006
a pharmacy located in Kermit, West Virginia, population 406,
ranked 22nd in the entire country in the overall number of
hydrocodone pills it received with a single distributor
supplying 76 percent of hydrocodone pills that year.
Would you agree that, on its face, these distribution
figures represent inordinate amounts of opioids shipped to such
rural markets?
Mr. Patterson. I would.
Mr. Harper. Distributors are required to file reports of
shipment amounts on certain controlled substances to the DEA
database called the Automated Reports and Consolidated Ordering
System, or ARCOS. These reports are filed monthly. Is that
correct?
Mr. Patterson. Sir, either monthly or quarterly.
Mr. Harper. What's the distinction between when one is done
quarterly or monthly? Who makes that determination?
Mr. Patterson. It is done by a distributor or a
manufacturer.
Mr. Harper. OK. Ten years ago, would the ARCOS database
have been able to flag DEA diversion investigators about
unusual patterns such as the stunning monthly increases of
shipment amounts or disproportionate volume of controlled
substance sales at a pharmacy?
Mr. Patterson. Ten years ago, I think that would be
doubtful.
Mr. Harper. OK. Did the DEA attempt to leverage the data in
ARCOS to help support DEA investigations of opioid diversion in
West Virginia?
Mr. Patterson. Back at that time frame?
Mr. Harper. Just tell me when. When did they start
utilizing that?
Mr. Patterson. Sir, so ARCOS data I think pre probably 2010
was an extremely manual process. As that system has gotten more
robust and, certainly, through the last handful of years we've
used that in a much more proactive manner.
Mr. Harper. Would the DEA ARCOS database be able to flag
such signals of opioid diversion today? Your answer is,
obviously, a yes.
In 2006 and 2007, DEA sent at least three letters to
wholesale drug distributors regarding their compliance
obligations under the Controlled Substances Act. The letters
reminded the companies of their duties to monitor and report
suspicious orders of opioids. Yet, during this time, according
to DEA enforcement actions, drug distributors failed to
maintain effective controls against diversion.
Why did the DEA communications with industry fail to
prevent the kinds of major breakdowns apparent in West
Virginia?
Mr. Patterson. I think when you go back to that timeframe
on the suspicious orders reports, there were two major
failures. One was either a lack of information contained
therein or not filing them in this instance that they had. I
think that started the problem, quite frankly and a lot of the
frustration came from chasing down the registrants and
ultimately reminding them of their responsibility in this
regulated area.
Mr. Harper. Over the last 10 years, the DEA reached
settlements with drug distributors for failing to maintain
effective controls against diversion of opioids or failing to
report suspicious orders. Yet, after these settlements, drug
distributors continued to fail to comply with the regulatory
requirements. Why were these initial settlements not effective
in achieving compliance from these distributors?
Mr. Patterson. And again, this goes back to the frustration
of the day, and I know that the folks that were in diversion
back in 2010 and 2012 struggled with the fact that these MOUs
or MOAs have been put in place with these companies and they
blatantly violated them again.
Mr. Harper. So how is DEA utilizing ARCOS today? Is it
effective today?
Mr. Patterson. So, sir, ARCOS as a stand-alone database is
a good pointer. I think, as I said in my opening statement,
ARCOS data and what we have learned, combined with state PMP
HHS data, gives you a much better outlier problem.
In some of the cases that we have looked at, depending on
the situation, ARCOS data would not have found those particular
issues, right. If it's a smaller level or a single place. So
the reality is is what we need is all of these data sets
essentially working in conjunction with each other.
Mr. Harper. Are there movements to improve ARCOS? Is that
constantly monitored and updated and refined?
Mr. Patterson. So we are constantly working with this data
now in a very proactive way. We've joined with two state
coalitions of states' attorneys-general to work with data
sharing in this space, especially with the PMP data as well as
our counterparts at HHS.
Mr. Harper. Thank you, Mr. Patterson.
The Chair now recognizes the ranking member, Ms. DeGette
from Colorado, for 5 minutes.
Ms. DeGette. Thank you so much, Mr. Chairman, and I agree,
Mr. Patterson, that we do need to look forward how we can
improve things. But I don't think we can do it without
examining the past, and this ARCOS system is the perfect
example.
I want to spend a few minutes following up on what the
chairman was asking you, my understanding is ARCOS was in place
during this whole time period, 2006 to 2016, correct?
Mr. Patterson. That's correct, ma'am.
Ms. DeGette. And so what was happening the data was just
being reported in but nothing was really being done with it.
Isn't that correct?
Mr. Patterson. I would say it was used in a very reactive
way.
Ms. DeGette. Right. So you said that a lot of times you
wouldn't have been able to tell this from ARCOS.
I am going to assume, though, if we had been analyzing this
data we would have found the 184,000 pills per month that
McKesson was sending to Kermit if someone had looked at it.
Wouldn't you think so?
Mr. Patterson. I do agree with that.
Ms. DeGette. Yes. And wouldn't you agree that in Kermit--I
think you said yes when the chairman said this--it was 2.2
million pills in a year in Kermit.
All you'd have to do is look at that raw data and see that,
wouldn't you?
Mr. Patterson. That's correct.
Ms. DeGette. And so really the fact--well, let me--let me
ask you another question. The Controlled Substances Act and the
applicable regulations require the distributors to know their
customer.
So distributors are supposed to report orders of unusual
size, orders deviating substantially from a normal pattern, and
orders of unusual frequency to the DEA.
Isn't that correct?
Mr. Patterson. It is, ma'am.
Ms. DeGette. So it's not just the DEA that has a burden to
analyze the ARCOS data and to identify problems. But even
before that, the distributors have a burden, right?
Mr. Patterson. The key burden is actually on the
distributor.
Ms. DeGette. Right. Exactly. So do you think that if you
were McKesson Corporation and you were looking at all these
prescriptions in Kermit, would you think they knew those
customers?
Mr. Patterson. Well, one, the obligation was there to know
their customers.
Ms. DeGette. Right. Do you think that you possibly could
know the customers when you're sending that many prescriptions
in there?
Mr. Patterson. I think McKesson's answer would be that they
did their part on this.
Ms. DeGette. Well, what's your answer?
Mr. Patterson. Obviously, I think they should have done
more.
Ms. DeGette. Well, I would think so. Do you think that
orders of this magnitude--2.2 million doses of hydrocodone to
one Sav-Rite pharmacy--do you think that that's an order of an
unusual size?
Mr. Patterson. I do, ma'am.
Ms. DeGette. And do you think that it deviates from a
normal pattern?
Mr. Patterson. I do.
Ms. DeGette. OK. Let me ask you another question.
Now, looking back on this case, do you think that the
distributors in all of these situations that the Chairman and I
have been talking about--do you think that they failed to
adequately exercise good due diligence over what they were
doing?
Mr. Patterson. Certainly, on the appearance of it. I can't
tell you what their due diligence was. But----
Ms. DeGette. Oh, we are going to ask them that. Don't
worry. You're not here to represent them.
Now, in December, the Washington Post and ``60 Minutes''
reported that McKesson distributed large volumes of opioids
from its Aurora, Colorado distribution facility in 2012. One
pharmacy that received these shipments reportedly sold as many
as 2,000 opioids per day. Have you retroactively applied ARCOS
data to the Colorado situation to see if there were
distribution patterns similar to what we saw in Kermit, West
Virginia?
Mr. Patterson. I believe that's the case, ma'am, that
ultimately the DEA litigated and received a settlement. I don't
know if we went back currently and have looked at that same
number.
Ms. DeGette. And what was the settlement?
Mr. Patterson. It was $150 million.
Ms. DeGette. From McKesson to----
Mr. Patterson. The U.S. government.
Ms. DeGette. The U.S. government. As a result of McKesson's
failure to adequately follow the law on distributing those
opioids. Is that right?
Mr. Patterson. That's correct.
Ms. DeGette. And so what do you think Congress can do so
that we don't have a total slip-up like we did in all of these
cases in West Virginia and around the country, really?
Mr. Patterson. Well, look, the fundamental change that we
have already made is our recognition of how we can use the
various data sets and paying attention to what we are doing.
The outreach to industry--and I think this is a topic that
I assume will come up at some point--we have to work with the
industry and the industry, obviously, has their responsibility.
But we have 1,500 people to monitor 1.73 million
registrants.
Ms. DeGette. So, really, you think the initial burden to
assess this is on the industry. But then the DEA has an
important enforcement?
Mr. Patterson. Oversight.
Ms. DeGette. Yes, thank you.
Thank you, Mr. Chairman.
Mr. Harper. Gentlewoman yields back.
The chair will now recognize the chairman of the full
committee, Mr. Walden, for 5 minutes for questions.
Mr. Walden. Thank you, Mr. Chairman.
Mr. Patterson, we need to find out whether DEA is really
addressing the lessons you say DEA has learned.
Case in point is the one I raised, the questionable
enforcement approach regarding the two Sav-Rite pharmacies in
Kermit, West Virginia that I mentioned in my opening statement.
Sav-Rite No. 2 was shut down in April of 2009, correct?
Mr. Patterson. I don't know the specific dates. I know
there were two pharmacies. One was shut down and one wanted
criminal----
Mr. Walden. Yes, our data show April of 2009 Sav-Rite 2 was
shut down. Sav-Rite 1 was not shut down until over 2 years
later when the owner of the pharmacy entered a guilty plea to
charges that he illegally issued prescriptions, correct?
Mr. Patterson. That's correct.
Mr. Walden. And in April 1st of 2009, an article in the
local Herald Dispatch reported that the two Sav-Rite pharmacies
and a local pain clinic were under federal investigation for
operating a drug operation. The article reported an affidavit
from Federal investigators who stated there were two overdose
deaths linked to this network.
So my question is why did DEA shut down Sav-Rite No. 2 but
not Sav-Rite No. 1 in April of 2009 if both pharmacies were
part of a network linked to deaths?
Mr. Patterson. Sir, I would have to get back to you on that
one particular issue and I will you the reason why. It's my
understanding it was part of the criminal process in that case
and I don't know the answer for why that was. But I would be
happy to get that back to you.
Mr. Walden. Thank you.
So why would the DEA even consider such an arrangement when
it knew the owner operated the pharmacies 2 miles apart, one of
which the DEA claimed to be the prime reception location for
the flood of pills--that's a direct quote--being sent to the
area and linked to overdose deaths? Same owner, same operator,
2 miles apart?
Mr. Patterson. I agree with you, and it's something I will
get back to you on.
Mr. Walden. During the time the DEA allowed Sav-Rite No. 1
to remain in operation, this pharmacy received somewhere
between 1 and 2 million hydrocodone and oxycodone pills.
Allowing Sav-Rite 1 to continue to dispense such a volume of
opioids posed a continuing risk to public health and safety.
Isn't that right?
Mr. Patterson. I would agree.
Mr. Walden. So, Mr. Patterson, what's the biggest priority?
Protecting public safety or deferring to an ongoing criminal
investigation?
Mr. Patterson. It should have been to protect public
safety.
Mr. Walden. So in this case, the government originally
entered a plea agreement with the pharmacy owner that didn't
even call for any prison time. The lack of any prison time
troubled the judge and eventually the defendant was sentenced
to 6 months in prison.
What kinds of evidentiary challenges would have been
involved in such a case and would putting an immediate
suspension order on hold really help solve these challenges?
Mr. Patterson. So putting an immediate suspension order on
hold, again, I don't know the particular facts of that criminal
case and I would be happy to get back to you.
I will tell you that I have a very strong opinion and this
has been relayed throughout our agency that whether it's an
immediate suspension or whether a surrender for cause, that if
we are having harm issues that that suspension needs to occur
even in lieu of a criminal prosecution.
Mr. Walden. And have you gone back and looked? Are there
any records in your possession that would speak to this issue
of why that decision was made?
Mr. Patterson. I would be happy to go back and look, sir.
Mr. Walden. And will you provide those to us unredacted?
Mr. Patterson. I would be happy to take that back and take
a look at it for you.
Mr. Walden. That wasn't the answer I was looking for.
Mr. Patterson. I don't want to commit to the department's
files. But I would be happy to take that back and I will take
your concern back about getting them unredacted.
Mr. Walden. Yes. We've had this discussion in private.
We'll have it in public. We'll have it in private.
The long and short of it is we just want to find out what
was going on, what was the thinking, why the change in
operation. People died and things were not--we don't want to
see your agency repeat that.
We are beholden to the constituents we represent and I
think the public has a right to know, don't you?
Mr. Patterson. I fully understand your concern and I agree
with you.
Mr. Walden. Would this happen again today?
Mr. Patterson. Certainly, I think with our mentality, the
answer would be no. Like I said, what we wish to do, sir, is
stop public harm. I've had this conversation with U.S.
attorneys' population, states' attorneys' population.
I see in too many instances on ISOs, current ones that I
sign off on, where there has been a delay that I don't find
appropriate.
Mr. Walden. So how do you weigh when to proceed with an ISO
versus a criminal case?
Mr. Patterson. I would take it, quite frankly, no different
than what we would do in a criminal case in the field, and in
this case, I find that we have the ability.
So we have certain protocols where we evaluate risk of
ongoing criminal activity in traditional criminal cases. In
this case, because the person has a registration, we can
immediately stop that harm.
Mr. Walden. And what's immediate? Is that 90 days? Twenty-
five days? Tomorrow?
Mr. Patterson. I think the frustration in this is it takes
time to build even that ISO charge, which is the reason why, in
a lot of cases, we've gone to surrenders for cause or a
voluntary surrender in which we go in and try and remove that
registration.
Mr. Walden. So how long are we talking about to build that
case?
Mr. Patterson. I think probably, in an efficient manner, 45
to 90 days.
Mr. Walden. So during that period, they can continue to
dispense these drugs?
Mr. Patterson. The same way an illicit person would be out
on the street as we gather the evidence we needed to present
the charge.
That's why, sir, I go back to my point on surrender for
cause, or a voluntary surrender. If I can walk in and lay out
to that person why they need to surrender that and I can do it
in a day and that's the method that we have actually been using
much more aggressively than the ISO process, then we are going
to do that.
Mr. Walden. What's the average time to go to a voluntary
surrender?
Mr. Patterson. It depends. With very aggressive people it
happens relatively quickly. There's always a quick balance with
a criminal case and then evidence that they need to look at for
that.
And, like I said, again, our conversations with prosecutors
in the field have been that decision has to get made quickly.
Mr. Walden. All right. I know my time has expired.
I would imagine Mr. Griffith is going to have a comment or
two on this as well.
With that, Mr. Chairman, I yield back, and thank you again.
Mr. Harper. Thank you, Mr. Chairman.
The chair now recognizes the ranking member of the full
committee, Mr. Pallone, for 5 minutes.
Mr. Pallone. Thank you, Mr. Chairman.
Mr. Patterson, I want to ask you about another pharmacy in
West Virginia so I can better understand why DEA was not able
to stop the distributors from oversupplying certain pharmacies.
This one is the Family Discount Pharmacy in Mount Gay-Shamrock,
West Virginia. Mount Gay-Shamrock has a population of just
under 2,000. DEA's data shows that distributors shipped 16.5
million opioid pills to this pharmacy between 2006 and 2016,
including 2 million pills in three consecutive years. By
contrast, the Rite-Aid Pharmacy down the street received a
total of about 2 million pills during this entire 11-year
period.
So do you agree that over 16 million pills is an excessive
amount of opioids for Family Discount Pharmacy to have received
relative to the size of the town it served?
Mr. Patterson. Especially when you compare it to the other
pharmacy. Correct.
Mr. Pallone. I thank you.
One distributor has provided evidence suggesting that
between May 2008 and May 2009 they sent DEA 105 suspicious
order reports stating that this pharmacy regularly ordered high
volumes of pills.
For example, this distributor apparently told DEA that
Family Discount ordered 25 500-count hydrocodone bottles on
June 16th, 2008, and that's 12,500 pills just in the one day.
On October 10th, Family Discount ordered 32 500-count
hydrocodone bottles, or 16,000 pills in a single day, again,
for a town of only 2,000 people.
Now, merely reporting these suspicious orders does not
absolve the distributor of its additional responsibilities. Is
that correct?
Mr. Patterson. That's correct.
Mr. Pallone. So distributors still have to actually refuse
shipments to suspicious pharmacies?
Mr. Patterson. They can, yes.
Mr. Pallone. Additionally, it appears that distributors
continue to ship this pharmacy over a million opioid pills each
year in the 5 years after these reports were made and even the
distributor who told us they reported the pharmacy to DEA
continued to supply them after submitting those reports.
So, Mr. Patterson, it would appear that, again, something
broke down to allow so many opioids to be shipped to this
pharmacy. Just tell us what happened here. Why are so many
opioids sent to this pharmacy at the same time that DEA has
received a number of suspicious order reports? What do you
think happened?
Mr. Patterson. Sir, so, again, on any of these
individualized cases I am going to have to go back and take a
look at the specific instances of what happened.
I will give you, I think, the concern I have with the
ARCOS--not just ARCOS data but the suspicious orders, which is
that was a decentralized function. It would go out to our
division--those reports.
We are now bringing those in as well to our headquarters
for proper deconfliction and visibility of what we see. I will
take on face value the facts that you just proffered to me and
I would be happy to go back and take a look at the Family
Discount scenario. As I sit here, I don't have the particulars
on the case from that time.
Mr. Pallone. Well, we appreciate your following up. That's
obviously why we are asking the questions. I don't expect you
to know everything right off the bat.
But let me just say this. Between 2006 and 2010, did the
DEA have any data analysts assigned to scrutinize information
from distributors about the amount of pills shipped to
particular pharmacies? Did you have any kind of data analysts,
in that respect?
Mr. Patterson. So my understanding of the people that were
handling the ARCOS data it was a completely manual process,
meaning everything was coming in on paper or tapes, which would
have to be verified.
So you have this 1-month to 3-month delay to begin with.
They would have to have errors in their report that would go
back and forth. So what you found yourself with is a set of
data that sometimes would take a year-plus to get correct, and
then in that timeframe, sir, we are using it very much as a
reactive tool. In other words, someone would come in and
provide some piece of information on a pharmacy or a doctor or
some other issue and then they would go and look at the ARCOS
data. It was not done in a----
Mr. Pallone. So does that mean then, if I understand you,
that it would be too long a period of time before would they
realize how excessive this was?
Mr. Patterson. Well, if it was still ongoing, obviously, it
would be an ability to look at that current situation. In a lot
of these cases you see where these problems occurred for either
a year or two and then disappeared or they were ongoing. But--
--
Mr. Pallone. And is that problem being corrected or what do
you suggest we do?
Mr. Patterson. It has been corrected, sir. So, again, I
think that for the Committee to understand is ARCOS is an
extremely different tool in 2018 than it was even in 2010 or
2011.
Mr. Pallone. So you feel that you already have the tools to
correct it--you don't need anything else?
Mr. Patterson. I feel that tool, with other data, is an
important way for us to look proactively at the very specific
issues that we are talking about today.
Mr. Pallone. All right. Thank you.
Mr. Harper. The gentleman yields back.
The chair will now recognize the gentleman from Texas, Mr.
Barton, for 5 minutes.
Mr. Barton. Thank you, Mr. Chairman.
This is a difficult hearing because I think everybody has
the same bottom line. But your agency doesn't appear to be
willing to aggressively try to help us solve this or at least
deal with this crisis.
According to the latest numbers that this committee staff
has, 115 people a day are dying of opioid overdoses and two-
thirds of those are legally prescribed drugs. So about 80
people a day are dying from taking legally-prescribed
prescription drugs. Now, they may be getting that prescription
in an illegal way--in other words, they don't really need it.
You're the head of the agency that's supposed to do something
about it.
Now, I don't know much about you but, apparently, your
background has been on the illegal side of DEA. Is that
correct?
Mr. Patterson. That is correct.
Mr. Barton. OK. How long have you been in your current
position?
Mr. Patterson. Since October of 2017.
Mr. Barton. OK. And I doubt that you volunteered for the
job. We still don't have a Trump administration appointee who's
been recommended to the Senate. So for the foreseeable future
in terms of drug enforcement the buck stops with you, even
though you're, as I understand it, a career civil servant. Is
that correct?
Mr. Patterson. That's correct.
Mr. Barton. OK. Are you familiar with the Washington Post
articles that have been running the last 3 to 4 months? One of
them talks about the tension between the field enforcement
offices and the Washington administrative officials.
Mr. Patterson. I have.
Mr. Barton. OK. Do you agree or disagree with the basic
thrust of those articles--that the enforcement people were very
enthusiastic and willing to really go after the distribution
centers and the drug manufacturers and the pharmacies and the
Washington staff, for lack of a better term, stonewalled them
or toned them down?
Mr. Patterson. So I believe that's an overstatement. I
think you have a number of issues that, quite frankly, play out
in this space, some of which have to do with personalities. But
I don't find that the folks in the field, for the most part,
had this belief that they were shut down. I do think there were
people that felt that way at headquarters but not necessarily
in the field.
Mr. Barton. Are you familiar with a gentleman named
Clifford Lee Reeves, II?
Mr. Patterson. I am.
Mr. Barton. You don't think he stonewalled them or toned
them down?
Mr. Patterson. Sir, as I've talked about with everybody
I've met on this situation, I will simply explain this. I could
put three people in a room and talk about probable cause and
they could all have different opinions on----
Mr. Barton. Well, let me put it this way. You and your
associates in Washington have stonewalled this committee for
the last 6 or 7 months.
It took a threat of Chairman Walden to subpoena the
attorney general of the United States to finally break loose
some documents. We didn't get those documents, I understand,
until yesterday. Now, that's not the Washington Post, sir.
That's your people in Washington interacting with Energy and
Commerce Committee staff on a bipartisan basis. That's not
hypothetical. That's real.
Now, we are as much a part of the problem as anybody
because the Congress has not aggressively addressed it. But we
are beginning to, and as long as you're the head of the DEA, I
personally, as Vice Chairman of this committee, expect you to
work with us and to tell your people to work with the committee
staff. Can you do that?
Mr. Patterson. Sir, I took over this job in October. I met
with----
Mr. Barton. OK. I want to know will you do what I just
asked you to do? Yes or no. Will you tell your people to work
with committee staff to help address this problem?
Mr. Patterson. Of course, and I have since November and
we've been turning documents over since that time.
Mr. Barton. Well, you didn't turn them over until
yesterday, sir, and some of the documents you turned over were
so redacted that it just looked like black marks on the pages.
Mr. Patterson. Sir, we've been turning documents over since
November to the tune of more than 10,000 pages of documents
that have come over here in the last month.
Mr. Barton. Yes, and how many of those pages do you think
are useable?
Mr. Patterson. Well, we sat down yesterday with staff to
go----
Mr. Barton. Because this hearing was today.
Mr. Patterson [continuing]. The concerns. Sir, I would
respectfully disagree with that.
Mr. Barton. Well, at least you're respectfully disagreeing
and I appreciate that.
Mr. Patterson. I am fully committed, sir, to working with
this committee and being as transparent as I can be.
Mr. Barton. Well, you just remember, 80 people a day are
dying because of legal prescription drugs that are probably
being illegally prescribed. Remember that.
I yield back.
Mr. Harper. Gentleman yields back.
The chair will now recognize the gentlewoman from Florida,
Ms. Castor, for 5 minutes.
Ms. Castor. Thank you, Chairman Harper.
Administrator Patterson, I am sure you know about the
multi-district opioid litigation in the Northern District of
Ohio, which consolidates over 400 lawsuits brought by cities
and counties and other states' communities against the drug
distributors, manufacturers, and pharmacy chains. The most
important source of information in that major lawsuit is going
to be most likely the ARCOS data, and I understand DEA
initially resisted providing ARCOS data to the federal judge.
A DEA official testified in response to my question in the
Health Subcommittee hearing last month that the resistance was
based upon a need to protect proprietary information. But now
the court in this case has recently entered a protective order
describing how the parties should treat the confidential ARCOS
data when DEA disclosed it.
It's apparent to me that the ARCOS data will be pivotal in
appropriately resolving the case and assigning accountability.
Do I understand now that DEA has agreed to provide 9 years of
data on opioid sales including the identifies of manufacturers
and distributors that sold 95 percent of opioids in every State
from 2006 to 2014?
Mr. Patterson. That is correct, under the protective order.
Ms. Castor. Under the protective order. So this will not be
the last major challenge to manufacturers and distributors and
others that are responsible. Will DEA likely cooperate in those
cases too? Have you set up a standard--is this a decision,
going forward, that other judges and litigants can count on?
Mr. Patterson. I would believe it's under the same
circumstances and conditions that we would comply the same way
with anyone else that came in under those same terms.
Ms. Castor. So when will that data be provided to the
Federal court in the northern Ohio case?
Mr. Patterson. I can get back to you on the date. I think
it's very short term.
Ms. Castor. OK. The Committee's analysis of ARCOS data has
been very concerning. The trends in West Virginia--we've just
really skimmed the surface, I think.
My colleagues have outlined some of these. I am concerned
that there are other regions all across the country where
distributors may have supplied pharmacies with excessive
quantities of opioid pills and that that information may be
overlooked.
How is DEA currently using the older ARCOS data, say, from
2006 to the present to go back and look at past crimes, and if
you could explain what you're doing now.
Mr. Patterson. No, I appreciate the question and I think
it's an important issue.
So the 400 packages that we just put out are current-day
packages that we want to investigate--in other words, where
harm is continuing. I shouldn't say where harm is definitely
continuing but where those outliers are that we want to go back
and take a look at, why is that occurring, right?
Some of these actually end up being reasonable issues.
There's an oncology department there. There's some reason why
there's a higher level of that medication going to that area.
I think the key is is that once we get a handle on current
issues that we are dealing with we want to roll backwards and
look at 2012, 2013, 2014, and 2015 where we still have the
ability to take a look at that data and make it make sense.
I can tell you that there's a number of cases ongoing in
DEA without going into detail on them, looking at just that
issue right now with manufacturers and----
Ms. Castor. And what is the statute of limitations? If you
go back and the Committee has seen some of this in graphical
forms where 2006 it ramped up and then because now the
spotlight is being shined on it that the excessive distribution
has scaled down.
Do you have the ability to go back and hold them
accountable for that peak dangerous distribution of opioids?
Mr. Patterson. So on the criminal side, I believe it would
be 5 years. On civil, I would have to find out. I am not sure
how far back you can go civilly.
Ms. Castor. So you are----
Mr. Patterson. As long as it is an ongoing issue, then you
fall into that timeframe.
Ms. Castor. And there was a lot of criticism by the
Pulitzer Prize-winning Charleston Gazette Mail that the state
didn't take advantage of data at their fingertips. How are you
cooperating with states in providing that data so they can hold
folks accountable?
Mr. Patterson. So this gets back to the issue, I think,
with PMP which--and this is why these two data sets are so
critical with each other.
We see the distribution to the pharmacy. PMP data in the
states will then show you the distribution out of the pharmacy,
right. So that whole connection, that's where those other
outliers become very critical for us to take a look at.
Some states, and this is the issue that we have addressed
throughout the members that we've met through and the states
that we've talked to, some states share this data. Some states
require a subpoena, which is also fine. Some states don't
share. This is a problem that we have and, frankly, I think an
issue that I would hope that someone looks at on a legislative
fix, at a minimum to make the states cooperate with each other
because you have bordering states, in some cases, that are
still not participating and cooperating with each other, which
is exactly how a lot of this diversion happens.
Ms. Castor. Thank you very much. I yield back.
Mr. Harper. Gentlewoman yields back.
Before we proceed, I want to clarify for the record that
the DEA has been producing documents and the vast majority of
the roughly 9,700 pages we have received have come in during
the last month.
Those documents had substantial redactions. Staff
identified key documents for you and yesterday the DEA brought
up some of those for us to view in camera. And I will note that
those documents still contain some redactions.
So there's still much work to be done. I wanted to clarify
that for the record, that the bulk of these came in after
Chairman Walden's press conference and we'll continue to work
with you in this effort.
Mr. Patterson. Thank you, sir.
Mr. Harper. Now the chair will recognize the Vice Chairman
of the Subcommittee, the gentleman from Virginia, Mr. Griffith,
for 5 minutes.
Mr. Griffith. Thank you, Mr. Chairman.
Mr. Patterson, I am going to need your assistance on some
of this because what I am going to do is ask a series of
questions which require a yes or no answer.
First, if you would take a look at the email before you
dated 5/6/2011. I show it to you here, and I would ask
unanimous consent to put that into the record.
Mr. Harper. Without objection.
[The information appears at the conclusion of the hearing.]
Mr. Griffith. And apparently, secret DEA official wrote,
because his name is blacked out, our first and most prominent
social responsibility as government officials in the DEA is to
protect the public. I think that trumps all other activities. I
think that's what Congress/citizens would expect us to do. You
agree with that statement, don't you? Yes or no.
Mr. Patterson. Yes.
Mr. Griffith. One of the key tools for DEA to fulfill this
mission is through an immediate suspension order--I will
henceforth refer to those as ISOs. This is an administrative
tool used as an emergency intervention to stop a rogue doctor
or pharmacist from continuing to prescribe or dispense opioids
that would possibly kill drug seekers and/or put the public at
risk.
You agree with that as well, don't you?
Mr. Patterson. I do.
Mr. Griffith. An essential element for requesting the ISO
is concern about imminent danger to public health or safety. A
pharmacy in Oviedo, Florida received an increase of oxycodone
of almost 2,500 percent compared to 1 year earlier. Local
police arrested customers in the parking lot of this pharmacy
for selling/trading pills. Police officers were concerned
customers were getting high in the parking lot and getting on
the roads, endangering the public. The continued dispensing of
opioids by this pharmacy with its parking lot of drug pushers
and drug users who get high and then drive on the public roads
would pose an imminent danger to the public, wouldn't you
agree? Yes or no.
Mr. Patterson. Yes.
Mr. Griffith. You would also agree, I assume, that speed is
crucial in issuing imminent suspension orders to protect the
public? Yes or no.
Mr. Patterson. I would.
Mr. Griffith. I will just tell you, 45 to 90 days that you
told the Chairman of the Full Committee is not acceptable.
Please refer to another email before you and I ask unanimous
consent to put that in the record and this one is dated August
22nd--or 20th--there's two different dates on it.
Mr. Harper. Without objection.
Mr. Griffith. 2013.
All right. The email chain in August 2013 shows that DEA
lawyers were requiring the DEA field to submit an expert
witness report to describe the expert's assessment of data and
documents prior to submitting either or both request for an
immediate suspension order and orders to show cause.
Are you aware of this new requirement that was imposed in
2013? Yes or no.
Mr. Patterson. No.
Mr. Griffith. And I expected that.
Regarding medical experts being required, DEA counsel Lee
Reeves wrote, ``To be clear, this is not a chief counsel office
requirement policy. This is the requirement of the
administrator and the courts.''
Are you aware that the medical experts are required by the
DEA administrator? Yes or no.
Mr. Patterson. No.
Mr. Griffith. Mr. Reeves also wrote that as a general
matter, these cases without expert testimony are the exception
rather than the rule.
So, generally, DEA is requiring medical expert testimony
before the field can submit an ISO to the chief counsel's
office for review. Is this still the policy of the DEA? Yes or
no.
Mr. Patterson. It is not a policy, no.
Mr. Griffith. I appreciate that. Thank you.
Mr. Reeves cites the DEA administrator's decision in the
Ruben case for requiring medical experts. However, the Ruben
case is a show cause case, not an ISO.
This decision basically says that if a state doesn't
provide guidance on certain medical standards, the DEA must use
an expert to explain why the doctor's activities fell below the
standard of care. However, you would not need a medical expert
if the state had a statute of regulations on prescribing
standards. Yes or no, or I don't know?
Mr. Patterson. I don't know that.
Mr. Griffith. All right. Fair enough.
Let's discuss this policy of requiring experts, and I know
that you're trying to shift from some of that but let's discuss
it.
It would take some time for the DEA field to find a medical
expert, wouldn't you agree?
Mr. Patterson. I would.
Mr. Griffith. And to obtain the services of a medical
expert the DEA would have to issue a sole source contract and
the agency and the expert would have to figure out and reach an
agreement on fee and deliverables. Isn't that true?
Mr. Patterson. I don't necessarily know about the contract
but it would require some type of compensation.
Mr. Griffith. And after all of that, the medical expert
would need to review prescription monitoring program, data
patient files, and other information. It's going to take some
time for the medical expert to review and render an opinion,
isn't it?
Mr. Patterson. It would.
Mr. Griffith. Yes. After the medical expert completes the
review then the chief counsel's office would need additional
time to review the field submission of the request for an
immediate suspension order. Isn't that true?
Mr. Patterson. Yes.
Mr. Griffith. This scenario assumes no delays along the
way, and realistically this process, in many ISO cases, will
take weeks, won't it?
Mr. Patterson. I would believe so.
Mr. Griffith. And that's where you get your 45 to 90 days.
If the DEA registrant sought a restraining order against the
ISO, the delay in timing getting the medical expert and going
through all the steps we just went through would in fact weaken
the DEA's case in court for immediacy, wouldn't it?
Mr. Patterson. I would believe so.
Mr. Griffith. Yes, it would.
And so in fact, insisting on an expert medical testimony
for the ISO--I get the trial in cheap, the merits. But to
protect the public, insistent on a medical expert in advance is
endangering the public and endangering your case on the ISO
because it takes away the immediacy factor. Wouldn't you agree?
Mr. Patterson. Yes, and I----
Mr. Griffith. OK. I got to keep moving because I am already
out of time.
All right. Maybe I can get some more opportunity later.
Thank you, Mr. Chairman. I yield back.
Mr. Harper. Gentleman yields back. The chair will now
recognize the gentleman from California, Mr. Ruiz, for 5
minutes.
Mr. Ruiz. Mr. Patterson, thank you for coming. I am a
board-certified emergency physician and I can't tell you how
personally I take it whenever a patient comes in overdosed, not
breathing, and blue.
It's not uncommon to see a blue-colored patient being
strolled in in an emergency situation, having been dumped from
a car from friends who found this person overdosed, not
breathing. And as emergency physicians we cut to the chase and
we start resuscitating the patient. We know exactly what to do
no matter if it's from overdose of opiates or any other reason
why a patient is comatose. Whether we start the ABCs--airway
breathing circulations--and we bring them back, as much as
possible.
So I am going to cut to the chase here and ask you to be
very frank and direct.
You screwed up. The DEA knew that there was a lot of
opioids being shipped, an extraordinary amount and not
outliers, and when you said earlier that there's two things
that you were going to do from now on it's very concerning that
those two things were to recognize how to use the data, and
two, pay more attention to what you're doing. That leads me to
believe that you were collecting data that you did not know how
to use, and two, you weren't paying attention to your job
within the DEA.
So I am going to be very straightforward. What are you
doing different now that you're going to recognize how to use
the data?
Mr. Patterson. Sir, I appreciate the concern and I think
what I've tried to explain is the data--when we are talking
about a lot of these cases that you have brought up we are
talking about a time period in which this data was----
Mr. Ruiz. OK. Be specific on what are the changes you're
going to do now. Not giving me the reasons why or an excuse.
Tell me what are you going to do now that's different.
Mr. Patterson. So let me give you a handful of the
differences.
Mr. Ruiz. Yes.
Mr. Patterson. On the suspicious orders, we have
regulations that are in the final stretch to deal with that. We
have a website that's now been built for the distributors to
understand their customers better where they can go in and see
partial information on other people that distributed to that
particular pharmacy for the past 6 months.
We are working with all of our other partners both in the
Health and Human Services side and the states to try and
combine all this data, to look at it in a very proactive
manner.
Mr. Ruiz. What are your flags? What numerical equations
have you used to flag something for the pharmacies and for the
distributors?
Mr. Patterson. I would have to get you what the specific
flags are for them. I mean, they----
Mr. Ruiz. Are they new flags or are they old flags, like--
--
Mr. Patterson. No, they're our baselines for any given area
as to traditional, what the prescribing rates have been in
those particular areas and anything that's an anomaly to that
is a flag.
All right. So when we've talked about these issues before
we have a----
Mr. Ruiz. And who's looking at those flags? Who's the one
in your department who's actually putting their eyes on this
computer and reporting these?
Mr. Patterson. A unit within the diversion.
Mr. Ruiz. OK. And how many people are in that unit?
Mr. Patterson. I would have to get that number for you.
Mr. Ruiz. OK, because you have----
Mr. Patterson. Again, most of it's generated by computer.
Mr. Ruiz. OK.
Mr. Patterson. So it's not necessarily a manpower-intensive
endeavor to do.
Mr. Ruiz. OK. And so when you said that now you're going to
start paying attention to what you're doing, tell me about
that. What are the organizational changes that you have made to
start paying attention to doing your job?
Mr. Patterson. I don't think I said now that we are doing
it. I think we've been doing it for a period of time.
Mr. Ruiz. Well, you said moving forward that now, what you
have to do is to pay attention to what you're doing. That means
to imply that there was some kind of slip-up before.
So what exactly are you doing? What are the changes? I want
to practice my ABCs for a patient who's coming in. I want to
know what you're doing exactly that you're going to make sure
that this doesn't happen again.
Mr. Patterson. Again, that's some of the issues I just
talked to you about and how we use data, or not community
outreach. Well, community outreach with the prescribing----
Mr. Ruiz. Have you changed any organizational structure? Is
there any accountability metrics that you have included in your
department? Have you increased the staffing in certain areas?
What are you doing to pay better attention to your job?
Mr. Patterson. Over the past few years, we've increased
staffing and diversion. We have a new head of diversion control
coming in. He and I have sat down and spent time on this
particular issue as to other proactive ways we can look at it.
I met with the U.S. attorney and states' attorneys to talk
about these issues of working criminal cases or civil cases and
how they impact our administrative issues for the criminal
prosecutions.
They want to continue to gather evidence. If we have some
harm that's being done and we can stop it, then we have to
start to balance this out in a better and more proactive way.
So there are dozens of things we are doing differently. This is
not just a one issue fix.
Mr. Ruiz. Well, those are the things that I am particularly
concerned and want to know more about because that's what's
going to create the change is by making changes in your
department in order to use your data more efficiently and also
to start paying attention whether it's through computers or
personnel, because a computer can flag all it wants to flag but
if a human is not taking those warnings and having action based
on what your computer is flagging then it's just going to be a
flashing flagging computer.
Mr. Patterson. Understood.
Mr. Harper. Gentleman yields back.
The chair will now recognize the gentleman from Texas, Dr.
Burgess, for 5 minutes.
Mr. Burgess. Thank you, Mr. Chairman.
And Mr. Patterson, I want to acknowledge that I asked for
you to come to my office and you complied with that, and for
that I am deeply appreciative with the information that you
shared with me.
Obviously, this is something about which many of us feel
very, very strongly. Clearly, we want to get some answers.
The subcommittee has interest in knowing about differences
between voluntary suspension orders and immediate suspension
orders. I will stipulate that both exist and that we could
argue which is a more propitious path to follow. Are there
other tools you have in your tool box in addition to immediate
suspension order and the voluntary suspension order?
Mr. Patterson. Sure. There's a whole range. There's letters
of admonition, orders to show cause. There's a host of
administrative tools that we have that we can use in this
space, and depending on--and to go back to an issue that Mr.
Griffith had brought up, depending on, quite frankly, whether
it's a doctor or a pharmacy may be a very different reaction
than what we would do or evidence we would gather against maybe
a distributor.
Mr. Burgess. Let me ask you a question, because I can't
take credit for it--my staff did this--but went to your
Diversion Control Division and pulled down a document that's
called ``Cases Against Doctors'' and this is produced by the
U.S. Department of Justice and Drug Enforcement Administration.
I presume it's your product. It's about a hundred pages
long. It goes back, basically, to 2002 through October 12th of
2017. It's a hundred pages or about three cases per page, so
that's 300 cases against doctors in the last 15 years. Does
that sound about right?
Mr. Patterson. Sir, I don't know. That's a complete list of
all doctors that cases have been worked or is it a guide to
help people and where people have gotten into trouble?
Mr. Burgess. Well, I will tell you what concerns me as I
look through this is that most of the dates are pre-2009. So I
guess my question would be where is the data from 2010 onward
and perhaps that's something we can follow up with together
because I do share the provider's perspective on this. We want
to be able to provide pain relief when it's required of us and
it's appropriate.
At the same time, we obviously do not want to be
jeopardizing public safety and the integrity of society the way
the opiate crisis is endangering us currently. But I think this
could be very important information. You referenced, at the
start of your testimony, that over-prescribing is perhaps one
of the number-one problems. Well, if that's the case, then it's
this sort of information that is, I think, going to be very
helpful to us as policy makers how do we develop the correct
policy.
Let me just ask you, did I understand this figure
correctly? You referenced $309 million in fines at the DEA
level. Is that correct?
Mr. Patterson. In civil fines, $390 million or $309
million.
Mr. Burgess. So OK, that ballpark--$300 to $400 million.
We'd appropriated a billion dollars in cures for treatment
of this problem. We are looking at another $6 billion in the
appropriations bills that are coming through right now. So you
see the disparity there.
Someone, whether it be suppliers, prescribers is causing a
problem to exist. You're finding them but it's only minuscule
compared with the amount that it's actually costing society in
trying to save people, salvage people, get people back to
productivity.
That doesn't even address the fact that, again, people are
taken out of being productive citizens when they enter into
this type of behavior. Is that correct?
Mr. Patterson. I agree, sir. And may I just add? So these
fines come as, again, and some of the members have already
mentioned this balance, right, of ensuring pain medicines for
people.
So I think the fines generally come with, quite frankly,
the heavier piece of that is the memoranda of understanding or
memoranda of agreement of how they'll behave, moving forward.
Mr. Burgess. Correct. I get that.
Let me just ask you this, because I think it was Mr. Barton
referenced 80 people a day who were dying--115 was the total
number but 80 per day are dying because of what you described
as over-prescribing. And then we've got these lists that in my
observation are not up to date. Do we know how many people were
dying a day from over-prescribing in 2007, 2008, 2009 in that
timeframe? Do you have a figure?
Mr. Patterson. I don't have it here. I would be happy to
get that stat for you. It still was an alarming number, even
back in that time period, sir.
Mr. Burgess. And then that begs the question. And again, I
appreciate the effort that you're putting into it now. But it's
been right there in front of us for well over a decade, decade
and a half and, clearly, it requires all hands on deck in our
approach. And, again, I appreciate your being very forthcoming
with my office and I appreciate that.
Mr. Chairman, I will yield back.
Mr. Harper. Gentleman yields back.
The chair will now recognize the gentlewoman from New York,
Ms. Clarke, for 5 minutes.
Ms. Clarke. I thank you, Mr. Chairman, and I thank our
ranking member.
Mr. Patterson, it's clear in many cases certain drug
distributors supply very large volumes of opioids to some
pharmacies in West Virginia. But we've also seen from DEA's
data that many of these pharmacies were buying from multiple
distributors. For example, in 2009, the West Virginia pharmacy,
Hurley Drug, received over 2 million opioid pills from six
different distributors, including over 300,000 from one
distributor, over 600,000 from a second distributor, and over
900,000 from a third.
So it's bad enough if one distributor over-supplies a
pharmacy. But when you look at the total shipments that Hurley
Drug received from all distributors, it was about 2 million
pills, which is over seven times what a similar pharmacy will
be expected to receive, according to DEA's own data.
So DEA is the only entity that can see the volumes that
multiple distributors are simultaneously sending to a single
pharmacy. Is that correct?
Mr. Patterson. From the distributor level, yes, ma'am.
Ms. Clarke. So, Mr. Patterson, was DEA performing analytics
a decade ago to identify these kinds of patterns at individual
pharmacies?
Mr. Patterson. Again, ma'am, in a reactive manner at that
time.
Ms. Clarke. OK. So I would like to look at DEA's data on
another pharmacy in West Virginia--Sav-Rite Pharmacy in the
small town of Kermit received hydrocodone from five different
distributors in 2008. A few distributors provided relatively
normal amounts that don't seem to raise alarms. However, one
distributor shipped 1.2 million pills and another shipped
nearly 2 million. All told this pharmacy got nearly 4 million
pills that year, which is nearly 15 times what a similar
pharmacy would be expected to receive, according to DEA's data.
Mr. Patterson, if you rely on distributors to report
suspicious orders from pharmacies, how do you flag pharmacies
trying to stay under the radar by buying from multiple
distributors?
Mr. Patterson. So, ma'am, this is where, again, the data
that we use today--not the data, I shouldn't say the data--but
how we use the data is very different today, and this is also
where the critical nature comes into us working with the
states.
Those same pharmacies, that PMP data which show that amount
of distribution from those pharmacies, so we have that
distributor in and then the pharmacy out, depending on the PMP
program.
So the key is for us to work together on that and, again, I
can say repeatedly in 2008, 2009, and 2010 we did not use this
data in the way that we are now using it and I think that's the
key.
I get that we have this issue from a decade ago, that we
have to resolve in terms of how we used it. And, again, where
we fell short in that we'll take responsibility for it. I think
the system is much more robust and used in a much different way
in----
Ms. Clarke. So can you give us a little bit more insight
into how you're proactively analyzing the data to ensure that
pharmacies are not being over supplied by multiple
distributors? That has not come across clearly to us this
morning. How are you actually doing that disruption?
Mr. Patterson. Again, so as we talked about in the opening,
we are proactively looking at data not just across DEA and that
ARCOS database that we've talked about but HHS, PMP programs
where we are sharing that information and looking to
proactively target outliers.
Ms. Clarke. So what happens once you're flagged in this
regard?
Mr. Patterson. So we----
Ms. Clarke. What exactly happens?
Mr. Patterson. We send that information out to the field
for investigators--those TDS groups or diversion groups,
depending on how they're being used to go out and work those
cases to find out is it a legitimate amount of prescriptions
that are going there or is there illegitimate diversion
occurring in those areas.
Ms. Clarke. And has that worked thus far? Because, you said
this was over a decade ago. I am assuming that you have already
begun sort of this new protocol. What are your findings?
Mr. Patterson. Yes, ma'am. So the interesting thing is of
those 400 packages that went out, a good majority of what we
saw in that data and the outliers and what they identified were
ongoing cases that we already had, which shows that that data
set works to develop and target those areas where we have
problems.
To the extent that we didn't have cases on those other ones
and they were warranted, we've opened cases on those facilities
or doctors or distributors to take a look at that behavior.
Ms. Clarke. Mr. Patterson, I just want to share with you
that this is an ongoing crisis. Once we are able to disrupt
this supply chain, we know that these supply chains become
supplanted by more nefarious actors.
And so, I really want to impress upon you and your agency
to be as forward leaning in this regard as possible because
once those pills are cut off, we know that that's when the
illicit trade picks up in velocity.
Mr. Patterson. Yes, ma'am. And as we've talked about,
again, in the opening, I think that shift has already occurred.
Ms. Clarke. Thank you. I yield back, Mr. Chairman.
Mr. Harper. Gentlewoman yields back. The chair will now
recognize the gentleman from New York, Mr. Collins, for 5
minutes.
Mr. Collins. Thank you, Mr. Chairman, and thank you, Mr.
Patterson for being here.
I think you can tell and your get out of jail free card
today, you have been in this particular job 5 months. I would
hope 5 months from now you would not be giving many of the same
answers.
Following up on what Mr. Ruiz said, I think we are just all
frustrated. There seems to be the bureaucracy mindset in the
DEA today, much like we've seen in the VA. And we are finally
seeing heads rolling in the VA. Not as fast as we want. I am
just curious, because there's no doubt there was an abject
failure of the DEA, going back the last 10 years.
Have a lot of heads been chopped off? Have you got a new
team in place?
Mr. Patterson. Sir, so as I said, we have a new head of
Diversion Control. I think the last two people that have done
that job have done and both successful in turning around that
program.
Mr. Collins. Well, not to interrupt but to interrupt, I
think the right people can turn this around in 48 hours. I am a
turn around guy. That's what I've spent my whole life doing.
You bring a new team in and people get called in the office
every day and they walk out saying, somebody just hit me up the
side of the head with a baseball bat. I am either going to get
my act together or I am going to get out of Dodge.
This isn't a time to be polite or nice or let's do better
tomorrow. No, this is an abject failure, and if I am sitting in
that seat and McKesson processed 1.6 million orders and only 16
were deemed suspicious, that's absurd. I don't know what kind
of computers you have but that's absurd. It means no one was
watching.
And you can say well, that was being done in the district
level. But it's indefensible. When we look in West Virginia and
two suspicious orders so, let's maybe jump ahead, and in 2008,
Cardinal Health was fined $34 million for not reporting
suspicious orders.
All right. So let's go forward 8 years later. They're still
not doing it. Two guesses. First--second one doesn't count. How
much do you think you fined them 8 years later for the same
problem? Thirty-four million dollars, the same amount. In most
places the second offense--all right, first offense $34
million, eight years later the same problem, the same fine?
Should have been tenfold. Should have been $340 million
dollars.
What did your agency do? And this was a year and a half
ago. You guys don't get it and if you're not--this committee
agrees on a lot. I don't think we've ever agreed across the
board on an issue as much as we are agreeing your agency needs
to be turned upside down, not just a little shakeup here and
there but turned upside down. It starts with you. If you can't
do it, you ought to get out.
So when I look at some of the things--so we have
distributors. We have pharmacies. We have doctors. Well, I
happen to live next door--literally, next door to one of the
doctors, Dr. Gosy, in Clarence, New York, and I saw his six
sports cars parked out there with all new--his name in the
community was Dr. Pain. And this wasn't something new.
When I look back, it took the DEA a good 7 years to come
after my next door neighbor. By the way, he doesn't live there
anymore. But he had set up a script line in 2012 where people
could call in and fill scripts with PAs under basically no
supervision.
So at what point--how could you allow a single physician--
my next door neighbor, literally, in Clarence, New York--to
write more prescriptions for opioids, millions of them, than
any other doctor or in fact any other hospital in the State of
New York?
There's 20 million people in New York. My particular town
of Clarence has about 50,000 people, and one doctor in the town
of Clarence was writing more prescriptions than any doctor in
the State of 20 million people or any hospital including New
York City.
Took you guys 5 years to figure out there might be
something suspicious? Would you agree that's unacceptable?
Mr. Patterson. Sir, so I wouldn't have any data on a
particular prescriber. DEA doesn't hold that set of data.
Mr. Collins. Well, he's now been indicted. They've seized
his cars. They've seized his bank accounts.
Mr. Patterson. So at some point, whether that was a DEA
case or a state local case, I don't know what it was that
investigated him and----
Mr. Collins. It was a federal case.
Mr. Patterson. OK. So at some point we learned of that and
then there was----
Mr. Collins. Yes, but what's going on with your computer
systems and other things? It takes you 4 or 5 years. I know how
computers work, pretty much. I don't know how old yours are.
Maybe they're XT tabletops. I am not sure.
But this kind of data should be instantaneously available.
Mr. Patterson. And, sir, I go back to the states control
prescription monitoring program, not DEA. We control into a
pharmacy. The doctor----
Mr. Collins. Well, maybe you should be kicking some butt
going down the chain. I mean, if I was sitting in your job and
you're on the hot seat right now, and you're telling me now, I
mean, placing the blame on the states, that doesn't cut it in
our world here. We are not looking to place blame. We are
looking for solutions.
My time has expired. We look forward to you coming back in
another 4 or 5 months and having a different set of answers.
Thank you, sir.
Mr. Harper. Gentleman yields back.
The chair will now recognize the gentleman from New York,
Mr. Tonko, for 5 minutes.
Mr. Tonko. Thank you, Mr. Chair.
I want to find out if DEA uses data gathered through its
ARCOS system to game disability into how many opioid pill
distributors send to a town or region as a whole, even if the
distributions are spread out over multiple pharmacies.
Administrator Patterson, one town examined by the committee
was Williamson, West Virginia, population 3,000. Our
committee's investigation focused on two pharmacies in
Williamson. The first is Tug Valley Pharmacy.
Mr. Chair, could I ask that we please show minority exhibit
three on the screen?
OK. We have here the Tug Valley Pharmacy. According to
DEA's ARCOS data, between 2006 and 2016, Tug Valley Pharmacy
received over 10 million doses of opioids from 13 different
distributors. This includes over 3 million pills just in 2009.
So Administrator Patterson, this is an unbelievable quantity of
opioids for a pharmacy this size in a town of 3,000. Does DEA
believe the amount of opioids this pharmacy received was
excessive?
Mr. Patterson. In 2009 I would say so, sir.
Mr. Tonko. And, again, Mr. Chair, if we could please put
minority exhibit four up on the screen. This is the second
pharmacy in Williamson--Hurley Drug--that we see on the screen
here.
ARCOS data show that Hurley received over 10.5 million
doses of opioids from 11 different distributors between 2006
and 2016. This includes over 2 million doses in both 2008 and
in 2009. Mr. Patterson, again, this strikes me as an excessive
amount of opioids for a pharmacy in a town of 3,000 to receive.
Do you agree that this is unreasonable?
Mr. Patterson. I would agree.
Mr. Tonko. I've mentioned that both of these pharmacies are
located in Williamson and, incidentally, both of them are still
in operation today.
I want to show you where they are located. So if we could
please post minority exhibit five on the screen, and combined
distributor shipped over 20.8 million doses of opioids to these
two pharmacies, which you can see on our screen, are located
only blocks apart and they did that 20.8 million doses of
opioids between 2006 and 2016.
Mr. Patterson, between 2006 and 2016, what kind of ARCOS
data analyses did DEA do to alert it when distributors shipped
an unwarranted amount of opioids into a town or region so that
it could stop these excessive distributions?
Mr. Patterson. Again, sir, I would have to go back and look
at that specific example and look at the data set in terms of
where those periods of time were.
As I already testified previously, we use the data in a
very different way today than we did then. But I would want to
go back and specifically look at the time frame and what was
going on and I can get back to you on that.
Mr. Tonko. If the data were used today, as you use it today
would it have avoided something like this?
Mr. Patterson. I would hope so.
Mr. Tonko. Well, can we have a little more of an answer? I
am hoping is good, but----
Mr. Patterson. I would like to--part of the important issue
that we are talking about today is to go back and look at these
specific examples.
Like I said, I have seen examples where on ARCOS data we
actually can't see some of these anomalies. So I think, in
taking these examples back and looking at them and we are using
a time frame of 2006 to 2016, I can't tell you for the last
couple of years what that ARCOS data has been, as I sit here.
Traditionally, what we've seen is very high levels of
distribution into those places between 2008 to 2010 or 2011
when we started to look at this data in different ways.
Still not nearly as proactively as we do today. But that's
why I would like to take this example back and look and get
back to you on essentially what's happened with that.
Mr. Tonko. Thank you.
I have been dealing with this issue a great deal in my
district and when I hear of opioids being the gateway to the
illness of addiction, it's very disturbing, and the heartache
and the pain and, unfortunately, the death associated with that
illness is a crisis and we need to do something very valuable
here and I would implore that the folks at DEA be smarter in
their approach.
And with that, I yield back, Mr. Chair.
Mr. Harper. Gentleman yields back.
The chair now recognizes the gentleman from Pennsylvania,
Mr. Costello, for 5 minutes.
Mr. Costello. Thank you, Mr. Chairman.
Are you aware that the DEA's chief ALJ authored quarterly
reports describing DEA's declining use of ISOs and noted in
June 2014, ``an alarming low rate of agency diversion
enforcement activity'' on a national level?
Mr. Patterson. I have read those, yes.
Mr. Costello. For the last several years, the chief ALJ has
reported declining number of ISOs to the DEA administrator on a
quarterly basis. This issue had also been raised in the
committee's investigation.
Why has the number of DEA ISOs declined significantly over
the past few years?
Mr. Patterson. I think there's two things when you look at
those statistics.
I think that, although warranted, the statistics were very
high in 2010 and 2011 because of the issue that we were dealing
with in Florida and how those ISOs were being used. I think
during this latter part we have gotten to a point of in trying
to expedite the surrender of registrations we have much more
gone into a posture of trying to get voluntary or surrender for
cause orders.
Mr. Costello. Is there still a need today, as there was in
2011, for the DEA enforcement tool of ISOs?
Mr. Patterson. Yes.
Mr. Costello. A 2013 report by the chief ALJ stated the
DEA's chief counsel had ``instituted a new vetting QA
initiative'' that could be slowing the progress of diversion
cases.
What was this initiative?
Mr. Patterson. I don't know if it was initiative or if it
was guidance. I think the----
Mr. Costello. What was the guidance? Yes.
Mr. Patterson. I think the issue at play here was directed
towards distributors, not necessarily directed at doctors and
pharmacies.
Mr. Costello. Have you provided that guidance in full to
this committee?
Mr. Patterson. We have not.
Mr. Costello. Will you?
Mr. Patterson. That's a conversation that we've had with
Mr. Walden and we'll continue to work forward on that----
Mr. Costello. When a state revokes the medical license of a
doctor, that doctor is no longer eligible to have a DEA
registration associated with that medical license, correct?
Mr. Patterson. That's correct.
Mr. Costello. When the doctor no longer has state authority
to prescribe does the DEA have to conduct any further
investigation or can DEA execute revocation of DEA registration
by just obtaining the certificate of the medical license
revocation?
Mr. Patterson. We can do an order to show cause.
Mr. Costello. No investigation is needed?
Mr. Patterson. That's correct, because they've lost state
authority.
Mr. Costello. After a state revocation of the doctor's
medical license, how quickly is DEA notified about the
revocation and how long does it take for DEA to revoke the
doctor's DEA registration?
Mr. Patterson. That's where we need to be working with the
state medical boards to learn of that information. Our field
division offices are responsible for that.
Mr. Costello. Are the vast majority of DEA enforcement
actions in diversion litigation cases comprised of these no
state authority cases that do not involve DEA investigation?
Mr. Patterson. In terms of the orders to show cause?
Mr. Costello. That's correct.
Mr. Patterson. That's correct.
Mr. Costello. Yes?
Mr. Patterson. Yes.
Mr. Costello. Is it estimated to be about 80 percent of
their actions?
Mr. Patterson. I would believe that's probably a fair
number.
Mr. Costello. Mr. Chair, I would like to yield the balance
of my time to you, Mr. Griffith.
Mr. Griffith. Thank you very much.
When I was asking you questions earlier, we talked about
the ISOs and the apparent requirement--I know you didn't do it
but the apparent requirement for a medical expert in advance of
issuing an ISO and the fact that that would take a number of
weeks and you said 45 to 90 days. I went through all the
different steps that might actually lead to that.
So you agree that it's the DEA's mission to protect the
public safety and we agree that there's a tremendous amount of
delay and part of that delay in no small measure is the
requirement that before you get that administrative tool of the
ISO you have to get a medical expert.
So can you, as acting administrator, agree with me today
that you would be willing to reexamine the medical expert
requirement?
Mr. Patterson. Absolutely.
Mr. Griffith. And I appreciate that.
Mr. Patterson. And again, we are using the word
requirement. I think these documents are in reference to
distributors and not doctors and pharmacies. But I would be
happy to go back and look into that further.
Mr. Griffith. Yes, it was actually reference to doctors and
pharmacies. But that's OK. As long as we are working it out,
that's where we want to go. We want to make things better.
And one of the reasons that I get so passionate about this
is you saw Mr. Tonko's minority slide of Hurley Drug earlier.
Well, Hurley, Virginia, is 33 miles from Williamson, West
Virginia, where that drug store is located. And anybody with
any sense knows that a big bunch of those pills were coming
into my district.
Likewise, I had some additional questions that dealt with
the fact that we have problems with red flags being raised that
apparently takes a while to be picked up on.
So we had a doctor in Giles County who was sending his
patients over to West Virginia to get drugs. We have a
situation in Martinsville where they have, according to the
CDC, they prescribe more opioid pain killers than anywhere else
in the U.S. per capita and where another doctor was prescribing
opioids for patients in North Carolina.
So I look forward to working with you to solve these
problems. But these are real world problems, real world people,
and real word deaths.
Mr. Patterson. I agree with you.
Mr. Griffith. I yield back. I now recognize Congresswoman
Walters for five minutes.
Mrs. Walters. Thank you, Mr. Chairman.
Mr. Patterson, it's my understanding that the DEA often
uses tips and information it receives from state and local law
enforcement to develop cases against entities or individuals
suspected of engaging in or facilitating illicit drug
diversion. Is that correct?
Mr. Patterson. Correct.
Mrs. Walters. According to the DEA, the Automated Reports
and Consolidated Ordering System, or ARCOS, provides the agency
with retail level data regarding controlled substance
transactions. Does this mean, for example, ARCOS can show many
doses of hydrocodone or oxycodone an individual pharmacy
received in a given year?
Mr. Patterson. Yes.
Mrs. Walters. In fact, as part of its investigation, the
Committee has obtained and analyzed ARCOS data for parts of
West Virginia to great effect. So we recognize how important a
tool it can be.
In February of this year, DEA announced that it was adding
a feature to ARCOS that will allow manufacturers and
distributors to view the number of companies that have sold a
particular controlled substance to a prospective customer in
the preceding 6 months.
Mr. Paterson, does this policy enable companies to see the
amount of controlled substances its current customers are
receiving from other suppliers?
Mr. Patterson. Yes. Part of the suspicious orders is them
knowing their customers to know when to file these concerns.
Mrs. Walters. Does the newly added features in ARCOS
provide state and local law enforcement with greater access to
the system's retail level data?
Mr. Patterson. I would have to find out if it provides at
the state level. When we work investigations with the state
level--the state and local level, obviously, we can share that
data as part of an investigation.
This is also part of the issue that we are dealing with the
states' attorneys general on as to how to share these data sets
to be more proactive.
Mrs. Walters. OK. According to a letter the DEA sent to the
committee in November of last year, DEA will share ARCOS data
with law enforcement on a need to know basis and when they are
operating in coordination with the DEA for investigative
purposes.
So is it fair to say that the state and local law
enforcement entities do not have access to DEA ARCOS data on a
real-time basis?
Mr. Patterson. If we are working an investigation we'll
share that data in real time with them.
Mrs. Walters. OK. Is DEA developing any proposals that will
enhance state and local law enforcement's ability to access and
utilize ARCOS data?
Mr. Patterson. Again, we are working jointly with them and
this also goes back to the effort with our states attorneys
general.
Mrs. Walters. OK. In order to effectively combat the opioid
epidemic we need an all hands on deck approach. The DEA has
data that could assist state and local law enforcement to
identify potential sources of illicit drugs in their
communities and I think the agency should be exploring every
avenue to provide this data to law enforcement as quickly as
possible.
It seems to me that providing state and local police with
access to ARCOS data would be beneficial to the DEA as well,
effectively providing the agency with additional eyes and ears
on the ground, likely resulting in additional leads being
produced to the agency.
Mr. Patterson, will you commit to examine ways to improve
state and local law enforcement's access to ARCOS data so that
bad actors might be able to be identified with greater
frequency and effectiveness?
Mr. Patterson. Yes, ma'am.
Mrs. Walters. Thank you, and I yield back the balance of my
time.
Mr. Harper. I now recognize the gentlelady from Indiana,
Mrs. Brooks.
Mrs. Brooks. Thank you, Mr. Chairman.
Hello, Mr. Patterson. Since 2011, the number of immediate
suspension orders issued by the DEA, as you have even noted,
declined significantly from a high of 65 in 2011 down to a low
of 6 in 2017. So I want to talk about that a little bit.
Are there instances in which the DEA pursues an immediate
suspension order, the ISO, in parallel with related potential
criminal investigation?
Mr. Patterson. So, ma'am, since October, so the
administrator's position signs the ISOs when they're issued.
What I have traditionally seen is because of the process of
where a criminal case is being investigated there's been a
delay in the ISO process as they're gathering evidence.
One of the concerns I have, and it goes back to, again,
what Mr. Griffith said, is that cuts against the very argument
that we have an imminent problem that we are trying to deal
with.
So, again, my conversations that I've had with both U.S.
and states attorneys are is that we have to act much faster in
these cases in terms of if we have ongoing harm and we have the
ability to stop that harm, even at the peril of a criminal
case, then that's what we should be doing.
Mrs. Brooks. And let's be clear. The U.S. doesn't do the
immediate suspension orders. Those are done by the DEA.
Mr. Patterson. The DEA. It's an administrative action.
Mrs. Brooks. And are you saying that the U.S. attorneys
were asking--as a former U.S. attorney are you saying the U.S.
attorneys were asking or telling DEA not to issue ISOs?
Mr. Patterson. In trying to gather evidence in their
criminal case.
Mrs. Brooks. I understand, but that can take months if not
years sometimes in criminal cases. Do you believe that's what
happened prior to you coming in October of 2017--that delays
happened?
Mr. Patterson. I think that's been an ongoing theme of what
some of these delays are caused by.
Mrs. Brooks. And why would the DEA delay that type of
administrative action in pursuit of a criminal investigation?
Why?
Mr. Patterson. Because people believe that the criminal
investigation is an important endeavor towards whether it's
that doctor or that pharmacy.
Mrs. Brooks. Well, it is very important, no doubt, because
that person is, obviously, distributing--or the belief is
distributing illicitly. But why would an immediate suspension--
is that so that undercover operations can happen with the
physician?
Mr. Patterson. Yes, ma'am.
Mrs. Brooks. And the prescriber?
Mr. Patterson. The gathering of evidence.
Mrs. Brooks. And what is the new guidance, and I appreciate
the importance of gathering of evidence, but what is the new
guidance relative to ISOs and criminal investigations that you
are contemplating or that are in place now, and is that
guidance in writing?
Mr. Patterson. So it is not formalized. This is
conversations that I've been having with the AGAC, the, you
know, advisory----
Mrs. Brooks. I served on the attorney general's advisory
counsel.
Mr. Patterson. And to the extent that I've been meeting
with states' attorneys to try and talk to them about the same
issues.
So I think we have to, again, a lot of this is striking a
balance. I, frankly, feel that a lot of these cases can be
worked backward on the criminal aspect.
I understand that their desire in a lot of these cases is
to be able to get contemporaneous evidence, use undercover,
right, as opposed to having to use witnesses that have come in
that maybe not have the best of backgrounds.
So I understand that balance. The concern I have, like I
said, if we are using an ISO, it feels awful weird to be
signing that ISO a year after we learned of that problem.
Mrs. Brooks. And I noticed in the document that Dr. Burgess
had there was some of that, that the ISO was a year after the
arrest even.
Mr. Patterson. Correct.
Mrs. Brooks. Although at the time of the arrest, typically
that individual would be under their medical licensing
procedures as well. Is that correct?
Mr. Patterson. Correct.
Mrs. Brooks. But wouldn't it make more sense to in many
ways implement an ISO in the middle of the criminal
investigation because those can take months if not years, and
in the meantime we've got all of these people dying.
Mr. Patterson. I couldn't agree with you more and, quite
frankly, even in the absence of the ISO, my concern is is that
why aren't we trying to get a voluntary surrender as quickly as
we have. And we have a lot of offices that do that in a very
expeditious manner.
Mrs. Brooks. And will your proposed guidelines impose a cap
on the length of time it can be delayed? Is that the kind of
discussion you're having. You're looking at, like, 30 days?
Forty-five days?
Mr. Patterson. I think, striking that balance, we have to
figure out where the days are. There will probably always be
that exception that comes up and I think as long as people are
willing to--whether it's a U.S. attorney or a states' attorney
that is willing to put in writing why we need to delay and we
can evaluate that, I think that's something.
The process itself I think we have to work through. Like I
said, we have new head of diversion control. This is an issue
that has been bothering me greatly. Since October I've seen
these and I've signed them and I have generally the same
question every time, which is why are they taking so long.
Mrs. Brooks. And for the record, I would just like to
acknowledge when I became a U.S. attorney in 2001 one of the
very first huge cases we did was against a doctor, Dr. Randolph
Lievertz, for over-prescription of oxycodone, and DEA in 2001,
2002 and beyond said prescription drugs were going to be the
next crisis in this country. Didn't start in 2010, didn't start
in 2011. It was back in 2001, 2002, and we had a huge focus on
it during that period of time and it's just really been very
devastating, seeing that we fell off of that commitment it
feels like in the last several years. I yield back.
Mr. Harper. Gentlewoman yields back.
The chair will now recognize the chairman of the Full
Committee for some follow-up questions. Mr. Walden.
Mr. Walden. Thank you. I appreciate the indulgence of the
committee.
You raise an interesting issue about the U.S. attorneys
weighing in here and saying to the DEA, stop--don't do your
ISO--we want to proceed with the criminal investigation.
One question--do they have the authority to override your
ISO authority? That would be one. And then I want to know the
who, what, when, where, why.
Who are the U.S. attorneys that interceded on which cases
in what areas and told the DEA suspend, and do they have that
authority? Because, to Mrs. Brooks' point, people continue to
die during this period, and I want to know this--this is part
of our public policy debate here is does a U.S. attorney's
office somewhere have the authority to tell you don't do the
ISO, don't stop the death because we got to investigate and go
criminal, which will have a bigger penalty, which I respect.
But is it one agent somewhere? One U.S. attorney in one
state, is that why West Virginia went off the rails? And so I
would like you to get back to the committee with answers to
those questions.
Mr. Patterson. I would be happy to do so, sir. And look,
what I can assure this committee is I think this is a topic
that we have had some robust discussion on lately as we've gone
through these and I will also assure you that the direction of
this administration is to stop the harm as quickly as possible.
Mr. Walden. But I think you should be able to answer the
one question. Do the U.S. attorneys have the authority to
overrule your agency's decision making? I know you weren't
there running it at the time.
Mr. Patterson. I would believe that we could issue the ISO
even against the wishes of a U.S. attorney or a state's
attorney. It probably doesn't help relationships to take those
kinds of unilateral actions.
But, that said, I think part of this is the education of us
holding up these things, why they look at either criminal or
civil actions.
Mr. Walden. I would go back to Mr. Griffith's analogy. If
you have got a drunk driver driving down the road, you don't
wait until they have the fatal accident to pull them over and
stop them.
Mr. Patterson. I couldn't agree with you more.
Mr. Walden. You can prosecute them along the way and I
would think you could make the case, going backwards, because
the prescriptions have been written. The pills have been sent
out.
These two pharmacies we raised with you months ago are, my
understanding, still operating in West Virginia. Are they not?
Mr. Patterson. I don't know. Those are the ones I have to
go----
Mr. Walden. They're not operating. All right.
Well, if you can get back to us on the who, what, when,
where, why on these U.S. attorneys that would be good.
Thank you.
Mr. Harper. Gentleman yields back.
The chair will now recognize the gentleman from Georgia,
Mr. Carter, for 5 minutes.
Mr. Carter. Thank you, Mr. Patterson.
Mr. Patterson, I suspect you know that currently I am the
only pharmacist serving in Congress, and Mrs. Brooks makes a
good point. This is not something that started in 2010 or 2011.
It was going on in 2001 and 2002. I was practicing back then.
Now, granted, I haven't practiced in quite a while. It's
probably been 4 or 5 years since I practiced. But I still know
what's going on out there.
We've been kind of nibbling or you have been nibbling
around the edges here. There have been great questions asked
here but I want to follow up on the questions that
Representative Collins asked about the beginning of where this
problem starts and that's the doctors who are writing these
prescriptions.
Now, I am not naive enough to believe that there aren't
pharmacies out there that are in collusion with doctors or
filling fraudulent prescriptions. But I want to talk about the
doctors who are writing these prescriptions who are obviously
out of control and why it's taken DEA so long to get them in
control or under control.
I will just give you an example. I served in the Georgia
State legislature for 10 years. I sponsored the legislation
that created the prescription drug monitoring program back in
2009. I was jumping up and down then, saying this is a problem,
we've got to get it under control, and it was falling on deaf
ears. There are doctors right now in our community that our
pharmacists won't fill prescriptions for. They just say no,
that doctor's out of control, I don't fill for that doctor.
I was working one President's Day. We were out during our
session. On President's Day we are always out. I had someone
come into my pharmacy, a young lady who had the holy trinity of
drug abuse--180, oxycodone, Xanax, and Soma, three
prescriptions there. I looked at them. She gave me her driver's
license from Florida. I said, I am not filling these
prescriptions. She drove off in a car with Kentucky driver's
license plates.
Now, I am not going to fill those prescriptions unless I
have a legitimate prescription, OK, and I didn't want to fill
that. But you're putting me in the position where I've got to
judge whether that patient is legitimate or not. I am not
trained in law enforcement, but as a pharmacist. But I want to
know why, when there are doctors out there who are writing
these prescriptions why can't you get them quicker?
Mr. Collins is right. You ought to be able to turn that
around in 48 hours. The first time I get three prescriptions
for 180 of the oxycodone, Xanax, and Soma I know that doctor is
out of control. Something's wrong there.
I had a doctor who we didn't fill for, Dr. B. I went home
about a year ago and some of the pharmacists were telling me,
oh, they finally busted Dr. B. I thought, wow, why did it take
them 5 years to bust him? We never filled his prescriptions for
5 years but he kept on practicing. Well, they didn't exactly
bust him. They got him for Medicare fraud. Didn't even get him
for writing those prescriptions--never did.
Another example here, Dr. D.N. He got literally thousands
of people addicted to these medications, and then he goes
before the Composite Medical Board and gets slapped on the
wrist, and they come back and they make him practice under the
supervision of another doctor. That's his penalty. Now he lives
on the waterfront, a beautiful home, beautiful cars, and yet
thousands of people have been addicted because of these
prescriptions that he has written.
We wouldn't fill his prescriptions. He's a rogue doctor. We
are not filling those. Tell me why it takes you so long to get
to the alpha, to the beginning, to the doctors who are writing
these prescriptions who are out of control. Explain that to me,
because I don't understand it.
All you have to do is go into a community and say, what
doctors do you not fill for, and the pharmacists will tell you,
we don't fill for this doctor and we don't fill for that
doctor.
Mr. Patterson. Well, and that's, quite frankly, what we
have to rely on. Look, the one thing I am not going to do in
this space is shift blame anyplace. This is a collective----
Mr. Carter. Well, it appears to me that that's what you're
doing because Mr. Collins is right. You can turn this around in
48 hours. Just get those doctors out of there.
Mr. Patterson. But in the cases of these doctors, look,
when we do our reviews we ask information, try and solicit
people to essentially, in the registrant community to come in
and talk about the registrants they have problems with.
If that doesn't happen, then our next course is someone
that's been arrested that says, this is what's happening in a
criminal case.
Mr. Carter. But you can understand our frustration. When we
don't fill prescriptions for that doctor but for years--
literally, 4 or 5 years, they continue to practice.
Mr. Patterson. I understand, and this is where PMP data
becomes absolutely critical and it's because that isn't----
Mr. Carter. But what can we do to help you to be able to
get these doctors under control? What can we do? Tell me what
we can do in Congress.
Mr. Patterson. The PMP data is really what it boils down
to.
Mr. Carter. We've had the PDMP since 2009 in Georgia.
Mr. Patterson. But, sir, DEA doesn't have access to that
data. It depends on the state.
Mr. Carter. Can you shut the doctor down? Can DEA shut the
doctor down or is that up to the Composite Medical Boards of
the states?
Mr. Patterson. No, if we had someone that was showing us
that a doctor was over-prescribing then----
Mr. Carter. But when you get this information of pill
dumping you know that that pharmacy is getting those
prescriptions from somewhere. Then that ought to be an
indication to you. We need to go to that community and we need
to find out what's going on here. They're coming from
somewhere.
Mr. Patterson. Understood.
Mr. Carter. Thank you, Mr. Chairman.
Mr. Harper. Gentleman yields back.
The chair will now recognize the gentleman from West
Virginia, Mr. McKinley, for 5 minutes.
Mr. McKinley. Thank you, Mr. Chairman. As not a member of
this committee, I appreciate you giving me the opportunity to
raise some issues with that.
Again, Mr. Patterson, thank you for being here. Are you
familiar with this book written by John Temple called
``American Pain?''
Mr. Patterson. No, sir.
Mr. McKinley. This is about the clinic down in south
Florida that was the epicenter of the opioids. I really would
suggest that you and everyone else that's paying attention to
this read that book.
But anyway, because with all due respect for the way some
of your testimony has gone on this about ARCOS, he was able to
assemble all of this book about drug abuse without access to
ARCOS. So for someone to say that we couldn't access it, we
couldn't use it because it was manual, it was too much
information, this man was able to put it together and be able
to demonstrate tthis ``American Pain'' clinic down in south
Florida prescribed two times the amount of medicine of all the
doctors combined in the State of Ohio. He was able to put that
together long hand, and he's not an agency with all the
resources you have to be able to do that. He also was able to
put together all of the pill mills in Florida combined. So nine
times the amount of pain medicine that was issued by every
state in the country. He did that long hand.
So with all due respect, I don't think you can hide behind
the fact that you didn't have the resources to be able to do
this because it was coming in manually.
If I could, I am curious about the production quotas with
it because in the book he talks about how speed pills back in
the 1970s were becoming a problem, and DEA stepped up and they
cut the production by 90 percent and the problem went away.
And then in the 1980s we had a problem with Quaaludes--same
thing. They cut the production and it went away. Now, fast
forward to today or what we've been dealing with over the last
10 years or so, the opioids.
We continue to increase the production of opioids, continue
to distribute those. Didn't we learn anything from the past
experience, that we should be cutting back? And it wasn't until
2017 that we actually had our first reduction. But it's still
nearly 50 percent more than we were 10 years ago in production
of opioids.
How would you respond to that? Didn't we learn anything?
Mr. Patterson. No, I understand that, sir.
And look, the quota numbers are set, unfortunately, to
ensure access to the patients and you can see the disturbing
trend that happened with quotas. The industry said more and
more people needed these prescriptions.
We worked aggressively in the last year and a half to try
and work on the quota issue and pull this back. I give a lot of
the credit to the states.
Mr. McKinley. If I could recover my time, because I think
that perhaps I know you're meaningful to do this, to correct
it, but it failed, because I am coming from that state that has
52 drug overdoses per 100,000 people. We are leading the Nation
with this. Someone has to get to this.
So I am just curious, I know you have the ability to
transfer resources and funds within DEA. So my question goes
back to you--have you made any transfer back into West
Virginia? Are you going to put more resources there in West
Virginia as a result of your ability to do transfer?
Mr. Patterson. We have, and we are continuing to do so.
Mr. McKinley. We just put in a year or so ago down, a
tactical diversion squad in Clarksburg. I think that's the
second one we have in West Virginia. Is that correct?
Mr. Patterson. That's correct.
Mr. McKinley. Leading the Nation--is that sufficient? Do
you think that you have diverted enough attention into West
Virginia that you don't need to divert any more funds and
resources into West Virginia?
Mr. Patterson. Sir, the creation of the Louisville
division, which polled three states all struggling with this
same problem: Tennessee, West Virginia, and----
Mr. McKinley. I am sorry. I am just dealing with West
Virginia. It's the epicenter. You know that and I know that----
Mr. Patterson. Sir, so we----
Mr. McKinley [continuing]. It has been there for nearly 10
years. It's been the highest level and we've not seen the
resources come in to West Virginia.
And now I appreciate very much that you put a tactical
diversion squad, or your predecessor did, into Clarksburg. But
I've got to think there is a lot more attention needs to go
with it because if this man can do this by long hand, can put
this information together, I think you all could do it. With
your resources, you could do a far better job and save a lot of
lives and turn some families around.
So I am asking you, please, to look at more diversion into
West Virginia--some of the funds and resources that you can to
help out in this situation.
Mr. Patterson. Again, sir, we've been working on that and
we are continuing to put more resources into that particular
division.
Mr. McKinley. So what are the optics on this, in the 10
seconds I've got left? How am I going to be able to measure
whether you're successful with what you're doing?
Because just last year in county we've already had a 50
percent increase in overdose drug--overdose deaths in West
Virginia in my county. How are we going to measure this? Are we
going to see a drop next year?
Mr. Patterson. Look, the concern we have had is that we've
seen the shift into fentanyl and other illicit substances. The
goal is to continue to drive down the prescription rates and
the diversion of prescription pills, and we are going to have
to work this licit market and, frankly, the place----
Mr. McKinley. Again, what are the optics? Am I going to see
a decline next year?
Mr. Patterson. I would hope we see declines across the
board. I think some states are going to take longer than
others, sir.
Mr. McKinley. Thank you. Yield back.
Mr. Harper. The gentleman yields back.
The chair will now recognize the vice chairman, Mr.
Griffith, for follow-up questions.
Mr. Griffith. Thank you very much, Mr. Chairman. Appreciate
it, and this question was from Mrs. Brooks, who, unfortunately,
had to step out for a minute.
Do the Medicaid fraud control units run by the state AG's
offices still exist in many states?
Mr. Patterson. I would have to find out, sir.
Mr. Griffith. All right, because what she was indicating
was was that these particular MFCUs who are going after
Medicaid fraud often can also pick up over prescribing data and
that that's a collaborative unit that you all ought to be
looking at in the various states to figure out who the rogue
doctors are and that would help you in that regard as well.
Mr. Patterson, moving on, can you explain to me how can you
all maintain that voluntary registration surrender can be as
effective a tool in protecting the public safety as an ISO if
it takes years to get the voluntary surrender as in the case of
the owner of the Sav-Rite No. 1 in Kermit, West Virginia?
Mr. Patterson. I would assume in that case and, again, I
need to get the particular facts on it--the voluntary surrender
probably came as part of the criminal case.
Mr. Griffith. And so what you would do is you would reverse
that order and have the voluntary surrender or an ISO happening
early on?
Mr. Patterson. Absolutely, sir.
Again, I can't go back and necessarily understand why
certain people did certain things----
Mr. Griffith. But you can make sure, going forward, that we
shorten the time?
Mr. Patterson. Absolutely, sir.
Mr. Griffith. All right. In your written testimony, you
mentioned prescription drug monitoring programs as a tool that
can be used to combat prescription drug diversion.
How does the DEA currently utilize the PDMP data in its
investigations?
Mr. Patterson. So this varies state to state because the
concern is, again, is our access to this data and how we can
access this data and that is a state by state decision. And so
every state varies. This is one of the big conversations that
we've had with the 48 states that are parts of these two
coalitions.
Mr. Griffith. All right. Let us know how we can help.
Your written testimony also mentioned that law enforcement
access to PDMP data varies widely from state to state, as you
have just told us. Can you tell me what the DEA is doing to
address those concerns and to address any access barriers the
agency currently faces with respect to the PDMPs?
Mr. Patterson. Again, working with all the states
individually on these issues and to the extent that we can
leverage the coalitions to help us in that.
Look, in a perfect world we have a federal PDMP process
that we can take all this data and put together. I think in a
less than perfect world at a minimum the states all need to be
able to share this data with each other.
Mr. Griffith. And in your experience, are there areas--and
you just have gone over some of it--but is there some other
areas that we might be able to improve the PDMP process?
Mr. Patterson. I think that's the key piece.
Mr. Griffith. All right.
I appreciate it, Mr. Chairman. I yield----
Mr. Harper. The gentleman yields back.
Mr. Patterson, just to give you a little update, I am going
to recognize Mr. Carter in just a minute for a follow-up
question. Then Ms. DeGette and myself will have concluding
questions and we'll be done shortly. So thank you for being
here with us today.
The chair will now recognize Mr. Carter, the gentleman from
Georgia.
Mr. Carter. Thank you, Mr. Chairman. I will be very brief.
I just want to follow up, Mr. Patterson. You're correct,
you can't do anything about what happened years ago. But you
can do a lot about what's happening now. I want to give you a
sincere caution here.
What's happening with the wholesalers when they are
limiting the pharmacies from getting a certain amount of drugs
whereas that has all the best of intentions--what it causes
sometimes is for some of our patients not to be able to get the
medications that they need and I just warn you to please be
careful with that. There are patients out there, i.e., hospice
patients, who truly need these medications.
We found ourselves running out and we couldn't order it
from the wholesalers because we'd already used up our limit for
that month. So that put these people in a very precarious
position and it's not a good position.
It's a very bad feeling for a pharmacist to have to profile
and have to go out and say, oh, this patient doesn't need pain
medication. Who am I to say that the long-haired tattooed body-
pierced person is not in pain? That's not fair.
We've got to make sure that we get this under control and I
still maintain that starting with the physicians and tell me
what I can do to help you, to give you the tools that you need
so that you can react quicker and get them under control when
they get out of control.
That's all I am asking you to do is tell me what you need
because I promise you I will do my best to get you those
resources so that you can get these rogue physicians--and
they're not all of them but some of them--a good amount of them
are out of control and they get out of control quickly and it
gets out of control very, very quickly.
Thank you, Mr. Patterson.
Mr. Patterson. Understood.
Mr. Harper. The gentleman yields back.
The chair will now recognize the ranking member, Ms.
DeGette, for concluding questions.
Ms. DeGette. Thanks, Mr. Chairman, and I want to echo, this
is a rough topic, Mr. Patterson, and we know you haven't been
there that long. But we also know that it's urgent that we get
this right. It's just urgent for the safety of our
constituents.
There's just a couple of areas I wanted to clarify. Mr.
Collins was asking you some questions about these--the
settlement that the DOJ has had with some of the distributors
because of issues--reporting suspicious orders and it's really
important that they report these suspicious orders to you
because you can't do your job unless you get this reporting.
Isn't that right?
Mr. Patterson. Absolutely.
Ms. DeGette. Now, for example, the DOJ has reached two
settlements with Cardinal Health. In 2008, Cardinal agreed to
pay $34 million to resolve allegations that it shipped large
quantities of opiates to pharmacies without reporting those
orders to the DEA.
And then in 2012 again, Cardinal agreed to pay $44 million
to resolve similar claims. Now, do you know, broadly speaking,
why the Department of Justice decided to pursue these cases
against Cardinal?
Mr. Patterson. I don't, ma'am. I know that, from the
documents I have seen on the 2012 case, the frustration was is
that the MOUs or MOAs in that scenario essentially they had
gone back and violated again.
Ms. DeGette. Right.
Mr. Patterson. So that is probably the basis for----
Ms. DeGette. That's your understanding?
Mr. Patterson. Yes, ma'am.
Ms. DeGette. Now, McKesson similarly reached two agreements
with DOJ agreeing to pay $13.25 million in 2008 and again $150
million in 2017 to resolve allegations that it failed to report
suspicious orders. Would you suspect it's the same kind of a
situation that you talked about a minute ago?
Mr. Patterson. Yes, ma'am.
Ms. DeGette. Now, do you agree that suspicious order
reports are a key part of preventing diversion?
Mr. Patterson. Absolutely, because, again, I go back to the
fact that the manufacturers and distributors are the key
registrants that we need to hear from.
Ms. DeGette. Right. Right.
Now, if distributors fail to report suspicious orders, they
really do undermine your ability to oversee the supply chain.
Is that right?
Mr. Patterson. Yes.
Ms. DeGette. One more topic, and this is following up on
something Ms. Walters was asking you about, and I don't think
maybe you understood her question.
On this website that you have been talking about that you
have for distributors to look at, it lets other distributors
see if other distributors are providing to these pharmacies.
But it does not tell volume. Isn't that correct?
Mr. Patterson. I would have to check it. I believe it does.
It goes back a 6-month window. But I would get back to you on
that particular issue.
Ms. DeGette. I think so, because it's my understanding that
the distributors object to disclosing volume. Here, your
associate's handing you something.
Mr. Patterson. No volume.
Ms. DeGette. No volume. OK. And, from my perspective I can
understand what they're saying about that impacting trade
secrets and so on.
But the problem, from my perspective, is if you're just
saying, OK, we are going to have a website where you can see if
other distributors are providing in that area, if you don't
know the volume then it's really hard for somebody to see
whether there's an abuse going on or not. Wouldn't you agree
with that?
Mr. Patterson. Yes, ma'am.
Ms. DeGette. I think this website is something we should
probably talk about more and maybe you can supplement your
answers to see how we can use that effectively, because just
knowing if other people are going in there I don't think that's
going to solve our problem.
Thanks, Mr. Chairman. I yield back.
Mr. Harper. The gentlewoman yields back.
Just for clarification, it appears in 2008 that Cardinal
Health paid $34 million in civil penalties and then again in
2016 an additional $10 million was paid out through one of its
subsidiaries, Kinray--if that clarifies that.
Through our investigation, Mr. Patterson, the committee has
learned certainly that as early as 2008 the DEA received almost
daily suspicious order reports, which received millions of
opioids that had been tied to known pill mill physicians like
Mr. Collins' neighbor that he referenced. Yet, most continue to
remain in operation and it's unclear to what extent, if any,
DEA followed up on the suspicious order reports it received.
So tell us what is the process that the DEA takes when
evaluating suspicious order reports it receives and the actions
that the agency takes in response?
Mr. Patterson. So, sir, when those come in they're
currently reviewed by and looked at for investigation by the
divisions. This is one of the changes that we are making by
bringing this into headquarters process.
Some of these companies, obviously, have districts all
throughout the country. One of the reasons why we want to look
at them is because we want to look at them as a corporation,
not just as individual entities or other problem areas.
So that is a change that we are doing. I would be happy to
go back and look at specific issues on----
Mr. Harper. Sure.
Mr. Patterson [continuing]. Any of SORS database and what
was or wasn't done. I think the decentralization--we have had
structural problems, I would say, in terms of how we used not
just some of this information but how we looked at it.
Those structural changes we are rapidly trying to get a
handle on to make these--especially in the suspicious orders
reports more beneficial because, one, we need them for the
registrants, but two, we have to do something with them when we
get them. And you have discussed implementing the process to
improve and to process those suspicious orders at DEA
headquarters.
Has DEA identified breakdowns in the way its field division
processes suspicious order reports in the past and what
corrections or adjustments have been made or do you anticipate
being made?
Mr. Patterson. So, again, I think the uniformness of how we
look at these things and the accountability that we hold the
people to when we get these reports is critical.
So that's one of the big changes for us to make sure that
as we are looking at these--I have had conversations with all
of the staff in this space, whether, it goes back to the ALJ or
the folks in chief counsel that do it with our expectations, to
go back to what Mr. Collins was talking about.
It has not been comfortable conversations. But we have to
essentially do the things that we are supposed to be doing each
and every day and personalities can't play a role in this.
Mr. Harper. And when you were making decisions at DEA
headquarters, the personnel at the headquarters probably have
field experience in some level in DEA. Would that be a fair
assessment?
Mr. Patterson. That's correct.
Mr. Harper. And as you're looking at these, are you also
taking into consideration those that are in the field now maybe
that have never been to headquarters to try to get their input
on the actual boots on the ground?
Mr. Patterson. I think it's important and, look, I haven't
spent years in this diversion world. In fact, I've really only
done it for about the last 18 months as the deputy and now as
acting.
What I will tell you is that fresh sets of eyes on problem
sets are always critically important.
Mr. Harper. OK.
You talked about well, what do we do--prevention,
education, treatment. Your role is really in enforcement and
prosecution, at least laying the groundwork for that.
The problem that we see as we look at this in great detail
is local law enforcement does not have the capability to take
care of this issue. That's why you see many of these cases
coming out of rural areas. So we would certainly want to make
sure that you're doing things to pivot, to take care of the
rural areas in this country as you're looking at that.
Now, there were a number of times that you referenced, I
will get back to you or we'll get you that information. So just
know that we'll have follow-up on that.
Mr. Patterson. Absolutely.
Mr. Harper. And we'll look for that.
We should be able to work together on this, and just know
that we are not happy that the chairman of the full committee,
Chairman Walden, had to even call for a press conference.
So we want to make sure, going forward, there are things
that we need to know or things that we need to inquire on or
things that you have for us. We would prefer more openness
between the committee and the DEA, going forward.
And with that we thank you for your time today, for what
turned into a fairly long time for you. It's been helpful to us
and we look forward to the follow-up questions that we have.
I want to thank the members who have attended today and
participated in today's hearing and I will remind members that
they have 10 business days to submit questions for the record
and I would ask, Mr. Patterson, if you would see that those are
responded to promptly as you receive those.
With that, the subcommittee is adjourned.
[Whereupon, at 12:23 p.m., the committee was adjourned.]
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