[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.]
    [Material submitted for inclusion in the record follows:]
    
    
    
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]