[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]





    EXAMINING PUBLIC HEALTH LEGISLATION TO HELP PATIENTS AND LOCAL 
                              COMMUNITIES

=======================================================================

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED FOURTEENTH CONGRESS

                             FIRST SESSION

                               __________

                            JANUARY 27, 2015

                               __________

                            Serial No. 114-5



[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]



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                    COMMITTEE ON ENERGY AND COMMERCE

                          FRED UPTON, Michigan
                                 Chairman

JOE BARTON, Texas                    FRANK PALLONE, Jr., New Jersey
  Chairman Emeritus                    Ranking Member
ED WHITFIELD, Kentucky               BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois               ANNA G. ESHOO, California
JOSEPH R. PITTS, Pennsylvania        ELIOT L. ENGEL, New York
GREG WALDEN, Oregon                  GENE GREEN, Texas
TIM MURPHY, Pennsylvania             DIANA DeGETTE, Colorado
MICHAEL C. BURGESS, Texas            LOIS CAPPS, California
MARSHA BLACKBURN, Tennessee          MICHAEL F. DOYLE, Pennsylvania
  Vice Chairman                      JANICE D. SCHAKOWSKY, Illinois
STEVE SCALISE, Louisiana             G.K. BUTTERFIELD, North Carolina
ROBERT E. LATTA, Ohio                DORIS O. MATSUI, California
CATHY McMORRIS RODGERS, Washington   KATHY CASTOR, Florida
GREGG HARPER, Mississippi            JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey            JERRY McNERNEY, California
BRETT GUTHRIE, Kentucky              PETER WELCH, Vermont
PETE OLSON, Texas                    BEN RAY LUJAN, New Mexico
DAVID B. McKINLEY, West Virginia     PAUL TONKO, New York
MIKE POMPEO, Kansas                  JOHN A. YARMUTH, Kentucky
ADAM KINZINGER, Illinois             YVETTE D. CLARKE, New York
H. MORGAN GRIFFITH, Virginia         DAVID LOEBSACK, Iowa
GUS M. BILIRAKIS, Florida            KURT SCHRADER, Oregon
BILL JOHNSON, Ohio                   JOSEPH P. KENNEDY, III, 
BILLY LONG, Missouri                 Massachusetts
RENEE L. ELLMERS, North Carolina     TONY CARDENAS, California
LARRY BUCSHON, Indiana
BILL FLORES, Texas
SUSAN W. BROOKS, Indiana
MARKWAYNE MULLIN, Oklahoma
RICHARD HUDSON, North Carolina
CHRIS COLLINS, New York
KEVIN CRAMER, North Dakota

                                 _____

                         Subcommittee on Health

                     JOSEPH R. PITTS, Pennsylvania
                                 Chairman
BRETT GUTHRIE, Kentucky              GENE GREEN, Texas
  Vice Chairman                        Ranking Member
ED WHITFIELD, Kentucky               ELIOT L. ENGEL, New York
JOHN SHIMKUS, Illinois               LOIS CAPPS, California
TIM MURPHY, Pennsylvania             JANICE D. SCHAKOWSKY, Illinois
MICHAEL C. BURGESS, Texas            G.K. BUTTERFIELD, North Carolina
MARSHA BLACKBURN, Tennessee          KATHY CASTOR, Florida
CATHY McMORRIS RODGERS, Washington   JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey            DORIS O. MATSUI, California
H. MORGAN GRIFFITH, Virginia         BEN RAY LUJAN, New Mexico
GUS M. BILIRAKIS, Florida            KURT SCHRADER, Oregon
BILLY LONG, Missouri                 JOSEPH P. KENNEDY, III, 
RENEE L. ELLMERS, North Carolina         Massachusetts
LARRY BUCSHON, Indiana               TONY CARDENAS, California
SUSAN W. BROOKS, Indiana             FRANK PALLONE, Jr., New Jersey (ex 
CHRIS COLLINS, New York                  officio)
JOE BARTON, Texas
FRED UPTON, Michigan (ex officio)












                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Joseph R. Pitts, a Representative in Congress from the 
  Commonwealth of Pennsylvania, opening statement................     1
    Prepared statement...........................................     2
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, opening statement.......................................     3
    Prepared statement...........................................     4
Hon. Fred Upton, a Representative in Congress from the State of 
  Michigan, opening statement....................................     6
    Prepared statement...........................................     7
Hon. Joseph P. Kennedy, III, a Representative in Congress from 
  the Commonwealth of Massachusetts, opening statement...........     8
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, prepared statement........................     9

                               Witnesses

Ben Chlapek, Public Safety Training Coordinator, Mid-America 
  Regional Council, on Behalf of the National Association of 
  Emergency Medical Technicians..................................    11
    Prepared statement...........................................    13
John L. Eadie, Director, Prescription Drug Monitoring Program 
  Center of Excellence, Brandeis University......................    20
    Prepared statement...........................................    22
Blaine Enderson, M.D., Chairman, Trauma Center Association of 
  America........................................................    27
    Prepared statement...........................................    29
Nathan B. Fountain, M.D., Chair, Professional Advisory Board, 
  Epilepsy Foundation of America.................................    37
    Prepared statement...........................................    40
D. Linden Barber, Partner and Director, DEA Compliance 
  Operations, Quarles & Brady, LLP...............................    49
    Prepared statement...........................................    51
    Answers to submitted questions...............................   163

                           Submitted Material

Report of the Pew Charitable Trusts, ``Prescription Drug 
  Monitoring Programs: An Assessment of the Evidence for Best 
  Practices,'' September 20, 2012, by Thomas Clark, et al., 
  submitted by Mr. Guthrie \1\...................................    83
H.R. 235, the Veteran Emergency Medical Technician Support Act of 
  2013, submitted by Mr. Pitts...................................    84
H.R. --------, the National All Schedules Prescription Electronic 
  Reporting Reauthorization Act of 2015, submitted by Mr. Pitts..    88
H.R. --------, the Trauma Systems and Regionalization of 
  Emergency Care Reauthorization Act, submitted by Mr. Pitts.....    99
H.R. --------, the Access to Life-Saving Trauma Care for All 
  Americans Act, submitted by Mr. Pitts..........................   103
H.R. --------, the Ensuring Patient Access and Effective Drug 
  Enforcement Act of 2015, submitted by Mr. Pitts................   106
H.R. 4299, the Improving Regulatory Transparency for New Medical 
  Therapies Act, submitted by Mr. Pitts..........................   112

----------
\1\ The information has been retained in committee files and also is 
available at http://docs.house.gov/meetings/IF/IF14/20150127/102844/
HMTG-114-IF14-20150127-SD054.pdf.
Statement of National Council for Prescription Drug Programs, 
  January 27, 2015, by Stephen C. Mullenix, Senior Vice 
  President, Public Policy and Industry Relations. submitted by 
  Mr. Whitfield..................................................   117
Report of the National Council for Prescription Drug Programs, 
  ``NCPDP Recommendations for Improving Prescription Drug 
  Monitoring Programs,'' March 2013, submitted by Mr. Whitfield..   121
Article of January 12, 2015, ``The Prescription Opioid and Heroin 
  Crisis: A Public Health Approach to an Epidemic of Addiction,'' 
  by Andrew Kolodny, et al., Annual Review of Public Health, 
  submitted by Mr. Guthrie.......................................   141
Statement of the National Association of Chain Drug Stores, 
  January 27, 2015, submitted by Mrs. Blackburn..................   157
Letter of January 22, 2015, from American Pharmacists 
  Association, et al., to Mrs. Blackburn, et al., submitted by 
  Mrs. Blackburn.................................................   161
Letter of January 22, 2015, from John M. Gray, President and 
  Chief Executive Officer, Healthcare Distribution Management 
  Association, to Mrs. Blackburn, et al., submitted by Mrs. 
  Blackburn......................................................   162

 
    EXAMINING PUBLIC HEALTH LEGISLATION TO HELP PATIENTS AND LOCAL 
                              COMMUNITIES

                              ----------                              


                       TUESDAY, JANUARY 27, 2015

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 11:16 a.m., in 
room 2322, Rayburn House Office Building, Hon. Joseph R. Pitts 
(chairman of the subcommittee) presiding.
    Members present: Representatives Pitts, Guthrie, Whitfield, 
Shimkus, Blackburn, Griffith, Bilirakis, Long, Bucshon, 
Collins, Upton (ex officio), Green, Capps, Butterfield, 
Sarbanes, Matsui, Schrader, Kennedy, Cardenas, and Pallone (ex 
officio).
    Staff present: Brenda Destro, Professional Staff Member, 
Health; Andy Duberstein, Deputy Press Secretary; Carly 
McWilliams, Professional Staff Member, Health; Katie Novaria, 
Professional Staff Member, Health; Chris Sarley, Policy 
Coordinator, Environment and the Economy; Macey Sevcik, Press 
Assistant; Adrianna Simonelli, Legislative Associate, Health; 
Heidi Stirrup, Policy Coordinator, Health; John Stone, Counsel, 
Health; Ziky Ababiya, Democratic Policy Analyst; Jeff Carroll, 
Democratic Staff Director; Eric Flamm, Democratic FDA Detailee; 
Hannah Green, Democratic Policy Analyst; Tiffany Guarascio, 
Democratic Deputy Staff Director and Chief Health Advisor; and 
Meredith Jones, Democratic Director, Outreach and Member 
Services.
    Mr. Pitts. The subcommittee will come to order. The Chair 
will recognize himself for an opening statement.

OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN 
         CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

    Today the subcommittee will consider some unfinished 
business from the last Congress in the form of six bills.
    The Veteran Emergency Medical Technician Support Act, 
sponsored by Representative Adam Kinzinger, would assist States 
in streamlining their certification requirements for those 
veterans with emergency medical technician training who want to 
work in the civilian workforce.
    The National All Schedules Prescription Electronic 
Reporting Reauthorization Act, or NASPER, sponsored by 
Representative Ed Whitfield, would reauthorize the NASPER 
program to support State prescription drug monitoring programs.
    The Trauma Systems and Regionalization of Emergency Care 
Reauthorization Act, sponsored by Representative Burgess and 
Ranking Member Green, would reauthorize certain trauma care 
programs through fiscal year 2019.
    The Access to Life-Saving Trauma Care for All Americans 
Act, to be sponsored by Representative Burgess, Ranking Member 
Green, would reauthorize trauma care--centered care grants.
    H.R. 471, introduced by Representative Marino, Blackburn, 
Welch, and Chu, the Ensuring Patient Access and Effective Drug 
Enforcement Act of 2015, would improve law enforcement efforts 
regarding prescription drug diversion and abuse.
    And the Improving Regulatory Transparency for New Medical 
Therapies Act, which I introduced, along with Ranking Member 
Pallone, last Congress and will be reintroducing shortly, seeks 
to improve the transparency and consistency of the Drug 
Enforcement Agency's scheduling of new FDA-approved drugs under 
the Controlled Substances Act.
    [The information appears at the conclusion of the hearing.]
    Mr. Pitts. I look forward to hearing the testimony of all 
of our witnesses today.
    [The prepared statement of Mr. Pitts follows:]

               Prepared statement of Hon. Joseph R. Pitts

    Today, the subcommittee will consider some unfinished 
business from the last Congress, in the form of six bills.
     The Veteran Emergency Medical Technician Support 
Act, sponsored by Rep. Adam Kinzinger, would assist States in 
streamlining their certification requirements for those 
veterans with emergency medical technician (EMT) training who 
want to work in the civilian workforce.
     The National All Schedules Prescription Electronic 
Reporting Reauthorization Act, or NASPER, sponsored by Rep. Ed 
Whitfield, would reauthorize the NASPER program to support 
State prescription drug monitoring programs.
     The Trauma Systems and Regionalization of 
Emergency Care Reauthorization Act, sponsored by Rep. Burgess 
and Ranking Member Green, would reauthorize certain trauma care 
programs through FY2019.
     The Access to Life-Saving Trauma Care for All 
Americans Act, to be sponsored by Rep. Burgess and Ranking 
Member Green, would reauthorize trauma center care grants.
     H.R. 471, introduced by Reps. Marino, Blackburn, 
Welch, and Chu, the Ensuring Patient Access and Effective Drug 
Enforcement Act of 2015, would improve law enforcement efforts 
regarding prescription drug diversion and abuse.
     And, the Improving Regulatory Transparency for New 
Medical Therapies Act, which I introduced along with Ranking 
Member Pallone last Congress, and will be reintroducing 
shortly, seeks to improve the transparency and consistency of 
the Drug Enforcement Agency's (DEA) scheduling of new FDA-
approved drugs under the Controlled Substances Act (CSA).
    I look forward to the testimony of all of our witnesses 
today.

    Mr. Pitts. I yield the remainder of my time to 
Representative Whitfield.
    Mr. Whitfield. Well, Chairman Pitts, thank you very much 
for having this hearing today on the important topic of public 
health and for including the NASPER reauthorization draft as 
part of that discussion.
    I am delighted that Mr. John Eadie is with us today, and we 
look forward to his testimony. He has 35 years or so of 
experience with the drug monitoring issues.
    And I look forward to your testimony.
    I might add that we have reached a point, unfortunately, in 
America today where more people are dying from drug overdoses 
than they--from prescription drug overdose than they are from 
automobile accidents.
    And I would just say that, back in 2001, the Appropriations 
Committee, without any authorization from the authorizing 
committee, started a drug monitoring program, which turned out 
to be a very good program. In 2005, this committee came back, 
through Congressman Pallone and Mr. Pitts and myself and 
others, and we authorized NASPER, a National All Prescription 
Drug Monitoring Program for the entire country. We had great 
difficulty obtaining funding for it because the appropriators 
always funneled the money through the drug monitoring program 
at the Department of Justice. NASPER was at HHS. And so, ever 
since 2005, we have had sort of two different programs. 
Unfortunately, the one at HHS was not getting any funding 
basically.
    Today, most States do have drug monitoring programs, but we 
still have these separate programs--one at DOJ and one at HHS. 
And so, hopefully, we tried to explore about a year ago a way 
to sort of combine these programs to just make it more 
efficient and more helpful to the American people. And I don't 
think we have totally resolved that yet, but I do think it is 
important we reauthorize this program.
    And I look forward to maybe having some discussions with 
you, Mr. Eadie, and others that have an interest. And is there 
a way that we can still try to get these programs together?
    And, with that, I yield back the balance of my time.
    Mr. Pitts. The Chair thanks the gentleman.
    Now, recognize the ranking member of the subcommittee, Mr. 
Green, 5 minutes for an opening statement.

   OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF TEXAS

    Mr. Green. Thank you, Mr. Chairman.
    And good morning to our witnesses for you all being here 
today.
    This hearing is called to examine six proposals which will 
strengthen public health, each which is the product of 
bipartisan efforts.
    I thank the chairman for having this hearing. It is not 
only an opportunity to further these important pieces of 
legislation. But it also serves as a reminder of the great work 
this committee can accomplish when we work together to advance 
our healthcare system.
    The Veteran Emergency Medical Technician Support Act, as 
led by Representatives Kinzinger and Capps, the legislation 
will save lives--will help States utilize the skills of our 
Nation's veterans and address emergency medical technician 
shortages by streamlining the certification and licensure 
requirements of returning veterans who have completed military 
EMT training.
    The Improving Regulatory Transparency for New Medical 
Therapies Act--that is the last time I will say that--provides 
a solution to current delays experienced by patients in need.
    The amount of time the DEA has asked before acting on FDA 
recommendations has lengthened in recent years, delaying the 
availability of new therapies. Led by Chairman Pitts and 
Ranking Member Pallone, this legislation will improve patient 
access by bringing clarity and transparency to the process of 
scheduling new FDA-approved therapy.
    Representatives Marino, Welch, Blackburn, and Chu 
introduced the Ensuring Patient Access and Effective Drug 
Enforcement Act. This legislation would promote patient access 
to medically necessary controlled substances and, with the 
DEA's authority, to suspend a DEA registrant acting in a manner 
that puts public health and safety at risk.
    The National All Schedules Prescription Electronic 
Reporting or NASPER Reauthorization Act, by our Ranking Member 
Pallone and Representative Whitfield, will reauthorize the 
improved prescription drug monitoring programs--are essential 
to part of our Nation's effort to combat the epidemic of 
prescription drug and opioid overdose. The reauthorization of 
NASPER will help States implement and improve their PDMs, which 
improve clinical decisionmaking and reduce diversion.
    The final two bills that are being considered today are the 
Trauma Systems and Regionalization of Emergency Care 
Authorization Act and the Access to Life-Saving Trauma Care for 
All Americans Act. My good friend and fellow Texan Dr. Mike 
Burgess--I wish Mike was here to hear me brag about him--and I 
have led these legislative efforts. I thank him and his staff 
for their continued dedication and hard work. Both bills will 
reauthorize important programs that are designed to ensure that 
availability and effectiveness of effective use of trauma care. 
Trauma is the leading cause of death under age 44. Federal 
investments in trauma centers and systems will save lives, 
improve patient outcomes, and provide downstream cost savings 
to the healthcare system.
    Again, I want to thank Dr. Burgess for his partnership on 
this issue and the chairman for bringing these legislative 
proposals before the committee today. I thank my colleagues on 
both sides of the aisle for their thoughtful and worthy 
proposals and their commitment to improving access and delivery 
of health care.
    I look forward to working on a bipartisan manner on many 
issues before our subcommittee, including our solutions with 
the expiration of the Health Centers Fund in September. Unless 
we take action, community health centers will reduce an 
immediate 60 to 70 percent funding cut. Health centers alone 
are bipartisan. And letting the fund expire without a solution 
in place will severely limit patient access to the cost 
effective primary and preventive care that is provided to 
millions of Americans.
    [The prepared statement of Mr. Green follows:]

                 Prepared statement of Hon. Gene Green

    Good morning and thank you all for being here. This hearing 
was called to examine six proposals that will strengthen public 
health, each of which is the product of bipartisan effort.
    I thank the chairman for having this hearing. It is not 
only an opportunity to further these important pieces of 
legislation, but it also serves as a reminder of the great work 
this committee can accomplish when we work together to advance 
our health care system.
    The Veteran Emergency Medical Technician Support Act is led 
by Representatives Kinzinger and Capps. This legislation will 
help States utilize the skills of our Nation's veterans and 
address emergency medical technician shortages by streamlining 
the certification and licensure requirements for returning 
veterans who have completed military EMT training.
    The Improving Regulatory Transparency for New Medical 
Therapies Act provides a solution to current delays experienced 
by patients in need. The amount of time the DEA has taken 
before acting on FDA recommendations has lengthened in recent 
years, delaying the availability of new therapies. Led by 
Chairman Pitts and Ranking Member Pallone, this legislation 
will improve patient access by bringing clarity and 
transparency to the process of scheduling a new FDA-approved 
therapy.
    Representatives Marino, Welch, Blackburn, and Chu 
introduced the Ensuring Patient Access and Effective Drug 
Enforcement Act. This legislation will promote patient access 
to medically necessary controlled substances and protects DEA's 
authority to suspend a DEA registrant acting in a manner that 
puts public health and safety at risk.
    The National All Schedules Prescription Electronic 
Reporting, or NASPER Reauthorization Act, led by Ranking Member 
Pallone and Representative Whitfield, will reauthorize and 
improve prescription drug monitoring programs. PDMPs are an 
essential part of our Nation's effort to combat the epidemic of 
prescription drug abuse and opioid overdose. The 
reauthorization of NASPER will help States implement and 
improve their PDMPs, which improve clinical decisionmaking and 
reduce diversion.
    The final two bills being considered today are the Trauma 
Systems and Regionalization of Emergency Care Reauthorization 
Act and the Access to Life-Saving Trauma Care for All Americans 
Act. My good friend and fellow Texan Dr. Mike Burgess and I 
have led these legislative efforts. I thank him and his staff 
for their continued dedication and hard work.
    Both bills will reauthorize important programs that are 
designed to ensure the availability and effective use of trauma 
care. Trauma is the leading cause of death under age 44. 
Federal investments in trauma centers and systems will save 
lives, improve patient outcomes, and provide downstream cost 
savings to the health care system. Thank you again to Dr. 
Burgess for your partnership on this issue and to Mr. Chairman 
for bringing these legislative proposals before the committee 
today.
    I thank all of my colleagues from both sides of the aisle 
for putting forward these thoughtful and worthy proposals, and 
for their commitment to improving access and delivery of health 
care.
    I look forward to continuing to work in a bipartisan manner 
on the many issues before our subcommittee, including on a 
solution to the expiration of the Health Centers Fund in 
September. Unless we take action, community health centers will 
experience an immediate 60-70 percent funding cut.
    Health centers have a long history of bipartisan support, 
and letting the fund expire without a solution in place will 
severely limit patient access to the cost-effective primary and 
preventive care they provide to millions of Americans.
    Thank you, and I yield the remainder of my time to the 
Congresswoman from California, Lois Capps.

    Mr. Green. With that, Mr. Chairman, I would like to yield 
the remainder of my time to my colleague from California, Lois 
Capps.
    Mrs. Capps. I thank the ranking member for yielding.
    And, Mr. Chairman, thank you for holding this important 
hearing today.
    I am pleased to, again, be working with Representative 
Kinzinger to introduce the Veteran Emergency Medical Technician 
Support Act, as we did in the past two Congresses, to see it up 
for discussion today.
    While our military men and women receive some of the best 
technical training in emergency medicine anywhere, when they 
return home, they are often required to start back at square 
one to receive the same certification for civilian jobs. At the 
same time, military medics with civilian credentials often must 
let these civilians certificates lapse while they are defending 
our country. Either way, this keeps our veterans out of the 
civilian workforce and withholds valuable medical personnel 
from our communities.
    Vets EMT is a small but straightforward bipartisan bill to 
help States streamline their certification processes to take 
military medic training into account for civilian licensure. I 
look forward to testimony today about the training these men 
and women have already received, the need for this bill, and 
the impact it could have as written or if expanded.
    I, also, must again plug my Emergency Medic Transition Act, 
a more comprehensive bill to help develop appropriate fast-
track military-to-community programs which also deserves a 
hearing. I am hopeful we can continue to work together in a 
bipartisan way to move these important pieces of legislation 
out of the committee so that we can help these talented 
professionals join our healthcare workforce and improve the 
care in our communities.
    And I am out of time.
    I will yield back and thank my colleague for yielding to 
me.
    Mr. Pitts. The Chair thanks the gentlelady.
    I now recognize the chairman of the full committee, Mr. 
Upton, for 5 minutes for an opening statement.

   OPENING STATEMENT OF HON. FRED UPTON, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF MICHIGAN

    Mr. Upton. Well, thank you, Mr. Chairman.
    In the last Congress, this committee established an 
impressive record of success with 51 bipartisan bills signed 
into law, many of which are now helping improve public health.
    Families in local communities expect us to work together to 
solve problems, and we look forward to using our prior success 
as a springboard to further boost the public health that this 
new--in this new Congress. Today, we are going to examine a 
half a dozen bills that collectively will help our Nation's 
veterans; address the prescription drug abuse crisis; secure 
access to trauma systems; and, yes, improve the Controlled 
Substances Act.
    First, we are going to hear testimony on our bill authored 
by Mr. Kinzinger, the Veteran Emergency Medical Technician 
Support Act, passed by the full House in February of 2013, 
which would help military medics in those States with a 
shortage of emergency medical technicians.
    We will also discussed the National All Schedules 
Prescription Electronic Reporting Reauthorization Act led by 
Mr. Whitfield to help address the prescription drug crisis 
here.
    We are also going to hear testimony on two trauma bills, 
led by Dr. Burgess and Ranking Member Green. The Trauma Systems 
and Regionalization of Emergency Care Reauthorization Act, 
which was passed to the full House in June of last year, would 
help support State and rural development trauma systems.
    The second bill will reauthorize language from the Public 
Health Service Act to fund trauma care centers.
    And, finally, the subcommittee will hear about two bills 
related to the Controlled Substances Act: Improving Regulatory 
Transparency for New Medical Therapies Act, led by Chairman 
Pitts and Ranking Member Pallone, which would amend the CSA to 
improve and streamline the DEA's process for scheduling new 
drugs approved by the FDA; ensuring Patient Access and 
Effective Drug Enforcement Act, led by Vice Chair Blackburn and 
Reps Marino, Welch and Chu, would help prevent prescription 
drug abuse, establish clear and consistent enforcement 
standards, and ensure that patients have access to medications 
by promoting collaboration among Government agencies, patients, 
industries, stakeholders.
    [The prepared statement of Mr. Upton follows:]

                 Prepared statement of Hon. Fred Upton

    In the 113th Congress, the Energy and Commerce Committee 
established an impressive Record of Success with 51 bipartisan 
bills signed into law, many of which are now helping improve 
public health. Families and local communities expect us to work 
together to solve problems, and we look forward to using our 
prior success as a springboard to further boost the public 
health this new Congress. Today we will examine a half dozen 
bills that collectively will help our Nation's veterans, 
address the prescription drug abuse crisis, secure access to 
trauma systems, and improve the Controlled Substances Act.
    First, we will hear testimony on a bill authored by Mr. 
Kinzinger. The Veteran Emergency Medical Technician Support 
Act, passed by the full House in February 2013, would help 
military medics and those States with a shortage of Emergency 
Medical Technicians.
    We also will discuss the National All Schedules 
Prescription Electronic Reporting Reauthorization Act led by 
Mr. Whitfield to help address the prescription drug abuse 
crisis.
    We will hear testimony on two trauma bills led by Dr. 
Burgess and Ranking Member Green. The Trauma Systems and 
Regionalization of Emergency Care Reauthorization Act was 
passed through the full House in June 2014 and would help 
support State and rural development of trauma systems. The 
second bill will reauthorize language from the Public Health 
Service Act to fund trauma care centers.
    Finally, the subcommittee will hear about two bills related 
to the Controlled Substances Act. The Improving Regulatory 
Transparency for New Medical Therapies Act, led by Chairman 
Pitts and full committee Ranking Member Pallone, would amend 
the CSA to improve and streamline the Drug Enforcement Agency's 
process for scheduling new drugs approved by the Food and Drug 
Administration.
    The Ensuring Patient Access and Effective Drug Enforcement 
Act, led by Vice Chairman Blackburn and Reps. Marino, Welch, 
and Chu would help prevent prescription drug abuse, establish 
clear and consistent enforcement standards, and ensure patients 
have access to medications by promoting collaboration among 
Government agencies, patients, and industry stakeholders.
    I thank the witnesses for attending today's hearing, and I 
look forward to their testimony and recommendations as we begin 
to build upon our strong record of bipartisan success.

    Mr. Upton. Thank you all for being here, and I yield to Mr. 
Whitfield.
    Mr. Whitfield. Thank you very much.
    I would like to ask unanimous consent to set in the record 
a statement from the National Council for Prescription Drug 
Programs and a white paper on recommendations for improving 
prescription drug monitoring programs.
    Mr. Pitts. Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Whitfield. Thank you.
    Mr. Pitts. All right. The gentlemen yields back.
    I would like to ask unanimous consent--since the ranking 
member, Mr. Pallone, is not here--to yield his time to 
Representative Kennedy.
    Without objection, Mr. Kennedy is recognized for 5 minutes 
for an opening statement.

      OPENING STATEMENT OF HON. JOSEPH P. KENNEDY, III, A 
      REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF 
                         MASSACHUSETTS

    Mr. Kennedy. Thank you, Mr. Chairman. I will take about 30 
seconds, I hope. But thank you for yielding and recognizing me.
    I want to thank the witnesses for their testimony today and 
Mr. Whitfield and Mr. Pallone for their work on the NASPER 
reauthorization.
    This is an issue that is of particular importance for me 
back in my home district. At the end of 2014, there were about 
209 heroin overdoses in Taunton, Massachusetts, alone. In less 
than 20 days into 2015, there have already been 10 suspected 
overdoses.
    We can often trace the origin of those overdoses back to 
opioid addiction and prescription drug abuse. Tufts Health Care 
Institute's Program on Opioid Risk Management released a report 
in 2011 with some alarming findings. They estimated that the 
societal cost of opioid abuse in the U.S. are substantial, with 
total societal costs being $55.7 billion and healthcare costs 
about $25 billion. The annual cost per patient diagnosed with 
opiate abuse dependance and misuse are considerably higher than 
those with patients without such diagnoses.
    I was a prosecutor for several years before running for 
Congress. I saw the effects of opioid addiction every single 
day in the courtroom through property crimes, breaking and 
entering, larcenies, and other such crimes that would end up--
this addiction would drive people to such lengths to break the 
law to try to continue to feed an addiction.
    Prescription drug abuse programs and prescription 
monitoring programs are an absolutely critical part to trying 
to come up with a comprehensive plan to combat this epidemic. 
And I applaud Mr. Pallone and Mr. Whitfield for their efforts 
on this.
    And I would like to yield 1 minute of my time back to Mr. 
Butterfield.
    Mr. Butterfield. Thank you very much, Mr. Kennedy, for 
yielding.
    And thank you, Mr. Chairman, and the ranking member for the 
opportunity to sit in Mr. Pallone's seat for just a few minutes 
and to claim some of his time this morning.
    But, Frank, I will be moving on in just a minute. I have 
got one or two other places to go.
    But, Mr. Chairman, I appreciate the opportunity to discuss 
a number of bipartisan bills that many of us have worked on in 
the past. In particular, I was a supporter of the Trauma 
Systems and Regionalization of Emergency Care, the 
reauthorization act, and the Regulatory Transparency for New 
Medical Therapies Act that we handled in the 113th Congress. 
Finding innovative ways to improve access to care in rural 
communities, particularly ones like mine in eastern North 
Carolina, can mean the difference between life and death. The 
ACA went a long way. It went a long way toward improving rural 
health care and created or reauthorized the four programs 
included in the Trauma Systems Act. We must reauthorize this 
program and put our money where our mouths are by fully funding 
these programs.
    Furthermore, the New Medical Therapies Act would improve 
access to care by accelerating the process to help patients 
access important medicines.
    I thank you, Mr. Kennedy.
    I yield back to you, sir.
    Mr. Kennedy. Thank you, Mr. Butterfield.
    I think I yield my time, which was Mr. Pallone's time, back 
to Mr. Pallone.
    Mr. Pitts. Mr. Pallone, you have 2 minutes left.
    Mr. Pallone. All right. Thank you, Mr. Chairman.
    I just wanted to say briefly that I think that these six 
public health bills are important. They all aim to address 
important public health issues within our communities. I am not 
going to go into all the details about them.
    The first two, the Improving Regulatory Transparency Act, 
speeds up Drug Enforcement Administration decisions on 
scheduling of new FDA-approved drugs with regard to controlled 
substance.
    And the second one, Ensuring Patient Access and Effective 
Drug Enforcement, adds two definitions to controlled 
substances. The goal of that bill is to help drug distributors, 
pharmacies, and others work with DEA to achieve the difficult 
balance between keeping controlled substance prescription drugs 
away from drug abusers but not from patients who need them.
    The next bill, the veterans bill, authorizes a 
demonstration grant programs for States to streamline 
certification and licensure requirements for returning veterans 
to become emergency medical technicians. We had some great good 
hearings with this.
    And I want to thank Congresswoman Capps for her work on 
this issue.
    And then we have the two bills reauthorizing a number of 
trauma programs, which are very important, because traumatic 
injury is the leading cause of death for children and adults 
under the age of 45. And it is critical that States are 
equipped to deliver these medical services.
    And the last one the subcommittee will review is the NASPER 
bill, which I coauthored with my colleague from Kentucky, Mr. 
Whitfield. And this legislation helps States establish and 
maintain prescription drug monitoring programs in order to 
combat drug abuses, which is an epidemic in the United States. 
So it is critical that we continue to support a program like 
this through Federal funding.
    Many of these bills passed our committee in the House last 
Congress with broad bipartisan support, as you know, Mr. 
Chairman. And I look forward to working with my colleagues to 
do the same this year. Thanks.
    [The prepared statement of Mr. Pallone follows:]

             Prepared statement of Hon. Frank Pallone, Jr.

    Thank you, Chairman Pitts, for holding this hearing on the 
six public health bills before us today. All of the bills aim 
to address important public health issues within our 
communities.
    The Improving Regulatory Transparency for New Medical 
Therapies Act would speed up Drug Enforcement Administration 
(DEA) decisions on scheduling of new FDA-approved drugs 
containing controlled substances, so that they could get to 
patients more quickly. It also would speed up the DEA 
registration process allowing the manufacture and distribution 
of controlled substances for use only in clinical trials. The 
bill aims to ensure that there are not unnecessary delays of 
medicines getting to patients in need. I want to thank Chairman 
Pitts for working with me on this bill last Congress and 
committing to move forward early this Congress.
    The Ensuring Patient Access and Effective Drug Enforcement 
Act would add two definitions to the Controlled Substances Act 
to better focus DEA's enforcement activities. It also would 
require DEA to provide registrants an opportunity to submit an 
action plan to correct any violations for which DEA is 
considering revoking or suspending their controlled substance 
registration. The goal of the bill is to help drug 
distributors, pharmacies, and others work with DEA to achieve 
the difficult balance between keeping controlled substance 
prescription drugs away from drug abusers but not from patients 
who need them. I thank Representatives Blackburn, Marino, 
Welch, and Chu for introducing this legislation.
    The next bill, the Veterans Emergency Medical Technician 
Support Act, authorizes a demonstration grant program for 
states to streamline the certification and licensure 
requirements for returning veterans to become emergency medical 
technicians. Returning vets have important skills and 
experiences that make them highly qualified for jobs in health 
care and particularly in emergency medicine. This bill passed 
both the committee and the House last Congress, and I want to 
thank Congresswoman Capps for her work on this issue.
    We are also considering two bills reauthorizing a number of 
trauma programs. The Trauma Systems and Regionalization of 
Emergency Care Reauthorization Act, which passed the House last 
year, is aimed at planning and implementing trauma care systems 
in the States and establishing pilot projects for innovative 
models of regionalized trauma care. The second bill, the Access 
to Life-Saving Trauma Care for All Americans Act, reauthorizes 
two additional trauma programs that expire this year that aim 
to increase the availability of trauma services, as well as an 
interagency program for basic and clinical research on trauma. 
Traumatic injury is the leading cause of death for children and 
adults under the age of 45, and it is critical that States are 
equipped to deliver these medical services. I would again like 
to thank Mr. Green and Mr. Burgess, who are both leaders on 
trauma care, for their work on these bills.
    Finally, the subcommittee will review the National All 
Schedules Prescription Electronic Reporting Reauthorization 
Act, which I coauthored with my colleague from Kentucky, Mr. 
Whitfield, during the last Congress. This legislation helps 
States establish and maintain prescription drug monitoring 
programs in order to combat prescription drug abuse, an 
epidemic in the United States. It is critical that we continue 
support for this program through Federal funding.
    Many of these bills passed our committee and the House last 
Congress with broad bipartisan support. I look forward to 
working with my colleagues to do the same this year.

    Mr. Pitts. The Chair thanks the gentlemen.
    That concludes the opening statement of the Members. As 
usual, all Members' written statements--opening statements will 
be made a part of the record.
    I would like to thank the witnesses for the efforts they 
made to be a part of the hearing today, especially in light of 
the hazardous travel conditions due to wintry weather. Since we 
announced a 1-hour delay in the start of our hearing today, one 
of our witnesses, Mr. John Eadie, has informed that he may need 
to leave early because of travel constraints. But thank you for 
all the effort that you made to get here.
    I want my colleagues to be aware of this so they can form 
their questions with this in mind. So thank you.
    On our panel today, we have five witnesses: Mr. Ben 
Chlapek, deputy director of Central Jackson County Fire in Blue 
Springs, Missouri; Mr. John Eadie, director of Prescription 
Drug Monitoring Program Center of Excellence at Brandeis 
University; Dr. Blaine Enderson from the Department of Surgery 
at the University of Tennessee Medical Center; Dr. Nathan 
Fountain, professor of neurology and director of the F.E. 
Dreifuss Comprehensive Epilepsy Program here on behalf of the 
Epilepsy Foundation; and Mr. Linden Barber, partner and 
director of DEA Compliance Operations at Quarles & Brady.
    Thank you for coming today. Your written testimony will be 
made a part of the record. You will be each given 5 minutes to 
summarize your testimony.
    And, Mr. Chlapek, we will begin you. You are recognized for 
5 minutes for your summary.

STATEMENTS OF BEN CHLAPEK, PUBLIC SAFETY TRAINING COORDINATOR, 
    MID-AMERICA REGIONAL COUNCIL, ON BEHALF OF THE NATIONAL 
 ASSOCIATION OF EMERGENCY MEDICAL TECHNICIANS; JOHN L. EADIE, 
   DIRECTOR, PRESCRIPTION DRUG MONITORING PROGRAM CENTER OF 
    EXCELLENCE, BRANDEIS UNIVERSITY; BLAINE ENDERSON, M.D., 
   CHAIRMAN, TRAUMA CENTER ASSOCIATION OF AMERICA; NATHAN B. 
 FOUNTAIN, M.D., CHAIR, PROFESSIONAL ADVISORY BOARD, EPILEPSY 
   FOUNDATION OF AMERICA; AND D. LINDEN BARBER, PARTNER AND 
   DIRECTOR, DEA COMPLIANCE OPERATIONS, QUARLES & BRADY, LLP

                    STATEMENT OF BEN CHLAPEK

    Mr. Chlapek. Thank you, Chairman Pitts, Vice Chairman 
Guthrie, and Mr. Green, and members of the subcommittee. My 
name is Ben Chlapek, and I am here to discuss the issue of 
military medics veterans who are honorable transitioning into 
the civilian EMS field. I am representing the National 
Association of Emergency Medical Technicians that represents 
roughly 40,000-plus EMTs, paramedics, and first responders of 
all delivery models, fire-based, hospital-based, privates, 
third services, industrial, and military medics.
    I currently serve on the Board of Directors and as the 
chair of the Military Relations Committee; recently retired as 
the deputy chief of Central Jackson County Fire; and have been 
a registered paramedic, nationally registered, for over 30 
years. Also, recently retired from the United States Army as 
Lieutenant Colonel and have 36 years of service in the Army, 
starting in 1975, with one small break.
    Bottom line up front is we have an obstacle course when a 
military medic transitions from the military and tries to get a 
civilian EMS license. Currently, the Army and Air Force 
graduate their medics at the Joint Training Facility in San 
Antonio with a National Registry EMT card. The Navy does not. 
They almost meet the criteria, but the medics split off at one 
point and get their specialty training or specialized training.
    We have a lot of people who are helping us with this. And 
when they have to repeat it, it is a waste of their skills. 
They are doing the same thing over and over. In addition, a lot 
of military medics gain advanced skills, such as suturing and 
doing other forms of advanced medicine that civilian medics 
don't.
    One of the biggest concerns--and it is voiced by Sergeant 
Major Harold Montgomery, the senior medical enlisted advisor of 
Special Operations Command at MacDill Air Force Base in Tampa, 
Florida, his biggest concern is that we lose the knowledge and 
advances we have gained in Iraq and Afghanistan and Kosovo and 
don't use those, don't learn from them, and they will be lost. 
These military medics that are transitioning have that ability. 
For example, many law enforcement agencies across the country 
now carry combat tourniquets and hemostatic agents, which have 
saved some lives. It has been documented by the first 
responders, the officers being able to use these skills.
    There is a shortage in rural America of paramedics. And 
when these medics get out, even as EMTs, they need to advance 
to paramedic. We have gone the gap analysis. We know what needs 
to be done. And House Bill 235 is a great, big jump in getting 
that achieved.
    It won't solve all the issues. But we have done the gap 
analysis. There are many States now passing legislation--over 
30 at this point--to help veterans and streamline the process 
to become civilian medics because the State licensing 
procedures differ. They aren't the same.
    Another thing we have done is written an interstate 
compact, and that is being presented to the States now.
    We need a common registry. The Senate bill would help make 
a solid jump to get this achieved. This is near and dear to my 
heart. I have deployed with fire department medics, with 
private medics who have gone back and tried to integrate back 
into their services. Some have. Some haven't. The National 
Registry of EMTs has gone a long way toward helping. The 
National Association of EMTs has led this charge. I had 40 
medics and EMTs on one tour and worked very hard for them to 
keep their certification.
    I suffered a traumatic brain injury in 2008 in Afghanistan. 
It was moderate, and I still receive therapy today at the 
Kansas City VA, who does a great job. This--this initiative is 
near and dear to my heart, and I thank you for letting me speak 
today. God bless.
    Mr. Pitts. The Chair thanks the gentleman.
    [The prepared statement of Mr. Chlapek follows:]
    
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    Mr. Pitts. Mr. Eadie, you are recognized for 5 minutes for 
your summary.

                   STATEMENT OF JOHN L. EADIE

    Mr. Eadie. Thank you, Chairman Pitts, Ranking Member Green, 
and Representative Whitfield for providing this opportunity to 
testify regarding proposed legislation to help fund State 
prescription drug monitoring programs, PDMPs, through the 
National All Schedule Prescription Electronic Reporting Act, 
i.e., NASPER.
    I am John Eadie. I have worked on public health for 45 
years and specifically on PDMPs for 30 years. I currently serve 
as director of the Prescription Drug Monitoring Program Center 
of Excellence at Brandeis University, where we identify what 
makes PDMPs effective and help them reach their full potential. 
For example, through a partnership with Pew Charitable Trust 
and support from BJA, we have published a white paper on PDMP 
best practices.
    PDMPs are operating in 49 States and Guam with another 
authorized for the District of Columbia. They are essential 
ingredients in the Nation's effort to reverse the epidemic of 
prescription opioid overdoses and deaths and rising heroin 
abuse. The health and safety of families across America depend 
on PDMPs being as effective as possible.
    The Center of Excellence reviews PDMP's performance and has 
found that they improve clinical decisionmaking and patient 
care by prescribers and pharmacies; identify and reduce doctor 
shopping; impact on controlled substances availability and 
prescribing; help improve health outcomes; reduce drug and 
medical costs related to inappropriate prescribing; reduce 
diversion into illegal use; and assist drug investigations; 
monitor compliance in drug abstinence; assist in substance 
abuse treatment and medical examiner practices; assist in drug 
abuse prevention and surveillance efforts.
    Some Sates have recently issued broad mandates on 
prescribers to obtain and review PDMP data prior to issuing the 
first scheduled controlled substance to each patient and 
periodically thereafter, for example, every 3 months. Kentucky, 
Tennessee, and New York report rapid increases in prescribers 
registering for PDMP use, increases in requests for PDMP data--
over a 300 percent increase in Tennessee, over 500 percent in 
Kentucky, and over 10,000 percent in New York--decreases in the 
prescribing of some commonly abused controlled substances and 
decreases in doctor shopping.
    Florida, in 2011, implemented its PDMP and other 
initiatives. The Florida Medical Examiner has just reported for 
2013 that there was an 8.3 percent decrease in 1 year in the 
number of deaths in which 1 or more controlled substance 
prescription was identified as the primary cause, while 
oxycodone deaths declined by 27.3 percent.
    Further developments are needed. One example, after 
proactively analyzing their data, PDMPs should proactively send 
out unsolicited reports to prescribers, pharmacists, healthcare 
professional licensing boards, and law enforcement. This is one 
of the most effective best practices. But more than two-thirds 
of PDMPs still need to fully implement that.
    A second example. Medicaid/Medicare, workers compensation, 
and other third-party payers need to protect their enrolled 
patients' health and safety and do so by helping prescribers 
and pharmacists avoid issuing and dispensing prescriptions that 
will cause harm to their patients. But this can only be done by 
PDMPs providing secure patient data access to third-party 
payers. And this is not a common practice today.
    In order to reduce the opioid epidemic, PDMPs need to adopt 
the most effective practices, and this requires money. But the 
cost is miniscule compared to the price in lives and dollars if 
PDMPs do not rise to their full potential.
    The reauthorization of NASPER, with proposed changes, will 
assist States by adding important funds that complement other 
initiatives. States need NASPER to encourage the technological 
development of PDMPs' interoperability with electronic health 
records and health information exchanges.
    This development will allow PDMP data to reach prescribers 
and pharmacists in their normal workflow, increase clinicians' 
ability to properly treat their patients and avoid prescribing 
or dispensing to doctor shoppers or persons counterfeiting or 
forging prescriptions. Importantly, NASPER can help States 
sustain critical PDMP operations.
    I thank the bill sponsors for their efforts to improve 
NASPER and encourage the Subcommittee on Health to approve it.
    Mr. Pitts. The Chair thanks the gentlemen.
    [The prepared statement of Mr. Eadie follows:]
    
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    Mr. Pitts. Dr. Enderson, you are recognized for 5 minutes 
for summary.

                  STATEMENT OF BLAINE ENDERSON

    Dr. Enderson. Chairman Pitts, Ranking Member Green, and 
members of the committee, thank you for holding this hearing on 
examining public health legislation to help patients in local 
communities and for inviting the Trauma Center Association of 
American, TCAA, to speak.
    TCAA is a nonprofit 501(c)(6) association representing 
trauma centers and systems across the country and is committed 
to ensuring access to lifesaving trauma services.
    TCAA, along with our advocacy partners--the American Trauma 
Society, the American Association for the Surgery of Trauma, 
the American College of Surgeons, the American College of 
Emergency Physicians, the American Burn Association, the 
American Association of Neurological Surgeons, the College of 
Neurological Surgeons, the Emergency Nurses Association, the 
Society of Trauma Nurses, the American Academy of Orthopedic 
Surgeons, and the Eastern Association for the Surgery of 
Trauma--are on the forefront of providing trauma and emergency 
care to millions of Americans. And it is out of that commitment 
that we submit these comments for your consideration.
    As organizations that care deeply about access to trauma 
and emergency care, we would like to thank you for passing the 
Trauma Systems and Regionalization of Emergency Care 
Reauthorization Act, H.R. 4080, last session and express our 
strong support for the passage of this vital legislation again 
this session.
    We would also like to thank Dr. Burgess and Representative 
Green for their continued leadership and recognize the 
importance of these systems of care in saving lives.
    Trauma is a major public health issue, as we have heard. In 
the United States, approximately 35 million are treated every 
year for traumatic injury. It is the leading cause of death 
under age 44. And at an annual cost of $67.3 billion, trauma is 
the third most expensive medical condition.
    The value proposition for trauma care is well documented. 
The care provided by trauma centers, including specialist 
physicians, nurses, and their entire trauma team, has a 
dramatic and cost-effective impact on a patient's subsequent 
quality of life. In fact, trauma care is more cost effective 
than many other interventions, including dialysis for kidney 
failure.
    Victims of traumatic injury treated at a level 1 trauma 
center are 25 percent more likely to survive than those treated 
at a general hospital. Unfortunately, 45 million Americans lack 
access to major trauma centers. And if they are taken to 
nontrauma centers, the risk of death increases to 30 percent 
within 48 hours.
    The Trauma Systems and Regionalization of Emergency Care 
Reauthorization Act would reauthorize two important grant 
mechanisms: The Trauma Care Systems Planning Grants Program and 
the Regionalization of Emergency Care Pilots Program, each 
authorized at $12 million per year.
    The Trauma Care Systems Planning Grant supports State and 
rural development of trauma systems. The Regionalization of 
Emergency Care Pilots Program funds pilot programs to design, 
implement, and evaluate innovate models of regionalized 
emergency care.
    Unfortunately, in 2015, we still lack effective 
regionalized care systems for infectious diseases, like Ebola, 
or even for cardiac or stroke patients. The vast majority of 
hospitals addressing patients with these conditions also serve 
as our Nation's regional trauma centers. These hospitals must 
have the tools and capabilities to care for all of these 
patients with emergent, time-sensitive, and life-threatening 
conditions, whether it is trauma, stroke, or Ebola. The funding 
to support these hospitals must follow and support their 
willingness to provide care to the sickest Americans in the 
greatest hour of need.
    In addition to the Trauma Care Systems Planning Grant and 
Regionalization of Emergency Care Pilots, there are two other 
programs contained in the Public Health Service Act, said to 
expire this year, which need to be addressed by Congress. The 
Access to Life-Saving Trauma Care For All Americans Act would 
reauthorize these vital programs to prevent more closures and 
improve access to trauma care.
    The Trauma Care Center Grants are authorized at $100 
million per year in an effort to prevent more trauma center 
closures by supporting their core missions, curtailing losses 
from uncompensated care, and providing emergency award to 
centers at risk of closing. Also, the Trauma Service 
Availability Grants, authorized at $100 million per year, are 
channelled through the States to address shortfalls in trauma 
service and improve access to and the availability of trauma 
care in underserved areas.
    In addition, the Interagency Program for Trauma Research is 
in need of reauthorization. This program is designed to 
facilitate collaboration across the National Institutes of 
Health on trauma research.
    All the programs are designed to ensure the availability 
and effective use of trauma care to save lives, cost, and 
improve patient outcomes. Trauma can happen to anyone any time 
and anywhere, as demonstrated by the Boston Marathon bombing 
and other recent casualties. And yet trauma care is not 
available for millions of Americans, especially in rural areas.
    We would encourage the Congress to reauthorize these vital 
programs to maintain trauma services for Americans in the 
United States. And if there are any questions, please feel free 
to contact the Trauma Center Association of America. Thank you.
    Mr. Pitts. The Chair thanks the gentlemen.
    [The prepared statement of Dr. Enderson follows:]
   
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    Mr. Pitts. Dr. Fountain, you are recognized for 5 minutes 
for your summary.

                STATEMENT OF NATHAN B. FOUNTAIN

    Dr. Fountain. Thank you, Chairman Pitts and Ranking Member 
Green, for allowing me to testify on behalf of the more than 
2.8 millions Americans living with epilepsy and, of course, 
their families.
    As chair of the Epilepsy Foundation's Professional Advisory 
Board, I am here to support a legislative initiative that I 
know is important to the committee. The reintroduction of and 
passage of last year's Improving Regulatory Transparency for 
New Medical Therapies Act. The Epilepsy Foundation is extremely 
grateful for the committee's leadership for what we believe is 
an important problem that has a reasonable and workable 
legislative solution.
    The most important thing I can tell you today is that the 
delay caused by the lack of a timeline for the Drug Enforcement 
Agency in making FDA-approved drugs available to patients 
threatens the lives and health of Americans. The magnitude of 
the problem is astounding by every reasonable measure.
    The timeline for DEA approval has increased significantly, 
when comparing the era of the late 1990s. So if you look at the 
period from 1997 to 1999, compared to late 2000--so 2009 
through 2013--the average time between FDA approval and then 
DEA final scheduling of a controlled substance has increased 
substantially. If we look at the late 1990s, it was 49.3 days. 
And it increased, then, in the most recent era, to 237 days. So 
many days--it is probably more appropriate to look at it in 
months. So from 49 days to almost 8 months.
    There is a particular anti-epileptic drug called Fycompa 
that was approved by the FDA in 2012, but the final scheduling 
by the DEA occurred almost 400 days later. Now, we have to talk 
in terms of years instead of months or days.
    The delay in drug approval by the DEA, as addressed by this 
legislation, is particularly important to people with epilepsy 
because epilepsy is common; it causes serious problems, 
including death; and previously approved epilepsy drugs that 
are scheduled by the DEA are not subject to abuse by any major 
we can identify. So it appears that there is a delay of 
potentially lifesaving treatments without a compelling reason.
    And, of course, this applies equally to people with other 
conditions that might very well die while waiting for new drugs 
to be approved. So you can imagine how this would apply to 
someone with cancer or heart disease that is advancing while 
waiting for a drug to be approved.
    But, today, I will specifically address this issue as a 
representative of the Epilepsy Foundation, which is the leading 
national voluntary health organization that speaks on behalf of 
the 2.8 million Americans with epilepsy. I serve as chair of 
our medical advisors, but I am also a practicing neurologist at 
the University of Virginia and director of a large epilepsy 
program, where I have firsthand experience with the problems 
caused by the delays in drug approval. I would like to share 
information about epilepsy so that you can better understand 
why our organization is steadfast in support of this bill.
    Epilepsy is any condition of the brain that causes 
seizures. So you can imagine it has diverse causes; acquired 
things like head trauma or stroke, or you can be born with a 
genetic predisposition and otherwise be perfectly normal. 
Approximately 1 in 26 people will develop epilepsy. That is a 
lot of people; 1 in 26 people develop epilepsy at some point in 
their lives. The onset is greatest in childhood and in older 
adults. That is why epilepsy is the fourth most common 
neurological condition--after migraine, stroke and Alzheimer's 
disease, then comes epilepsy. So that might beg the question, 
``What is a seizure,'' for your own curiosity.
    A seizure is an electrical storm of the brain. The storm 
can be confined to just one small area of the brain and cause 
something as isolated as just staring and responsiveness or 
jerking of one arm, or it can involve the whole brain.
    The type of seizure most people are familiar with is a 
generalized tonic-clonic or grand mal seizure, during which the 
whole brain is involved. The person becomes stiff, straightens 
out, falls to the ground, is unconscious and jerks all over for 
a few minutes. Afterwards, their brain is entirely exhausted 
and so is the person. They are unresponsive, but then they 
recover to normal over the course of typically about an hour.
    You can understand that this can cause injury from falling, 
choking, crashing a car, drowning. Even milder seizures that 
consist only of staring and confusion can cause serious 
problems. During confusion, people may put their hand into 
boiling water, thinking they are stirring it with their arm, 
for instance; pick up an iron by the hot face and not realize 
it; or be chopping vegetables and not realize it becomes part 
of them that they are cutting.
    In addition to the direct injury that seizures can cause, 
it can also result in the tragic circumstance of sudden, 
unexpected death in epilepsy or SUDEP, S-U-D-E-P, sudden 
unexpected death in epilepsy, which is the most common cause of 
epilepsy-related death.
    SUDEP occurs when someone with epilepsy dies for no obvious 
reason. That is, there may be evidence of a typical seizure, a 
seizure like they have had a hundred or a thousand times 
before, for instance, but there is no evidence of choking; 
there is no evidence of trauma or prolonged seizure.
    In my last testimony to this committee, I related a story 
of Matthew, a delightful, young engineering college student, 
who was very much like my own son, who is a college student. 
Matthew died from SUDEP during the time that Fycompa was 
waiting to be scheduled by the DEA. It had been approved by the 
FDA, had already been suggested, had been scheduled, and DEA 
was waiting its approval. 2,800 Americans die from SUDEP each 
year. For people like Matthew, waiting a year to get an 
effective drug to treat their seizures, is not acceptable since 
the drug could be lifesaving.
    It is troubling, as a patient advocacy organization as 
well, that we can't offer a clear explanation of why the delay 
occurs at the DEA, since the DEA review has never made a change 
to the drug schedule recommended by the FDA. They have always 
followed FDA recommendations. Nor can we offer an explanation 
of why there is no timeline for DEA approval. After all, the 
FDA drug review process is largely transparent with predictable 
timelines. And our committee wonders why the DEA approval 
process doesn't have a similar timeline or transparency 
requirement.
    The current delays discouraging innovation in epilepsy 
therapy development, the unpredictable delay at the DEA means 
companies cannot accurately predict the amount of time they 
will have left on their drug patent or exclusivity. This bill 
proposes a simple solution to the problem and will ensure that 
drugs will not sit idly waiting to be scheduled while patients 
wait for potentially lifesaving drugs.
    We urge all members to consider full support of this 
legislation. Predictable and timely access to new therapies 
would be a phenomenal accomplishment for epilepsy patients and 
all Americans suffering from conditions like epilepsy. I thank 
the committee for its time and attention today.
    Mr. Pitts. The Chair thanks the gentleman.
    [The prepared statement of Dr. Fountain follows:]
    
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    Mr. Pitts. Now recognizes Mr. Barber, 5 minutes for an 
opening statement.

                 STATEMENT OF D. LINDEN BARBER

    Mr. Barber. Good morning, Mr. Chairman, Ranking Member 
Green, members of the subcommittee.
    For the last 3 and a half years as the director of the DEA 
compliance and litigation practice at Quarles & Brady, I have 
dealt with registrants on a daily basis. But, prior to that, I 
was the associate chief counsel at DEA. I worked at the agency 
for 12 years. And there I was the associate chief counsel in 
charge of the litigation section that took administrative 
actions against registrants.
    Over these last 15 years, we have seen a chain of well-
intentioned actions and reactions by DEA and by the industry 
that have unintentional consequences, consequences that 
undermine the ability of DEA and industry to address the issue 
of prescription drug abuse while ensuring that there is 
adequate supply of controlled substances to meet the legitimate 
medical needs of the United States.
    These unintended consequences are produced, in large part, 
by a lack of clarity in the law and the uncertainty produced in 
the regulatory environment. Ensuring Patient Access and 
Effective Drug Enforcement Act of 2015 provides much needed 
clarity in the Controlled Substances Act. Consider the 
unintended consequences that have occurred as a result of the 
lack of clarity. Communication between DEA and members of 
industry is thwarted. And communication is the cornerstone of a 
regulatory environment that promotes compliance and 
collaboration, particularly in an area like prescription drug 
abuse, an area that changes frequently and is difficult for DEA 
and industry to detect those who are attempting to obtain 
controlled substances for an illicit purpose.
    This breakdown has led to a lack of access to controlled 
substances for certain patients. It has altered the ordering 
patterns of pharmacies, making it more difficult for DEA and 
members of the supply chain to detect suspicious orders. And 
there is growing evidence to suggest that these actions and 
reactions are contributing to the rise in heroin use.
    When patients with chronic pain are forced to go from 
pharmacy to pharmacy in search of a pharmacist who will 
dispense a controlled substance that the patient has taken for 
years to control legitimate pain, we have a problem. When a 
pharmacist fears that filling such a prescription will result 
in being second-guessed by DEA and having their DEA 
registration suspended, we have a problem. When wholesale 
distributors decide to limit the supply of narcotics to 
pharmacies simply to avoid the risk of regulatory action, we 
have a problem. And certainly, if the lack of supply of 
controlled substances leads some people to use heroin, as some 
of the recent evidence suggests, we have a problem. That is why 
clarity in the law is so important.
    H.R. 471 provides clarity in a way that will allow DEA and 
industry to address these unintended consequences. While 
addressing these unintended consequences is essential, it is 
also important to preserve DEA's ability to issue immediate 
suspensions to address imminent danger to public health and 
safety. The lack of clarity and an inconsistent approach to 
immediate suspensions over the last 40 years has led to 
judicial challenges of DEA's authority.
    In 2006, when I was the associate chief counsel at DEA, the 
agency stopped issuing immediate suspensions because of a 
Federal court ruling that found that the DEA had--its process 
for immediate suspensions was unconstitutional. During an 8-
month period while the Internet pharmacies were out of control, 
fueling prescription drug abuse, the agency issued no immediate 
suspensions. That is Exhibit A for why clarity in the law and 
protecting DEA's authority is so important.
    Clarity also promotes access to controlled medications for 
patients. Without clarity, registrants often act to reduce 
perceived regulatory risk. A pharmacist refuses to fill 
legitimate prescriptions for narcotics simply because 
dispensing a high volume of narcotics brings scrutiny from DEA 
and from the wholesale distributor. No one wants cancer 
patients, wounded veterans, those in chronic pain to go without 
medication, but restricting access is an unintended consequence 
of a regulatory environment that lacks clarity.
    The Ensuring Patient Access and Effective Drug Enforcement 
Act of 2015 holds the promise of fulfilling its name. By 
defining key terms in the CSA, the regulatory and enforcement 
environment will be clarified. Communication between DEA and 
registrants will be enhanced. Registrants will be less likely 
to restrict access to legitimate patients out of a fear that 
they may be second-guessed by DEA. Registrants will also be 
encouraged to assist DEA in detecting controlled substance 
diversion. And DEA's authority to issue immediate suspensions 
will be protected from judicial curtailment because there will 
be a clear, legal standard.
    I thank the chairman and the committee.
    Mr. Pitts. The Chair thanks the gentleman.
    [The prepared statement of Mr. Barber follows:]
    
    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    
    Mr. Pitts. I will begin questioning and recognize myself 5 
minutes for that purpose.
    Dr. Fountain, in your testimony, you mention that the DEA 
has no set timeline or transparency requirements when making 
scheduling determinations. How does this impact patients, 
particularly those who have not benefited from currently 
available therapies?
    Dr. Fountain. About one-third of people with epilepsy will 
continue to have seizures, despite available treatments. For 
those third of patients, every new therapy is vitally 
important. Because the incidence of SUDEP, sudden unexplained 
death in epilepsy, seems to be related to the number of 
seizures, logically. So for those patients who are most 
severely affected, they are in most need of new therapies. And 
those new--the sooner those new therapies are available, the 
sooner that their seizures can be reduced in frequency; the 
less likely they are going to die as well as suffer those other 
consequences.
    So, of course, the epilepsy community, the Epilepsy 
Foundation wants to have safe and effective drugs. That is 
paramount. But if the FDA has already determined them to be 
safe and effective, then, for our community, it is difficult to 
understand why it would be delayed at the FDA--I mean, at the 
DEA while waiting to be scheduled. So it can impact patients 
very directly.
    Mr. Pitts. Now, give me the length of time, the longest 
time patients have had to wait on DEA after FDA has conducted 
its own detailed abuse liability analysis and approved a new 
therapy.
    Dr. Fountain. I think, based on the analysis that has been 
done in the published literature, the drug I mentioned before, 
Fycompa, I think, is the longest time. And it was 400 days. So 
400 days after FDA approval was when the drug was finally made 
available, scheduled, and finally scheduled by the DEA. So 
approximately 400 days, more than a year.
    Mr. Pitts. Do you know of any widespread abuse or criminal 
diversion of epilepsy treatments?
    Dr. Fountain. I am not aware of a single case report. So I 
have done my own literature search of the medical literature. 
And I am not aware of even a single case report of abuse of 
what we would consider standard epilepsy drugs. It is true in 
epilepsy, we sometimes, in special circumstances, use other 
drugs that might be subject to control, the so-called 
benzodiazepines, that have a different role. But for normal 
epilepsy drugs, the ones that have been approved in the recent 
many decades, I am not aware of any actual abuse.
    Mr. Pitts. Mr. Chlapek, both the GAO and the IOM have 
addressed the need of the EMS system in the U.S. Two of the 
areas of need, personnel and training, were highlighted. Since 
those reports were issued, there have been several events that 
have reinforced the need for a highly trained effective 
responsive EMS system--terrorist attacks, natural disasters, 
pandemics. Do you see this bill as another way of improving 
preparedness?
    Mr. Chlapek. Chairman Pitts, absolutely.
    This bill will help take a trained and--a trained group of 
medics and transition them so they take care of the shortfall. 
They are more able to help in disasters. They are more able to 
help with protection of a license or certification in incidents 
like Boston or Katrina and can go from State to State.
    Mr. Pitts. Now, if you were making recommendations to the 
States to streamline the process for veterans to become EMTs, 
what would you focus on?
    Mr. Chlapek. Approving education programs, the training 
centers and education facilities to offer something similar to 
Lansing Community College in Michigan, that sits down with the 
veteran and looks at their electronic military training record 
and gives them credit--transcripts credit--for that at no cost 
and then fills the gap and gets them out within a few weeks or 
a weekend.
    Mr. Pitts. OK.
    Mr. Eadie, you have mentioned that there is a white paper 
that describes best practices PDMPs need to adopt.
    Mr. Eadie. Yes, sir. It is available on our--the Web site 
of the--at PDMPexcellence.org. And it is the--that is the Web 
site for the PDMP Center of Excellence at Brandeis University. 
Yes.
    Mr. Pitts. Could you highlight a few of the practices you 
think are important to improve PDMPs.
    Mr. Eadie. Absolutely. I would first comment that there are 
35 best practices listed, so it comes--deals with everything 
from the way data is collected from pharmacies right through 
how the data is used.
    In terms of the data use, the recent advent of the mandated 
use of the systems by prescribers has certainly proven to be 
very effective in the States that have already initiated that, 
and I mentioned the examples of that in my earlier comments.
    The major one that has yet to be fully implemented is the 
use of unsolicited reporting or proactive reporting called 
both--proactively States analyze the data that is in their 
system and then share it with those people who need to see it 
based upon what the analysis shows. To date, only about a third 
of States are covering that--doing that adequately. And so 
there is a great deal of room there.
    There are other things, like, the--the excellent effort 
that is underway to allow data to be shared through electronic 
health records and health information exchanges that is a 
technological fix, so to speak, that will allow the prescribers 
and pharmacists to get data faster and right within their 
normal workflow so they can review it more readily.
    Mr. Pitts. Thank you. My time has expired.
    The Chair recognizes the ranking member, Mr. Green, 5 
minutes for questions.
    Mr. Green. Thank you, Mr. Chairman.
    And I am going to focus my questions on the two trauma-
related bills that Dr. Burgess and I have introduced. And Dr. 
Burgess is actually chairing another subcommittee of our full 
Energy and Commerce Committee downstairs.
    Both bills will reauthorize a number of important programs 
aimed at strengthening trauma systems, developing regionalized 
systems of care, and improving availability of high-level 
trauma services.
    Dr. Enderson, it is a disappointing fact that 44 million 
Americans currently lack access to the major trauma centers 
within the golden hour of the injury, the time period when the 
chances of survival are greatest. Can you elaborate on the 
issue of access and why timely and appropriate care within the 
first hour of injury is so critical?
    Dr. Enderson. Traumatic injury is a surgical disease. 
Basically the injuries that kill patients when they are injured 
are--frequently, they are bleeding to death and they need 
access to surgical care within that time to stop the dying 
process while they are bleeding.
    The access problems occur commonly in the United States in 
rural areas, but we also have access problems in some of our 
major cities where there is a maldistribution of level 1 trauma 
centers. So someone who is injured on one side of the city has 
problems getting transported to that trauma center in the 
length of time before they bleed to death. And if they are 
taken to a hospital that is not part of the system, that delays 
the care until they reach that definitive surgical care.
    Mr. Green. Thank you.
    I represent Houston, Texas. And I first became involved in 
this issue when hurricane Allison--or Tropical Storm Allison 
flooded our two level 1 trauma centers in our Medical Center 
and the area was under water. While tropical storms and 
hurricanes are not typically the greatest threat to trauma 
centers' operations, cost pressures, providers shortages have 
caused many trauma centers to close and many more are 
struggling to maintain operations.
    As you mentioned in your testimony, from 1990 to 2005, 30 
percent of our trauma centers closed their doors. Can you 
discuss why access to trauma care is threatened by losses 
associated with the high cost of treating severely injured 
patients, a problem compounded by uncompensated care and the 
growing shortage of trauma-related physicians?
    Dr. Enderson. The cost does keep going up. The demands on 
providers are increasing. And if we close down trauma centers, 
that just puts a further strain on the system. In many areas, 
such as our area, we are the only trauma center in our area. 
And we don't have any backup. And the fewer trauma centers you 
have, they are more likely to get overloaded with all of the 
patients so that, when they are needed for critical events, 
they can't provide care for their patients.
    So it is nice to have some redundancy in that system, but 
that redundancy has to make sense. It has to be in places where 
they can work with the higher level trauma centers where they 
can take care of their patients and provide the care that is 
needed in that region and for those injured patients.
    Mr. Green. And I want to point out that some of these 
programs have not received funding for several years.
    Dr. Enderson. They have not. They have been authorized, but 
they have not had appropriations.
    Mr. Green. Dr. Enderson, what can you talk about the value 
of investing in trauma centers and trauma care programs like 
these?
    Dr. Enderson. We have heard that trauma is the leading 
cause of death in patients under the age of 44. If you have 
young patients who are injured and you treat them and get them 
back to normal life, they can return to a long working life for 
society.
    As an example, we recently had a young man. He was at work. 
He got ill. He was driving home, and he had a bad wreck. He had 
terrible injuries. He had a ruptured thoracic aorta. He had 
extremity fractures. He had a head injury. And yet, by getting 
brought quickly to our trauma center, we were able to treat 
those injuries over a period of time, and in 6 months, he was 
back working and back with his family.
    Mr. Green. Well--and, Mr. Chairman, I realize a lot of us 
have been to both Iraq and Afghanistan. And that was the same 
goal that we had for our military, to make sure that there was 
a--within that hour period, they could reach a trauma center, 
whether it be in Kabul, Kandahar in Afghanistan, or in Baghdad, 
or Balad in Iraq.
    Mr. Enderson, can you talk about the value of investing in 
trauma systems and trauma care programs like these?
    Dr. Enderson. I think the value is simply what you pointed 
out. So, in the military, they have a great regionalized system 
where they provide lifesaving care at the screen. They quickly 
transport to a place for more definitive care. And then they 
transfer them back to the United States for rehabilitation.
    What we need is a system that involves all levels of trauma 
care so that we can take our young people and return them to a 
normal life.
    Mr. Green. Thank you, Mr. Chairman, again.
    I will yield back my time, except I want to thank Dr. 
Burgess for his partnership and leadership.
    And I also thank the Trauma Coalition, who has worked hard 
on the of reauthorization of these programs.
    And I yield back.
    Mr. Guthrie [presiding]. Thank you.
    The gentleman yields back, and I will recognize myself for 
5 minutes for questioning
    Mr. Eadie, I am from Kentucky, and we have been very active 
in this area. According to the Department of Health and Human 
Services, as of July 2013, 47 States had operational 
prescription drug monitoring plans or PDMPs. However, they are 
significantly underutilized by providers. A number of factors 
contribute to this underutilization, including the cumbersome 
nature of accessing current systems and privacy concerns. Would 
you elaborate on some of the factors that may lead to 
underutilization of PDMPs?
    Mr. Eadie. Certainly, I am happy to do that, and I want to 
acknowledge Kentucky's leadership for the country on many 
issues, including this one.
    In many cases, the cumbersome nature of this process as you 
describe it is correct. Doctors have to take the time to do it. 
Recent developments in Kentucky and other States has been 
actually to allow the physicians to delegate the responsibility 
to a subordinate person in the practice, with the prescriber 
keeping responsibility. That is also a practical thing that can 
be done, and we encourage every State to look at that. And in 
fact, those States that have mandated use have found it 
essential because of the increased workload of having to pull 
up the data.
    Mr. Guthrie. I want to ask you, on the mandate, do you 
think that is the right approach, to mandate the use? Kentucky 
and I think New York--I know my State has and also the State of 
New York.
    Mr. Eadie. Yes.
    Mr. Guthrie. Will you elaborate on mandating?
    Mr. Eadie. Yes. What those mandates--there are multiple 
types of mandates out there, some, like the State of Nevada, 
which mandates the prescribers use the system but only when 
they have a reason to believe that the patient in front of them 
is not there for legitimate medical purposes. Such States have 
not significantly increased their use of the data by 
prescribers with that kind of a mandate. But Kentucky, New 
York, and Tennessee have pioneered a new one in which basically 
every patient is required, with a few logical exceptions, 
before the first prescription is issued and then periodically 
thereafter. And, in the case of Kentucky, it is at least every 
3 months, they have to check before issuing an additional 
prescription beyond 3 months. What that does is it allows a 
prescriber in each case to check.
    We know from work that we did with the State of 
Massachusetts that in that State, when these unsolicited 
reports I talked about were sent out and they sent to 
prescribers and then we, with them, did a survey, found that 
only 8 percent of the prescribers acknowledged after receiving 
those reports that they had known about the multiple doctor 
episodes or doctor shopping that was going on by their 
patients. Putting it the other way, more than 90 percent of the 
prescribers did not know what was going on and, therefore, 
would not have asked for the data had it not been sent to them. 
Or, in the case of a mandate, they have to look, which is why 
they are effective.
    And we have seen in Kentucky and, frankly, in all three of 
those States, that medical opposition at first to being 
required to use the system has modified itself after 
implementation.
    Mr. Guthrie. I am going to try to get another question in 
from another panelist.
    Mr. Eadie. Please.
    Mr. Guthrie. That was very helpful. I appreciate what you 
were saying.
    Mr. Chlapek, when you were talking about the situation, you 
said there were a lot of people helping and involved and 
working in this, and so I have two questions really I will ask 
you because we have a minute and a half. Who were the 
stakeholders that should be addressing this and giving us 
information for policy questions? And you also said H.R. 235 
will address issues, but there is still a lot of other issues 
to be addressed. You talk about State licensing, and I 
understand how that, you know, with each State having its own 
and us reluctant to get into that because that is a States 
issue would be a problem. What other issues besides the State 
licensing do you think maybe other legislation would help? So 
who are the stakeholders, and what other issues need to be 
addressed?
    Mr. Chlapek. Vice Chairman Guthrie, other issues are 
standardization of training at the Joint Services Medical 
Training Facility in San Antonio. If we could get all of those 
folks with a National Registry EMT card, that would really help 
as they try to transition out.
    Other issues, H.R. 235 mainly helps with providing some 
funds for educational facilities to develop their transition 
program, especially in the rural or shortage areas. Other 
issues are standardization of State licenses. If there was a 
National Registry, that would really help us. Many States 
accept the registry now, but all don't.
    Mr. Guthrie. I used to be a State legislator. It probably 
would be easy for States to adopt rules if it came out with a 
standard uniform service. As you said, if the uniform services 
would have a standard training program with a standard card or 
standard criteria, then it would be easy for States to--so 
maybe that is where to start.
    But my time is actually expired. I appreciate you doing so.
    I would like to recognize Mr. Schrader from Oregon for 5 
minutes of questioning.
    Mr. Schrader. Thank you, Mr. Chairman.
    I appreciate the opportunity. First question for Mr. Eadie. 
I am curious, as you have heard testified by Mr. Whitfield that 
we currently have a program, a registry, if you will, that is 
operated out of the DOJ unit and wondered what the advantages 
of or need for the unit out of HHS would be and why that is 
critical for making this program work effectively?
    Mr. Eadie. I appreciate your question. It is my experience 
that both law enforcement and the public health professions 
have to be involved in addressing these issues. Neither one can 
address it. I mean, a fundamental thing is that prescriptions 
are issued by healthcare professionals. And the entire system 
of delivery of opioids, for example, are through the health 
care system. So a public health involvement and regulatory 
involvement involving health care is essential. At the same 
time, as long as we have had these types of drugs available for 
medical use, which is so important, they have also had the risk 
of making people addicted. And when that happens, people move 
into all sorts of illegal and criminal behavior patterns, 
including forgeries, counterfeitings, organized rings of drug 
shoppers, et cetera, and pill mills. Those are outside the 
realm that can be dealt with and addressed effectively by 
traditional public health entities.
    And I give you simply the examples. Public health, if you 
look at seatbelts, that is a triumph basically of both public 
health and law enforcement working together. The simple thing 
of people being quarantined in a public health emergency and an 
epidemic, public health orders it; law enforcement enforces it. 
And I could go on.
    But my point is that both aspects are essential, and we 
cannot hope to solve this epidemic if we don't keep both parts 
working together.
    Mr. Schrader. Very good. Thank you.
    Mr. Barber, I was wondering if you could elaborate a little 
bit on the lack of clarity in the DEA guidelines, particularly 
as it affects distributors, and talk about why the definition 
of ``imminent danger'' is so important, and modifying the 
corrective action is important also?
    Mr. Barber. Yes, sir. The statute currently does not have a 
definition for ``imminent danger,'' unlike other Federal 
statutes designed to protect public health and safety, such as 
the Mines Safety Act. When an attorney, when an agent for DEA 
is faced with making a decision about whether or not, prior to 
a hearing, to issue an immediate suspension, which brings due 
process rights to bear, the question is, what constitutes an 
imminent danger? In my written testimony, I cite an example 
where DEA has issued a suspension for conduct that they knew 
had ceased for months. So it is those types of scenarios that 
create a lack of clarity about what the standard is that will 
lead to an immediate suspension, and that is why courts have at 
times intervened.
    And going back to the year after DEA was created in 1974, 
all the way to as recently as 2013, courts have questioned and 
in many cases overturned suspensions issued by the agency 
because of that lack of clarity. As far as the corrective 
action plan, that is an important piece of the legislation in 
that it provides an assurance to a registrant who has taken 
corrective action that that will be taken into account, thereby 
enhancing collaboration and communication with the agency. 
There are times where registrants get it wrong, and the agency 
needs to take action. But if the registrant has taken 
corrective action, it is appropriate for the agency to consider 
that.
    Mr. Schrader. Very good. Thank you.
    Mr. Enderson, could you talk very briefly about what the 
benefits are with regard to regionalization. What does that 
translate into? What does that really mean?
    Dr. Enderson. What regionalization really means is that all 
of the parts of a system work together, and it may be under one 
head. So you have a Level 1 trauma center. You may have other 
trauma centers. You have other hospitals, but there is a system 
set up to ensure that the right patient gets to the right place 
at the right time, and they all work together. In the past, we 
have talked about exclusive trauma systems where you just have 
one center. Now we talk about inclusive trauma centers. You 
want everyone involved so that they know what their role is in 
making sure that the patient gets to the right pace.
    Mr. Schrader. So they can get the immediate care they need 
no matter what.
    Dr. Enderson. The immediate care. So there is not delays. 
If they are closer to another hospital, there is not a delay 
there. There are ways set up to automatically get the patient 
to where they need to be.
    Mr. Schrader. Thank you.
    I yield back.
    Mr. Guthrie. The gentleman yields back.
    Recognizes Mr. Griffith of Virginia for 5 minutes of 
questioning.
    Mr. Griffith. Thank you, Mr. Chairman.
    Dr. Fountain, if you could talk a little bit about where 
you think we ought to go in regard to the DEA and how we can 
better improve that process. I know the bills that we have here 
today, but are there other things that we can be doing as a 
committee to assist in making sure that we get some action on 
those things that have already been approved by the DEA or 
maybe even some research into things that we know might help 
epileptic patients that we are not able to do studies on yet?
    Dr. Fountain. I guess there are two other DEA-related 
issues that are important to the epilepsy community and to 
Americans in general. One of them peculiar to epilepsy drugs is 
that although they are scheduled by the FDA, they are scheduled 
at a low level. And for administrative reasons, they have been 
scheduled because the FDA, when it makes a recommendation to 
the DEA, follows eight specific criteria, and if these eight 
specific criteria boxes are checked off, then it requires DEA 
to schedule it. But those boxes--while they are perfectly 
reasonable, for instance, if the drug is approved in a class in 
which that class of drugs is already regulated, then the DEA is 
forced to schedule it. Well, for epilepsy drugs, because of 
historical reasons, they are in those classes, so they end up 
getting scheduled by the DEA. But from a medical perspective, 
it sort of somewhere between unbelievable and comical because 
they aren't the kind of drugs that you would typically regulate 
like that. So the physicians who are not epilepsy physicians 
always ask the question, Well, why is that a regulated drug?
    So specifically for our community and maybe for other drugs 
regulated by the DEA, especially given the burden that the DEA 
has of dealing with these specific and important issues that we 
have been addressing, it might be reasonable to revisit for 
epilepsy drugs but perhaps other drugs, speaking for myself, 
that don't necessarily need to be regulated by the DEA.
    Mr. Griffith. And there may be some drugs that do need to 
be regulated by the DEA, but maybe we need to take a look at 
how they are regulated. Currently I am working on some language 
with the epilepsy folks in regard to figuring out a way that we 
can use the cannabinoid oil from the marijuana plant. Of 
course, it is hard to figure out how much cannabinoid oil and 
how much THC you need to make it work for the children who 
apparently--at least anecdotally, it appears that is a 
treatment plan for some patients. But we haven't had a lot of 
studies done over the years by the DEA. Would you agree?
    Dr. Fountain. That is right. So the other issue relevant to 
the epilepsy community and to those with severe medical 
conditions is regulation of cannabis derivatives and 
cannabidiol, which is one derivative of marijuana that doesn't 
cause a high, doesn't cause euphoria or anything like that, 
seems to have some effectiveness in treating seizures and a few 
other medical conditions and is not the part of the plant or 
the compound that typically is associated with drug abuse. THC 
is, and so, consequently, for the epilepsy community, we would 
like to find a way to have cannabidiol oil available, first of 
all, to be studied and have research to know it is safe and 
effective; but then, beyond that, to make it available to 
people with the most severe epilepsies in certain 
circumstances.
    Mr. Griffith. And we definitely want to go in that 
direction but also make sure--because clearly that is a drug 
that can be abused--and we want to make sure that we don't 
overlook that when we go down that path.
    Mr. Barber, I know you sometimes get on the hot seat in 
here because we are trying to get things accomplished and get 
new treatments out there at the same time you are trying to 
make sure we don't have a lot of abuse of drugs. When last we 
were here and discussing these items, I had a situation where a 
small town pharmacy couldn't do what they can do. You mentioned 
that in your opening statement, and I appreciate that. You felt 
like we needed to try to make a better system so that we didn't 
have those problems where small town pharmacies with one 
supplier might have these issues. Do you have any suggestions 
that you can think of that we can do to be of assistance in 
that? Is there legislation that we need to pass that we haven't 
thought of yet or aren't moving on?
    Mr. Barber. I believe the Ensuring Patient Access and 
Effective Drug Enforcement Act of 2015 is a great step in the 
right direction. I do think that there are certainly oversight 
roles that committees such as this can play. For example, DEA's 
regulation calls on distributors to detect and report 
suspicious orders to DEA. Those are, according to the 
regulations, orders of unusual size, unusual frequency, or 
those that deviate substantially from a normal ordering 
pattern. What is unusual depends on the context of the ordering 
pharmacy. What deviates substantially is somewhat amorphous, 
and so if there is greater clarity around regulatory 
obligations like that, it will help pharmacies who now find 
themselves oftentimes not having sufficient drug supply to meet 
the needs of their patients.
    Mr. Griffith. If I can take just a minute, Mr. Chairman, 
and just say I understand what he is saying. If I am 
translating it correctly, what that means is if you have a 
pharmacy that serves a lot of older people who are more likely 
to have pain needs, a senior population, than a pharmacy that 
serves a younger, you can't have a one-size-fits-all for the 
pharmacy that is in a community that is younger and a pharmacy 
that is in a community that is substantially older and is going 
to have more pain issues. Is that a fair translation?
    Mr. Barber. That is a fair translation. Context always 
matters, both in the law enforcement and healthcare arena.
    Mr. Griffith. I appreciate it, and I appreciate the panel 
being here today.
    Thank you, Mr. Chairman. I yield back.
    Mr. Guthrie. Thank you. The gentleman's time is expired.
    The Chair recognizes Mr. Sarbanes from Maryland for 5 
minutes for questioning.
    Mr. Sarbanes. Thank you, Mr. Chairman. I won't take 5 
minutes.
    Most of you have come from great distances to share your 
expertise with us, and it is deeply appreciated by the 
committee.
    Mr. Chlapek, is that how I pronounce it?
    Mr. Chlapek. It is Chlapek, sir.
    Mr. Sarbanes. Chlapek, sorry. I gather you were here to 
testify primarily with respect to the helping veterans with 
emergency medical training proposal----
    Mr. Chlapek. Yes, sir.
    Mr. Sarbanes. Which I think is a terrific opportunity to 
showcase how we can streamline bringing providers of all kinds, 
frankly, more quickly into the healthcare workforce. I have 
been working for many years on this idea of looking in 
nontraditional places for people that can help meet some of the 
shortages we have, whether that is physicians or nurses or, in 
this case, EMTs. In looking at military medics, who obviously 
come with a vast amount of experience, for that resource makes 
a tremendous amount of sense, and seeing if there is ways that 
we can streamline the process for actually getting them 
deployed here in the homeland to help respond to these 
emergencies makes a lot of sense.
    So this demonstration project that Adam Kinzinger and 
Congresswoman Capps have proposed I think could make a 
tremendous amount of difference.
    I was just curious whether you have had the opportunity--I 
imagine you have--to work with some EMT professionals who are 
former military medics and what your observation has been as to 
the kind of expertise and experience that they bring to the 
job?
    Mr. Chlapek. It depends, sir. You have the Special Forces 
or SEAL or PJ medic that is deployed forward that does a whole 
lot of different things--puts chest tubes in, uses conscious 
sedation, and some other adjuncts. These folks can come out and 
go--they should be able to challenge the paramedic test right 
away. And I will get phone calls that ask, What can I do, from 
these medics, and so I try to link them up with an educational 
institution that will let them do a weekend refresher and then 
challenge the test through their institution.
    Mr. Sarbanes. Excellent. Excellent. Well, that is a good 
perspective, and I think what they can bring to a team, to an 
EMT team on the ground, given their experience and perspective, 
is incredibly valuable. In other words, it is not just another 
source of finding people for this job. It is finding people 
that are particularly qualified in certain respects for the 
job, and that is why I support this bill in particular. Thank 
you very much for your testimony. Appreciate it.
    And all of you.
    Mr. Guthrie. The gentleman yields back.
    The next recognized is Mr. Long from Missouri for 5 minutes 
for questions.
    Mr. Long. Thank you, Mr. Chairman.
    Mr. Chlapek, number one, it is nice to have a fellow 
Missourian here, so welcome. Can you kind of walk us through 
the traditional State credentialing or licensing process for 
EMTs?
    Mr. Chlapek. Yes, sir. The military EMTs or the civilian 
EMTs, Mr. Long?
    Mr. Long. Well, the traditional--just the civilian is what 
I am getting at.
    Mr. Chlapek. Civilian EMTs, normally for the basic course, 
go through a one-semester or roughly 6-month time period with 
two clinical shifts and then take the test. The State of 
Missouri, for example, as well as about 40 other States, have 
adopted the National Registry exam because it takes a lot of 
pressure off of them. It is standardized. It is vetted, and 
they will take that exam and then receive a license. For 
paramedics, they go anywhere from two to three semesters and do 
an excess of 600 to 700 clinical hours, both in a hospital and 
in an ambulance. And then, once they do a certain number of 
skills, they are allowed to move on.
    Mr. Long. OK. Can you kind of juxtapose that with the 
military training? For someone with previous training, such as 
a military medic in Missouri, would they be qualified as EMT 
basic or EMT intermediate or EMT paramedic?
    Mr. Chlapek. The military medics, for the most part, that 
go through the program at San Antonio at the Joint Training 
Facility qualify; if they are in the Army or the Air Force, 
they will have a National Registry card. They present that to 
most States, and they are handed a State license to work within 
that State.
    The Special Forces medics come in, and they are expected--
they have done everything to qualify to test for a paramedic 
level card. Sometimes they do, and sometimes they don't. It 
depends. A Navy SEAL medic retired after 22 years and went to 
LA County Fire, and he wound up going through their whole 
paramedic course again. But it was one of the few things he 
could do that really satisfied him after the job he had been 
doing.
    Mr. Long. I know there are EMT shortages, and would you 
characterize that problem--is it a problem of recruitment or a 
problem of retention or both?
    Mr. Chlapek. Both, along with pay. EMS is severely 
underfunded, especially in rural areas, and some of these folks 
either volunteer or work for about $15,000 a year. If they are 
paramedic level, they can make 50 to 60 or a little more. There 
is a huge difference, and it is underfunded.
    Mr. Long. I was going to ask how you think that State 
healthcare systems could keep qualified EMTs working in the 
field, but I think you kind of answered that.
    Mr. Chlapek. Yes, sir.
    Mr. Long. With that, Mr. Chairman, I yield back.
    Mr. Chlapek. Thank you.
    Mr. Guthrie. The gentleman yields back.
    The next recognized is Mr. Bucshon of Indiana for 5 minutes 
of questions.
    Mr. Bucshon. Thank you, Mr. Chairman.
    Prior to coming to Congress, I was a cardiovascular and 
thoracic surgeon for 15 years, so I am pretty familiar with the 
subject matter, especially as it relates to trauma and really 
all the medical issues, including EMT and how you deal with 
pharmacies and what the process is. And I just would like to 
say at the top that this is a huge problem. My law enforcement 
in my community, in Evansville, Indiana, recently told me that 
prescription drug issues have overtaken methamphetamine as a 
community health problem in our county. And that I think is 
probably widespread across the country.
    Mr. Eadie, your comments about combining law enforcement 
and medical are very critical. I can tell you, as a practicing 
physician, one of the issues is time and the information in an 
expedient manner. Most physicians, as you know, 99.9 percent 
don't want to prescribe narcotics to people that are doctor 
shopping, but available information quickly is so critical if 
we can provide that.
    As a surgeon, of course, I provided acute medical care and 
acute pain management, which is a completely different area 
than our primary care physicians or neurologists and others 
have to deal with, so maybe you can expand further on how you 
think--I mean, getting the information from medical records, 
for example, the two major hospital systems in Evansville have 
two EMR systems that don't communicate with each other. And 
some of the medical practices have EMR systems that don't 
communicate with either hospital. How do we make progress in 
that area, because I know that there is a lot of smart IT 
professionals that can probably fix this problem overnight. 
Right? But it is about proprietary information. It is about 
economics. It is about profit for different systems, and I 
totally understand that. But how do we get past that and get 
the physicians the information immediately so that they, on the 
prescribing side, we don't overprescribe?
    Mr. Eadie. I thank you for your question, and I want to 
also acknowledge that I would be happy to put you in contact 
with the people in Indiana who are experimenting with this. 
There is a trial underway in Indiana. You are one of the 16 
States where there is an effort being made to translate PDMP 
data directly into the existing systems of electronic health 
records and health information exchanges. The details of that, 
they would have to provide to you, but it is important work. 
And that is why we support the NASPER. It is one of the major 
reasons we support NASPER, is that--and feel it is so 
important--is that we have seen the value and importance of 
doing exactly what you are talking about. And these 16 States 
have started, but that is not nearly enough, and they have got 
a long way to go. They are just experimenting. NASPER funding 
has, in its refocused form, in the redrafted legislation would 
really encourage this. It would provide funding to support 
States to do the necessary work. And it is going to take time. 
The complications of proprietary systems, multiple systems in 
each State, it is going to take a while to overcome those 
barriers and hurdles that have been put in place by multiple 
systems, but it is doable.
    And there is a real national effort underway, and in fact, 
the Substance Abuse and Mental Health Services, or SAMHSA, is 
the one that is spearheading this effort with the office from 
the White House on technological developments for health care. 
There is a lot of work that has been done, and I would be very 
happy to put you in touch with them to learn about that.
    Mr. Bucshon. That would be great.
    And, of course, the medical systems need to be able to 
communicate with pharmacies and, honestly, with law enforcement 
also in some way. So it is a complicated problem. But my wife 
is a anesthesiologist--still practicing--so she tells me every 
day the number of patients that come to the hospital for other 
procedures that are on, have been taking narcotics or, 
honestly, benzodiazepines for many, many years. This is really 
an epidemic problem. It is across socioeconomic class. It is 
something I have been working on since I have been in Congress 
in the State, on the methamphetamine issue, trying to solve 
that. But now the prescription drug issue is, it has been and 
is surpassing that.
    So I can tell you firsthand, you know, the significance. 
And I appreciate all your testimony and everyone working 
towards solutions to solve the problem.
    And on the EMT side, quickly, Mr. Chairman, the last 
Congress, we were able to get legislation passed on commercial 
driver's license for veterans who had driving experience in the 
military, making that a streamlined process so that they could 
get a commercial driver's license to drive a semi, for example, 
across the country because of their military experience. So I 
do think there is a good chance that this legislation will move 
forward and become law, and I hope it does.
    So I yield back.
    Mr. Guthrie. The gentleman yields back.
    And I ask unanimous consent to enter into the record a 
report, ``The Prescription Opioid and Heroin Crisis: A Public 
Health Approach to an Epidemic of Addiction.''
    Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Guthrie. The Chair now recognized Mr. Collins of New 
York for 5 minutes of questions.
    Mr. Collins. Thank you, Mr. Chairman. This has been a great 
hearing.
    I think, first of all, Mr. Chlapek, we all agree: Anything 
we can do help our vets coming back, we want to do. And while 
this may not be a lot of money per year--a couple hundred 
thousand per year I understand is what has been requested--do 
you know how many States have this issue? I mean, one of the 
requirements is the State claim a shortage of EMTs, and there 
is a need. Do you happen to know, is this 2 or 3 States or 10 
or 15? How great is the need for what we are proposing here?
    Mr. Chlapek. Nearly every State that has a rural area has a 
shortage in those areas. They are currently served by 
volunteers, but as more and more folks go back into the city 
for work and both members of the household work and 
requirements keep increasing for the mobile healthcare 
providers, the folks on the street, EMS professionals, they 
can't keep people at all. And veterans are coming out. They 
know how to be on time for work. They know how to follow 
orders, and they just need help with the license.
    Illinois is a prime example. And Carle out in Champaign-
Urbana, has a conference every year on rural health care. EMS 
is the big thing.
    Mr. Collins. I know this has bipartisan support, and we 
won't know until we get this approved and appropriated just how 
many folks are going to apply for it, but certainly a worthy 
objective. And thank you for bringing that up.
    My other question really is for Dr. Enderson on the trauma 
piece. First of all, I am just curious, do we know, since this 
one is a reauthorization, in the last couple of years, how many 
hospitals have applied? And what is the average amount of money 
they are getting? And have we seen a report that tracks how 
this money has allowed us to either get new trauma centers or 
keep trauma centers open? In other words, what are the metrics 
coming back at us?
    Dr. Enderson. Well, sir, unfortunately, these have been 
authorized over the past several years, but there have been no 
appropriations for that.
    Mr. Collins. I am glad you brought that up as well. As an 
authorizing committee but not the appropriators, that is 
information I didn't know as a new Member, and I am glad to 
know that so we can move forward. Certainly the access to 
trauma, as we talked about, that golden hour is critical. I 
represent the western New York area, and Erie County Medical 
Center has one of the best Level 1 trauma centers in the 
country. And it is quite expensive to set that up, and I know 
it is always the issue with the county government and others, 
tight budget times deciding where this money goes; but it is a 
lifesaver quite literally, whether it is the ski resorts that 
are 60 miles away and the incidents there, which tend to be 
head trauma and the like, that access has saved many lives in 
western New York, and I know we are blessed to have that. I 
know it is very much of a cost burden, but we have decided as a 
community it is worth that money.
    Would you see that in something like I am explaining--they 
are existing, they are there, the community is behind them--
would they qualify for one of these grants, or is this really 
more focused on, assuming it is appropriated, those areas that 
don't have one now?
    Dr. Enderson. Both. So part of it applies to trauma centers 
that exist, especially trauma centers that are having 
significant difficulties and are in danger of closing, we are 
trying to prevent that, but we are also trying to help States 
look at the models of trauma care that they have and make sure 
that they are allocating the resources the way that make sense. 
So, in a regionalized system, these, as you pointed out, are 
very expensive resources. You don't want every hospital 
duplicating those resources. You have to understand how it 
works best in a system, know how it works, and how that system 
can work together to take care of their patients.
    Mr. Collins. Yes. I mean, the good news for our area is we 
did designate the Erie County Medical Center as the Level 1 
trauma center. The other hospitals recognize that. It is also 
the regional arm, and in many cases, that 1 hour works with our 
mercy flight, the helicopters coming in. I suspect we are 
probably an example of best practices, both in the type of 
facility and also the way the other hospitals recognize that 
that is our designated trauma center.
    Dr. Enderson. Absolutely.
    Mr. Collins. So, again, very important issue. Thank you for 
your testimony.
    Mr. Chairman, I yield back my remaining 5 seconds.
    Mr. Guthrie. The gentleman yields back.
    The gentlelady from Tennessee is recognized for 5 minutes 
for questions.
    Mrs. Blackburn. Thank you, Mr. Chairman.
    I want to thank you all for being here, especially Dr. 
Enderson, my fellow Tennessean, and we are delighted to have 
him here and with us today.
    Mr. Chairman, I have got some things to submit for the 
record. First of all, the statement of the National Association 
of Chain Drug Stores on today's hearing.
    [The information appears at the conclusion of the hearing.]
    Mrs. Blackburn. And, secondly, letters of support for the 
Ensuring Patient Access and Effective Drug Enforcement Act of 
2015, which is the work product of Ms. Chu, Mr. Welch, Mr. 
Marino, and I. These are from the American Pharmacists 
Association, the Healthcare Distribution Management 
Association, the National Association of Chain Drug Stores, and 
the National Community Pharmacists Association.
    Mr. Guthrie. Seeing no objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mrs. Blackburn. Thank you, Mr. Chairman.
    Very quickly as we wrap up, I did have a couple of 
questions on H.R. 471, which is the Ensuring Patient Access and 
Effective Drug Enforcement Act.
    Mr. Barber, you mentioned in your remarks to one of the 
questions that context matters, and I appreciate hearing that. 
So I wanted to go back to your testimony. You said that little 
has changed in the past year in regard to the issue of dealing 
with DEA and guidance. And I want to know, has there been any 
improvement in the guidance the DEA is giving to distributors 
and pharmacists on this issue?
    Mr. Barber. It hasn't changed, so I would say there has 
been no improvement or any decrement. It is unchanged.
    Mrs. Blackburn. Well, I was hoping there was a sliver of a 
right step in the right direction, but I guess not, and it 
shows why we need to go ahead and get this bill passed.
    I wanted to also ask you, we hear some discussion about 
whether or not to define ``imminent danger,'' and I would like 
for you briefly to touch on why giving definition to ``imminent 
danger'' would benefit the DEA?
    Mr. Barber. Well, as a former counsel who appeared in 
Federal courts, assisted U.S. Attorney's Office in defending 
the suspension power of the agency, having a clear legal 
standard is always best. There are Federal statutes that were 
passed around the same time as the CSA that contain a 
definition of ``imminent danger,'' and rather than having it 
undefined and having courts second-guess the agency's important 
power, to me it seems like if Congress gave a clear standard in 
the law, then the agency could enforce it and courts would not 
be left to second-guess DEA.
    Mrs. Blackburn. OK. So you would say the harm comes in 
having no definition of ``imminent danger''?
    Mr. Barber. I believe that is the harm. It is a harm both 
to the agency and to the regulated community, who doesn't know 
where the lines are, and we have those unintended consequences 
I mentioned in my testimony.
    Mrs. Blackburn. Thank you.
    And, Mr. Chairman, just for the record, we are speaking in 
reference to the Controlled Substance Act.
    Well, I know you all are ready to step away from the desk. 
And we are appreciative that you are here.
    And, Mr. Chairman, in the interest of time and ending the 
hearing, I will yield back my time.
    Mr. Guthrie. Thank you. The gentlelady yields back her 
time.
    All Members have been recognized. I remind Members that 
they have 10 business days to submit questions for the record, 
and I ask that the witnesses respond to the questions promptly. 
Members should submit their questions by the close of business 
on Tuesday, February 10.
    Without objection, we have one more. We have a unanimous 
consent request for ``Prescription Drug Monitoring Programs: An 
Assessment of the Evidence for Best Practices'' for the record.
    Without objection, so ordered. \1\
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    \1\ The information has been retained in committee files and also 
is available at http://docs.house.gov/meetings/IF/IF14/20150127/102844/
HMTG-114-IF14-20150127-SD054.pdf.
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    Without objection, the subcommittee is adjourned.
    [Whereupon, at 12:52 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]
   
   
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