[Congressional Record (Bound Edition), Volume 160 (2014), Part 9]
[House]
[Pages 13403-13406]
[From the U.S. Government Publishing Office, www.gpo.gov]




   ENSURING PATIENT ACCESS AND EFFECTIVE DRUG ENFORCEMENT ACT OF 2014

  Mr. PITTS. Mr. Speaker, I move to suspend the rules and pass the bill 
(H.R. 4709) to improve enforcement efforts related to prescription drug 
diversion and abuse, and for other purposes, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 4709

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Ensuring Patient Access and 
     Effective Drug Enforcement Act of 2014''.

     SEC. 2. REGISTRATION PROCESS UNDER CONTROLLED SUBSTANCES ACT.

       (a) Definitions.--
       (1) Factors as may be relevant to and consistent with the 
     public health and safety.--Section 303 of the Controlled 
     Substances Act (21 U.S.C. 823) is amended by adding at the 
     end the following:
       ``(i) In this section, the phrase `factors as may be 
     relevant to and consistent with the public health and safety' 
     means factors that are relevant to and consistent with the 
     findings contained in section 101.''.
       (2) Imminent danger to the public health or safety .--
     Section 304(d) of the Controlled Substances Act (21 U.S.C. 
     824(d)) is amended--
       (A) by striking ``(d) The Attorney General'' and inserting 
     ``(d)(1) The Attorney General''; and
       (B) by adding at the end the following:
       ``(2) In this subsection, the phrase `imminent danger to 
     the public health or safety' means that, in the absence of an 
     immediate suspension order, controlled substances--
       ``(A) will continue to be intentionally distributed or 
     dispensed--
       ``(i) outside the usual course of professional practice; or
       ``(ii) in a manner that poses a present or foreseeable risk 
     of serious adverse health consequences or death; or
       ``(B) will continue to be intentionally diverted outside of 
     legitimate distribution channels.''.
       (b) Opportunity To Submit Corrective Action Plan Prior to 
     Revocation or Suspension.--Subsection (c) of section 304 of 
     the Controlled Substances Act (21 U.S.C. 824) is amended--
       (1) by striking the last two sentences in such subsection;
       (2) by striking ``(c) Before'' and inserting ``(c)(1) 
     Before''; and
       (3) by adding at the end the following:
       ``(2) An order to show cause under paragraph (1) shall--
       ``(A) contain a statement of the basis for the denial, 
     revocation, or suspension, including specific citations to 
     any laws or regulations alleged to be violated by the 
     applicant or registrant;
       ``(B) direct the applicant or registrant to appear before 
     the Attorney General at a time and place stated in the order, 
     but no less than thirty days after the date of receipt of the 
     order; and
       ``(C) notify the applicant or registrant of the opportunity 
     to submit a corrective action plan on or before the date of 
     appearance.
       ``(3) Upon review of any corrective action plan submitted 
     by an applicant or registrant pursuant to paragraph (2), the 
     Attorney General shall determine whether denial, revocation 
     or suspension proceedings should be discontinued, or deferred 
     for the purposes of modification, amendment, or clarification 
     to such plan.
       ``(4) Proceedings to deny, revoke, or suspend shall be 
     conducted pursuant to this section in accordance with 
     subchapter II of chapter 5 of title 5. Such proceedings shall 
     be independent of, and not in lieu of, criminal prosecutions 
     or other proceedings under this title or any other law of the 
     United States.
       ``(5) The requirements of this subsection shall not apply 
     to the issuance of an immediate suspension order under 
     subsection (d).''.

     SEC. 3. REPORT TO CONGRESS ON EFFECTS OF LAW ENFORCEMENT 
                   ACTIVITIES ON PATIENT ACCESS TO MEDICATIONS.

       (a) In General.--Not later than one year after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services, acting through the Commissioner of Food and Drugs 
     and the Director of the Centers for Disease Control and 
     Prevention, and in consultation with the Administrator of the 
     Drug Enforcement Administration and the Director of National 
     Drug Control Policy, shall submit a report to the Committees 
     on the Judiciary of the House of Representatives, the 
     Committee on Energy and Commerce of the House of 
     Representatives, the Committee on the Judiciary of the 
     Senate, and the Committee on Health, Education, Labor and 
     Pensions of the Senate identifying--
       (1) obstacles to legitimate patient access to controlled 
     substances;
       (2) issues with diversion of controlled substances; and
       (3) how collaboration between Federal, State, local, and 
     tribal law enforcement agencies and the pharmaceutical 
     industry can benefit patients and prevent diversion and abuse 
     of controlled substances.
       (b) Consultation.--The report under subsection (a) shall 
     incorporate feedback and recommendations from the following:
       (1) Patient groups.
       (2) Pharmacies.
       (3) Drug manufacturers.
       (4) Common or contract carriers and warehousemen.
       (5) Hospitals, physicians, and other health care providers.
       (6) State attorneys general.
       (7) Federal, State, local, and tribal law enforcement 
     agencies.
       (8) Health insurance providers and entities that provide 
     pharmacy benefit management

[[Page 13404]]

     services on behalf of a health insurance provider.
       (9) Wholesale drug distributors.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Pennsylvania (Mr. Pitts) and the gentleman from New Jersey (Mr. 
Pallone) each will control 20 minutes.
  The Chair recognizes the gentleman from Pennsylvania.


                             General Leave

  Mr. PITTS. Mr. Speaker, I ask unanimous consent that all Members may 
have 5 legislative days in which to revise and extend their remarks and 
to include extraneous materials into the Record on the bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Pennsylvania?
  There was no objection.
  Mr. PITTS. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, the bill before us today is important and necessary 
legislation to bring greater clarity to the requirements for the safe 
and secure distribution and dispensing of controlled substances to 
combat the abuse of prescription drugs. H.R. 4709, the Ensuring Patient 
Access and Effective Drug Enforcement Act, introduced by my colleagues, 
Representative Tom Marino of Pennsylvania, Marsha Blackburn of 
Tennessee, Peter Welch of Vermont, and Judy Chu of California, will 
facilitate greater collaboration between industry stakeholders and 
regulators in an effort to combat our Nation's prescription drug abuse 
epidemic.
  Safeguarding our prescription drug supply chain is important to 
protect against diversion and abuse of prescription medicines. H.R. 
4709 will clarify key terminology in the Controlled Substances Act to 
give registrants a better understanding of their responsibilities under 
the law.
  Further, the bill will allow DEA-registered companies to submit 
corrective action plans to address potential violations in the absence 
of an imminent danger, creating a more robust and meaningful dialogue 
about addressing drug diversion.
  That should in turn curtail unnecessary supply chain disruptions that 
adversely affect patient access to much-needed medications.
  Additionally, the legislation requires that a report be submitted to 
Congress by the Secretary of HHS in consultation with the DEA and other 
government and industry stakeholders about how collaboration between 
enforcement agencies and industry can benefit patients and prevent 
diversion and abuse.
  Equally important, H.R. 4709 will improve enforcement efforts 
regarding the complex and challenging problem of prescription drug 
diversion and abuse. It will ensure patient access to necessary 
medications by creating a more collaborative partnership between drug 
manufacturers, wholesalers, retail pharmacies, and Federal enforcement 
and oversight agencies such as DEA and the FDA.
  After hearings last April in the Health Subcommittee of the Energy 
and Commerce Committee, which I chair, we heard that a more feasible 
and practical solution to this serious problem of drug diversion and 
abuse is attainable, and those provisions are included in H.R. 4709. 
The legislation is supported by the National Community Pharmacists 
Association, the National Association of Chain Drug Stores, the 
Healthcare Distribution Management Association, as well as the Alliance 
to Prevent the Abuse of Medicines, among others.
  I would like to acknowledge and thank my good friend, Congressman Tom 
Marino, for his excellent work with this legislation. My friend from 
Pennsylvania is a former district attorney and former U.S. attorney. He 
understands the importance of law enforcement in this area. But he also 
understands that we will be more effective if we proceed in a 
collaborative, communicative, and transparent fashion. He has done 
excellent work here.
  Mr. Speaker, by approving this legislation, we will be giving our 
Nation's law enforcement additional tools while protecting our patients 
and securing our drug supply chain in a reasonable, commonsense way.
  I urge all of my colleagues to support this bill and vote for H.R. 
4709.
  I reserve the balance of my time.

                                         House of Representatives,


                                   Committee on the Judiciary,

                                    Washington, DC, July 28, 2014.
     Hon. Fred Upton,
     Chairman, Committee on Energy and Commerce, Rayburn House 
         Office Building, Washington, DC.
       Dear Chairman Upton: On June 10, 2014, the Committee on 
     Energy and Commerce ordered reported H.R. 4709, the 
     ``Ensuring Patient Access and Effective Drug Enforcement Act 
     of 2014.'' As you know, the Committee on the Judiciary was 
     given an additional referral on this measure upon 
     introduction. As a result of your having consulted with the 
     Judiciary Committee concerning provisions of the bill that 
     fall within our Rule X jurisdiction, I agree to discharge the 
     Committee on the Judiciary from further consideration of H.R. 
     4709.
       The Judiciary Committee takes this action with our mutual 
     understanding that, by foregoing consideration of H.R. 4709 
     at this time, we do not waive any jurisdiction over the 
     subject matter contained in this or similar legislation, and 
     that our committee will be appropriately consulted and 
     involved as the bill or similar legislation moves forward. 
     Our committee also reserves the right to seek appointment of 
     an appropriate number of conferees to any House-Senate 
     conference involving this or similar legislation, and 
     requests your support for any such request.
       Finally, I would appreciate your response to this letter 
     confirming this understanding with respect to H.R. 4709, and 
     would ask that a copy of our exchange of letters on this 
     matter be included in the Congressional Record during 
     consideration of the legislation on the House floor.
           Sincerely,
                                                    Bob Goodlatte,
     Chairman.
                                  ____

                                         House of Representatives,


                             Committee on Energy and Commerce,

                                    Washington, DC, July 29, 2014.
     Hon. Bob Goodlatte,
     Chairman, Committee on the Judiciary, Rayburn House Office 
         Building, Washington, DC.
       Dear Chairman Goodlatte: Thank you for your letter 
     regarding H.R. 4709, the ``Ensuring Patient Access and 
     Effective Drug Enforcement Act of 2014.'' As you noted, the 
     Committee on the Judiciary was given an additional referral 
     on this measure upon introduction, and I appreciate your 
     willingness to discharge the Committee from further 
     consideration of H.R. 4709.
       I agree that this action is not a waiver of any of the 
     Committee on the Judiciary's jurisdiction over the subject 
     matter contained in this or similar legislation, and that the 
     Committee will be appropriately consulted and involved as the 
     bill or similar legislation moves forward. In addition, I 
     understand the Committee reserves the right to seek 
     appointment of an appropriate number of conferees to any 
     House-Senate conference involving this or similar 
     legislation, and you will have my support for any such 
     request.
       Finally, I will include a copy of your letter and this 
     response in the Congressional Record during consideration of 
     H.R. 4709 on the House floor.
           Sincerely,
                                                       Fred Upton,
                                                         Chairman.

  Mr. PALLONE. Mr. Speaker, at this time, I yield as much time as he 
may consume to the gentleman from Vermont (Mr. Welch).
  Mr. WELCH. Mr. Speaker, I thank the gentleman, and I endorse 
everything that the chairman just spoke about.
  I am proud that the House is taking up this bipartisan action today 
to address an issue that impacts each of our districts, and that is 
prescription drug abuse.
  I want to thank especially Mr. Marino, who is using his experience to 
bring this legislation to the floor, and it was great working with him, 
Mrs. Blackburn, and also with Congresswoman Chu.
  Vermont is facing an opiate epidemic. That is true in many States 
around the country. In addition to the alarming increases in heroin 
abuse, we have had admissions in Vermont for prescription drug abuse 
that have increased 361 percent from 2005 to 2013.
  As we have seen in my State, we are most effective in dealing with 
this public health crisis when everybody who has a stake in this works 
together. That is the collaborative approach that Mr. Pitts mentioned. 
That has got to be the providers, the public health officials, law 
enforcement, distributors, pharmacists. They have all got to come 
together to tackle this problem.
  If we don't have flexibility and collaboration we can do something 
that

[[Page 13405]]

might make enforcement tighter, but access to legitimate prescription 
drugs tougher. So the goal here is to get the balance right. We want to 
help folks get access to the prescription medication that they need. It 
alleviates suffering and it eliminates pain, but we want to make sure 
that the enforcement is solid so there isn't the abuse.
  Today, distributors, like Burlington Drug Company in Vermont, and 
local pharmacies face very unpredictable enforcement from the DEA. DEA 
has a job, but so do the drug distributors and the doctors. That 
inconsistent enforcement--that unpredictable enforcement, I should 
say--can lead to disruptions in the supply chain, which end up limiting 
patient access to legitimate prescription drugs.

                              {time}  1445

  The Ensuring Patient Access and Effective Drug Enforcement Act will 
encourage collaboration between law enforcement, members of the supply 
chain, and public health providers and officials, while ensuring that 
patients have the access to the treatment their doctor has prescribed.
  So this is, as you mentioned, Mr. Pitts, common sense. It is 
collaboration. It is working together and having mutual respect that 
each entity in this process has its own job to do, but for all of us to 
do it together, we have got to work together and communicate.
  It has been great to work with Representatives Marino, Blackburn, and 
Chu on this bill. I thank them for their leadership. I want to also 
thank Chairman Upton and Ranking Member Waxman for their leadership, 
and, of course, Mr. Pallone and Mr. Pitts.
  I urge my colleagues to support H.R. 4709.
  Mr. PITTS. Mr. Speaker, I am pleased to yield 3 minutes to the 
gentlewoman from Tennessee (Mrs. Blackburn), vice chairman of the 
Energy and Commerce Committee and another leader on this issue.
  Mrs. BLACKBURN. Mr. Speaker, I want to thank the chairman for his 
work on this issue and for working with Congressmen Marino and Welch 
and Congresswoman Chu as we sought to move the issue forward. We also 
thank Chairman Upton for working with us as we brought the issue 
forward.
  The gentleman from Vermont mentioned the epidemic and the widespread 
abuse that is taking place in prescription drugs and the need to do 
something about that. We all agree on this, and here are some stats 
that really back this up and show why it has become an epidemic.
  In 2013, more people died in the U.S. from prescription drug abuse 
than from heroin and cocaine combined. Deaths involving prescription 
pills quadrupled between 1999 and 2010.
  In 2012, the number one cause of death in 17 States was prescription 
drug abuse. In 2008, more than 36,000 people died from drug overdoses. 
Most of these deaths were caused by prescription drugs. That 36,000 
number isn't a number to be taken lightly. It is associated with names 
and faces and serves as a stark reminder to every family member who has 
lost a loved one to an overdose.
  More can and must be done to treat this growing epidemic. That is why 
we have all worked together on H.R. 4709, the Ensuring Patient Access 
and Effective Drug Enforcement Act of 2014. Our bill seeks to 
facilitate greater collaboration between industry stakeholders and 
regulations in our Nation's effort to combat prescription drug abuse.
  There are three things that we set out to accomplish in this bill. 
Number one is to provide clarity to the phrase ``imminent danger to the 
public health or safety'' to ensure the law is crystal clear for both 
the DEA and legitimate businesses who want to understand what the rules 
of the road are, so they can do the right thing. Definitions matter and 
have real consequences.
  Number two is require the Secretary of HHS to consult with industry 
players in the pharmaceutical supply chain; key regulatory agencies; 
Federal, State, local, and tribal law enforcement agencies; and public 
health experts to create a report to come to Congress within 1 year of 
enactment.
  Number three is establish procedures for companies registered with 
the DEA to work together to develop corrective action that addresses 
concerns and clarifies key terminology in the Controlled Substances 
Act, so that everyone knows and has a better understanding of how to 
comply with the law.
  This bill will not solve every problem that prescription drug abuse 
faces. It is one that is important that we take this meaningful step. 
It is a good step.
  Congressman Marino, who has led on this issue, is to be commended. We 
have appreciated the opportunity to work with him to address what is an 
epidemic in so many of our communities and States.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise in support of H.R. 4709, the Ensuring Patient 
Access and Effective Drug Enforcement Act of 2014. This bill would help 
prevent prescription drug abuse, establish clear and consistent 
enforcement standards, and ensure patients have access to needed 
medications by promoting collaboration between government agencies, 
patients, and industry stakeholders.
  It will help drug distributors and others work with the Drug 
Enforcement Administration to keep controlled substance prescription 
drugs out of the hands of drug abusers. It will also help them avoid 
inappropriately limiting legitimate access to these same drugs by 
patients who need them. Achieving that balance is a difficult 
challenge.
  H.R. 4709 would provide definitions in the Controlled Substances Act 
for the phrases ``consistent with the public health and safety'' and 
``imminent danger.'' It also would require the DEA to provide 
registrants an opportunity to submit an action plan to correct any 
violations of law or regulation for which DEA is considering revoking 
or suspending their controlled substance.
  It would require FDA, in consultation with DEA, to submit a report to 
Congress 1 year after enactment on collaborative efforts to benefit 
patients and prevent diversion and abuse of controlled substances.
  I want to commend Energy and Commerce members Marsha Blackburn and 
Peter Welch, as well as Representatives Tom Marino and Judy Chu, for 
their sponsorship of this bipartisan legislation. Of course, I also 
thank my colleagues, Chairman Upton, Chairman Pitts, Ranking Member 
Waxman, and all other staff who have all been instrumental in bringing 
H.R. 4709 to the floor today.
  I urge my colleagues to join me in supporting this legislation, and I 
yield back the balance of my time.
  Mr. PITTS. Mr. Speaker, I am pleased to yield such time as he may 
consume to my friend, the gentleman from Pennsylvania (Mr. Marino), the 
leader on this issue.
  Mr. MARINO. Mr. Speaker, in early 2013, a pharmacist told me about 
problems he was having accessing necessary prescriptions for his 
customers, many of whom were older cancer patients suffering with 
chronic pain.
  What started out as a simple conversation with a constituent soon 
turned into serious concerns about problems in the prescription drug 
supply chain, problems that we aim to address here today by passing 
H.R. 4709, the Ensuring Patient Access and Effective Drug Enforcement 
Act.
  Any legitimate business involved in distributing or dispensing 
prescriptions welcomes appropriate oversight and regulation. Further, 
we know these businesses value a collaborative working relationship 
with agencies like the Drug Enforcement Administration.
  Manufacturers, distributors, and pharmacies alike are on the front 
lines every day in the fight to end the prescription drug abuse 
epidemic. They are making efforts to educate prescribers and patients 
about the safe use and disposal of prescriptions and working to 
implement prescription drug monitoring programs that will reduce the 
illegal diversion of powerful opioid pain relievers.
  Despite a strong commitment to being part of the solution, 
distributors and pharmacists are finding that the unnecessary 
adversarial regulatory environment created by the DEA is putting 
effective enforcement outcomes in jeopardy.

[[Page 13406]]

  As a former district attorney and United States attorney, I have fond 
memories of working with DEA agents to put away drug dealers. To say 
that I have the highest regard for the DEA and the work they do does 
not even begin to convey my respect for the agency and its front-line 
employees.
  I actually went with agents and busted down drug houses. They were 
watching my back. I trusted them then, and I trust them now. That is 
why I am so passionate about this subject and why I think it is 
necessary to pass H.R. 4709 today.
  This bill will bring much-needed clarity to critical provisions of 
the Controlled Substances Act. In doing so, we will ensure that the 
DEA's authorities are not abused and threatened by future legal 
challenges; foster greater collaboration, communication, and 
transparency between the DEA and supply chain; create more 
opportunities to identify bad actors at the end of the supply chain; 
and, most importantly, be certain that prescriptions are accessible to 
patients in need.
  We are all in this together. We cannot enforce our way out of this 
epidemic. Education, treatment, and enforcement are all critical to 
addressing the problem, but so is collaboration.
  The clarity that H.R. 4709 brings will ensure that the current 
regulatory culture evolves into one that rewards cooperation and brings 
more successful diversion control efforts in the future.
  I want to thank my friend, Congresswoman Blackburn, for working 
closely with my team and me to develop the bill. I want to thank our 
champions on the other side of the aisle, Dr. Judy Chu and 
Representative Peter Welch, for their leadership and efforts to bring 
us here today.
  We could not have achieved this without the efforts of Chairman Pitts 
and Chairman Upton and their staff on the Energy and Commerce 
Committee. I also must thank House Judiciary Committee Chairman 
Goodlatte for his forthright suggestions that made this a more 
effective measure worthy of consideration by this House.
  Mr. PITTS. Mr. Speaker, I urge all of my colleagues to support this 
bipartisan legislation, and I yield back the balance of my time.
  The SPEAKER pro tempore (Mr. McClintock). The question is on the 
motion offered by the gentleman from Pennsylvania (Mr. Pitts) that the 
House suspend the rules and pass the bill, H.R. 4709, as amended.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill, as amended, was passed.
  A motion to reconsider was laid on the table.

                          ____________________