[Congressional Record (Bound Edition), Volume 161 (2015), Part 4]
[House]
[Pages 5270-5273]
[From the U.S. Government Publishing Office, www.gpo.gov]




   ENSURING PATIENT ACCESS AND EFFECTIVE DRUG ENFORCEMENT ACT OF 2015

  Mrs. BLACKBURN. Madam Speaker, I move to suspend the rules and pass 
the bill (H.R. 471) 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. 471

       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 2015''.

     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 will 
     continue to be distributed or dispensed by a registrant who 
     knows or should know through fulfilling the obligations of 
     the registrant under this Act--
       ``(A) the dispensing is outside the usual course of 
     professional practice;
       ``(B) the distribution or dispensing poses a present or 
     foreseeable risk of adverse health consequences or death due 
     to the abuse or misuse of the controlled substances; or
       ``(C) the controlled substances will continue to be 
     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;
       (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 not less than 30 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, United States Code. 
     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).''.

[[Page 5271]]



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

       (a) In General.--Not later than 1 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, in coordination with the Administrator of the 
     Drug Enforcement Administration and in consultation with the 
     Secretary of Defense and the Secretary of Veterans Affairs, 
     shall submit a report to the Committee 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 services on behalf of a health 
     insurance provider.
       (9) Wholesale drug distributors.
       (10) Veterinarians.

  The SPEAKER pro tempore. Pursuant to the rule, the gentlewoman from 
Tennessee (Mrs. Blackburn) and the gentleman from Vermont (Mr. Welch) 
each will control 20 minutes.
  The Chair recognizes the gentlewoman from Tennessee.


                             General Leave

  Mrs. BLACKBURN. Madam Speaker, I ask unanimous consent that all 
Members may have 5 legislative days in which to revise and extend their 
remarks and insert extraneous materials into the Record.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentlewoman from Tennessee?
  There was no objection.
  Mrs. BLACKBURN. Madam Speaker, I yield myself such time as I may 
consume.
  I rise in strong support of H.R. 471, the Ensuring Patient Access and 
Effective Drug Enforcement Act of 2015. This critical legislation 
combats inappropriate use of prescription drugs by bringing greater 
clarity and transparency to the requirements for safe and secure 
distribution of these medicines.
  It accomplishes these goals by clarifying some key terminology in the 
Controlled Substances Act. This comprehensive approach to the 
legislation will result in better protections against diversion and 
abuse of controlled substances.
  What it does is it provides the DEA with the clarity to collaborate 
with the very people responsible for ensuring that these medications 
get to the patients who need them without hurting and harming that 
distribution chain and while clamping down on diversions and abuse. 
These collaborations will lead to improved policies to prevent 
diversion while allowing legitimate patients to have access to the 
medications they need.
  Now, like so many components and pieces and bills and parts of 
legislation, the best example of why this is needed is a story that 
comes from home. In the case of this bill, we had a constituent who 
called our office after one of the recent ice storms that we saw in 
middle Tennessee this winter. It seemed as if these storms would never 
stop. The ice would come, and then it would not melt.
  We had a constituent who has a son who has a severe seizure disorder, 
and he takes three different medicines to control these seizures. 
Although his medicines are not opioids, two of them are controlled 
substances. So this mother, taking care of her son, decided she better 
get herself to the drugstore before the storm hit, and she did just 
that, to refill his prescriptions. She was anticipating that the 
prescriptions would run out before the ice melted and she would be able 
to get to the store.
  At the drugstore, she was told that she could not refill them because 
it was too early. She explained the situation. The pharmacist 
sympathized, but the pharmacist went on to say if the prescription were 
to be filled early, there would be problems with the DEA and other 
agencies.

                              {time}  1600

  The pharmacist was worried that his license might be lost.
  Our legislation is simply to ensure that patients who have a 
legitimate need for medications can receive them while we are battling 
diversion and abuse, which truly is a problem in this country.
  So, Madam Speaker, I encourage all of my colleagues to support this 
effort.
  I reserve the balance of my time.

                                         House of Representatives,


                                   Committee on the Judiciary,

                                   Washington, DC, April 20, 2015.
     Hon. Fred Upton,
     Chairman, Committee on Energy and Commerce, Washington, DC.
       Dear Chairman Upton: I am writing with respect to H.R. 471, 
     the ``Ensuring Patient Access and Effective Drug Enforcement 
     Act of 2015.'' As a result of your having consulted with us 
     on provisions in H.R. 471 that fall within the Rule X 
     jurisdiction of the Committee on the Judiciary, I agree to 
     discharge our Committee from further consideration of this 
     bill so that it may proceed expeditiously to the House floor 
     for consideration.
       The Judiciary Committee takes this action with our mutual 
     understanding that by foregoing consideration of H.R. 471 at 
     this time, we do not waive any jurisdiction over subject 
     matter contained in this or similar legislation, and that our 
     Committee will be appropriately consulted and involved as 
     this bill or similar legislation moves forward so that we may 
     address any remaining issues in our jurisdiction. 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 asks 
     that you support any such request.
       I would appreciate a response to this letter confirming 
     this understanding with respect to H.R. 471, and would ask 
     that a copy of our exchange of letters on this matter be 
     included in the Congressional Record during Floor 
     consideration of H.R. 471.
           Sincerely,
                                                    Bob Goodlatte,
     Chairman.
                                  ____

                                         House of Representatives,


                             Committee on Energy and Commerce,

                                   Washington, DC, April 20, 2015.
     Hon. Bob Goodlatte,
     Chairman, Committee on the Judiciary, Washington, DC.
       Dear Chairman Goodlatte: Thank you for your letter 
     regarding H.R. 471, the ``Ensuring Patient Access and 
     Effective Drug Enforcement Act of 2015''. As you noted, there 
     are provisions of the bill that fall within the Committee on 
     the Judiciary's Rule X jurisdiction.
       I appreciate your willingness to forgo consideration of 
     H.R. 471, and I agree that your decision 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 this bill or similar legislation moves forward. 
     In addition, I understand the Committee reserves the right to 
     seek the appointment of an appropriate number of conferees to 
     any House-Senate conference involving this or similar 
     legislation, for which you will have my support.
       I will include a copy of your letter and this response in 
     the Congressional Record during consideration of H.R. 471 on 
     the House floor.
           Sincerely,
                                                       Fred Upton,
                                                         Chairman.

  Mr. WELCH. Mr. Speaker, I yield myself such time as I may consume.
  I am pleased that the House is taking up again bipartisan action 
today to address the serious issue that impacts families in each of our 
districts: prescription drug abuse.
  Vermont, like Tennessee and many States around the country, is 
grappling with a serious opiate epidemic. In addition to alarming 
increases in heroin abuse, admissions for treatment of prescription 
drug abuse increased 361 percent between 2005 and 2013.
  As we have experienced in Vermont, we are most effective in dealing 
with this public health crisis when stakeholders--providers, public 
health officials, law enforcement, distributors, and pharmacists--come 
together to tackle the problem head-on.

[[Page 5272]]

  Today, the distributors of prescription drugs, along with local 
pharmacies, are experiencing unpredictable enforcement from the DEA. 
This has led to disruptions in the supply chain which limit patient 
access to prescription drugs for legitimate uses, as was evidenced by 
my colleague's story.
  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 
patients have access to the treatment their doctor has prescribed.
  It has been a pleasure to work with Representative Marino, 
Representative Blackburn, and Representative Chu, who has been a major 
leader on this, and I thank them for their efforts and their 
leadership. I also thank Chairman Upton and Ranking Member Pallone for 
making this issue a priority of the Energy and Commerce Committee.
  I urge my colleagues to support H.R. 471, and I reserve the balance 
of my time.
  Mrs. BLACKBURN. Mr. Speaker, I think it is so important for us to 
note that the gentleman from Pennsylvania (Mr. Marino) has been the 
primary author of this legislation and has brought to the table to work 
on this bill his experience of 7 years as a U.S. attorney--10 years 
prior to that as a district attorney--and has seen firsthand and dealt 
with drug diversion, drug enforcement issues, and the needs of the 
patient.
  At this time, I yield 5 minutes to the gentleman from Pennsylvania 
(Mr. Marino).
  Mr. MARINO. Mr. Speaker, in early 2013, a pharmacist told me about a 
problem 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. 471, 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.
  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 begin to convey my respect for the agency and its employees. That 
is why I am so passionate about this subject and why I think it is 
necessary to pass H.R. 471 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 the 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. 471 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 must thank House Judiciary Committee Chairman Goodlatte 
for his forthright suggestions that made this a more effective, 
efficient measure worthy of consideration by this House.
  Again, I want to stress the fact that this is bipartisan. The 
Democrats and the Republicans saw the importance in this and got 
together, and we worked it out, and I thank everyone involved.
  Mr. WELCH. Mr. Speaker, I yield such time as she may consume to the 
gentlewoman from California (Ms. Judy Chu), one of the lead sponsors of 
this legislation.
  Ms. JUDY CHU of California. Mr. Speaker, prescription drugs improve 
the quality of life for millions of Americans. They treat illnesses, 
alleviate pain, and help cure disease. But the ease of abuse has turned 
a solution into a problem.
  Each year, nearly 15,000 overdose deaths are attributed to 
prescription pain relievers--more than heroin and cocaine combined. Our 
government and private entities in the prescription drug supply chain 
must do what they can to prevent drug abuse and diversion.
  At the same time, we must ensure that pharmacists, who are our 
Nation's most accessible healthcare providers, are able to dispense 
drugs to patients who are in legitimate need and have proper 
prescriptions without groundless disruptions.
  The bipartisan bill we vote on today that I am proud to have 
introduced with my colleagues would do just that. Our bill encourages 
collaboration between stakeholders and the Drug Enforcement 
Administration to ensure effective enforcement of abuse while also 
ensuring that patients will continue to have safe access to the drugs 
they need. This will lead to fewer disruptions for pharmacists and, in 
turn, ensure that patients will not be left behind.
  I urge an ``aye'' vote on this very important bill.
  Mrs. BLACKBURN. Mr. Speaker, at this time I yield 2 minutes to the 
gentleman from Florida (Mr. Jolly), one of our colleagues from the 
Appropriations Committee handling Commerce, Justice, Science 
appropriations.
  Mr. JOLLY. I thank the gentlewoman.
  Mr. Speaker, I rise today in strong support of this commonsense 
measure that will help us more effectively fight prescription drug 
abuse while also ensuring that Americans are able to get their needed 
pain medications.
  Florida has been at the epicenter of the debate concerning combating 
prescription drug abuse while ensuring legitimate patient access to 
critical pain medications.
  Florida was one of the first States to be affected by the 
proliferation of ``pill mills'' and took strong action to shut them 
down, under the stellar leadership of our State attorney general.
  We have seen similar challenges nationally, and DEA has taken action. 
Unfortunately, Federal agencies have not coordinated their efforts to 
ensure appropriate access to prescription controlled substances.
  In Florida and elsewhere, we are seeing legitimate patients who are 
getting caught up in the efforts to stop prescription drug abuse.
  My own father was one of those patients: an 80-year-old retired 
minister prescribed a legitimate medication for chronic pain and yet 
unable to fill that prescription at his local pharmacy. All of the best 
intentions in the world by all of the actors but, unfortunately, there 
were very unintended consequences for a patient who needed care.
  The issue is largely due to DEA policies and extremely poor 
coordination between DEA and FDA.

[[Page 5273]]

  The key to this legislation is collaboration and coordination. This 
bill requires HHS and DEA to collaboratively assess the obstacles 
patients like my own father face and more effectively coordinate those 
efforts to prevent diversion and abuse of prescription drugs, while 
including the input of private sector stakeholders who are vital to 
these efforts.
  I urge my colleagues to support this very important and commonsense 
legislation.
  Mr. WELCH. Mr. Speaker, I yield myself such time as I may consume.
  I want to thank my colleagues, particularly Mr. Marino. We have the 
practical application of a commonsense approach here, where, on the one 
hand, you have got this enormous health need that the people whom we 
represent can have some of their suffering alleviated if they can get 
access to the appropriate prescription drugs. On the other hand, we do 
have an abuse. Folks get stuck on them, and we have got law enforcement 
out there trying to make sure they are enforcing the laws.
  The need for law enforcement and the need for proper access to 
prescription medication have to coexist. This practical presentation 
that was spearheaded by somebody who knows how law enforcement works 
and is committed to the principles of good law enforcement, I think, 
really gave this Congress a boost in coming up with a practical, 
bipartisan approach to finding the right balance.
  So I thank my colleague, Mrs. Blackburn, as well as Mr. Jolly, for 
what I thought was a very helpful statement, and I yield back the 
balance of my time.
  Mrs. BLACKBURN. Mr. Speaker, at this time I yield 1 minute to the 
gentleman from Pennsylvania (Mr. Costello), a member of the Veterans' 
Affairs Committee who has worked through this issue with some veterans.
  Mr. COSTELLO of Pennsylvania. Mr. Speaker, I rise today in support of 
H.R. 471.
  We have all seen reports in our local newspapers about the fight 
against prescription drug abuse by our local law enforcement officials 
and the damaging effect that prescription drug abuse has on families 
and communities across this country.
  According to the CDC, since 1999, the amount of prescription 
painkillers prescribed and sold in the United States has quadrupled. 
There is, indeed, a trend in the abuse of prescription painkillers, 
which is, in part, attributed to the changes in how providers prescribe 
painkillers.
  The best way to crack down on prescription drug abuse is to have a 
broad coalition of specialists, including supply chain stakeholders and 
regulators, to encourage a constructive dialogue to help minimize the 
impact of this serious public health issue. This legislation does just 
that.
  Our Federal agencies will be required to consult with our local 
pharmacies and stakeholders on how best to prevent prescription drug 
abuse, while not taking away the access for individuals who rely on 
these drugs for medicinal needs.
  I commend the efforts of Congressman Marino and Congresswoman 
Blackburn to create a more constructive environment between 
manufacturers, wholesalers, retail pharmacies, and enforcement agencies 
to crack down on this epidemic.
  I urge my colleagues on both sides of the aisle to support this 
legislation.

                              {time}  1615

  Mrs. BLACKBURN. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, as our colleagues have heard today, this is a bipartisan 
effort, and Mr. Marino has really worked diligently with his team and 
with all of us on this legislation to make certain that we got it right 
the first time and we didn't have to come back and revisit it.
  I thank him, the gentleman from Vermont (Mr. Welch), and the 
gentlewoman from California (Ms. Judy Chu) for the efforts that they 
have put into this, and also Chairman Pitts and Chairman Upton for the 
diligence that they have shown to the issue to make certain that we 
moved the bill through the process.
  As I said earlier, this is about access to the supply chain and 
making certain that those with legitimate needs for these medicines 
have the ability to access them in a timely manner, also bringing our 
pharmacists and the DEA into a collaborative process, with clarity, so 
that they make certain that this supply chain remains open to those 
that need it and that the DEA has the ability to continue to fight 
diversion and drug abuse.
  Prescription drugs kill more people than heroin. This is something we 
need to realize is a problem. At the same time, those that need these 
medicines, we need to make certain that supply chain is clear.
  I thank my colleagues for their diligence and their work, and I 
encourage an ``aye'' vote.
  Mr. Speaker, I yield back the balance of my time.
  Mr. PALLONE. Mr. Speaker, I rise in support of H.R. 471, the Ensuring 
Patient Access and Effective Drug Enforcement Act of 2015.
  Millions of Americans rely on prescription drugs to treat and cure 
illnesses and improve the overall quality of their lives. 
Unfortunately, we also have a significant problem in this country with 
abuse of prescription drugs.
  H.R. 471 would 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 urgently need them.
  It would achieve this goal by making several changes to the 
Controlled Substances Act. It would provide definitions for the phrases 
``factors as may be relevant to and consistent with the public health 
and safety'' and ``imminent danger to the public health or safety.'' It 
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. And it 
would require FDA, in consultation with DEA, to submit a report one 
year after enactment to Congress on obstacles to legitimate patient 
access to controlled substances and collaborative efforts to benefit 
patients and prevent abuse of these substances.
  I want to thank Representatives Blackburn, Marino, Welch and Chu for 
introducing this bipartisan legislation and I urge my colleagues to 
join me in supporting this legislation.
  The SPEAKER pro tempore (Mr. Duncan of Tennessee). The question is on 
the motion offered by the gentlewoman from Tennessee (Mrs. Blackburn) 
that the House suspend the rules and pass the bill, H.R. 471, 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.

                          ____________________