[Congressional Record Volume 160, Number 120 (Tuesday, July 29, 2014)]
[House]
[Pages H7004-H7007]
From the Congressional Record Online through the 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
[[Page H7005]]
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 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).
[[Page H7006]]
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 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 death 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.
[[Page H7007]]
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 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.
____________________