[Congressional Record Volume 161, Number 58 (Tuesday, April 21, 2015)]
[House]
[Pages H2329-H2332]
From the Congressional Record Online through the 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).''.
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
[[Page H2330]]
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.
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
[[Page H2331]]
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.
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
[[Page H2332]]
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.
____________________