[Congressional Record Volume 162, Number 74 (Wednesday, May 11, 2016)]
[House]
[Pages H2254-H2256]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                OPIOID REVIEW MODERNIZATION ACT OF 2016

  Mr. GUTHRIE. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 4976) to require the Commissioner of Food and Drugs to seek 
recommendations from an advisory committee of the Food and Drug 
Administration before approval of certain new drugs that are opioids 
without abuse-deterrent properties, and for other purposes.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 4976

       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 ``Opioid Review Modernization 
     Act of 2016''.

     SEC. 2. FDA OPIOID ACTION PLAN.

       Chapter V of the Federal Food, Drug, and Cosmetic Act is 
     amended by inserting after section 569 of such Act (21 U.S.C. 
     350bbb-8) the following:

     ``SEC. 569-1. OPIOID ACTION PLAN.

       ``(a) New Drug Application.--
       ``(1) In general.--Subject to paragraph (2), prior to the 
     approval pursuant to an application under section 505(b) of a 
     new drug that is an opioid and does not have abuse-deterrent 
     properties, the Secretary shall refer the application to an 
     advisory committee of the Food and Drug Administration to 
     seek recommendations from such advisory committee.
       ``(2) Public health exemption.--A referral to an advisory 
     committee under paragraph (1) is not required with respect to 
     a new drug if the Secretary--
       ``(A) finds that such a referral is not in the interest of 
     protecting and promoting public health;
       ``(B) finds that such a referral is not necessary based on 
     a review of the relevant scientific information; and
       ``(C) submits a notice containing the rationale for such 
     findings to the Committee on Health, Education, Labor, and 
     Pensions of the Senate and the Committee on Energy and 
     Commerce of the House of Representatives.
       ``(b) Pediatric Opioid Labeling.--The Secretary shall 
     convene the Pediatric Advisory Committee of the Food and Drug 
     Administration to seek recommendations from such Committee 
     regarding a framework for the inclusion of information in the 
     labeling of

[[Page H2255]]

     drugs that are opioids relating to the use of such drugs in 
     pediatric populations before the Secretary approves any 
     labeling or change to labeling for any drug that is an opioid 
     intended for use in a pediatric population.
       ``(c) Sunset.--The requirements of subsections (a) and (b) 
     shall cease to be effective on October 1, 2022.''.

     SEC. 3. PRESCRIBER EDUCATION.

       Not later than 1 year after the date of the enactment of 
     this Act, the Secretary of Health and Human Services, acting 
     through the Commissioner of Food and Drugs, as part of the 
     Food and Drug Administration's evaluation of the Extended-
     Release/Long-Acting Opioid Analgesics Risk Evaluation and 
     Mitigation Strategy, and in consultation with relevant 
     stakeholders, shall develop recommendations regarding 
     education programs for prescribers of opioids pursuant to 
     section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355-1), including recommendations on--
       (1) which prescribers should participate in such programs; 
     and
       (2) how often participation in such programs is necessary.

     SEC. 4. GUIDANCE ON EVALUATING THE ABUSE DETERRENCE OF 
                   GENERIC SOLID ORAL OPIOID DRUG PRODUCTS.

       Not later than 2 years after the end of the period for 
     public comment on the draft guidance entitled ``General 
     Principals for Evaluating the Abuse Deterrence of Generic 
     Solid Oral Opioid Drug Products'' issued by the Center for 
     Drug Evaluation and Research of the Food and Drug 
     Administration in March 2016, the Commissioner of Food and 
     Drugs shall publish in the Federal Register a final version 
     of such guidance.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Kentucky (Mr. Guthrie) and the gentleman from Texas (Mr. Gene Green) 
each will control 20 minutes.
  The Chair recognizes the gentleman from Kentucky.


                             General Leave

  Mr. GUTHRIE. Mr. Speaker, I ask unanimous consent that all Members 
have 5 legislative days in which to revise and extend their remarks and 
insert extraneous materials in the Record on the bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Kentucky?
  There was no objection.
  Mr. GUTHRIE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise in support of H.R. 4976, the Opioid Review 
Modernization Act of 2016, introduced by the gentleman from New York 
(Mr. Sean Patrick Maloney) and the gentleman from New Jersey (Mr. 
Lance).

                              {time}  1630

  Opioid use disorder and overdose deaths have reached epidemic levels. 
A comprehensive approach is needed to reverse these trends and the 
tragic toll they have taken on families and communities across our 
country.
  The Food and Drug Administration does have a critical role to play in 
such an approach. Patients living with serious pain must have access to 
safe and effective therapies to help them function and lead productive 
lives. FDA reviews prescription pain relievers, like all new drug 
products, to determine whether their benefits outweigh their risks.
  It is important that the FDA hear recommendations from expert 
advisory committees prior to making key product and labeling decisions, 
particularly to ensure that any such risks are effectively 
communicated, understood, and mitigated.
  Specifically, H.R. 4976 requires that FDA receives input from an 
advisory committee regarding approval of new opioids that do not 
utilize abuse-deterrent properties, in addition to developing a 
framework for labeling any opioid intended for pediatric use.
  The bill also requires the agency to finalize guidance on evaluating 
abuse deterrence in generic opioid medications and issue 
recommendations regarding prescriber education tied to the risk 
evaluation mitigation strategy programs.
  This bill would strengthen FDA's Opioid Action Plan, defining 
outcomes with meaningful timeframes. I urge my colleagues to support 
H.R. 4976.
  Mr. Speaker, I reserve the balance of my time.
  Mr. GENE GREEN of Texas. Mr. Speaker, I yield myself such time as I 
may consume.
  Mr. Speaker, I rise in support of H.R. 4976, the Opioid Review 
Modernization Act.
  We know that there is not one solution addressing the opioid crisis 
that is striking communities across the country. A comprehensive 
approach that balances the appropriate use of opioids, while deterring 
misuse and diversion, requires the involvement of many government 
agencies, including the Food and Drug Administration.
  As the agency tasked with reviewing pain medications for safety and 
effectiveness, we know that the FDA can play a critical role in 
addressing the safe use of these products for patients with chronic or 
acute pain.
  I was pleased when the FDA announced earlier this year that the 
agency developed a comprehensive action plan to help reduce the burden 
of opioid abuse on American families and communities. In this plan, the 
FDA outlined concrete steps it intended to take, including:
  Expanding its use of advisory committees before approving any new 
opioid drug that does not have abuse-deterrent properties;
  Updating the risk evaluation and mitigation strategy program to 
incorporate advisory committee recommendations regarding medical 
training on pain management and safe prescribing of opioids; and
  Taking actions to expand patient access to abuse-deterrent 
formulations for opioids to help discourage their abuse.
  The Opioid Review Modernization Act builds on these efforts and would 
require the FDA to work closely with expert advisory committees before 
making critical opioid approach and labeling decisions, develop 
recommendations regarding prescriber education programs that address 
extended-release and long-acting opioids, including those who should 
participate and how often, and encouraging development and approval of 
generic opioids with abuse-deterrent properties.
  H.R. 4976 will engage a key public agency, the FDA, to help address 
our current opioid crisis by improving regulatory oversight of opioids 
early in the process while also assisting prescribers in the safe 
dispensing of these products.
  I would like to thank Representative Sean Patrick Maloney and 
Congressman Leonard Lance for their leadership in introducing this 
bill. I encourage my colleagues to support H.R. 4976.
  I reserve the balance of my time.
  Mr. GUTHRIE. Mr. Speaker, I yield 3 minutes to the gentleman from New 
Jersey (Mr. Lance), my good friend and a fellow member of the Energy 
and Commerce Committee.
  Mr. LANCE. Mr. Speaker, I certainly thank Mr. Guthrie of Kentucky and 
Mr. Gene Green of Texas for their leadership on this overall issue. We 
on the Energy and Commerce Committee have worked in a completely 
bipartisan fashion on this terrible crisis that affects the American 
people.
  Mr. Speaker, I rise in strong support of H.R. 4976, the Opioid Review 
Modernization Act. I thank Congressman Sean Patrick Maloney from the 
State of New York for his partnership on this legislation, and I 
certainly thank Chairman Upton and Ranking Member Pallone of the Energy 
and Commerce Committee for leading this and many other bipartisan bills 
to passage today that address this pressing national issue.
  This bill and the larger package together are a great step forward in 
the fight against the scourge of drug addiction. In my home State of 
New Jersey, we face a drug epidemic that is hitting many communities 
hard, and that is true across the entire Nation. This crisis strains 
law enforcement and taxpayer resources, and, of course, tragically, it 
cuts too many lives short.
  H.R. 4976 targets opioid addiction's strong ties to prescription drug 
abuse and the issue of overprescription. Studies have shown healthcare 
providers write nearly 300 million opioid prescriptions a year in this 
country. That number is truly staggering.
  Our legislation will make sure that the Food and Drug Administration 
rigorously reviews the benefits and risks of opioid pain medications 
and how they are communicated to prescribers and patients. The bill 
reforms critical product approval and labeling decisions and encourages 
the development and approval of opioids with abuse-deterrent 
properties.
  Our Federal health agencies must be working in concert with the 
medical and pharmaceutical communities to combat drug abuse, and this 
legislation helps make that happen.

[[Page H2256]]

  Just last week I met with Hunterdon County, New Jersey, Prosecutor 
Anthony Kearns on what law enforcement is doing on the ground level to 
fight this epidemic. In New Jersey, Mr. Speaker, the county prosecutor 
is the equivalent of the county district attorney in most States across 
the Nation.
  Public servants like Prosecutor Kearns and others are doing all they 
can to protect our children and keep our local communities drug free, 
but this legislative package will help in their efforts and give them 
and other governmental entities more critical tools.
  Those in Washington and local leaders need to be working together for 
the benefit of the American people. H.R. 4976 and the larger package 
will work toward that goal and ultimately help combat this drug abuse 
crisis.
  Mr. GENE GREEN of Texas. Mr. Speaker, I yield 3 minutes to the 
gentleman from New York (Mr. Sean Patrick Maloney), a cosponsor of this 
bill.
  Mr. SEAN PATRICK MALONEY of New York. Mr. Speaker, I thank my good 
friend from Texas for yielding. I want to echo my thanks as well to 
Chairman Upton and Ranking Member Pallone and my good friend, Mr. Lance 
of New Jersey.
  I rise in support of my legislation, H.R. 4976, the Opioid Review 
Modernization Act.
  Heroin and opioid addiction is a serious and growing epidemic, 
especially in the communities I represent in the lower Hudson Valley of 
New York. After more than 55 townhalls with my neighbors across the 
Hudson Valley in the last 3\1/2\ years, I can say there is no subject I 
have heard about more in visits to communities throughout my district. 
Really, everywhere I go, I hear heartbreaking stories of addiction and 
of loss, and we have had far too many funerals.
  I spoke to a woman named Cynthia in Newburgh who told me her son 
struggles every day with addiction. He is trying to stay clean, but he 
can't find a meeting locally to visit.
  A woman named Samantha from Brewster said she is worried about the 
basic lack of options for treating addicts like her son.
  Patricia in Warwick has said the facilities there lack the basic 
necessities for treating addicts like her son.
  We have a shortage of beds for patients who are seeking treatment. In 
Dutchess County, New York, alone, we have seen a 160 percent increase 
in the number of drug overdoses since 2009. This epidemic is being felt 
nationwide. It doesn't care about the color of your skin or the size of 
your paycheck.
  Deaths from heroin overdoses have more than tripled since 2010 in our 
country, and it is often driven by an addiction first to prescription 
pain medicine. We now have more than 47,000 people dying a year, the 
equivalent of 125 Americans every day. It is a staggering figure, Mr. 
Speaker, and we in Congress can and must do more to fight this growing 
epidemic.
  So my bill takes an important, but simple, step to avoid opioid 
addiction and to avoid further loss by using both new technologies and 
a little common sense.
  Specifically, it would require the Food and Drug Administration to 
consult with expert advisory committees for the approval of new opioids 
that do not use deterrent properties, such as extended-release 
capsules. We know this can thwart the misuse of these products by 
people who are struggling with addiction.
  Additionally, the legislation will encourage the development of 
generic opioids that utilize these abuse-deterrent properties. And, of 
course, the FDA can do more.
  We can require them to evaluate and make recommendations on better 
programs to prevent prescribers of opioids from overprescribing, since 
we often hear that it is that overprescription that leads people into 
trouble with opioids and, later, with heroin.
  As part of a comprehensive package of legislation to combat the 
opioid epidemic, my bill is just one more tool in our toolkit, 
providing incentives for pharmaceutical companies to use antiabuse 
technologies and create a plan to educate our well-meaning doctors 
about the potential dangers of prescription opioids.
  I urge my colleagues to vote ``yes'' on this important measure.
  Mr. GENE GREEN of Texas. Mr. Speaker, I yield back the balance of my 
time.
  Mr. GUTHRIE. Mr. Speaker, I yield myself the balance of my time.
  Mr. Speaker, this bill, the FDA's Opioid Action Plan, is important in 
our larger package of bills. I urge my colleagues to support this 
measure, H.R. 4976.
  Mr. Speaker, I yield back the balance of my time.
  Mr. PALLONE. Mr. Speaker, I wish to voice my support for H.R. 4976, 
which would complement the efforts taken by the Food and Drug 
Administration to combat the opioid abuse crisis.
  The opioid epidemic has hit nearly all communities across the 
country--young and old, rich and poor, urban and rural. The Energy and 
Commerce Committee has held a number of hearings on this issue, 
inviting a wide range of stakeholders to come and share with us their 
suggestions on how Congress can help to address this crisis. What has 
been made clear is that there is not one solution. It will take the 
collaboration and expertise of a variety of agencies, and it must not 
only appropriately account for the need for access to opioids for those 
with acute and chronic pain, but it must also discourage misuse and 
diversion.
  As the public health agency responsible for reviewing pain 
medications for safety and efficacy, the Food and Drug Administration 
should play a critical role in making clear how prescription opioids 
can be safely used, in encouraging the development of technologies to 
prevent abuse, and identifying what education would assist prescribers 
who treat patients with opioids.
  In February, FDA outlined an action plan that included a number of 
steps focused on the agency's regulatory approach to opioids.
  These actions included: reassessing the risk-benefit approval 
framework for opioid use; convening an expert advisory committee before 
approving any new drug application for an opioid that does not have 
abuse-deterrent properties; consulting with the Pediatric Advisory 
Committee regarding recommendations for pediatric opioid labeling 
before any new labeling is approved; updating the Risk Evaluation and 
Mitigation Strategy or REMS program for extended-release and long-
acting opioids regarding prescriber training; developing changes to 
immediate-release opioid labeling to include additional warnings and 
safety information; reviewing options to make naloxone more accessible, 
such as availability over-the-counter; and strengthening post-market 
requirements, among other steps.
  I was pleased by the agency's announcement as I believe it was an 
important step forward in improving regulatory oversight of opioids, 
and would help to take another step towards addressing the opioid 
crisis holistically.
  H.R. 4976, the Opioid Review Modernization Act, was introduced by 
Representatives Sean Patrick Maloney and Leonard Lance to build on the 
actions announced by the FDA. The legislation would require the agency 
to work closely with expert advisory committees before making critical 
product approval and labeling decisions, make recommendations regarding 
education programs for prescribers of extended-release and long-acting 
opioids, and would encourage the development and approval of generic 
opioids with abuse-deterrent properties.
  These actions will be critical to improving the way we regulate 
opioids to ensure that these products are used safely and appropriately 
and I urge my colleagues to support this legislation.
  The SPEAKER pro tempore (Mr. Stewart). The question is on the motion 
offered by the gentleman from Kentucky (Mr. Guthrie) that the House 
suspend the rules and pass the bill, H.R. 4976.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill was passed.
  A motion to reconsider was laid on the table.

                          ____________________