[House Report 114-557]
[From the U.S. Government Publishing Office]


114th Congress    }                                    {        Report
                        HOUSE OF REPRESENTATIVES
 2d Session       }                                    {       114-557

======================================================================



 
                OPIOID REVIEW MODERNIZATION ACT OF 2016

                                _______
                                

  May 10, 2016.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

  Mr. Upton, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 4976]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
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, having considered the same, report 
favorably thereon without amendment and recommend that the bill 
do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     2
Background and Need for Legislation..............................     2
Hearings.........................................................
Committee Consideration..........................................     2
Committee Votes..................................................     2
Committee Oversight Findings.....................................     2
Statement of General Performance Goals and Objectives............     2
New Budget Authority, Entitlement Authority, and Tax Expenditures     3
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......     3
Committee Cost Estimate..........................................     3
Congressional Budget Office Estimate.............................     3
Federal Mandates Statement.......................................     4
Duplication of Federal Programs..................................     4
Disclosure of Directed Rule Makings..............................     4
Advisory Committee Statement.....................................     4
Applicability to Legislative Branch..............................     4
Section-by-Section Analysis of the Legislation...................     4
Changes in Existing Law Made by the Bill, as Reported............     5

                          Purpose and Summary

    H.R. 4976 would require the Food and Drug Administration 
(FDA) to refer certain applications for new opioid drug 
products to an advisory committee before approval; seek 
advisory committee recommendations regarding a framework for 
including information about pediatric use on an opioid label 
prior to making any labeling decisions for opioids intended for 
use in pediatric populations; develop recommendations on 
education programs for prescribers of certain opioids; and 
finalize guidance on the evaluation of abuse deterrence in 
generic opioids.

                  Background and Need for Legislation

    The number of prescriptions for opioid pain medications has 
significantly increased in recent years. Further, opioid use 
disorder and overdose deaths have reached epidemic levels. 
While a comprehensive approach to address this crisis is 
needed, FDA does play a critical role in reviewing opioid pain 
medications to determine whether their benefits outweigh their 
risks. It is important that FDA seeks the advice of the 
agency's expert advisory committees prior to making key product 
approval and labeling decisions, particularly to ensure that 
such risks are effectively communicated and mitigated. Further, 
the agency can play a role in ensuring prescribers have access 
to education regarding pain management and safe prescribing of 
opioids so as to decrease inappropriate prescribing.

                                Hearings

    The Committee on Energy and Commerce did not hold a hearing 
on this legislation.

                        Committee Consideration

    On April 20, 2016, the Subcommittee on Health met in open 
markup session and forwarded H.R. 4976, without amendment, to 
the full Committee by a voice vote. On April 26, 27, and 28, 
2016, the Committee on Energy and Commerce met in open markup 
session and ordered H.R. 4976, without amendment, favorably 
reported to the House by a voice vote.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. 
There were no record votes taken in connection with ordering 
H.R. 4976 reported.

                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee did not hold a hearing 
on this legislation.

         Statement of General Performance Goals and Objectives

    The purpose of this act is to ensure that an advisory 
committee of FDA provides input regarding the approval of new 
opioids that do not utilize abuse deterrent properties and 
obtain recommendations regarding a framework for labeling any 
opioid intended for pediatric use. Additionally, this act 
requires FDA to develop recommendations regarding prescriber 
opioid education and finalize guidance on evaluating abuse 
deterrence in generic opioids.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that H.R. 
4976 would result in no new or increased budget authority, 
entitlement authority, or tax expenditures or revenues.

       Earmark, Limited Tax Benefits, and Limited Tariff Benefits

    In compliance with clause 9(e), 9(f), and 9(g) of rule XXI 
of the Rules of the House of Representatives, the Committee 
finds that H.R. 4976 contains no earmarks, limited tax 
benefits, or limited tariff benefits.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                       Washington, DC, May 6, 2016.
Hon. Fred Upton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 4976, the Opioid 
Review Modernization Act of 2016.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Ellen Werble.
            Sincerely,
                                                        Keith Hall.
    Enclosure.

H.R. 4976--Opioid Review Modernization Act of 2016

    H.R. 4976 would require the Food and Drug Administration 
(FDA) to seek recommendations from an expert advisory committee 
before approving any new drug that contains an opioid that does 
not have abuse-deterrent properties. The bill would also 
require that the Pediatric Advisory Committee recommend 
labeling information for opioid use by children. In addition, 
the bill would require FDA to develop recommendations for 
educating prescribers of opioids and to publish final guidance 
on evaluating efforts to deter abuse of generic opioid drugs.
    CBO estimates that enacting H.R. 4976 would not have a 
significant budgetary effect because FDA is currently 
implementing similar requirements through their action plan on 
opioids. Enacting H.R. 4976 would not affect direct spending or 
revenues; therefore, pay-as-you-go procedures do not apply. CBO 
estimates that enacting H.R. 4976 would not increase net direct 
spending or on-budget deficits in any of the four consecutive 
10-year periods beginning in 2027.
    H.R. 4976 contains no intergovernmental or private-sector 
mandates as defined in the Unfunded Mandates Reform Act and 
would not affect the budgets of state, local, or tribal 
governments.
    The CBO staff contact for this estimate is Ellen Werble. 
The estimate was approved by Holly Harvey, Deputy Assistant 
Director for Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                    Duplication of Federal Programs

    No provision of H.R. 4976 establishes or reauthorizes a 
program of the Federal Government known to be duplicative of 
another Federal program, a program that was included in any 
report from the Government Accountability Office to Congress 
pursuant to section 21 of Public Law 111-139, or a program 
related to a program identified in the most recent Catalog of 
Federal Domestic Assistance.

                  Disclosure of Directed Rule Makings

    The Committee estimates that enacting H.R. 4976 does not 
direct any specific rule making within the meaning of 5 U.S.C. 
551.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation


Section 1. Short title

    Section 1 provides the short title of ``Opioid Review 
Modernization Act of 2016.''

Section 2. FDA Opioid Action Plan

    This section requires FDA to refer any new drug application 
for an opioid that does not have abuse-deterrent properties to 
an advisory committee prior to making an approval decision. 
Such a referral is not required if FDA determines that it is 
not in the interest of the public health or based on a review 
of the relevant scientific information. If such an application 
is not referred to an advisory committee based on one of these 
factors, FDA must submit a notice containing the rationale for 
this decision to the Congressional authorizing committees.
    In addition, this section requires FDA to convene the 
Pediatric Advisory Committee before to provide recommendations 
regarding the framework for including any information about 
pediatric use on an opioid label before approving any labeling 
or labeling change for a drug that is an opioid intended for 
use in a pediatric population.

Section 3. Prescriber education

    This section would require FDA, within one year of 
enactment, to evaluate the Risk Evaluation and Mitigation 
Strategy (REMS) program currently in place for extended-release 
and long-acting opioids and develop recommendations, in 
consultation with relevant stakeholders, regarding education 
programs for prescribers of opioids, including which 
prescribers should participate in such programs and how often.

Section 4. Guidance on Evaluating the Abuse Deterrence of Generic Solid 
        Oral Opioid Products

    This section would require FDA, not later than two years 
after the close of the comment period for the draft guidance 
entitled ``General Principles for Evaluating the Abuse 
Deterrence of Generic Solid Oral Opioid Drug Products'' to 
issue a final version of the guidance.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (new matter is 
printed in italic and existing law in which no change is 
proposed is shown in roman):

       SECTION 569-1 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

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 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.

                                  [all]