[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]