[Congressional Record Volume 162, Number 88 (Monday, June 6, 2016)]
[Senate]
[Pages S3454-S3455]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 4422. Mr. BENNET (for himself, Mr. Hatch, Mr. Blumenthal, and Mr.
Kirk) submitted an amendment intended to be proposed by him to the bill
S. 2943, to authorize appropriations for fiscal year 2017 for military
activities of the Department of Defense, for military construction, and
for defense activities of the Department of Energy, to prescribe
military personnel strengths for such fiscal year, and for other
purposes; which was ordered to lie on the table; as follows:
At the end of title X, add the following:
Subtitle J--Promise for Antibiotics and Therapeutics
SEC. 1097. SHORT TITLE.
This subtitle may be cited as the ``Promise for Antibiotics
and Therapeutics for Health Act'' or the ``PATH Act''.
SEC. 1097A. ANTIBACTERIAL RESISTANCE MONITORING.
Section 319E of the Public Health Service Act (42 U.S.C.
247d-5) is amended--
(1) by redesignating subsections (f) and (g) as subsections
(k) and (l), respectively; and
(2) by inserting after subsection (e), the following:
``(f) Monitoring at Federal Health Care Facilities.--The
Secretary shall encourage reporting on aggregate
antibacterial drug use and bacterial resistance to
antibacterial drugs and the implementation of antibiotic
stewardship programs by health care facilities of the
Department of Defense, the Department of Veterans Affairs,
and the Indian Health Service and shall provide technical
assistance to the Secretary of Defense and the Secretary of
Veterans Affairs, as appropriate and upon request.
``(g) Report on Antibacterial Resistance in Humans and Use
of Antibacterial Drugs.--Not later than 1 year after the date
of enactment of this subsection, and annually thereafter, the
Secretary shall prepare and make publically available data
and information concerning--
``(1) aggregate national and regional trends of bacterial
resistance in humans to antibacterial drugs, including those
approved under section 506(g) of the Federal Food, Drug, and
Cosmetic Act;
``(2) antibacterial stewardship, which may include
summaries of State efforts to address bacterial resistance in
humans to antibacterial drugs and antibacterial stewardship;
and
[[Page S3455]]
``(3) coordination between the Director of the Centers for
Disease Control and Prevention and the Commissioner of Food
and Drugs with respect to the monitoring of--
``(A) any applicable resistance under paragraph (1); and
``(B) drugs approved under section 506(g) of the Federal
Food, Drug, and Cosmetic Act.
``(h) Information Related to Antibiotic Stewardship
Programs.--The Secretary shall, as appropriate, disseminate
guidance, educational materials, or other appropriate
materials related to the development and implementation of
evidence-based antibiotic stewardship programs or practices
at health care facilities, such as nursing homes and other
long-term care facilities, ambulatory surgical centers,
dialysis centers, and community and rural hospitals.
``(i) Supporting State-based Activities to Combat
Antibacterial Resistance.--The Secretary shall continue to
work with State and local public health departments on
statewide or regional programs related to antibacterial
resistance. Such efforts may include activities to related
to--
``(1) identifying patterns of bacterial resistance in
humans to antibacterial drugs;
``(2) preventing the spread of bacterial infections that
are resistant to antibacterial drugs; and
``(3) promoting antibiotic stewardship.
``(j) Antibacterial Resistance and Stewardship
Activities.--
``(1) In general.--For the purposes of supporting
stewardship activities, examining changes in bacterial
resistance, and evaluating the effectiveness of section
506(g) of the Federal Food, Drug, and Cosmetic Act, the
Secretary shall--
``(A) provide a mechanism for facilities to report data
related to their antimicrobial stewardship activities
(including analyzing the outcomes of such activities); and
``(B) evaluate--
``(i) antimicrobial resistance data using a standardized
approach; and
``(ii) trends in the utilization of drugs approved under
such section 506(g) with respect to patient populations.
``(2) Use of systems.--The Secretary shall use available
systems, including the National Healthcare Safety Network or
other systems identified by the Secretary, to fulfill the
requirements or conduct activities under this section.
``(3) Availability of data.--The Secretary shall make the
data collected pursuant to this subsection public. Nothing in
this subsection shall be construed as authorizing the
Secretary to disclose any information that is a trade secret
or confidential information subject to section 552(b)(4) of
title 5, United States Code, or section 1905 of title 18,
United States Code.''.
SEC. 1097B. LIMITED POPULATION PATHWAY FOR ANTIBACTERIAL
DRUGS.
Section 506 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 356) is amended--
(1) by transferring subsection (e) so that it appears
before subsection (f); and
(2) by adding at the end the following:
``(g) Limited Population Pathway for Antibacterial Drugs.--
``(1) In general.--The Secretary may approve an
antibacterial drug, alone or in combination with one or more
other drugs, as a limited population drug pursuant to this
subsection only if--
``(A) the drug is intended to treat a serious or life-
threatening infection in a limited population of patients
with unmet needs;
``(B) the standards for approval under section 505(c) and
(d), or the standards for licensure under section 351 of the
Public Health Service Act, as applicable, are met; and
``(C) the Secretary receives a written request from the
sponsor to approve the drug as a limited population drug
pursuant to this subsection.
``(2) Benefit-risk consideration.--The Secretary's
determination of safety and effectiveness of a limited
population antibacterial drug shall reflect the benefit-risk
profile of the drug in the intended limited population,
taking into account the severity, rarity, or prevalence of
the infection the drug is intended to treat and the
availability or lack of alternative treatment in such limited
population. Such drug may be approved under this subsection
notwithstanding a lack of evidence to fully establish a
favorable benefit-risk profile in a population that is
broader than the intended limited population.
``(3) Additional requirements.--A drug approved under this
subsection shall be subject to the requirements of this
paragraph, in addition to any other applicable requirements
of this Act:
``(A) Labeling.--To indicate that the safety and
effectiveness of a drug approved under this subsection has
been demonstrated only with respect to a limited population--
``(i) all labeling and advertising of an antibacterial drug
approved under this subsection shall contain the statement
`Limited Population' in a prominent manner and adjacent to,
and not more prominent than--
``(I) the proprietary name of such drug, if any; or
``(II) if there is no proprietary name, the established
name of the drug, if any, as defined in section 503(e)(3), or
for drugs which are biological products, the proper name, as
defined by regulation; and
``(ii) the prescribing information for such antibacterial
drug required by section 201.57 of title 21, Code of Federal
Regulations (or any successor regulation) shall also include
the following statement: `This drug is indicated for use in a
limited and specific population of patients.'.
``(B) Promotional material.--The sponsor of an
antibacterial drug subject to this subsection shall submit to
the Secretary copies of all promotional materials related to
such drug at least 30 calendar days prior to dissemination of
the materials.
``(4) Other programs.--A sponsor of a drug that seeks
approval of a drug under this subsection for antibacterial
drugs may also seek designation or approval, as applicable,
of such drug under other applicable sections or subsections
of this Act of the Public Health Service Act.
``(5) Guidance.--Not later than 18 months after the date of
enactment of the Promise for Antibiotics and Therapeutics for
Health Act, the Secretary shall issue draft guidance
describing criteria, processes, and other general
considerations for demonstrating the safety and effectiveness
of limited population antibacterial drugs. The Secretary
shall publish final guidance within 18 months of the close of
the public comment period on such draft guidance. The
Secretary may approve antibacterial drugs under this
subsection prior to issuing guidance under this paragraph.
``(6) Advice.--The Secretary shall provide prompt advice to
the sponsor of a drug for which the sponsor seeks approval
under this subsection for antibacterial drugs to enable the
sponsor to plan a development program to obtain the necessary
data for approval of such drug under this subsection for
antibacterial drugs and to conduct any additional studies
that would be required to gain approval of such drug for use
in a broader population.
``(7) Termination of limitations.--If, after approval of a
drug under this subsection, the Secretary approves a broader
indication for such drug for which the sponsor applies under
section 505(b) or section 351(a) of the Public Health Service
Act, the Secretary may remove any postmarketing conditions,
including requirements with respect to labeling and review of
promotional materials under paragraph (3), applicable to the
approval of the drug under this subsection.
``(8) Rules of construction.--Nothing in this subsection
shall be construed to alter the authority of the Secretary to
approve drugs pursuant to this Act and section 351 of the
Public Health Service Act, including the standards of
evidence, and applicable conditions, for approval under such
Acts, the standards of approval of a drug under this Act or
the Public Health Service Act, or to alter the authority of
the Secretary to monitor drugs pursuant to this Act or the
Public Health Service Act.
``(9) Reporting and accountability.--
``(A) Biannual reporting.--The Secretary shall report to
Congress not less often than once every 2 years on the number
of requests for approval, and the number of approvals, of an
antibacterial drug under this subsection.
``(B) Gao report.--Not later than December 2021, the
Comptroller General of the United States shall report on the
coordination of activities required under section 319E of the
Public Health Service Act, a review of such activities, and
the extent to which the use of the pathway established under
this subsection has streamlined premarket approval for
antibacterial drugs for limited populations, if such pathway
has functioned as intended, if such pathway has helped
provide for safe and effective treatment for patients, if
such premarket approval would be appropriate for other
categories of drugs, and if the authorities under this
subsection have affected antibiotic resistance.''.
SEC. 1097C. PRESCRIBING AUTHORITY.
Nothing in this subtitle, or an amendment made by this
subtitle, shall be construed to restrict the prescribing of
antibacterial drugs or other products, including drugs
approved under section 506(g) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356(g)), by health care
professionals, or to limit the practice of health care.
______