Antibiotic Development to Advance Patient Treatment Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to authorize the Secretary of Health and Human Services (HHS) to approve the use of an antibacterial or antifungal drug that is intended for treatment of a serious or life-threatening disease or condition to treat a limited population of patients for which there is an unmet medical need.
Requires the labeling of such drugs to prominently include in the prescribing information the statement that the drug is indicated for use in a limited and specific population of patients.
Amends the Public Health Service Act to authorize the Secretary to license those antibacterial or antifungal drugs as biological products.
Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to: (1) monitor the use of antibacterial and antifungal drugs, (2) monitor changes in bacterial and fungal resistance to drugs, and (3) make the information derived from such monitoring available to the public.
Amends the FFDCA to direct the Secretary: (1) to identify upon approval, and subsequently update, susceptibility test interpretive criteria for antibacterial drugs by relying upon preclinical and clinical data, Bayesian and pharmacometric statistical methodologies, and such other confirmatory evidence the Secretary deems necessary; (2) on a quarterly basis, to evaluate new or updated criteria published by a nationally or internationally recognized standard development organization; and (3) to publish on the Food and Drug Administration's (FDA's) website a notice adopting, declining to adopt, or partially adopting such new or updated criteria.
[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3742 Introduced in House (IH)]
113th CONGRESS
1st Session
H. R. 3742
To provide for approval of certain drugs and biological products
indicated for use in a limited population of patients in order to
address increases in bacterial and fungal resistance to drugs and
biological products, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 12, 2013
Mr. Gingrey of Georgia (for himself, Mr. Gene Green of Texas, Mr.
Shimkus, Ms. Eshoo, Mr. Whitfield, Ms. DeGette, Mrs. Blackburn, Mr.
Engel, Mr. Griffith of Virginia, and Mr. Butterfield) introduced the
following bill; which was referred to the Committee on Energy and
Commerce
_______________________________________________________________________
A BILL
To provide for approval of certain drugs and biological products
indicated for use in a limited population of patients in order to
address increases in bacterial and fungal resistance to drugs and
biological products, and for other purposes.
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 ``Antibiotic Development to Advance
Patient Treatment Act of 2013''.
SEC. 2. APPROVAL OF CERTAIN DRUGS FOR USE IN A LIMITED POPULATION OF
PATIENTS.
(a) Approval of Certain Antibacterial and Antifungal Drugs.--
Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355)
is amended by adding at the end the following:
``(x) Approval of Certain Antibacterial and Antifungal Drugs for
Use in a Limited Population of Patients.--
``(1) Approval.--At the request of the sponsor of an
antibacterial or antifungal drug that is intended to treat a
serious or life-threatening disease or condition, the
Secretary--
``(A) may approve the drug under subsection (c) to
treat a limited population of patients for which there
is an unmet medical need;
``(B) in determining whether to grant such approval
for a limited population of patients, may rely on
traditional endpoints, alternative endpoints, or a
combination of traditional and alternative endpoints;
datasets of limited size; pharmacologic or
pathophysiologic data; data from phase 2 clinical
studies; and such other confirmatory evidence as the
Secretary deems necessary; and
``(C) shall require the labeling of drugs approved
pursuant to this subsection to prominently include in
the prescribing information required by section 201.57
of title 21, Code of Federal Regulations (or any
successor regulation) the following statement: `This
drug is indicated for use in a limited and specific
population of patients.'.
``(2) Promotional materials.--The provisions of section
506(c)(2)(B) shall apply with respect to approval under this
subsection to the same extent and in the same manner as such
provisions apply with respect to accelerated approval under
section 506(c)(1).
``(3) Withdrawal of limited population approval
requirements.--If a drug is approved pursuant to this
subsection to treat a limited population of patients and is
subsequently approved or licensed under this section or section
351 of the Public Health Service Act, respectively, without
such a limitation, the Secretary may remove any labeling
requirements or postmarketing conditions made applicable to the
drug during the earlier approval process.
``(4) Relation to other provisions.--Nothing in this
subsection shall be construed to prohibit designation and
expedited review of a drug as a breakthrough therapy under
section 506(a), designation and treatment of a drug as a fast
track product under section 506(b), or accelerated approval of
the drug under section 506(c), in combination with approval of
the drug for use in a limited population of patients under this
subsection.
``(5) Rule of construction.--Nothing in this subsection
shall be construed to alter the standards of evidence under
subsection (c) or (d) (including the substantial evidence
standard in subsection (d)). Subsections (c) and (d) and such
standards of evidence apply to the review and approval of drugs
under this subsection, including whether a drug is safe and
effective. Nothing in this subsection shall be construed to
limit the authority of the Secretary to approve products
pursuant to this Act and the Public Health Service Act as
authorized prior to the date of enactment of this subsection.
``(6) Effective immediately.--The Secretary shall have the
authorities vested in the Secretary by this subsection
beginning on the date of enactment of this subsection,
irrespective of when and whether the Secretary promulgates
final regulations to carry out this subsection.''.
(b) Licensure of Certain Biological Products.--Section 351(j) of
the Public Health Service Act (42 U.S.C. 262(j)) is amended--
(1) by striking ``(j)'' and inserting ``(j)(1)'';
(2) by inserting ``505(x),'' after ``505(p),''; and
(3) by adding at the end the following:
``(2) In applying section 505(x) of the Federal Food, Drug,
and Cosmetic Act to the licensure of biological products under
this section--
``(A) references to an antibacterial or antifungal
drug that is intended to treat a serious or life-
threatening disease or condition shall be construed to
refer to biological products intended to treat a
bacterial or fungal infection associated with a serious
or life-threatening disease; and
``(B) references to approval of a drug under
section 505(c) of such Act shall be construed to refer
to licensure of a biological product under subsection
(a) of this section.''.
(c) Monitoring.--Title III of the Public Health Service Act is
amended by inserting after section 317T (42 U.S.C. 247b-22) the
following:
``SEC. 317U. MONITORING ANTIBACTERIAL AND ANTIFUNGAL DRUG USE AND
RESISTANCE.
``(a) Monitoring.--The Secretary, acting through the Director of
the Centers for Disease Control and Prevention, shall use the National
Healthcare Safety Network or another appropriate monitoring system to
monitor--
``(1) the use of antibacterial and antifungal drugs,
including those receiving approval or licensure for a limited
population pursuant to section 505(x) of the Federal Food,
Drug, and Cosmetic Act; and
``(2) changes in bacterial and fungal resistance to drugs.
``(b) Public Availability of Data.--The Secretary, acting through
the Director of the Centers for Disease Control and Prevention, shall
make the data derived from monitoring under this section publicly
available for the purposes of--
``(1) improving the monitoring of important trends in
antibacterial and antifungal resistance; and
``(2) ensuring appropriate stewardship of antibacterial and
antifungal drugs, including those receiving approval or
licensure for a limited population pursuant to section 505(x)
of the Federal Food, Drug, and Cosmetic Act.''.
SEC. 3. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR MICROBIAL
ORGANISMS.
(a) In General.--Section 511 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360a) is amended to read as follows:
``SEC. 511. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR MICROBIAL
ORGANISMS.
``(a) In General.--The Secretary shall identify upon approval and
subsequently update susceptibility test interpretive criteria for
antibacterial drugs (including biological products intended to treat a
bacterial infection and other types of antimicrobial drugs, as deemed
appropriate by the Secretary), including qualified infectious disease
products, by relying upon, to the extent available--
``(1) preclinical and clinical data, including
pharmacokinetic, pharmacodynamic, and epidemiological data;
``(2) Bayesian and pharmacometric statistical
methodologies; and
``(3) such other confirmatory evidence as the Secretary
deems necessary.
``(b) Responding to Susceptibility Test Interpretive Criteria
Identified or Updated by Private Entities.--
``(1) In general.--Each quarter of each fiscal year, the
Secretary shall--
``(A) evaluate any appropriate new or updated
susceptibility test interpretive criteria published by
a nationally or internationally recognized standard
development organization; and
``(B) publish on the public Website of the Food and
Drug Administration a notice--
``(i) adopting the new or updated
interpretive criteria;
``(ii) declining to adopt the new or
updated interpretive criteria and explaining
the reason for such decision; or
``(iii) adopting one or more parts of the
new or updated interpretive criteria, declining
to adopt the remainder of such criteria, and
explaining the reason for so declining.
``(2) Annual compilation of notices.--Each year, the
Secretary shall compile the notices published under paragraph
(1)(B) and publish such compilation in the Federal Register.
``(3) Relation to section 514(c).--Any susceptibility test
interpretive criterion for which an approval is in effect under
paragraph (1) may be recognized as a standard by the Secretary
under section 514(c)(1).
``(4) Use of non-adopted criteria.--Nothing in this section
prohibits the sponsor of a drug or device from seeking approval
or clearance of the drug or device, or changes to the drug, the
device, or its labeling, on the basis of susceptibility test
interpretive criteria which differ from those adopted pursuant
to paragraph (1).
``(c) Definitions.--In this section:
``(1) The term `qualified infectious disease product' means
a qualified infectious disease product designated under
505E(d).
``(2) The term `susceptibility test interpretive criteria'
means one or more specific values which characterize the degree
to which bacteria or other microbes are resistant to the drug
(or drugs) tested, such as clinically susceptible,
intermediate, or resistant.''.
(b) Conforming Amendment.--Section 1111 of the Food and Drug
Administration Amendments Act of 2007 (42 U.S.C. 247d-5a; relating to
identification of clinically susceptible concentrations of
antimicrobials) is repealed.
(c) Report to Congress.--Not later than one year after the date of
enactment of this Act, the Secretary of Health and Human Services shall
submit to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor, and
Pensions of the Senate a report on the progress made in implementing
section 511 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360a), as amended by this section.
SEC. 4. NO EFFECT ON HEALTH CARE PRACTICE.
Nothing in the Antibiotic Development to Advance Patient Treatment
Act of 2013 (including the amendments made thereby) shall be construed
to restrict, in any manner, the prescribing of antibiotics or other
products by health care professionals, or to limit the practice of
health care.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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