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SECTION 1. SHORT TITLE.

This Act may be cited as the ''Helping Effective Antibiotics Last
Act of 2015'' or the ''HEAL Act''.

SEC. 2. APPROVAL OF CERTAIN DRUGS FOR USE IN A WELL-DEFINED POPULATION
OF PATIENTS.

(a) Approval of Certain Antibacterial.--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 Drugs for Use in a Well-
Defined Population of Patients.--
''(1) Unmet medical need defined.--In this subsection, the
term 'unmet medical need' means that the antibacterial drug
involved--
''(A) has improved efficacy, as demonstrated in
adequate, well-controlled studies in humans, for
specific diseases or conditions, where current
therapies have been shown to be less effective;
''(B) has clinically meaningful decreased harms,
demonstrated in adequate, well-controlled studies in
humans, for diseases or conditions, where current
therapies have unacceptable adverse effects; or
''(C) has improved convenience, as demonstrated in
adequate, well-controlled studies in humans, where
improved convenience results in improved effectiveness
or decreased harms.
''(2) Approval.--Upon receipt of an application under
subsection (b) for an antibacterial drug that is intended to
treat a serious or life-threatening disease or condition,
irrespective of whether the drug is intended to address an
unmet medical need, the Secretary--
''(A) may approve the drug under subsection (c)
only for treating a well-defined population of
patients, and based upon the results of clinical trials
inclusive of human subjects representative of such
well-defined population;
''(B) in determining whether to grant such
approval, shall rely on superior outcomes over
available therapies based on direct measures of patient
benefits, as demonstrated in adequate, well-controlled
studies in the well-defined patient population, such
as--
''(i) decreased mortality;
''(ii) irreversible morbidity; or
''(iii) validated surrogate endpoints that
reflect mortality or irreversible morbidity;
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)--
''(i) the population of patients with
respect to which the added benefit over
available therapies is expected as studied in
adequate, well-controlled studies that form the
basis for approval; and
''(ii) the method for identifying members
of that population.
''(3) Risk evaluation and mitigation strategy.--The
Secretary--
''(A) shall require a risk evaluation and
mitigation strategy (REMS) under section 505-1 for each
drug approved under this subsection; and
''(B) may include in any such strategy additional
elements to assure the safe use of the drug under
subsections (e) and (f) of section 505-1.
''(4) 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.
''(5) 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 drug with added
benefits over available therapies for a well-defined population
that is intended to treat a serious or life-threatening disease
or condition shall be construed to refer to biological products
with added benefits over available therapies for a well-defined
population intended to treat a bacterial infection associated
with a serious or life-threatening disease; and
''(B) references to an application submitted under section
505(b) of such Act and to approval of a drug under section
505(c) of such Act shall be construed to refer to an
application submitted under subsection (a) of this section and
to licensure of a biological product under such subsection (a),
respectively.''.
(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 OF ANTIBACTERIAL DRUG USE, PATIENT OUTCOMES,
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) changes in patient outcomes such as mortality and
irreversible morbidity causally related to antibacterial
resistance; and
''(2) changes in bacterial resistance to drugs in relation
to patient outcomes.
''(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
patient outcomes in relation to antibacterial resistance; and
''(2) ensuring appropriate stewardship of antibacterial
drugs, including those receiving approval or licensure for a
well-defined 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--
''(1) identify upon approval or licensing of 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, susceptibility test interpretive
criteria for such drugs based upon patient outcomes of
mortality and morbidity from adequate and well-controlled
studies and such other confirmatory evidence as the Secretary
deems necessary; and
''(2) update, consistent with subsection (b), such criteria
as needed based upon scientific evidence of changes in patient
outcomes.
''(b) Responding to Changes in Patient Outcomes To Evaluate
Susceptibility Test Interpretive Criteria.--
''(1) In general.--As needed based on evidence related to
changes in patient outcomes, the Secretary shall--
''(A) evaluate any new scientific studies on
changes in patient outcomes in relation to
susceptibility test interpretive criteria; and
''(B) publish on the public Website of the Food and
Drug Administration a notice--
''(i) presenting suggested new or updated
interpretive criteria; and
''(ii) if needed, hold a public advisory
committee to discuss scientific evidence
related to changes in interpretative criteria.
''(2) Annual compilation of notices.--Each year, the
Secretary shall compile the notices published under paragraph
(1)(B) noting any changes from prior notices and publish such
compilation in the Federal Register.
''(c) Definition.--In this section, the term 'susceptibility test
interpretive criteria' means one or more specific values which
characterize patient outcomes in relation to the degree to which
bacteria or other microbes are more resistant to treatment as measured
by patient outcomes.''.
(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. REQUIRING DEMONSTRATION OF SUPERIOR OUTCOMES FOR QUALIFIED
INFECTIOUS DISEASE PRODUCTS TO RECEIVE AN EXTENDED
EXCLUSIVITY PERIOD.

Section 505E(g) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355f(g)) is amended by striking ''means an antibacterial or
antifungal drug for human use intended to treat'' and inserting ''means
an antibacterial or antifungal drug for human use that is demonstrated
to produce superior outcomes over available therapies, based on direct
measures of patient benefits in clinical trials, and that is intended
to treat''.

SEC. 5. GUIDANCE ON TARGET PRODUCT PROFILES.

Not later than 18 months after the date of enactment of this Act,
the Commissioner of Food and Drugs, in consultation with the
Administrator of the Centers for Medicare & Medicaid Services, the
Director of the Indian Health Service, the Secretary of Defense, and
the Secretary of Veterans Affairs, shall issue guidance on the
development of target product profiles for novel antibacterial drugs
focused on public health priorities.
Helping Effective Antibiotics Last Act of 2015 or the HEAL Act This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to approve an antibacterial drug or biological product that is intended to treat a serious or life-threatening condition only for treating a well-defined population of patients. To be approved, the antibacterial product must produce superior outcomes over available therapies in the well-defined patient population. A product approved by this pathway must include in its prescribing information the population of patients expected to benefit from using the product and the method for identifying members of that population. The FDA must require each product to have a risk evaluation and mitigation strategy. The Centers for Disease Control and Prevention must monitor changes to bacterial drug resistance and changes to patient outcomes caused by bacterial drug resistance. Upon approval of antibacterial products, the FDA must identify susceptibility test interpretive criteria (the drug concentrations where a type of bacteria is categorized as susceptible, intermediate, or resistant) and update the criteria as needed based upon evidence of changes in patient outcomes. To be eligible for an exclusivity period extension, a qualified infectious disease product must be demonstrated to produce superior outcomes over available therapies. The FDA must issue guidance on the development of target product profiles for antibacterial drugs.