HEAL Act

Summary: 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.

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.