[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>