A bill to provide incentives for the development of qualified infectious disease products.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Generating Antibiotic Incentives Now 
Act of 2011''.

SEC. 2. TABLE OF CONTENTS.

    The table of contents of this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Extension of exclusivity period for drugs.
Sec. 4. Additional extension of exclusivity period for qualified 
                            infectious disease products for which a 
                            companion diagnostic test is cleared or 
                            approved.
Sec. 5. Priority review.
Sec. 6. Fast track product.
Sec. 7. Study on incentives for qualified infectious disease biological 
                            products.
Sec. 8. Clinical trials.

SEC. 3. EXTENSION OF EXCLUSIVITY PERIOD FOR DRUGS.

    (a) In General.--The Federal Food, Drug, and Cosmetic Act is 
amended by inserting after section 505D (21 U.S.C. 355e) the following:

``SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW QUALIFIED 
              INFECTIOUS DISEASE PRODUCTS.

    ``(a) Extension.--If, prior to approval of a drug pursuant to an 
application submitted under section 505(b), the Secretary determines 
that the drug is a qualified infectious disease product, then the four- 
and five-year periods described in subsections (c)(3)(E)(ii) and 
(j)(5)(F)(ii) of section 505, the three-year periods described in 
clauses (iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and 
(iv) of subsection (j)(5)(F) of section 505, or the seven-year period 
described in section 527, as applicable, shall be extended by five 
years.
    ``(b) Relation to Pediatric Exclusivity.--Any extension under 
subsection (a) of a period shall be in addition to any extension of the 
period under section 505A with respect to the drug.
    ``(c) Limitations.--Subsection (a) does not apply to the approval 
of--
            ``(1) a supplement to an application under section 505(b) 
        for any qualified infectious disease product for which an 
        extension described in subsection (a) is in effect or has 
        expired; or
            ``(2) a subsequent application filed by the same sponsor or 
        manufacturer of a qualified infectious disease product 
        described in paragraph (1) (or a licensor, predecessor in 
        interest, or other related entity) for--
                    ``(A) a change (not including a modification to the 
                structure of the qualified infectious disease product) 
                that results in a new indication, route of 
                administration, dosing schedule, dosage form, delivery 
                system, delivery device, or strength; or
                    ``(B) a modification to the structure of the 
                qualified infectious disease product that does not 
                result in a change in safety or effectiveness.
    ``(d) Determination.--The manufacturer or sponsor of a drug may 
request the Secretary to designate a drug as a qualified infectious 
disease product. Such a request for designation shall be made at least 
45 days before the submission of an application under section 505(b) 
for such drug. The Secretary shall, not later than 30 days after the 
submission of such request, determine whether the drug is a qualified 
infectious disease product.
    ``(e) Regulations.--The Secretary shall promulgate regulations for 
carrying out this section. The Secretary shall promulgate the initial 
regulations for carrying out this section not later than 12 months 
after the date of the enactment of this section.
    ``(f) Definitions.--In this section:
            ``(1) Qualified infectious disease product.--The term 
        `qualified infectious disease product' means an antibiotic drug 
        for treating, detecting, preventing, or identifying a 
        qualifying pathogen.
            ``(2) Qualifying pathogen.--The term `qualifying pathogen' 
        means--
                    ``(A) resistant gram positive pathogens, including 
                methicillin-resistant Staphylococcus aureus (MRSA), 
                vancomycin-resistant Staphylococcus aureus (VRSA), and 
                vancomycin-resistant enterococcus (VRE);
                    ``(B) multi-drug resistant gram negative bacteria, 
                including Acinetobacter, Klebsiella, Pseudomonas, and 
                E. coli species;
                    ``(C) multi-drug resistant tuberculosis; or
                    ``(D) any other infectious pathogen identified for 
                purposes of this section by the Secretary.''.
    (b) Application.--Section 505E of the Federal Food, Drug, and 
Cosmetic Act, as added by subsection (a), applies only with respect to 
a drug that is first approved under section 505(c) of such Act (21 
U.S.C. 355(c)) on or after the date of the enactment of this Act.

SEC. 4. ADDITIONAL EXTENSION OF EXCLUSIVITY PERIOD FOR QUALIFIED 
              INFECTIOUS DISEASE PRODUCTS FOR WHICH A COMPANION 
              DIAGNOSTIC TEST IS CLEARED OR APPROVED.

    The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), 
as amended by section 3, is further amended by inserting after section 
505E the following:

``SEC. 505E-1. ADDITIONAL EXTENSION OF EXCLUSIVITY FOR QUALIFIED 
              INFECTIOUS DISEASE PRODUCTS FOR WHICH A COMPANION 
              DIAGNOSTIC TEST IS CLEARED OR APPROVED.

    ``(a) In General.--If the sponsor or manufacturer of a qualified 
infectious disease product identifies in accordance with subsection (b) 
a companion diagnostic test described in subsection (c), any period 
extended under section 505E(a) with respect to such product shall be 
further extended by 6 months.
    ``(b) Identification Requirements.--For purposes of subsection (a), 
the identification of a companion diagnostic test shall--
            ``(1) be made in such manner as the Secretary may require; 
        and
            ``(2) occur before the expiration of the period to be 
        extended under subsection (a), not counting any extension to 
        such period under section 505E(a) or 505A.
    ``(c) Companion Diagnostic Test.--For purposes of subsection (a), a 
device is a companion diagnostic test with respect to a qualified 
infectious disease product if each of the following is met:
            ``(1) The device is determined by the Secretary under 
        subsection (f) to be a test for diagnosis of a qualifying 
        pathogen.
            ``(2) The qualified infectious disease product has been 
        determined under section 505E(d) to be for treating, detecting, 
        preventing, or identifying such qualifying pathogen.
            ``(3) The device is cleared under section 510(k) or 
        approved under section 515.
            ``(4) The sponsor or manufacturer, as applicable, of the 
        qualified infectious disease product has the exclusive rights 
        to submit an identification under subsection (a) with respect 
        to the device.
    ``(d) Relation to Pediatric Exclusivity.--Any extension under 
subsection (a) of a period with respect to a qualified infectious 
disease product shall be in addition to any extension of the period 
under section 505A of this Act with respect to the product.
    ``(e) Limitations.--After the extension of any period under 
subsection (a) with respect to a qualified infectious disease product 
pursuant to the identification of a device as a companion diagnostic 
test, subsection (a) does not authorize--
            ``(1) any subsequent extension with respect to such 
        product; or
            ``(2) any extension with respect to any other product 
        pursuant to identification of such device.
    ``(f) Determination.--The sponsor or manufacturer of a drug may 
request the Secretary to determine that a device is a test for 
diagnosis of a qualifying pathogen. Such a request shall be made at 
least 45 days before the submission of a notification under section 
510(k) or an application under section 515 for such device. The 
Secretary shall, not later than 30 days after the submission of such 
request, determine whether the device is a test for diagnosis of a 
qualifying pathogen.
    ``(g) Definitions.--In this section:
            ``(1) The term `qualified infectious disease product' means 
        a drug that is determined to be a qualified infectious disease 
        product under section 505E.
            ``(2) The term `qualifying pathogen' has the meaning given 
        to such term in section 505E.''.

SEC. 5. PRIORITY REVIEW.

    (a) Amendment.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act is amended by inserting after section 524 (21 U.S.C. 360n) the 
following:

``SEC. 524A. PRIORITY REVIEW FOR QUALIFIED INFECTIOUS DISEASE PRODUCTS.

    ``(a) In General.--If the Secretary makes a determination under 
section 505E(c) that a drug is a qualified infectious disease product, 
then the Secretary shall give priority review to any application 
submitted for approval for such drug under section 505(b).
    ``(b) Definition.--In this section, the term `priority review', 
with respect to an application described in subsection (a), means 
review and action by the Secretary on such application not later than 6 
months after receipt by the Secretary of such application.''.
    (b) Application.--Section 524A of the Federal Food, Drug, and 
Cosmetic Act, as added by subsection (a), applies only with respect to 
an application that is submitted under section 505(b) (21 U.S.C. 
355(b)) on or after the date of the enactment of this Act.

SEC. 6. FAST TRACK PRODUCT.

    Paragraph (1) of section 506(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356(a)) is amended by inserting after ``if it 
is intended for the treatment of a serious or life-threatening 
condition and it demonstrates the potential to address unmet medical 
needs for such a condition'' the following: ``or if the Secretary 
determines under section 505E that the drug is a qualified infectious 
disease product''.

SEC. 7. STUDY ON INCENTIVES FOR QUALIFIED INFECTIOUS DISEASE BIOLOGICAL 
              PRODUCTS.

    (a) In General.--The Comptroller General of the United States 
shall--
            (1) conduct a study on the need for incentives to encourage 
        the research, development, and marketing of qualified 
        infectious disease biological products; and
            (2) not later than 1 year after the date of the enactment 
        of this Act, submit a report to the Congress on the results of 
        such study, including any recommendations of the Comptroller 
        General on appropriate incentives for addressing such need.
    (b) Definitions.--In this section:
            (1) The term ``biological product'' has the meaning given 
        to such term in section 351 of the Public Health Service Act 
        (42 U.S.C. 262).
            (2) The term ``qualified infectious disease biological 
        product'' means a biological product for treating, detecting, 
        preventing, or identifying a qualifying pathogen.
            (3) The term ``qualifying pathogen'' has the meaning given 
        to such term in section 505E of the Federal Food, Drug, and 
        Cosmetic Act, as added by section 3 of this Act.

SEC. 8. CLINICAL TRIALS.

    (a) Review and Revision of Guidelines.--
            (1) In general.--Not later than 1 year after the date of 
        the enactment of this Act, and not later than 4 years 
        thereafter, the Secretary shall--
                    (A) review the guidelines of the Food and Drug 
                Administration for the conduct of clinical trials with 
                respect to antibiotic drugs; and
                    (B) as appropriate, revise such guidelines to 
                reflect developments in scientific and medical 
                information and technology and to ensure clarity 
                regarding the procedures and requirements for approval 
                of an antibiotic drug under chapter V of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.).
            (2) Issues for review.--At a minimum, the review under 
        paragraph (1) shall address the appropriate animal models of 
        infection, in vitro techniques, valid micro-biological 
        surrogate markers, the use of non-inferiority versus 
        superiority trials, and appropriate delta values for non-
        inferiority trials.
            (3) Rule of construction.--Except to the extent to which 
        the Secretary of Health and Human Services makes revisions 
        under paragraph (1)(B), nothing in this section shall be 
        construed to repeal or otherwise affect the guidelines of the 
        Food and Drug Administration.
    (b) Recommendations for Investigations.--
            (1) Request.--The sponsor of a drug intended to be used to 
        treat, detect, prevent, or identify a qualifying pathogen may 
        request that the Secretary provide written recommendations for 
        nonclinical and clinical investigations which may be conducted 
        with the drug before it may be approved for such use under 
        section 505 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355).
            (2) Recommendations.--If the Secretary has reason to 
        believe that a drug for which a request is made under this 
        subsection is a qualified infections disease product, the 
        Secretary shall provide the person making the request written 
        recommendations for the nonclinical and clinical investigations 
        which the Secretary believes, on the basis of information 
        available to the Secretary at the time of the request, would be 
        necessary for approval under section 505 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 355) of such drug for the use 
        described in paragraph (1).
    (c) Definitions.--In this section:
            (1) The term ``drug'' has the meaning given to such term in 
        section 201 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321).
            (2) The term ``qualifying pathogen'' has the meaning given 
        to such term in section 505E of the Federal Food, Drug, and 
        Cosmetic Act, as added by section 3 of this Act.
            (3) The term ``Secretary'' means the Secretary of Health 
        and Human Services, acting through the Commissioner of Food and 
        Drugs.

Summary: Generating Antibiotic Incentives Now Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to extend the exclusivity period for a new prescription drug by five years for a drug that the Secretary of Health and Human Services (HHS) determines to be a qualified infectious disease product. Defines "qualified infectious disease product" to mean an antibiotic drug for treating, detecting, preventing, or identifying a qualifying pathogen (certain pathogens that are resistant to antibiotics). Excludes drugs that are: (1) a supplement to a new drug application for which an extension is in effect or has expired; or (2) a subsequent application for a change that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device or strength, or a modification to the structure of the product that does not result in a change in safety or effectiveness.

Extends such period of exclusivity an additional six months for a sponsor or manufacturer of a qualified infectious disease product that identifies a companion diagnostic test.

Requires the Secretary to give priority review to any drug determined to be a qualified infectious disease product.

Includes qualified infectious disease products as fast track products for which the Secretary shall facilitate development and expedite review.

Directs the Comptroller General to study the need for incentives to encourage the research, development, and marketing of qualified infectious disease biological products.

Requires the Secretary to: (1) review Food and Drug Administration (FDA) guidelines for clinical trials of antibiotic drugs; and (2) revise such guidelines, as appropriate, to reflect developments in scientific and medical information and technology and to ensure clarity regarding the procedures and requirements for approval of an antibiotic drug.