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 2010''.

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.
Sec. 4. Priority review.
Sec. 5. Fast track product.
Sec. 6. Clinical trials.

SEC. 3. EXTENSION OF EXCLUSIVITY PERIOD.

    (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 or licensure of a drug or 
biological product pursuant to an application that is submitted under 
section 505(b) of this Act or section 351(a) of the Public Health 
Service Act, the Secretary determines that the drug or biological 
product is a qualified infectious disease product, then the exclusivity 
period for such qualified infectious disease product is deemed to be 
extended by 5 years.
    ``(b) Limited to First Licensure.--Subsection (a) does not apply to 
the approval or licensure of--
            ``(1) a supplement for the qualified infectious disease 
        product; or
            ``(2) a subsequent application filed by the same sponsor or 
        manufacturer of the qualified infectious disease product (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--
                            ``(i) safety or effectiveness in the case 
                        of a drug; or
                            ``(ii) safety, purity, or potency in the 
                        case of a biological product.
    ``(c) Determination.--At the request of any person submitting an 
application described in subsection (a), the Secretary shall, not later 
than 30 days after the submission of such request and prior to approval 
of the application, determine whether the drug or biological product is 
a qualified infectious disease product.
    ``(d) 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 such date of enactment.
    ``(e) Definitions.--In this section:
            ``(1) Exclusivity period.--The term `exclusivity period' 
        means, with respect to a qualified infectious disease product 
        approved or licensed under section 505 of this Act or section 
        351 of the Public Health Service Act, the period of time (as 
        extended under section 505A or 527 of this Act or section 
        351(m) of the Public Health Service Act) during which such 
        section 505 or 351 prohibit the Secretary from making effective 
        the approval of another application under such section 505 or 
        351 for such product for a person who is not the holder of such 
        approved application or of such approved license.
            ``(2) Qualified infectious disease product.--The term 
        `qualified infectious disease product' means an antibiotic 
        drug, or a diagnostic test including a point-of-care diagnostic 
        test, for treating, detecting, preventing, or identifying a 
        qualifying pathogen.
            ``(3) 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, in 
                concurrence with infectious disease clinicians and 
                appropriate professional associations, as a significant 
                threat to public health because of drug resistance or 
                other factors (or likely to become such a threat).''.
    (b) Application.--Section 505E of the Federal Food, Drug, and 
Cosmetic Act, as added by subsection (a), shall apply with respect to 
any drug or biological product that is first approved or licensed under 
section 505 of such Act (21 U.S.C. 355) or section 351 of the Public 
Health Service Act (42 U.S.C. 262) on or after the date of the 
enactment of this Act.

SEC. 4. 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 determines under section 505E 
that a drug is a qualified infectious disease product, the Secretary 
shall give priority review to the application for approval or licensure 
of such product submitted under section 505(b) of this Act or section 
351(a) of the Public Health Service Act.
    ``(b) Definition.--In this section, the term `priority review', 
with respect to an application described in subsection (b), 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), shall apply with respect to 
an application that is submitted under section 505(b) of such Act (21 
U.S.C. 355(b)) or section 351(a) of the Public Health Service Act (42 
U.S.C. 262(a)) on or after the date of the enactment of this Act.

SEC. 5. 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. 6. 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.) or 
                section 351 of the Public Health Service Act (42 U.S.C. 
                262).
            (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) Reports to congress.--Not later than 1 year after the 
        date of the enactment of this Act, and annually thereafter for 
        the next 4 years, the Secretary shall submit a report to the 
        Congress on the progress of the review under paragraph (1).
            (4) 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--
                    (A) it may be approved for such use under section 
                505 of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 355); or
                    (B) if the drug is a biological product, it may be 
                licensed for such use under section 351 of the Public 
                Health Service Act.
            (2) Recommendations.--If the Secretary has reason to 
        believe that a drug for which a request is made under this 
        subsection is a qualified infectious 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--
                    (A) 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); or
                    (B) licensing under section 351 of the Public 
                Health Service Act (42 U.S.C. 262) of such drug for 
                such use.
    (c) 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 ``drug'' has the meaning given to such term in 
        section 201 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321).
            (3) The term ``qualifying pathogen'' has the meaning given 
        such term in section 505E of the Federal Food, Drug, and 
        Cosmetic Act, as added by section 3.
            (4) 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 2010 - Amends the Federal Food, Drug, and Cosmetic Act to: (1) extend for five years the exclusivity period for the first licensure of a qualified infectious disease product. (2) grant priority review to an application for approval or licensure of a qualified infectious disease product. And (3) deem a qualified infectious disease product as a fast track product, for review and approval purposes. Defines qualified infectious disease product as an antibiotic drug, or a diagnostic test including a point-of-care diagnostic test, for treating, detecting, preventing, or identifying a qualifying pathogen. Requires the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs, to review the guidelines of the Food and Drug Administration (FDA) for the conduct of clinical trials for antibiotic drugs and revise such guidelines to reflect developments in medical information and technology. Allows the sponsor of a drug intended to be used to treat, detect, prevent, or identify a qualifying pathogen, as defined by this Act, to request that the Secretary provide written recommendations for nonclinical and clinical investigations before such drug may be approved for use or licensed.