GAIN TOOLS Act of 2022
Bill: S.3478 | Sponsor: Sen. Casey, Robert P., Jr. (D-PA)
Policy area: Health

Summary:
Generating Antibiotic Incentives Now Through Opening Opportunities to Leverage Science Act of 2022 or the GAIN TOOLS Act of 2022
This bill expands the definition of a qualified infectious disease product (QIDP) to include eligible biological products. Under current law, the first application (or supplement) for a specific product and indication to be designated a QIDP shall receive priority review for market approval by the Food and Drug Administration.
Generally, a biological product designated as a QIDP is one that acts on bacteria or fungi and is intended to treat a serious or life-threatening infection.
However, a biological product with a QIDP designation shall not receive the market exclusivity extension currently available to drugs that receive the designation.

To provide for the designation of biological products as qualified 
                      infectious disease products.

    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 ``Generating Antibiotic Incentives Now 
Through Opening Opportunities to Leverage Science Act of 2022'' or the 
``GAIN TOOLS Act of 2022''.

SEC. 2. EXPANDING QUALIFIED INFECTIOUS DISEASE PRODUCTS TO INCLUDE 
              BIOLOGICAL PRODUCTS.

    (a) In General.--Section 505E of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355f) is amended--
            (1) in subsection (c)--
                    (A) in paragraph (2), by striking ``; or'' and 
                inserting ``;'';
                    (B) in paragraph (3), by striking the period and 
                inserting ``; or''; and
                    (C) by adding at the end the following:
            ``(4) an application pursuant to section 351(a) of the 
        Public Health Service Act.'';
            (2) in subsection (d)(1), by inserting ``of this Act or 
        section 351(a) of the Public Health Service Act'' after 
        ``section 505(b)''; and
            (3) by amending subsection (g) to read as follows:
    ``(g) Qualified Infectious Disease Product.--The term `qualified 
infectious disease product' means a drug or biological product for 
human use that--
            ``(1) is--
                    ``(A) an antibacterial or antifungal drug; or
                    ``(B) a biological product that acts directly on 
                bacteria or fungi or on substances produced by such 
                bacteria or fungi; and
            ``(2) is intended to treat a serious or life-threatening 
        infection, including such an infection caused by--
                    ``(A) an antibacterial or antifungal resistant 
                pathogen, including novel or emerging infectious 
                pathogens; or
                    ``(B) qualifying pathogens listed by the Secretary 
                under subsection (f).''.
    (b) Priority Review.--Section 524A(a) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360n-1(a)) is amended by inserting ``of 
this Act, or section 351(a) of the Public Health Service Act, that 
requires clinical data (other than bioavailability studies) to 
demonstrate safety or effectiveness'' before the period.
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