S. 3478Senate117th Congress (2021-2023)In Committee

GAIN TOOLS Act of 2022

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Updated February 8, 2026 at 8:48 AM UTC

The GAIN TOOLS Act of 2022 expands the definition of “qualified infectious disease product” to include certain biological products, not just drugs. By doing so, it allows these biologics to qualify for incentives such as priority review, helping bring new treatments for serious bacterial or fungal infections to market faster. The changes affect manufacturers of antibacterial, antifungal drugs and relevant biologics intended for serious or life‑threatening infections.

Key Provisions

Amends the Federal Food, Drug, and Cosmetic Act to add a new category (paragraph 4) allowing applications for biological products under the Public Health Service Act to be considered qualified infectious disease products.
Redefines “qualified infectious disease product” to cover both antibacterial/antifungal drugs and biological products that act directly on bacteria, fungi, or their substances, intended for serious or life‑threatening infections, including resistant or emerging pathogens.
Extends the priority‑review provision to these newly qualified biological products, inserting language that the review applies to products requiring clinical data beyond bioavailability studies.

Legislative Activity

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1 earlier action

SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

January 11, 2022

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SenateIntro Referral

Introduced in Senate

January 11, 2022

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

January 11, 2022

Bill Text

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Introduced in SenateIssued January 11, 2022

117th CONGRESS

2d Session

S. 3478

IN THE SENATE OF THE UNITED STATES

January 11 (legislative day, January 10), 2022

Mr. Casey (for himself, Mr. Cassidy, and Mr. Murphy) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

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

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.

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.