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.
| Action Date | Type | Text | Source |
|---|---|---|---|
| 2022-01-11 | IntroReferral | Read twice and referred to the Committee on Health, Education, Labor, and Pensions. | Senate |
| 2022-01-11 | IntroReferral | Introduced in Senate | Library of Congress |