Legis Daily

GAIN TOOLS Act of 2022

USA117th CongressS-3478| Senate 
| Updated: 1/11/2022
Robert P. Casey

Robert P. Casey

Democratic Senator

Pennsylvania

Cosponsors (2)
Bill Cassidy (Republican)Christopher Murphy (Democratic)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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.
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Timeline
Jan 11, 2022
Introduced in Senate
Jan 11, 2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • January 11, 2022
    Introduced in Senate


  • January 11, 2022
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Related Bills

  • HR 117-7667: Food and Drug Amendments of 2022

GAIN TOOLS Act of 2022

USA117th CongressS-3478| Senate 
| Updated: 1/11/2022
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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Jan 11, 2022
Introduced in Senate
Jan 11, 2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • January 11, 2022
    Introduced in Senate


  • January 11, 2022
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Robert P. Casey

Robert P. Casey

Democratic Senator

Pennsylvania

Cosponsors (2)
Bill Cassidy (Republican)Christopher Murphy (Democratic)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • HR 117-7667: Food and Drug Amendments of 2022
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted