Legis Daily

FDASLA Act of 2022

USA117th CongressS-4348| Senate 
| Updated: 7/13/2022
Patty Murray

Patty Murray

Democratic Senator

Washington

Cosponsors (1)
Richard Burr (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Food and Drug Administration Safety and Landmark Advancements Act of 2022 or the FDASLA Act of 2022 This bill modifies Food and Drug Administration (FDA) authority to collect certain fees. It also expands FDA authority to regulate certain products, including cosmetics. Among other provisions, the bill reauthorizes FDA authority to collect certain fees related to drugs, medical devices, and biosimilar biological products and modifies such fees, including the base fee amounts; establishes that certain requirements related to obtaining market approval for a new drug or a biosimilar may be satisfied using alternatives to animal testing, such as in vitro tests; authorizes the FDA to require that certain drugs be dispensed with a safe disposal system even if the system does not render a drug nonretrievable (current law requires such a system to render the drug nonretrievable); establishes time lines for the FDA to respond to requests to determine whether a drug is a therapeutic equivalent to an approved drug; modifies the accelerated process for approving products for a serious or life-threatening disease or condition and establishes an intra-agency coordinating council to ensure consistent and appropriate use of the process; requires additional regulation of cosmetics, including by requiring manufacturers to register manufacturing facilities and each cosmetic product with the FDA; requires dietary supplement manufacturers to provide to the FDA certain information, including a list of all ingredients, about each dietary supplement that it markets; requires an in vitro clinical test to receive FDA premarket approval or a technology certification (or be otherwise exempted) before being introduced into interstate commerce; and requires the FDA to temporarily relax certain premarket requirements for a manufacturer that intends to market a new infant formula.

Bill Text Versions

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2 versions available

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Timeline
May 26, 2022
Introduced in Senate
May 26, 2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Jun 14, 2022
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Jul 13, 2022
Committee on Health, Education, Labor, and Pensions. Reported by Senator Murray with an amendment in the nature of a substitute. Without written report.
Jul 13, 2022
Placed on Senate Legislative Calendar under General Orders. Calendar No. 444.
  • May 26, 2022
    Introduced in Senate


  • May 26, 2022
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • June 14, 2022
    Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.


  • July 13, 2022
    Committee on Health, Education, Labor, and Pensions. Reported by Senator Murray with an amendment in the nature of a substitute. Without written report.


  • July 13, 2022
    Placed on Senate Legislative Calendar under General Orders. Calendar No. 444.

Health

Related Bills

  • S 117-4303: Interchangeable Biologics Clarity Act
  • S 117-2628: Better ODDS To Reduce Diversion Act of 2021
  • HR 117-7035: Biologics Market Transparency Act of 2022
  • HR 117-9329: Small Business Establishment Registration Waiver Act
  • S 117-4302: Biologics Market Transparency Act of 2022
  • S 117-4152: A bill to amend the Federal Food, Drug, and Cosmetic Act to reauthorize the Critical Path Public-Private Partnerships.
  • HR 117-7640: To amend the Orphan Drug Act to reauthorize a program of grants and contracts for the development of drugs for rare diseases and conditions (commonly referred to as "orphan drugs").
  • S 117-4535: FDASRA Act of 2022
  • S 117-4446: Modernizing the Accelerated Approval Pathway Act of 2022
  • HR 117-7658: To amend the Federal Food, Drug, and Cosmetic Act to reauthorize the Critical Path Public-Private Partnerships.
Administrative law and regulatory proceduresAdministrative remediesAllergiesAnimal protection and human-animal relationshipsBusiness recordsChild healthCongressional oversightCosmetics and personal careDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationDrug therapyDrug trafficking and controlled substancesEmployee hiringExecutive agency funding and structureFederal preemptionFood and Drug Administration (FDA)Food industry and servicesFood supply, safety, and labelingGovernment employee pay, benefits, personnel managementGovernment information and archivesGovernment studies and investigationsHazardous wastes and toxic substancesHealth technology, devices, suppliesHearing, speech, and vision careIndustrial facilitiesLicensing and registrationsManufacturingMedical researchMedical tests and diagnostic methodsNutrition and dietPrescription drugsProduct safety and qualityPublic-private cooperationSmall businessSolid waste and recyclingState and local government operationsUser charges and fees

FDASLA Act of 2022

USA117th CongressS-4348| Senate 
| Updated: 7/13/2022
Food and Drug Administration Safety and Landmark Advancements Act of 2022 or the FDASLA Act of 2022 This bill modifies Food and Drug Administration (FDA) authority to collect certain fees. It also expands FDA authority to regulate certain products, including cosmetics. Among other provisions, the bill reauthorizes FDA authority to collect certain fees related to drugs, medical devices, and biosimilar biological products and modifies such fees, including the base fee amounts; establishes that certain requirements related to obtaining market approval for a new drug or a biosimilar may be satisfied using alternatives to animal testing, such as in vitro tests; authorizes the FDA to require that certain drugs be dispensed with a safe disposal system even if the system does not render a drug nonretrievable (current law requires such a system to render the drug nonretrievable); establishes time lines for the FDA to respond to requests to determine whether a drug is a therapeutic equivalent to an approved drug; modifies the accelerated process for approving products for a serious or life-threatening disease or condition and establishes an intra-agency coordinating council to ensure consistent and appropriate use of the process; requires additional regulation of cosmetics, including by requiring manufacturers to register manufacturing facilities and each cosmetic product with the FDA; requires dietary supplement manufacturers to provide to the FDA certain information, including a list of all ingredients, about each dietary supplement that it markets; requires an in vitro clinical test to receive FDA premarket approval or a technology certification (or be otherwise exempted) before being introduced into interstate commerce; and requires the FDA to temporarily relax certain premarket requirements for a manufacturer that intends to market a new infant formula.

Bill Text Versions

View Text
2 versions available

Suggested Questions

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

Timeline
May 26, 2022
Introduced in Senate
May 26, 2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Jun 14, 2022
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Jul 13, 2022
Committee on Health, Education, Labor, and Pensions. Reported by Senator Murray with an amendment in the nature of a substitute. Without written report.
Jul 13, 2022
Placed on Senate Legislative Calendar under General Orders. Calendar No. 444.
  • May 26, 2022
    Introduced in Senate


  • May 26, 2022
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • June 14, 2022
    Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.


  • July 13, 2022
    Committee on Health, Education, Labor, and Pensions. Reported by Senator Murray with an amendment in the nature of a substitute. Without written report.


  • July 13, 2022
    Placed on Senate Legislative Calendar under General Orders. Calendar No. 444.
Patty Murray

Patty Murray

Democratic Senator

Washington

Cosponsors (1)
Richard Burr (Republican)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • S 117-4303: Interchangeable Biologics Clarity Act
  • S 117-2628: Better ODDS To Reduce Diversion Act of 2021
  • HR 117-7035: Biologics Market Transparency Act of 2022
  • HR 117-9329: Small Business Establishment Registration Waiver Act
  • S 117-4302: Biologics Market Transparency Act of 2022
  • S 117-4152: A bill to amend the Federal Food, Drug, and Cosmetic Act to reauthorize the Critical Path Public-Private Partnerships.
  • HR 117-7640: To amend the Orphan Drug Act to reauthorize a program of grants and contracts for the development of drugs for rare diseases and conditions (commonly referred to as "orphan drugs").
  • S 117-4535: FDASRA Act of 2022
  • S 117-4446: Modernizing the Accelerated Approval Pathway Act of 2022
  • HR 117-7658: To amend the Federal Food, Drug, and Cosmetic Act to reauthorize the Critical Path Public-Private Partnerships.
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresAdministrative remediesAllergiesAnimal protection and human-animal relationshipsBusiness recordsChild healthCongressional oversightCosmetics and personal careDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationDrug therapyDrug trafficking and controlled substancesEmployee hiringExecutive agency funding and structureFederal preemptionFood and Drug Administration (FDA)Food industry and servicesFood supply, safety, and labelingGovernment employee pay, benefits, personnel managementGovernment information and archivesGovernment studies and investigationsHazardous wastes and toxic substancesHealth technology, devices, suppliesHearing, speech, and vision careIndustrial facilitiesLicensing and registrationsManufacturingMedical researchMedical tests and diagnostic methodsNutrition and dietPrescription drugsProduct safety and qualityPublic-private cooperationSmall businessSolid waste and recyclingState and local government operationsUser charges and fees