US HR7667

Bill

Biosimilar User Fee Amendments of 2022 Generic Drug User Fee Amendments of 2022 Prescription Drug User Fee Amendments of 2022 Medical Device User Fee Amendments of 2022

Introduced
05/06/2022

In Committee
05/18/2022

Crossed Over
06/09/2022

Passed

Dead
01/03/2023

Introduced Session

117th Congress

Bill Summary

AN ACT To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar bio- logical products, and for other purposes.

AI Summary

This bill: This bill amends various provisions of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to reauthorize and modify the prescription drug, medical device, generic drug, and biosimilar biological product user fee programs. It also includes provisions to improve diversity in clinical studies, enhance access to affordable medicines, support research and development, and make various regulatory improvements related to transparency, program integrity, and inspections. The bill aims to expedite the drug development and review process, ensure product safety and effectiveness, and facilitate access to affordable medicines.

Committee Categories

Business and Industry, Health and Social Services

Sponsors (4)

Anna Eshoo (D)*, Brett Guthrie (R), Cathy McMorris Rodgers (R), Frank Pallone (D),

Last Action

Received in the Senate. (on 06/09/2022)

Official Document

https://www.congress.gov/bill/117th-congress/house-bill/7667/all-info

(21 Companion Bills)

Version:

Document Type	Source Location
State Bill Page	https://www.congress.gov/bill/117th-congress/house-bill/7667/all-info
BillText	https://www.congress.gov/117/bills/hr7667/BILLS-117hr7667eh.pdf
Bill	https://www.congress.gov/117/bills/hr7667/BILLS-117hr7667eh.pdf.pdf
BillText	https://www.congress.gov/117/bills/hr7667/BILLS-117hr7667rh.pdf
Bill	https://www.congress.gov/117/bills/hr7667/BILLS-117hr7667rh.pdf.pdf
BillText	https://www.congress.gov/117/bills/hr7667/BILLS-117hr7667ih.pdf
Bill	https://www.congress.gov/117/bills/hr7667/BILLS-117hr7667ih.pdf.pdf

Bill	Bill Name	Last Action	Type
HR2565	FDA Modernization Act of 2021	Referred to the Subcommittee on Health.	Related
HR6888	Helping Experts Accelerate Rare Treatments Act of 2022	Referred to the Subcommittee on Health.	Related
HR6980	To direct the Secretary of Health and Human Services to conduct a pilot program under which the Secretary increases the conduct of unannounced inspections of foreign human drug establishments and evaluates the differences between inspections of domestic and foreign human drug establishments, including the impact of announcing inspections to persons who own or operate foreign human drug establishments in advance of an inspection.	Referred to the Subcommittee on Health.	Related
HR6988	Drug Manufacturing Innovation Act of 2022	Referred to the Subcommittee on Health.	Related
HR7006	INSPECTIONS Act Improving the Nation’s Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act	Referred to the Subcommittee on Health.	Related
HR7032	Increasing Transparency in Generic Drug Applications Act of 2022	Referred to the Subcommittee on Health.	Related
HR7035	Biologics Market Transparency Act of 2022	Referred to the Subcommittee on Health.	Related
HR7084	PATCH Act of 2022 Protecting and Transforming Cyber Health Care Act of 2022	Referred to the Subcommittee on Health.	Related
HR7649	To direct the Secretary of Health and Human Services to open a public docket for the submission of public comments regarding factors that should be taken into consideration when reviewing a proposed modification to an approved risk evaluation and mitigation strategy, and for other purposes.	Referred to the House Committee on Energy and Commerce.	Related
HR7658	To amend the Federal Food, Drug, and Cosmetic Act to reauthorize the Critical Path Public-Private Partnerships.	Referred to the House Committee on Energy and Commerce.	Related
HR7679	To amend the Federal Food, Drug, and Cosmetic Act to reauthorize the authority to grant certain exemptions, and for other purposes.	Referred to the House Committee on Energy and Commerce.	Related
HR9297	Pre-Approval Information Exchange Act of 2022	Referred to the Subcommittee on Health.	Related
S2952	FDA Modernization Act of 2021	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.	Related
S3478	GAIN TOOLS Act of 2022 Generating Antibiotic Incentives Now Through Opening Opportunities to Leverage Science Act of 2022	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.	Related
S3983	PATCH Act	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.	Related
S4152	A bill to amend the Federal Food, Drug, and Cosmetic Act to reauthorize the Critical Path Public-Private Partnerships.	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.	Related
S4302	Biologics Market Transparency Act of 2022	Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S2709)	Related
S4333	CLEAR Act Consistent Legal Evaluation And Regulation of Medical Products Act	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.	Related
S4338	Increasing Transparency in Generic Drug Applications Act	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.	Related
S4351	Enhanced Access to Affordable Medicines Act of 2022	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.	Related
S4535	FDASRA Act of 2022 Food and Drug Administration Simple Reauthorization Act of 2022 Biosimilar User Fee Amendments of 2022 Generic Drug User Fee Amendments of 2022 Medical Device User Fee Amendments of 2022 Prescription Drug User Fee Amendments of 2022	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.	Related

Bill

Bill Name

Last Action

Type

HR2565

FDA Modernization Act of 2021

Referred to the Subcommittee on Health.

HR6888

Helping Experts Accelerate Rare Treatments Act of 2022

Referred to the Subcommittee on Health.

HR6980

To direct the Secretary of Health and Human Services to conduct a pilot program under which the Secretary increases the conduct of unannounced inspections of foreign human drug establishments and evaluates the differences between inspections of domestic and foreign human drug establishments, including the impact of announcing inspections to persons who own or operate foreign human drug establishments in advance of an inspection.

Referred to the Subcommittee on Health.

HR6988

Drug Manufacturing Innovation Act of 2022

Referred to the Subcommittee on Health.

HR7006

INSPECTIONS Act Improving the Nation’s Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act

Referred to the Subcommittee on Health.

HR7032

Increasing Transparency in Generic Drug Applications Act of 2022

Referred to the Subcommittee on Health.

HR7035

Biologics Market Transparency Act of 2022

Referred to the Subcommittee on Health.

HR7084

PATCH Act of 2022 Protecting and Transforming Cyber Health Care Act of 2022

Referred to the Subcommittee on Health.

HR7649

To direct the Secretary of Health and Human Services to open a public docket for the submission of public comments regarding factors that should be taken into consideration when reviewing a proposed modification to an approved risk evaluation and mitigation strategy, and for other purposes.

Referred to the House Committee on Energy and Commerce.

HR7658

To amend the Federal Food, Drug, and Cosmetic Act to reauthorize the Critical Path Public-Private Partnerships.

Referred to the House Committee on Energy and Commerce.

HR7679

To amend the Federal Food, Drug, and Cosmetic Act to reauthorize the authority to grant certain exemptions, and for other purposes.

Referred to the House Committee on Energy and Commerce.

HR9297

Pre-Approval Information Exchange Act of 2022

Referred to the Subcommittee on Health.

S2952

FDA Modernization Act of 2021

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

S3478

GAIN TOOLS Act of 2022 Generating Antibiotic Incentives Now Through Opening Opportunities to Leverage Science Act of 2022

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

S3983

PATCH Act

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

S4152

A bill to amend the Federal Food, Drug, and Cosmetic Act to reauthorize the Critical Path Public-Private Partnerships.

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

S4302

Biologics Market Transparency Act of 2022

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S2709)

S4333

CLEAR Act Consistent Legal Evaluation And Regulation of Medical Products Act

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

S4338

Increasing Transparency in Generic Drug Applications Act

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

S4351

Enhanced Access to Affordable Medicines Act of 2022

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

S4535

FDASRA Act of 2022 Food and Drug Administration Simple Reauthorization Act of 2022 Biosimilar User Fee Amendments of 2022 Generic Drug User Fee Amendments of 2022 Medical Device User Fee Amendments of 2022 Prescription Drug User Fee Amendments of 2022

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

Bill > HR7667

summary

Introduced Session

Bill Summary

AI Summary

Committee Categories

Sponsors (4)

Last Action

Official Document

bill text

bill summary

bill summary

bill summary