PlainBillCongress, translated.Legislation. Context. Public interest.Congressional Research Service
Version 53 · Passed House · Jun 8, 2022
Food and Drug Amendments of 2022
This bill reauthorizes Food and Drug Administration (FDA) user fee programs for certain drugs and devices, establishes requirements to increase diversity in clinical trials, and modifies requirements relating to the overall supply chain for drugs and devices.
Specifically, the bill reauthorizes through FY2027 the FDA user fee programs for prescription drugs, medical devices, generic drugs, and biosimilars.
Showing the opening paragraphs of the official summary.
The bill also requires the development of action plans and related reporting to increase the diversity of participants in clinical trials.
In addition, the bill requires the FDA to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why).
The bill also (1) establishes requirements and reauthorizes programs to support the development of specific categories of drugs and devices (e.g., pediatric drugs) and inspections of drug manufacturing facilities; and (2) establishes and revises requirements relating to the approval of drugs and devices, including requirements for postapproval studies and guidance about using real-world evidence to support drug and device applications.
People & committees
Rep. Eshoo, Anna G. [D-CA-18] · D–CA
Legislative record
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Received in the Senate.
Motion to reconsider laid on the table Agreed to without objection.
On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 392 - 28 (Roll no. 254). (text: 06/07/2022 CR H5298-5319)
House roll call 254 · Individual votesPassed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 392 - 28 (Roll no. 254).
House roll call 254 · Individual votesConsidered as unfinished business. (consideration: CR H5402-5403)
At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed.
DEBATE - The House proceeded with forty minutes of debate on H.R. 7667.
Considered under suspension of the rules. (consideration: CR H5298-5321)
Mr. Pallone moved to suspend the rules and pass the bill, as amended.
Placed on the Union Calendar, Calendar No. 262.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-348.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-348.
Ordered to be Reported (Amended) by the Yeas and Nays: 55 - 0.
Committee Consideration and Mark-up Session Held.
Forwarded by Subcommittee to Full Committee (Amended) by the Yeas and Nays: 30 - 0 .
Subcommittee Consideration and Mark-up Session Held.
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
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Source last updated: Apr 7, 2025. Consult Congress.gov for the current record.
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Analyze H.R.7667 as objectively as possible. Explain its main provisions, who would be affected, possible benefits and harms, implementation, exceptions, and uncertainties. Present the strongest arguments for and against it, and identify evidence needed to assess its public impact.
Examine H.R.7667 through a progressive lens, focusing on fairness, access, economic inequality, and effects on vulnerable communities. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and distinguish stated goals from demonstrated outcomes.
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