Food and Drug Amendments of 2022

openUnited States· United States Congress· EN

Introduced

6 May 2022

Last action

9 June 2022 · Introduced

Status

Received in the Senate.

Summary

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. 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.

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Timeline

6 May 2022
Introduced
Referred to the House Committee on Energy and Commerce.
Source: IntroReferral
6 May 2022
Introduced
Introduced in House
Source: IntroReferral
6 May 2022
Introduced
Introduced in House
Source: IntroReferral
9 May 2022
Referred
Referred to the Subcommittee on Health.
Source: Committee
11 May 2022
Vote
Forwarded by Subcommittee to Full Committee (Amended) by the Yeas and Nays: 30 - 0 .
Source: Committee
11 May 2022
Committee
Subcommittee Consideration and Mark-up Session Held.
Source: Committee
18 May 2022
Vote
Ordered to be Reported (Amended) by the Yeas and Nays: 55 - 0.
Source: Committee
18 May 2022
Committee
Committee Consideration and Mark-up Session Held.
Source: Committee
7 June 2022
Vote
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.
Source: Floor
7 June 2022
Floor
DEBATE - The House proceeded with forty minutes of debate on H.R. 7667.
Source: Floor
7 June 2022
Floor
Considered under suspension of the rules. (consideration: CR H5298-5321)
Source: Floor
7 June 2022
Floor
Mr. Pallone moved to suspend the rules and pass the bill, as amended.
Source: Floor
7 June 2022
Calendars
Placed on the Union Calendar, Calendar No. 262.
Source: Calendars
7 June 2022
Reported
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-348.
Source: Committee
7 June 2022
Reported
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-348.
Source: Committee
8 June 2022
Passed
Motion to reconsider laid on the table Agreed to without objection.
Source: Floor
8 June 2022
Vote
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)
Source: Floor
8 June 2022
Vote
Passed/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).
Source: Floor
8 June 2022
Floor
Considered as unfinished business. (consideration: CR H5402-5403)
Source: Floor
9 June 2022
Introduced
Received in the Senate.
Source: IntroReferral

Votes

9 June 2022 · passed · On Motion to Suspend the Rules and Pass, as Amended · Passed · Official source

Yes 392 · No 28 · Abstain — · Absent/not voting 7

Showing the first 4 recorded positions. Vote totals above are complete.

Versions

Received in Senate · 9 June 2022 · Download file
Engrossed in House · 8 June 2022 · Download file
Reported in House · 7 June 2022 · Download file
Introduced in House · 6 May 2022 · Download file

Documents

11 official files

Received in Senate (text)

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Received in Senate (text)
Received in Senate · EN · 9 June 2022
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Received in Senate (PDF)
Received in Senate · EN · 9 June 2022
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Engrossed in House (text)
Engrossed in House · EN · 8 June 2022
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Engrossed in House (PDF)
Engrossed in House · EN · 8 June 2022
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Passed House
summary · EN · 8 June 2022
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Reported in House (text)
Reported in House · EN · 7 June 2022
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Reported in House (PDF)
Reported in House · EN · 7 June 2022
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Reported to House
summary · EN · 7 June 2022
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Introduced in House (text)
Introduced in House · EN · 6 May 2022
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Introduced in House (PDF)
Introduced in House · EN · 6 May 2022
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Introduced in House
summary · EN · 6 May 2022
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Related records

related to → FDA Modernization Act of 2021
related to → Helping Experts Accelerate Rare Treatments Act of 2022
related to → 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.
related to → INSPECTIONS Act
related to → Increasing Transparency in Generic Drug Applications Act of 2022
related to → Biologics Market Transparency Act of 2022
related to → PATCH Act of 2022
related to → 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.
related to ← Biologics Market Transparency Act of 2022
related to ← Increasing Transparency in Generic Drug Applications Act
related to ← CLEAR Act
related to ← Enhanced Access to Affordable Medicines Act of 2022
related to ← FDASRA Act of 2022
related to ← Pre-Approval Information Exchange Act of 2022

Showing 14 of 20 related records.

Sources

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Official source: https://www.congress.gov/bill/117th-congress/house-bill/7667
Open data entity: https://api.congress.gov/v3/bill/117/hr/7667
us · 117-hr-7667 · source updated 7 April 2025