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H.R. 7667 117th Congress House

Food and Drug Amendments of 2022

Official title: 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 biosim… Show full official titleShow less

Official title: 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 biological products, and for other purposes.

Introduced: May 6, 2022 See on congress.gov
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This bill died when the 117th Congress ended
It never became law before the 117th Congress (2021–2022) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 17 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jun 9, 2022
Received in the Senate.
Jun 8, 2022
Motion to reconsider laid on the table Agreed to without objection.
Jun 8, 2022
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)
Jun 8, 2022
Considered as unfinished business. (consideration: CR H5402-5403)
Jun 7, 2022
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.
Jun 7, 2022
DEBATE - The House proceeded with forty minutes of debate on H.R. 7667.
Jun 7, 2022
Considered under suspension of the rules. (consideration: CR H5298-5321)
Jun 7, 2022
Mr. Pallone moved to suspend the rules and pass the bill, as amended.
Jun 7, 2022
Placed on the Union Calendar, Calendar No. 262.
Jun 7, 2022
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-348.
May 18, 2022
Ordered to be Reported (Amended) by the Yeas and Nays: 55 - 0.
May 18, 2022
Committee Consideration and Mark-up Session Held.
May 11, 2022
Forwarded by Subcommittee to Full Committee (Amended) by the Yeas and Nays: 30 - 0 .
May 11, 2022
Subcommittee Consideration and Mark-up Session Held.
May 9, 2022
Referred to the Subcommittee on Health.
May 6, 2022
Referred to the House Committee on Energy and Commerce.
May 6, 2022
Introduced in House
 Votes taken on this bill 1
DateChamberWhat was voted onResultYes–No
Jun 8, 2022 House · vote #254 On Motion to Suspend the Rules and Pass, as Amended Passed 392–28 See who voted →
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 Latest action June 9, 2022

Received in the Senate.

 Plain-English summary Congressional Research Service

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.

 Related & companion bills 20
  • HR 2565 FDA Modernization Act of 2021
  • HR 6888 Helping Experts Accelerate Rare Treatments Act of 2022
  • HR 6980 To direct the Secretary of Health and Human Services to conduct a pilot program under which the Secretary increases the…
  • HR 7006 INSPECTIONS Act
  • HR 7032 Increasing Transparency in Generic Drug Applications Act of 2022
  • HR 7035 Biologics Market Transparency Act of 2022
  • HR 7084 PATCH Act of 2022
  • HR 7649 To direct the Secretary of Health and Human Services to open a public docket for the submission of public comments rega…
  • HR 7658 To amend the Federal Food, Drug, and Cosmetic Act to reauthorize the Critical Path Public-Private Partnerships.
  • S 2952 FDA Modernization Act of 2021
Show all 20 related billsShow fewer related bills
  • S 3983 PATCH Act
  • S 4152 A bill to amend the Federal Food, Drug, and Cosmetic Act to reauthorize the Critical Path Public-Private Partnerships.
  • S 3478 GAIN TOOLS Act of 2022
  • HR 6988 Drug Manufacturing Innovation Act of 2022
  • S 4351 Enhanced Access to Affordable Medicines Act of 2022
  • S 4302 Biologics Market Transparency Act of 2022
  • S 4333 CLEAR Act
  • S 4338 Increasing Transparency in Generic Drug Applications Act
  • S 4535 FDASRA Act of 2022
  • HR 9297 Pre-Approval Information Exchange Act of 2022
 Bill text 4 versions

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Cosponsors 3
All 3 Democratic 1 Republican 1
R
Guthrie, Brett
Kentucky · May 6, 2022
 D
Pallone, Frank
New Jersey · May 6, 2022
Rodgers, Cathy
· May 6, 2022
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 7667: Food and Drug Amendments of 2022. 117th Congress. Open America. https://openamerica.io/bill/117-HR-7667/
MLA
"H.R. 7667: Food and Drug Amendments of 2022." 117th Congress, 2026, Open America, https://openamerica.io/bill/117-HR-7667/.
Bluebook (legal)
H.R. 7667, 117th Cong. (2026), https://openamerica.io/bill/117-HR-7667/.
Markdown link
[H.R. 7667: Food and Drug Amendments of 2022](https://openamerica.io/bill/117-HR-7667/)
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