Food and Drug Amendments of 2022
- Introduced May 6
- Committee May 6
- Passed House Jun 8
- Passed Senate Next
- To President Not yet
- Law Not yet
Where it stands
Passed House, Jun 8, 2022Next: Senate vote
1602d ago Jun 9, 2022: Received in the Senate.
Final votes
House 392-28
1 roll call on this bill
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Votes
House roll 254
On Motion to Suspend the Rules and Pass, as Amended
R 176-28 D 216-0
392-28
Passed
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Summary
Food and Drug Amendments of 2022
Full summary5 paragraphs
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.
Library of Congress summary, Jun 8, 2022
Summary versions
- Passed HouseJun 8, 2022
- Reported to HouseJun 7, 2022
- Introduced in HouseMay 6, 2022
Actions
- SenateReceived in the Senate.Jun 9, 2022
- HouseMotion to reconsider laid on the table Agreed to without objection.Jun 8, 2022
- HouseOn 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
- HouseConsidered as unfinished business. (consideration: CR H5402-5403)Jun 8, 2022
- HouseAt 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
- HouseDEBATE - The House proceeded with forty minutes of debate on H.R. 7667.Jun 7, 2022
- HouseConsidered under suspension of the rules. (consideration: CR H5298-5321)Jun 7, 2022
- HouseMr. Pallone moved to suspend the rules and pass the bill, as amended.Jun 7, 2022
- HouseReported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-348.Jun 7, 2022
- HousePlaced on the Union Calendar, Calendar No. 262.Jun 7, 2022
- HouseCommittee Consideration and Mark-up Session Held.May 18, 2022
- HouseOrdered to be Reported (Amended) by the Yeas and Nays: 55 - 0.May 18, 2022
All actions17
- HouseSubcommittee Consideration and Mark-up Session Held.May 11, 2022
- HouseForwarded by Subcommittee to Full Committee (Amended) by the Yeas and Nays: 30 - 0 .May 11, 2022
- HouseReferred to the Subcommittee on Health.May 9, 2022
- HouseIntroduced in HouseMay 6, 2022
- HouseReferred to the House Committee on Energy and Commerce.May 6, 2022
Bill record
Text versions4
- Received in SenateJun 9, 2022PDF: Received in Senate
- Engrossed in HouseJun 8, 2022PDF: Engrossed in House
- Reported in HouseJun 7, 2022PDF: Reported in House
- Introduced in HouseMay 6, 2022PDF: Introduced in House
Committees1
- House Energy and Commerce CommitteeReported By Jun 7, 2022Markup By, May 18, 2022Referred To, May 6, 2022
- Subcommittee: Health SubcommitteeReported by
Sponsor and cosponsors3 cosponsors
- Rep. ANNA ESHOO (D-CA-18)Sponsor, May 6, 2022
- Brett Guthrie (R-KY-2)OriginalJoined May 6, 2022
- Cathy Rodgers (R-WA-5)OriginalJoined May 6, 2022
- FRANK PALLONE (D-NJ-6)OriginalJoined May 6, 2022
Amendments0
No amendments offered
Cost estimates and reports2
- CBO: Estimated Budgetary Effects of H.R. 7667, the Food and Drug Amendments of 2022 ActJun 6, 2022As Posted on the Website of the Clerk of the House on June 3, 2022
- H. Rept. 117-348Committee report
Titles6
Short titles
- Food and Drug Amendments of 2022Short Title(s) as Passed House
- Biosimilar User Fee Amendments of 2022Short Title(s) as Passed House for portions of this bill
- Generic Drug User Fee Amendments of 2022Short Title(s) as Passed House for portions of this bill
- Medical Device User Fee Amendments of 2022Short Title(s) as Passed House for portions of this bill
- Prescription Drug User Fee Amendments of 2022Short Title(s) as Passed House for portions of this bill
Official titles
- 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.Official Title as Introduced
Subjects45
Policy area
Legislative subjects
Advanced technology and technological innovationsAdvisory bodiesAnimal protection and human-animal relationshipsBlood and blood diseasesBusiness recordsCardiovascular and respiratory healthChild healthComputer security and identity theftCongressional oversightCriminal investigation, prosecution, interrogationDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationEmergency medical services and trauma careEmployee hiringEvidence and witnessesExecutive agency funding and structureFood and Drug Administration (FDA)GeneticsGovernment employee pay, benefits, personnel managementGovernment information and archivesGovernment studies and investigationsHealth care coverage and accessHealth programs administration and fundingHealth technology, devices, suppliesIndustrial facilitiesInfectious and parasitic diseasesInflation and pricesLicensing and registrationsManufacturingMarketing and advertisingMedical researchMinority healthMusculoskeletal and skin diseasesOrgan and tissue donation and transplantationPerformance measurementPhotography and imagingPrescription drugsProduct development and innovationPublic participation and lobbyingPublic-private cooperationRadiationResearch and developmentSmall businessUser charges and fees
Related bills20
- H.R. 2565 117th, Related bill FDA Modernization Act of 2021
- H.R. 6888 117th, Related bill Helping Experts Accelerate Rare Treatments Act of 2022
- H.R. 6980 117th, Related bill 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.
- H.R. 7006 117th, Related bill INSPECTIONS Act
- H.R. 7032 117th, Related bill Increasing Transparency in Generic Drug Applications Act of 2022
- H.R. 7035 117th, Related bill Biologics Market Transparency Act of 2022
- H.R. 7084 117th, Related bill PATCH Act of 2022
- H.R. 7649 117th, Related bill 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.
- H.R. 7658 117th, Related bill To amend the Federal Food, Drug, and Cosmetic Act to reauthorize the Critical Path Public-Private Partnerships.
- S. 2952 117th, Related bill FDA Modernization Act of 2021
- S. 3983 117th, Related bill PATCH Act
- S. 4152 117th, Related bill A bill to amend the Federal Food, Drug, and Cosmetic Act to reauthorize the Critical Path Public-Private Partnerships.
- S. 3478 117th, Related bill GAIN TOOLS Act of 2022
- H.R. 6988 117th, Related bill Drug Manufacturing Innovation Act of 2022
- S. 4351 117th, Related bill Enhanced Access to Affordable Medicines Act of 2022
- S. 4302 117th, Related bill Biologics Market Transparency Act of 2022
- S. 4333 117th, Related bill CLEAR Act
- S. 4338 117th, Related bill Increasing Transparency in Generic Drug Applications Act
- S. 4535 117th, Related bill FDASRA Act of 2022
- H.R. 9297 117th, Related bill Pre-Approval Information Exchange Act of 2022
Official record from Congress.gov, the House Clerk and the Senate; lobbying from Lobbying Disclosure Act filings. Updated Oct 27, 2026.