Health Subcommittee, Energy and Commerce Committee
Introduced
In Committee
On Floor
Passed Chamber
Enacted
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
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Forwarded by Subcommittee to Full Committee (Amended) by the Yeas and Nays: 30 - 0 .
Subcommittee Consideration and Mark-up Session Held.
Ordered to be Reported (Amended) by the Yeas and Nays: 55 - 0.
Committee Consideration and Mark-up Session Held.
Placed on the Union Calendar, Calendar No. 262.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-348.
Mr. Pallone moved to suspend the rules and pass the bill, as amended.
Considered under suspension of the rules. (consideration: CR H5298-5321)
DEBATE - The House proceeded with forty minutes of debate on H.R. 7667.
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.
Considered as unfinished business. (consideration: CR H5402-5403)
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)
Motion to reconsider laid on the table Agreed to without objection.
Received in the Senate.
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Forwarded by Subcommittee to Full Committee (Amended) by the Yeas and Nays: 30 - 0 .
Subcommittee Consideration and Mark-up Session Held.
Ordered to be Reported (Amended) by the Yeas and Nays: 55 - 0.
Committee Consideration and Mark-up Session Held.
Placed on the Union Calendar, Calendar No. 262.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-348.
Mr. Pallone moved to suspend the rules and pass the bill, as amended.
Considered under suspension of the rules. (consideration: CR H5298-5321)
DEBATE - The House proceeded with forty minutes of debate on H.R. 7667.
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.
Considered as unfinished business. (consideration: CR H5402-5403)
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)
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
Food and Drug Amendments of 2022
USA117th CongressHR-7667| House
| Updated: 6/9/2022
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. 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.
Get AI-generated questions to help you understand this bill better
Timeline
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Forwarded by Subcommittee to Full Committee (Amended) by the Yeas and Nays: 30 - 0 .
Subcommittee Consideration and Mark-up Session Held.
Ordered to be Reported (Amended) by the Yeas and Nays: 55 - 0.
Committee Consideration and Mark-up Session Held.
Placed on the Union Calendar, Calendar No. 262.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-348.
Mr. Pallone moved to suspend the rules and pass the bill, as amended.
Considered under suspension of the rules. (consideration: CR H5298-5321)
DEBATE - The House proceeded with forty minutes of debate on H.R. 7667.
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.
Considered as unfinished business. (consideration: CR H5402-5403)
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)
Motion to reconsider laid on the table Agreed to without objection.
Received in the Senate.
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Forwarded by Subcommittee to Full Committee (Amended) by the Yeas and Nays: 30 - 0 .
Subcommittee Consideration and Mark-up Session Held.
Ordered to be Reported (Amended) by the Yeas and Nays: 55 - 0.
Committee Consideration and Mark-up Session Held.
Placed on the Union Calendar, Calendar No. 262.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-348.
Mr. Pallone moved to suspend the rules and pass the bill, as amended.
Considered under suspension of the rules. (consideration: CR H5298-5321)
DEBATE - The House proceeded with forty minutes of debate on H.R. 7667.
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.
Considered as unfinished business. (consideration: CR H5402-5403)
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)
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