Legis Daily

Food and Drug Amendments of 2022

USA117th CongressHR-7667| House 
| Updated: 6/9/2022
Anna G. Eshoo

Anna G. Eshoo

Democratic Representative

California

Cosponsors (3)
Brett Guthrie (Republican)Frank Pallone (Democratic)Cathy McMorris Rodgers (Republican)

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.

Bill Text Versions

View Text
4 versions available

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
May 6, 2022
Introduced in House
May 6, 2022
Referred to the House Committee on Energy and Commerce.
May 9, 2022
Referred to the Subcommittee on Health.
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 18, 2022
Ordered to be Reported (Amended) by the Yeas and Nays: 55 - 0.
May 18, 2022
Committee Consideration and Mark-up Session Held.
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.
Jun 7, 2022
Mr. Pallone moved to suspend the rules and pass the bill, as amended.
Jun 7, 2022
Considered under suspension of the rules. (consideration: CR H5298-5321)
Jun 7, 2022
DEBATE - The House proceeded with forty minutes of debate on H.R. 7667.
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 9, 2022
Considered as unfinished business. (consideration: CR H5402-5403)
Jun 9, 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)
View Vote
Jun 9, 2022
Motion to reconsider laid on the table Agreed to without objection.
Jun 9, 2022
Received in the Senate.
  • May 6, 2022
    Introduced in House


  • May 6, 2022
    Referred to the House Committee on Energy and Commerce.


  • May 9, 2022
    Referred to the Subcommittee on Health.


  • 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 18, 2022
    Ordered to be Reported (Amended) by the Yeas and Nays: 55 - 0.


  • May 18, 2022
    Committee Consideration and Mark-up Session Held.


  • June 7, 2022
    Placed on the Union Calendar, Calendar No. 262.


  • June 7, 2022
    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-348.


  • June 7, 2022
    Mr. Pallone moved to suspend the rules and pass the bill, as amended.


  • June 7, 2022
    Considered under suspension of the rules. (consideration: CR H5298-5321)


  • June 7, 2022
    DEBATE - The House proceeded with forty minutes of debate on H.R. 7667.


  • June 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.


  • June 9, 2022
    Considered as unfinished business. (consideration: CR H5402-5403)


  • June 9, 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)
    View Vote


  • June 9, 2022
    Motion to reconsider laid on the table Agreed to without objection.


  • June 9, 2022
    Received in the Senate.

Health

Related Bills

  • HR 117-7035: Biologics Market Transparency Act of 2022
  • S 117-4302: Biologics Market Transparency Act of 2022
  • S 117-3983: PATCH Act
  • HR 117-6888: Helping Experts Accelerate Rare Treatments Act of 2022
  • S 117-4152: A bill to amend the Federal Food, Drug, and Cosmetic Act to reauthorize the Critical Path Public-Private Partnerships.
  • S 117-4535: FDASRA Act of 2022
  • HR 117-6988: Drug Manufacturing Innovation Act of 2022
  • HR 117-7006: INSPECTIONS Act
  • S 117-4333: CLEAR Act
  • HR 117-7084: PATCH Act of 2022
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.

Bill Text Versions

View Text
4 versions available

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
May 6, 2022
Introduced in House
May 6, 2022
Referred to the House Committee on Energy and Commerce.
May 9, 2022
Referred to the Subcommittee on Health.
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 18, 2022
Ordered to be Reported (Amended) by the Yeas and Nays: 55 - 0.
May 18, 2022
Committee Consideration and Mark-up Session Held.
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.
Jun 7, 2022
Mr. Pallone moved to suspend the rules and pass the bill, as amended.
Jun 7, 2022
Considered under suspension of the rules. (consideration: CR H5298-5321)
Jun 7, 2022
DEBATE - The House proceeded with forty minutes of debate on H.R. 7667.
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 9, 2022
Considered as unfinished business. (consideration: CR H5402-5403)
Jun 9, 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)
View Vote
Jun 9, 2022
Motion to reconsider laid on the table Agreed to without objection.
Jun 9, 2022
Received in the Senate.
  • May 6, 2022
    Introduced in House


  • May 6, 2022
    Referred to the House Committee on Energy and Commerce.


  • May 9, 2022
    Referred to the Subcommittee on Health.


  • 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 18, 2022
    Ordered to be Reported (Amended) by the Yeas and Nays: 55 - 0.


  • May 18, 2022
    Committee Consideration and Mark-up Session Held.


  • June 7, 2022
    Placed on the Union Calendar, Calendar No. 262.


  • June 7, 2022
    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-348.


  • June 7, 2022
    Mr. Pallone moved to suspend the rules and pass the bill, as amended.


  • June 7, 2022
    Considered under suspension of the rules. (consideration: CR H5298-5321)


  • June 7, 2022
    DEBATE - The House proceeded with forty minutes of debate on H.R. 7667.


  • June 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.


  • June 9, 2022
    Considered as unfinished business. (consideration: CR H5402-5403)


  • June 9, 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)
    View Vote


  • June 9, 2022
    Motion to reconsider laid on the table Agreed to without objection.


  • June 9, 2022
    Received in the Senate.
Anna G. Eshoo

Anna G. Eshoo

Democratic Representative

California

Cosponsors (3)
Brett Guthrie (Republican)Frank Pallone (Democratic)Cathy McMorris Rodgers (Republican)

Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • HR 117-7035: Biologics Market Transparency Act of 2022
  • S 117-4302: Biologics Market Transparency Act of 2022
  • S 117-3983: PATCH Act
  • HR 117-6888: Helping Experts Accelerate Rare Treatments Act of 2022
  • S 117-4152: A bill to amend the Federal Food, Drug, and Cosmetic Act to reauthorize the Critical Path Public-Private Partnerships.
  • S 117-4535: FDASRA Act of 2022
  • HR 117-6988: Drug Manufacturing Innovation Act of 2022
  • HR 117-7006: INSPECTIONS Act
  • S 117-4333: CLEAR Act
  • HR 117-7084: PATCH Act of 2022
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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