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Bill117th CongressFiled May 6, 2022Health
H.R. 7667

Food and Drug Amendments of 2022

Bill journey · stage 2 of 5

Under committee review

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What it doesSummary passed house (Jun 8, 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.

What just happenedJun 9, 2022

Received in the Senate.

Who’s behind it

Rep. Eshoo, Anna G. [D-CA-18](D-CA)Sponsor
3 cosponsors1 D2 R
Read on Congress.gov
3cosponsors1committees20actions20related bills44subjects
  1. Jun 9, 2022IntroReferral

    Received in the Senate.

  2. Jun 8, 2022FloorH38310

    Motion to reconsider laid on the table Agreed to without objection.

  3. Jun 8, 2022FloorH37300

    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)

  4. Jun 8, 2022Floor8000

    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).

  5. Jun 8, 2022FloorH30000

    Considered as unfinished business. (consideration: CR H5402-5403)

  6. Jun 7, 2022FloorH37220

    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.

  7. Jun 7, 2022FloorH8D000

    DEBATE - The House proceeded with forty minutes of debate on H.R. 7667.

  8. Jun 7, 2022FloorH30000

    Considered under suspension of the rules. (consideration: CR H5298-5321)

  9. Jun 7, 2022FloorH30300

    Mr. Pallone moved to suspend the rules and pass the bill, as amended.

  10. Jun 7, 2022CalendarsH12410

    Placed on the Union Calendar, Calendar No. 262.

  11. Jun 7, 2022CommitteeH12200

    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-348.

    Energy and Commerce Committee
  12. Jun 7, 2022Committee5000

    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-348.

    Energy and Commerce Committee
  13. May 18, 2022Committee

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

    Energy and Commerce Committee
  14. May 18, 2022Committee

    Committee Consideration and Mark-up Session Held.

    Energy and Commerce Committee
  15. May 11, 2022Committee

    Forwarded by Subcommittee to Full Committee (Amended) by the Yeas and Nays: 30 - 0 .

    Health Subcommittee
  16. May 11, 2022Committee

    Subcommittee Consideration and Mark-up Session Held.

    Health Subcommittee
  17. May 9, 2022Committee

    Referred to the Subcommittee on Health.

    Health Subcommittee
  18. May 6, 2022IntroReferralH11100

    Referred to the House Committee on Energy and Commerce.

    Energy and Commerce Committee
  19. May 6, 2022IntroReferralIntro-H

    Introduced in House

  20. May 6, 2022IntroReferral1000

    Introduced in House

Passed HouseJun 8, 202253

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.

Reported to HouseJun 7, 20227

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.

Introduced in HouseMay 6, 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.

Food and Drug Amendments of 2022 — Informed