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.
| Action Date | Type | Text | Source |
|---|---|---|---|
| 2022-06-09 | IntroReferral | Received in the Senate. | Senate |
| 2022-06-08 | Floor | Motion to reconsider laid on the table Agreed to without objection. | House floor actions |
| 2022-06-08 | Vote | 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) | House floor actions |
| 2022-06-08 | Floor | Considered as unfinished business. (consideration: CR H5402-5403) | House floor actions |
| 2022-06-07 | Floor | 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. | House floor actions |
| 2022-06-07 | Floor | DEBATE - The House proceeded with forty minutes of debate on H.R. 7667. | House floor actions |
| 2022-06-07 | Floor | Considered under suspension of the rules. (consideration: CR H5298-5321) | House floor actions |
| 2022-06-07 | Floor | Mr. Pallone moved to suspend the rules and pass the bill, as amended. | House floor actions |
| 2022-06-07 | Calendars | Placed on the Union Calendar, Calendar No. 262. | House floor actions |
| 2022-06-07 | Committee | Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-348. | House floor actions |
| 2022-05-18 | Committee | Ordered to be Reported (Amended) by the Yeas and Nays: 55 - 0. | House committee actions |
| 2022-05-18 | Committee | Committee Consideration and Mark-up Session Held. | House committee actions |
| 2022-05-11 | Committee | Forwarded by Subcommittee to Full Committee (Amended) by the Yeas and Nays: 30 - 0 . | House committee actions |
| 2022-05-11 | Committee | Subcommittee Consideration and Mark-up Session Held. | House committee actions |
| 2022-05-09 | Committee | Referred to the Subcommittee on Health. | House committee actions |
| 2022-05-06 | IntroReferral | Referred to the House Committee on Energy and Commerce. | House floor actions |
| 2022-05-06 | IntroReferral | Introduced in House | Library of Congress |