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Food and Drug Amendments of 2022

Introduced: May 6, 2022 See on congress.gov
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 Everywhere this bill has been 18 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jun 9, 2022
Received in the Senate.
Jun 8, 2022
Motion to reconsider laid on the table Agreed to without objection.
Jun 8, 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)
Jun 8, 2022
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).
Jun 8, 2022
Considered as unfinished business. (consideration: CR H5402-5403)
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 7, 2022
DEBATE - The House proceeded with forty minutes of debate on H.R. 7667.
Jun 7, 2022
Considered under suspension of the rules. (consideration: CR H5298-5321)
Jun 7, 2022
Mr. Pallone moved to suspend the rules and pass the bill, as amended.
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.
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.
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 9, 2022
Referred to the Subcommittee on Health.
May 6, 2022
Referred to the House Committee on Energy and Commerce.
May 6, 2022
Introduced in House
 Votes taken on this bill 1
DateChamberWhat was voted onResultYes–No
Jun 9, 2022 House · vote #254 On Motion to Suspend the Rules and Pass, as Amended Passed 392–28 See who voted →
 Plain-English summary Congressional Research Service

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's happening now June 9, 2022

Received in the Senate.

 Committees of jurisdiction 2
 Cosponsors 2
All 2 Democratic 1 Republican 1