Accelerated Approval Integrity Act of 2022
Latest action · Mar 8, 2022 Referred to the Subcommittee on Health.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedMar 7, 2022
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Accelerated Approval Integrity Act of 2022
This bill establishes requirements relating to postapproval studies for drugs that receive accelerated approval for serious or life-threatening diseases or conditions, such as requiring product sponsors to agree in advance to conduct such studies and terminating product approval if certain benchmarks are not met.
Cosponsors 1
Members who signed on, in the order they did. All signed on Mar 16, 2022.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-NY | Carolyn B. Maloney | Mar 16, 2022 |
Committees 1
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| House | Energy and Commerce Committee | Referred Mar 7, 2022 |
| Health Subcommittee | Referred Mar 8, 2022 |
Actions 3
Everything that happened, newest first.
- Mar 8, 2022Referred to the Subcommittee on Health.
- Mar 7, 2022Introduced in House
- Mar 7, 2022Referred to the House Committee on Energy and Commerce.
Research
What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.
Constitutional authority
The sponsor’s statement, as printed in the Congressional Record, vol. 168, no. 40, March 7, 2022, page H1330.
Printed hearings 1
Hearings whose printed record names this bill, newest first: hearings on it, and wider hearings where it came up.
| Number | Hearing | Committee | Held |
|---|---|---|---|
| Serial No. 117-75 | THE FUTURE OF MEDICINE: LEGISLATION TO ENCOURAGE INNOVATION AND IMPROVE OVERSIGHT308 pages | Energy and Commerce Committee | Mar 17, 2022 |
Titles 2
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- To amend the Federal Food, Drug, and Cosmetic Act to strengthen requirements for postapproval studies for drugs approved using accelerated approval, and for other purposes.
- Short Title(s) as Introduced
- Accelerated Approval Integrity Act of 2022
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 1
Each version as it was printed, newest first.
- Mar 7, 2022Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.
