Food and Drug Amendments of 2022
Latest action. Received in the Senate.
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.
Written by analysts at the Congressional Research Service and published on Congress.gov, not by Civibrief. Summarized at the "Passed House" stage on June 8, 2022. It describes the bill, it is not the legal text.
Received in the Senate.
Civibrief does not map this action to a stage in the process. See the official record.
Where is it in the process, and what happens next?
The latest action on file does not map to a stage Civibrief recognizes, so the page will not name one. The record's own words are the reliable fact here.
The record's latest action, on June 9, 2022: Received in the Senate.
How likely is it to become law?
Civibrief does not forecast outcomes and this page has no opinion about this one. What the record supports is a base rate, which is a fact about the whole pile, not a prediction about this measure.
In the 117th Congress (2021-22), 362 of the 15,242 bills and joint resolutions introduced became law, about 2.4 percent. That count covers every measure at every stage, including the many that never left committee.
This one has no outstanding steps listed above.
Has anyone actually voted on it?
No. No roll call in this Congress cites this measure. That is the ordinary outcome: most measures never reach a recorded floor vote, and a committee ends most of them simply by not acting.
A vote is not the only thing that happens to a measure. Hearings, markups, and referrals are all recorded actions, and none of them is a vote of the full chamber.
Who is behind it?
ANNA ESHOO (D-CA) introduced it on May 6, 2022, and 3 members have since signed on as cosponsors.
They come from both major parties: 1 Democrat, 2 Republicans.
Cosponsoring is a formal signature on the text. It is not a commitment to vote for the measure, it does not bind anyone's party, and a long list of cosponsors is a measure of attention rather than of prospects.
How long has it been in play?
It was introduced on May 6, 2022, 1588 days ago. The most recent recorded action was 1554 days ago, on June 9, 2022.
Measures do not carry over. Anything the 117th Congress has not finished by January 3, 2023 dies when the term ends, and has to be introduced again from the start in the next Congress.
Every answer above is assembled from this measure's own record on Congress.gov and from published counts of what Congress has passed before. Civibrief does not predict outcomes and takes no position on any measure.
Vote history
- HouseReceived in the Senate.
- SenateNot stated in the latest action
- PresidentNot stated in the latest action