FDASLA Act of 2022
Latest action. Placed on Senate legislative calendarThe list of measures reported out of committee and eligible for floor action. Being on the calendar is not a promise of a vote.Read the full definition (opens a new tab) under General Orders. Calendar No. 444.
Food and Drug Administration Safety and Landmark Advancements Act of 2022 or the FDASLA Act of 2022
This bill modifies Food and Drug Administration (FDA) authority to collect certain fees. It also expands FDA authority to regulate certain products, including cosmetics.
Among other provisions, the bill
reauthorizes FDA authority to collect certain fees related to drugs, medical devices, and biosimilar biological products and modifies such fees, including the base fee amounts;
establishes that certain requirements related to obtaining market approval for a new drug or a biosimilar may be satisfied using alternatives to animal testing, such as in vitro tests;
authorizes the FDA to require that certain drugs be dispensed with a safe disposal system even if the system does not render a drug nonretrievable (current law requires such a system to render the drug nonretrievable);
establishes time lines for the FDA to respond to requests to determine whether a drug is a therapeutic equivalent to an approved drug;
modifies the accelerated process for approving products for a serious or life-threatening disease or condition and establishes an intra-agency coordinating council to ensure consistent and appropriate use of the process;
requires additional regulation of cosmetics, including by requiring manufacturers to register manufacturing facilities and each cosmetic product with the FDA;
requires dietary supplement manufacturers to provide to the FDA certain information, including a list of all ingredients, about each dietary supplement that it markets;
requires an in vitro clinical test to receive FDA premarket approval or a technology certification (or be otherwise exempted) before being introduced into interstate commerce; and
requires the FDA to temporarily relax certain premarket requirements for a manufacturer that intends to market a new infant formula.
Written by analysts at the Congressional Research Service and published on Congress.gov, not by Civibrief. Summarized at the "Reported to Senate" stage on July 13, 2022. It describes the bill, it is not the legal text.
Where is it in the process, and what happens next?
4 steps remain before this bill could become law.
The record's latest action, on July 13, 2022: Placed on Senate Legislative Calendar under General Orders. Calendar No. 444.
- Clearing the committees it was referred to, and being scheduled for a floor vote
- Passage by the Senate
- Passage by the House
- The President's signature. If the President vetoes it, two-thirds of both chambers must vote to override.
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 is not there yet: 4 steps are still outstanding, 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?
Patty Murray (D-WA) introduced it on May 26, 2022, and 1 member has since signed on as a cosponsor.
They are 1 Republican.
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 26, 2022, 1568 days ago. The most recent recorded action was 1520 days ago, on July 13, 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
- SenateIn committee, no floor vote yet
- HouseAwaits Senate passage
- PresidentAwaits both chambers