FDASLA Act of 2022
Latest action · Jul 13, 2022 Placed on Senate Legislative Calendar under General Orders. Calendar No. 444.
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.
- IntroducedMay 26, 2022
- Passed SenateNot reached
- Passed HouseNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
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.
Cosponsors 1
Members who signed on, in the order they did. All signed on May 26, 2022.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-NC | Richard Burr | Original | May 26, 2022 |
Committees 1
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| Senate | Health, Education, Labor, and Pensions Committee | Referred May 26, 2022Markup Jun 14, 2022Reported Jul 13, 2022 |
Actions 5
Everything that happened, newest first.
- Jul 13, 2022Committee on Health, Education, Labor, and Pensions. Reported by Senator Murray with an amendment in the nature of a substitute. Without written report.
- Jul 13, 2022Placed on Senate Legislative Calendar under General Orders. Calendar No. 444.
- Jun 14, 2022Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
- May 26, 2022Introduced in Senate
- May 26, 2022Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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.
Congressional Budget Office cost estimate
- Jul 21, 2022Estimated Direct Spending and Revenue Effects of S. 4348, the Food and Drug Administration Safety and Landmark Advancements Act of 2022As Reported by the Committee on Health, Education, Labor, and Pensions on July 13, 2022
CRS reports 3
Congressional Research Service work that CRS links to this bill or the law it became, newest first.
Cite it 3
Products on other subjects that cite it, usually among other measures.
| Product | Title | Kind | Published |
|---|---|---|---|
| IF11056 | Prescription Drug Importation | Resource | Mar 10, 2026 |
| R47373 | Science and Technology Issues for the 118th Congress Archived | Report | Oct 15, 2024 |
| IF12628 | Regulation of Laboratory-Developed Tests: FDA’s Proposed Rule | Resource | Apr 8, 2024 |
Related bills 15
Companion bills and other measures the record links to this one.
Titles 17
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes.
- Short Title(s) as Introduced
- FDASLA Act of 2022
- Food and Drug Administration Safety and Landmark Advancements Act of 2022
- Short Title(s) as Reported to Senate
- FDASLA Act of 2022
- Food and Drug Administration Safety and Landmark Advancements Act of 2022
- Short Title(s) as Introduced for portions of this bill
- VALID Act of 2022
- Food and Drug Administration Safety and Landmark Advancements Act of 2022
- Modernization of Cosmetics Regulation Act of 2022
- Generic Drug User Fee Amendments of 2022
- Short Title(s) as Reported to Senate for portions of this bill
- Prescription Drug User Fee Amendments of 2022
- Biosimilar User Fee Amendments of 2022
- Medical Device User Fee Amendments of 2022
- Modernization of Cosmetics Regulation Act of 2022
- Generic Drug User Fee Amendments of 2022
- Verifying Accurate Leading-edge IVCT Development Act of 2022
- VALID Act of 2022
- Food and Drug Administration Safety and Landmark Advancements Act of 2022
Subjects
Assigned by the Library of Congress. Policy area: Health.
- Administrative law and regulatory procedures
- Administrative remedies
- Allergies
- Animal protection and human-animal relationships
- Business records
- Child health
- Congressional oversight
- Cosmetics and personal care
- Department of Health and Human Services
- Drug safety, medical device, and laboratory regulation
- Drug therapy
- Drug trafficking and controlled substances
- Employee hiring
- Executive agency funding and structure
- Federal preemption
- Food and Drug Administration (FDA)
- Food industry and services
- Food supply, safety, and labeling
- Government employee pay, benefits, personnel management
- Government information and archives
- Government studies and investigations
- Hazardous wastes and toxic substances
- Health
- Health technology, devices, supplies
- Hearing, speech, and vision care
- Industrial facilities
- Licensing and registrations
- Manufacturing
- Medical research
- Medical tests and diagnostic methods
- Nutrition and diet
- Prescription drugs
- Product safety and quality
- Public-private cooperation
- Small business
- Solid waste and recycling
- State and local government operations
- User charges and fees
Text 2
Each version as it was printed, newest first.
- Jul 13, 2022Reported to Senate
- May 26, 2022Introduced in Senate
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.
