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FDASLA Act of 2022

S. 4348 Sen. Patty Murray (D-WA) In committee
Bill text PDF
  1. Introduced May 26
  2. Committee May 26
  3. Passed Senate Next
  4. Passed House Not yet
  5. To President Not yet
  6. Law Not yet
Where it stands
In committee, May 26, 2022Next: Senate vote
1570d ago Jul 13, 2022: Placed on Senate Legislative Calendar under General Orders. Calendar No. 444.
Final votes
No roll callsNo recorded vote on this bill yet
Lobbying
1company, 1 filing
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Summary

Food and Drug Administration Safety and Landmark Advancements Act of 2022 or the FDASLA Act of 2022

Full summary11 paragraphs

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.

Library of Congress summary, Jul 13, 2022

Summary versions
  • Reported to SenateJul 13, 2022
  • Introduced in SenateMay 26, 2022

Official record from Congress.gov, the House Clerk and the Senate; lobbying from Lobbying Disclosure Act filings. Updated Oct 27, 2026.