S. 4348

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.