FDASLA Act of 2022

Bill: 117-s-4348
Sponsor: Sen. Murray, Patty [D-WA]
Introduced: 2022-05-26 in the Senate
Policy area: Health
Subjects: 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 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

Summary:
action_date: 2022-05-26
text: 

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; and
 
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. 
 

action_date: 2022-07-13
text: 

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. 
 


Legislative actions:
action_date: 2022-07-13
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 444.
action_date: 2022-07-13
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Murray with an amendment in the nature of a substitute. Without written report.
action_date: 2022-07-13
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Murray with an amendment in the nature of a substitute. Without written report.
action_date: 2022-06-14
text: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
action_date: 2022-05-26
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2022-05-26
text: Introduced in Senate