FDA Modernization Act 2.0

Bill: 117-s-5002
Sponsor: full_name: Sen. Paul, Rand [R-KY]
Introduced: 2022-09-29
Policy area: Health
Subjects: Animal protection and human-animal relationships

Drug safety, medical device, and laboratory regulation

Medical research

Prescription drugs

Research and development
Latest action: action_date: 2022-09-29
text: Held at the desk.

Summaries:
action_date: 2022-09-29
action_desc: Introduced in Senate
text: <p><strong>FDA Modernization Act 2.0</strong></p> <p>This bill authorizes the use of certain alternatives to animal testing, including cell-based assays and computer models, to obtain an exemption from the Food and Drug Administration to investigate the safety and effectiveness of a drug. </p> <p>The bill also removes a requirement to use animal studies as part of the process to obtain a license for a biological product that is biosimilar or interchangeable with another biological product.</p>

action_date: 2022-09-29
action_desc: Passed Senate
text: <p><strong>FDA Modernization Act 2.0</strong></p> <p>This bill authorizes the use of certain alternatives to animal testing, including cell-based assays and computer models, to obtain an exemption from the Food and Drug Administration to investigate the safety and effectiveness of a drug. </p> <p>The bill also removes a requirement to use animal studies as part of the process to obtain a license for a biological product that is biosimilar or interchangeable with another biological product.</p>

tv_txt: II 117th CONGRESS 2d Session S. 5002 IN THE SENATE OF THE UNITED STATES September 29, 2022 Mr. Paul (for himself, Mr. Booker , Mr. Braun , Mr. Crapo , Mr. Marshall , Ms. Collins , Mr. King , Mr. Padilla , Mr. Sanders , Mr. Tuberville , Mr. Luján , and Mr. Scott of Florida ) introduced the following bill; which was read twice, considered, read the third time, and passed A BILL To allow for alternatives to animal testing for purposes of drug and biological product applications.

1. Short title This Act may be cited as the FDA Modernization Act 2.0 . 2. Alternatives to animal testing (a) In general Section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) is amended— (1) in subsection (i)— (A) in paragraph (1)(A), by striking preclinical tests (including tests on animals) and inserting nonclinical tests ; and (B) in paragraph (2)(B), by striking animal and inserting nonclinical tests ; and (2) after subsection (y), by inserting the following: (z) Nonclinical test defined For purposes of this section, the term nonclinical test means a test conducted in vitro, in silico, or in chemico, or a non-human in vivo test that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug, and may include animal tests, or non-animal or human biology-based test methods, such as cell-based assays, microphysiological systems, or bioprinted or computer models. . (b) Biosimilar biological product applications Item (bb) of section 351(k)(2)(A)(i)(I) of the Public Health Service Act ( 42 U.S.C. 262(k)(2)(A)(i)(I) ) is amended to read as follows: (bb) an assessment of toxicity (which may rely on, or consist of, a study or studies described in item (aa) or (cc)); and .

tv_txt: 117th CONGRESS 2d Session S. 5002 IN THE SENATE OF THE UNITED STATES AN ACT To allow for alternatives to animal testing for purposes of drug and biological product applications.

1. Short title This Act may be cited as the FDA Modernization Act 2.0 . 2. Alternatives to animal testing (a) In general Section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) is amended— (1) in subsection (i)— (A) in paragraph (1)(A), by striking preclinical tests (including tests on animals) and inserting nonclinical tests ; and (B) in paragraph (2)(B), by striking animal and inserting nonclinical tests ; and (2) after subsection (y), by inserting the following: (z) Nonclinical test defined For purposes of this section, the term nonclinical test means a test conducted in vitro, in silico, or in chemico, or a non-human in vivo test that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug, and may include animal tests, or non-animal or human biology-based test methods, such as cell-based assays, microphysiological systems, or bioprinted or computer models. . (b) Biosimilar biological product applications Item (bb) of section 351(k)(2)(A)(i)(I) of the Public Health Service Act ( 42 U.S.C. 262(k)(2)(A)(i)(I) ) is amended to read as follows: (bb) an assessment of toxicity (which may rely on, or consist of, a study or studies described in item (aa) or (cc)); and .

Passed the Senate September 29, 2022. Secretary