Title: FDA Modernization Act 2.0
Policy area: Health

Summary:
FDA Modernization Act 2.0
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.
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.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 5002 Considered and Passed Senate (CPS)]

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117th CONGRESS
  2d Session
                                S. 5002

 To allow for alternatives to animal testing for purposes of drug and 
                    biological product applications.


_______________________________________________________________________


                   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. 
 Lujan, 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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``FDA Modernization Act 2.0''.

SEC. 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''.
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