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.
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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FDA Modernization Act 2.0
A bill to allow for alternatives to animal testing for purposes of drug and biological product applications.
FDA Modernization Act 2.0
FDA Modernization Act 2.0
Sen. Paul, Rand