Alternatives to Animals for Regulatory Fairness Act of 2021
Bill: H.R.1905 | Sponsor: Rep. Boyle, Brendan F. (D-PA)
Policy area: Health

Summary:
Animals for Regulatory Fairness Act of 2021 or the AARF Act of 2021
This bill requires the Food and Drug Administration to allow an applicant for approval to market a new drug to use a non-animal test to demonstrate the safety and effectiveness of the drug if the non-animal test satisfies all other applicable requirements.

To amend the Federal Food, Drug, and Cosmetic Act to allow the sponsor 
of a drug to use a non-animal test as an alternative to an animal test 
for purposes of demonstrating the safety and effectiveness of a drug if 
such approach satisfies the requirements of the applicable statutes and 
                              regulations.

    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 ``Alternatives to Animals for 
Regulatory Fairness Act of 2021'' or the ``AARF Act of 2021''.

SEC. 2. FINDINGS.

    The Congress finds that--
            (1) the Food and Drug Administration (in this section 
        referred to as the ``FDA'') often requires pharmaceutical 
        companies to conduct or commission testing on dogs and other 
        animals to assess the safety or effectiveness of new drugs, 
        even though such testing is inefficient, expensive, and 
        ineffective;
            (2) the National Institutes of Health states, 
        ``Approximately 30 percent of promising medications have failed 
        in human clinical trials because they are found to be toxic 
        despite promising preclinical studies in animal models. About 
        60 percent of candidate drugs fail due to lack of efficacy'';
            (3) current FDA nonbinding pharmaceutical testing 
        guidelines support the use of alternatives to animal testing to 
        improve the effectiveness and efficiency of drug development;
            (4) current FDA drug testing guidance for the 
        pharmaceutical industry states, ``consideration should be given 
        to use of new in vitro alternative methods for safety 
        evaluation'';
            (5) the FDA's drug testing guidance for industry 
        additionally states, ``alternative approaches . . . can also be 
        used . . . . The use of any of these approaches can reduce 
        overall animal use in drug development'';
            (6) the FDA writes that alternatives to animal testing, 
        ``may help bring FDA-regulated products to market faster, with 
        improved efficacy, or prevent products with increased 
        toxicological risk from reaching the market. Also critical is 
        the potential for these advances to replace, reduce, and/or 
        refine animal testing'';
            (7) pharmaceutical companies are reducing animal testing by 
        investing in the development and use of alternative methods, 
        which studies show are often more effective and efficient than 
        traditional animal use;
            (8) the FDA states, ``FDA encourages sponsors to consult 
        with us if they wish to use a non-animal testing method they 
        believe is suitable, adequate, validated, and feasible''; and
            (9) in some cases, drug manufacturers and sponsors have not 
        been allowed by the FDA to use alternatives to animal testing 
        to fulfill regulatory requirements, despite the FDA's support 
        for this technology in its industry guidance document.

SEC. 3. ALTERNATIVES TO ANIMAL TESTS.

    Section 505 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 
355) is amended by adding at the end the following new subsection:
    ``(z) Alternatives to Animal Tests.--The Secretary shall allow the 
sponsor of a drug to use a non-animal test as an alternative to an 
animal test for purposes of demonstrating the safety and effectiveness 
of a drug under this section if such approach satisfies the 
requirements of the applicable statutes and regulations.''.
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