Patient Safety and Toxicology Modernization Act of 2016

Summary: Patient Safety and Toxicology Modernization Act of 2016 This bill requires the Food and Drug Administration to issue and periodically update guidance on: (1) novel tools for testing the toxicology and efficacy of medications, and (2) three-dimensional human tissue models.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Patient Safety and Toxicology 
Modernization Act of 2016''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) Preclinical testing serves a fundamental role in 
        characterizing the potential risks and benefits associated with 
        regulated medicines and products.
            (2) Critical gaps remain in the understanding of the 
        relationship between patient response and preclinical findings.
            (3) Serious, rare, and unexpected adverse events may be 
        observed in clinical trials or postapproval, particularly 
        toxicology effects not identified in animals that may harm 
        human organs.
            (4) Patient efficacy, safety, dosage information, and 
        speedier access to new medicines will benefit from models that 
        are more predictive than animals and that mimic key elements of 
        human organs.
            (5) A 2011 report by the Food and Drug Administration, 
        entitled ``Advancing Regulatory Science at FDA'', prioritized 
        toxicology testing and the development of models of human 
        adverse response as one of the areas of regulatory science 
        where new or enhanced engagement by the agency is essential to 
        the continued success of the public health and regulatory 
        mission of the Food and Drug Administration.
            (6) The Food and Drug Administration's 2016 draft 
        commitment letter concerning the reauthorization of fees 
        relating to drugs under part 2 of subchapter C of chapter VII 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et 
        seq.) proposes a process to add new preclinical models that 
        will not be finalized until at least 2021.
            (7) Peer-reviewed data is readily available to illustrate 
        the benefits of commercially available human tissue models to 
        improve the drug discovery process by replicating key elements 
        of living human tissue.
            (8) The Food and Drug Administration should take immediate 
        steps to validate new models, including three-dimensional human 
        tissue models, that improve regulatory decisionmaking in 
        preclinical, clinical, labeling, and postmarket safety and 
        efficacy testing, or other uses by product sponsors.

SEC. 3. GUIDANCE WITH RESPECT TO THREE-DIMENSIONAL HUMAN TISSUE MODELS.

    (a) In General.--Not later than December 31, 2018, the Secretary of 
Health and Human Services, acting through the Commissioner of Food and 
Drugs, shall issue guidance addressing--
            (1) the development and use of novel tools for toxicology 
        and efficacy testing, including three-dimensional human tissue 
        models; and
            (2) the use of three-dimensional human tissue models for 
        preclinical, clinical, and postmarket safety and efficacy 
        testing, labeling, or other uses by product sponsors.
    (b) Periodic Updates.--The Secretary shall periodically update the 
guidance issued under subsection (a).

SEC. 4. RULE OF CONSTRUCTION.

    Nothing in this Act shall be construed to prohibit or limit the use 
of three-dimensional human tissue models by product sponsors with 
respect to--
            (1) obtaining approval or licensure of a drug or biological 
        product, including a combination product, under section 505 of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or 
        section 351 of the Public Health Service Act (42 U.S.C. 262); 
        or
            (2) meeting the requirements of a regulatory decision 
        issued by the Secretary of Health and Human Services.

SEC. 5. DEFINITIONS.

    In this Act:
            (1) Biological product.--The term ``biological product'' 
        has the meaning given such term in section 351(i) of the Public 
        Health Service Act (42 U.S.C. 262(i)).
            (2) Combination product.--The term ``combination product'' 
        means a combination product described in section 503(g) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)).
            (3) Drug.--The term ``drug'' has the meaning given such 
        term in section 201 of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 321).
            (4) Three-dimensional human tissue model.--The term 
        ``three-dimensional human tissue model'' means a three-
        dimensional model that--
                    (A) approximates human tissue composition and 
                physiology using spatially controlled deposition of 
                adult human cells or cell-containing materials in user-
                defined, geometric patterns;
                    (B) can be used to detect toxicity that is not 
                identifiable in animal models;
                    (C) can be used to test the efficacy of a drug that 
                is not possible or not able to be sufficiently tested 
                in an animal model; and
                    (D) can predict toxicity in clinical testing or 
                detect toxicity in known clinical failures.