Patient Safety and Toxicology Modernization Act of 2016

To direct the Secretary of Health and Human Services to issue guidance with respect to three-dimensional human tissue models, and for other purposes. 1. Short title This Act may be cited as the Patient Safety and Toxicology Modernization Act of 2016 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 (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. (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. 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). 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 42 U.S.C. 262 (2) meeting the requirements of a regulatory decision issued by the Secretary of Health and Human Services. 5. Definitions In this Act: (1) Biological product The term biological product 42 U.S.C. 262(i) (2) Combination product The term combination product 21 U.S.C. 353(g) (3) Drug The term drug 21 U.S.C. 321 (4) Three-dimensional human tissue model The term three-dimensional human tissue model (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.

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.