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  1. Good Science Digest

  2. Jun 29, 2023

House and Senate Committees Pass FDA Funding Bill, Supports Nonanimal Testing Methods

Washington, D.C., Capitol
Photo: Getty Images

Last week, the U.S. Senate Appropriations Committee voted to advance the Fiscal Year 2024 (FY24) funding bill and committee report for the Food and Drug Administration (FDA), following the House committee’s work the previous week to pass its version of the legislation.

The House and Senate bill reports include several provisions supported by the Physicians Committee to advance progress for the wider acceptance of nonanimal methods. Nonanimal approaches, including modern in vitro and computational innovations, rely on human cells, tissues, and data to improve safety and efficacy of medical product development, and increase efficiency by cutting down on resource-intensive animal testing. The Physicians Committee appreciates the Appropriations Committees in both chambers for including these provisions in their bill reports to help both protect animals and improve FDA-regulated product testing.

Animal Testing for Cosmetics

Both House and Senate committees included language, supported by the Physicians Committee, in the FDA’s FY24 appropriations bill report to ensure that the FDA continues to support nonanimal test methods for cosmetic product development. Bill reports accompany legislative measures when they are reported by committees for further consideration, and often contain directives and suggestions to agencies on how to implement the bill.

Thousands of cosmetic companies already conduct safety testing without using animals, with more moving away from animal testing each year. Additionally, 10 states have banned the sale of animal tested cosmetics, and more than 30 countries around the world now require the use of nonanimal approaches in lieu of animal testing. This evidence demonstrates that animal testing is not needed to develop safe cosmetics and for industry to thrive.

Last year, Congress increased the FDA’s authority to regulate cosmetic products by enacting the Modernization of Cosmetics Regulation Act. Given this newly increased authority, it is important that the FDA further supports and encourages industry’s trend away from animal tests and toward predictive, nonanimal science. The Physicians Committee worked with Members of Congress and the Appropriations Committees to ensure the inclusion of report language to reaffirm that animal testing should not be performed for safety testing of cosmetics.

New Alternative Methods Program

After the urging of the Physicians Committee, the House and Senate committees also included report language that makes progress on key points for broader FDA integration of nonanimal approaches. Last year, Congress provided funding for the FDA to establish a New Alternative Methods Program to spur the adoption of nonanimal methods for regulatory use that can improve predictivity of nonclinical testing, bring safe and effective products to patients faster, and reduce animal testing, as described by the FDA. The House and Senate reports build on this effort for 2024 by directing the agency to make meaningful and measurable impacts for advancing alternative methods, requesting a report on the progress of this program’s formation which includes essential information on priorities, metrics, and policy communications. This information is critical to understanding how the FDA intends to leverage this program to make significant progress for nonanimal methods, and to comprehensively remove remaining barriers to integrating nonanimal methods.

Congress and the FDA have been building toward this broad effort actualized by the New Alternative Methods Program for many years, including through previous appropriations report language supported by the Physicians Committee, reflecting congressional support for nonanimal approaches, and the FDA’s launch of a smaller pilot program (Innovative Science and Technology Approaches for New Drugs) to aid in evaluating nonanimal methods for specific regulatory uses. The Physicians Committee appreciates the committees’ inclusion of this language to build upon the momentum for integrating nonanimal approaches at the FDA.

Predictive Toxicology Roadmap Guideline Studies

The Senate Appropriations Committee included report language, backed by the Physicians Committee, to redirect plans at the FDA’s National Center for Toxicological Research (NCTR) for extensive new animal testing intended to implement goals set in the agency’s Predictive Toxicology Roadmap. This provision importantly urges the FDA to use human data or existing animal data to validate nonanimal methods, rather than conducting new animal testing for this purpose as the NCTR proposed.

Although evaluating nonanimal methods for their strengths and shortcomings is a necessary step to their widespread use, ultimately, methods intended for testing human products should be evaluated for their abilities to predict human, not animal, outcomes. Existing human information should be used as reference, or if animal data is deemed necessary to fill gaps, only existing animal data from previously conducted tests should be used to remain aligned with animal testing reduction and replacement goals described in the FDA’s Predictive Toxicology Roadmap.

In comparison, the House’s report does not address this issue as comprehensively as the Senate’s. The Physicians Committee urges Congress to retain the Senate’s version of this report language to prevent the NCTR from pursuing additional animal testing for validating nonanimal methods.

Next Steps

The FY24 FDA funding bill will soon be considered by the full House and Senate, after which the chambers will need to reconcile differences to pass a final, unified bill and report. The Physicians Committee will continue to work with allies in Congress to retain these important provisions for ethical nonanimal science as the 2024 appropriations bills move forward.

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