FDA Modernization Act 2.0 passed by Senate, awaits House support

9.29.22 Today in Washington, S5002 A bill to allow for alternatives to animal testing for purposes of drug and biological product applications (aka FDA Modernization Act 2.0, formerly HR2565/S2952) passed the Senate as part of a larger package of bills called the Food and Drug Amendments of 2022. The bill now awaits House approval. A proposed amendment to the Federal Food, Drug and Cosmetics Act (FFDCA) of 1938, the bill would allow manufacturers and sponsors of a drug to employ alternative research and testing methods to investigate the safety and effectiveness of a drug, and for other purposes that traditionally, animals have been employed for. Non-animal models such as organ-chips, microphysiological systems, cell-based assays, computer modeling, and other human biology-based methods would all be considered acceptable methods.

In 1938, the US Congress passed the Federal Food, Drug and Cosmetics Safety Act (FFDCA), mandating toxicity testing on animals before food, drugs, medical devices and cosmetics could come to market. The impetus for this law was a result of the introduction of an anti-biotic called Elixir Sulfanilamide in 1937 that resulted in the death of more than 100 people across 15 states. The law established the authority of the Secretary of Health and Human Services (called the Secretary of Agriculture in 1938) to promulgate regulations to enforce the law. Among subsequent laws that amended provisions of the FFDCA included FFDCA Amendments in 1951 regulating over-the-counter and prescription drugs, and in 1962 requiring manufacturers to provide proof of drug efficacy, safety and side effects. In 1996, the Food Quality and Protection Act established health-based standards to govern the use of pesticides in food cultivation. This act and each subsequent amendment has required either FDA or EPA to promulgate regulatory guidelines that have resulted in tens of thousands of dogs used in toxicity tests of pesticides, medical device development, and drugs and cosmetics every year. This bill will now allow researchers to employ any of these new approach methods (or NAMs) that do not involve dogs (or other animals). A critical next step will be to ensure the regulatory agencies promulgate reasonable standards of acceptance of these model results, and tech companies continue to improve their efficacy and predicability. Despite the fact that many dog and other animal models are poor predictors of human response to a drug or chemical, ‘benchmark’ data from their use for over 7 decades has been argued as justification for their continued use. As an increasing number of alternative, non-animal methods are refined, validated and accepted by regulatory agencies and the scientific community, and tax payer funding for research traditionally involving animal models is diverted to prioritize their development and use of these alternatives, dogs may one day gain their freedom as research subjects—and our Mission at The Aisling Center will be accomplished. Reach out to your representatives in Washington and ask them to support the passage of S5002 FDA Modernization Act 2.0.