Bill of the Month — February 2024: The FDA Modernization Act 3.0

H.R. 7249, the FDA Modernization Act 3.0

Introduced by Reps. Buddy Carter (R-Ga.), Nanette Diaz Barragan (D-Calif), Diana Harshbarger (R-Tenn.), Vern Buchanan (R-Fla.), Troy Carter (D-La.), Michael Waltz (R-Fla.), Rosa DeLauro (D-Conn.), Troy Nehls (R-Texas), Lance Gooden (R-Texas), Dan Crenshaw (R-Texas), and Brian Fitzpatrick (R-Pa.).

Millions of animals are being needlessly killed and significant taxpayer dollars are wasted on the mandated animal-testing process. This is especially heinous considering that 90-95 percent of drugs that succeed in animal testing later fail in human clinical trials. The FDA Modernization Act 3.0 would require the Food and Drug Administration (FDA) to publish a final rule implementing the FDAMA 2.0. It would also mandate that the Health and Human Services (HHS) Secretary establish processes and transparency factors for new test methods and require the FDA to publish annual reports on qualification process successes. It is for these reasons, among others, that TPA is pleased to make the FDA Modernization Act 3.0 its Bill of the Month for February 2023.

Background:

Beginning in 1938 with the enactment of the Federal Food, Drug, and Cosmetics Act (FDCA), Congress has mandated that new drugs must be first tested on animals. However, after nearly a century without update, many have questioned the ethics and effectiveness of this practice. Every year about 50 million animals, ranging from rodents and monkeys to cats and dogs, are used by American researchers in experiments. This long-standing statutory requirement is cruel, expensive, and time-consuming.

At the end of 2022, Congress passed the FDA Modernization Act 2.0 (FDAMA 2.0), sponsored by Sens. Rand Paul (R-Ky.) and Cory Booker (D-N.J.), as part of the Consolidated Appropriations Act, 2023. This legislation eliminated the animal testing requirement and empowered researchers to employ less harmful, or non-animal methods for human-use drugs, such as cell-based arrays, organ chips, computer modeling, and bioprinting. When applicable to research, the new alternative testing methods allowed by the FDAMA 2.0 can yield more reliable scientific results at significantly less cost to researchers and regulators. Since the bill’s passage the agency has failed to finalize rules for implementation.

FDA Modernization Act 3.0

The FDA Modernization Act 3.0 would require the agency to publish a final rule implementing the FDAMA 2.0. It would also mandate that the HHS Secretary establish processes and transparency factors for new test methods and require the FDA to publish annual reports on qualification process successes.

Millions of animals are being needlessly killed and significant taxpayer dollars are wasted on the mandated animal-testing process. This is especially heinous considering that 90-95 percent of drugs that succeed in animal testing later fail in human clinical trials. The FDA must be forced to finalize rulemaking and provide for alternative testing methods. It is for these reasons, among others, that TPA is pleased to make the FDA Modernization Act 3.0 from Reps. Carter, Barragan, and their colleagues, its Bill of the Month for February 2024.