The FDA Modernization Act 2.0 Allows Animal Trials Alternatives

On December 29, 2022, President Biden signed the FDA Modernization Act 2.0 into law, allowing clinical trial leaders to use animal trial alternatives before human clinical trials. Senators Rand Paul, MD, and Cory Booker introduced this bill in 2021. The act authorizes a handful of alternatives to animal models — previously the gold standard for prehuman testing — including cell-based assays and computer models.

This bill updates section 505 of the Federal Food, Drug, and Cosmetics Act. According to the bill, pharmaceutical companies can apply for animal trial exemptions from the FDA. The FDA can use the application to evaluate whether forgoing animal trials would compromise the understanding of the safety and efficacy of the drug. Additionally, the new law does not require animal studies to license biosimilars.

This new act marks a significant shift in the clinical trial landscape in the United States. Animal trials can be a considerable deterrence for drug development. In addition to being expensive, the trials pose some ethical concerns.

Additionally, shortages in approved animal models can contribute to delayed drug development. Toward the end of 2022, an eight-count indictment for smuggling and conspiracy to illegally export an endangered species of non-human primates for research in the US led Cambodia to halt the export of all non-human primates. Many predict that the impacts of this delay will linger and cause further delays in drug development. With this new bill signed into law, drug developers may be able to work around the limited access to animal models and further drug development with non-animal or computerized models.

“The FDA Modernization Act 2.0 will accelerate innovation and get safer, more effective drugs to market more quickly by cutting red tape that is not supported by current science, and I’m proud to have led the charge. The inclusion of this bipartisan effort is a step toward ending the needless suffering and death of animal test subjects — which I’m glad both Republicans and Democrats can agree needs to end,” said Paul in a January press release regarding the act.

Despite this act’s benefits, many expect delays in shifting away from animal models. Pharmaceutical companies and researchers will have to consider alternative methods, conduct an analysis, and obtain FDA approval before being rid of animal models.