February 1, 2023

Included are a few statements related to the passing of the FDA Moderization Act:

• It is important to note that before the FDA Modernization Act was passed, the Food and Drug Administration already had tremendous discretion when it comes to the use of both animal and nonanimal alternatives in the critically important task of safety testing new medications prior to their approved use in humans.
• The FDA has always required drug developers to provide evidence that safety and efficacy has been shown. And while the previous version of the law referenced the use of animal studies to do this, it did not expressly require them. This is a claim that has been put forward by animal research opponents but is not actually reflected in the law’s prior language.
• In essence, the FDA Modernization Act made relatively minor changes to the existing statute. These edits added and expanded references to nonanimal alternatives, technologies that did not exist in any great extent when the previous law was written.
• While these updates to the law will not lead to transformative changes to the biomedical research process, passage of the FDA Modernization Act will likely increase dialogue amongst scientists, Congress and the public about the development and funding for new methods to test medications before they approval for human use.

Click here to read the full press release.