FDA Modernization Act 2.0

Dear Clients,

US President Biden recently signed into law a landmark update to the US Federal Food, Drug, and Cosmetic Act, which could have broad implications for companies in the biotech and drug-development space.

The FDA Modernization Act 2.0., inter alia, eliminates, in certain circumstances, the need for animal testing in the drug development process. Historically, the law mandated that all drugs be tested on animals prior to the commencement of human clinical trials, as animal-testing was considered, until now, the only way to test whether new drugs were safe enough to be tried on humans. As such, all drug developers, wherever they were located in the world, seeking FDA approval of their products, were forced to undertake animal testing as a prerequisite to their human trials.

Developments in modern science and technology, an increased sensitivity to animal rights and recognition of the shortcomings of the animal testing model have led to the obviation of this FDA requirement. Instead, the law now allows developers of drugs and biosimilars to adopt alternative methodologies to establish drug safety and effectiveness instead of animal testing where appropriate. These alternatives may include cell-based assays, bioprinted models and microphysiological systems, including organ-chips or computer models.

This is exciting news for companies with products and services in this space, as well as for the pharma companies and drug developers for whom the alternative non-clinical methodologies are more appropriate, and may lead to quicker time to market, than animal testing.

We are at your disposal for any queries you might have
Regards
Agmon with Tulchinsky

*The foregoing is for informational purposes only and does not constitute legal advice. Please contact us for specific legal advice.