December 13, 2022 EUROoCS

FDA Modernization Act 2.0 passes U.S. Senate


On Thursday, September 29, 2022 Senate Bill 5002, ‘FDA Modernization Act 2.0’ was both introduced in the Senate and passed by unanimous consent.

The Federal Food, Drug and Cosmetics Act (FFDCA) of 1938 mandated that all new drugs be tested in animals to protect patients from unknown toxicity. New technologies have now come to the point that they can often better protect society against unforeseen toxic effects of new medicines than animal testing. Animal models have been essential in the development of all kinds of medicines. But now it is known that a large proportion of the drugs that are safe in animals eventually fail in human trials. So on Sept. 7, representatives from several universities and companies wrote an open letter to representatives of the US Congress encouraging them to pass the FDA Modernization Act. This law provides the opportunity to use suitable alternative methods. This law has now been passed.

This bill marks a turning point in how animal testing is seen in drug development.  By stating that innovative technologies such as Organs-on-Chip and microphysiological systems can be used to evaluate drug safety and efficacy, the bill enables relevant validated human models to replace animal tests. Importantly, the FDA Modernization Act doesn’t call for the immediate elimination of animal testing. Rather, it allows researchers to use the models that are most appropriate for their studies, which may often mean using microphysiological systems (MPS) instead of animals.

For more information:

FDA Modernization Act 2.0 pdf
Open Letter to the U.S. Congress
Act to end animal testing requirement passes Senate

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