The US Food and Drug Administration has reduced requirements for preclinical animal testing, leading to a surge of interest in organoids, tissue chips and in silico testing

_NATURE MEDICINE

The removal of one word from an 85-year-old American regulation sends a signal of change to the whole field of drug development and could mean a major shift away from animal testing. Approved by Congress and signed by President Joe Biden in late December 2022, the Food and Drug Administration (FDA) Modernization Act 2.0 replaced the word “animal” with “nonclinical tests” in the law governing the agency’s drug assessments. The change removed the requirement that pharmaceutical companies test therapies on animals before starting clinical trials and opened the way for expanding the use of alternative methods.

Supported by over 200 organizations and strongly pushed by the lobby of animal rights defenders, the new legislation extends the range of methods that can be used in preclinical trials to assess the safety and efficacy of drugs, vaccines and biological treatments. Regulators will now allow cell-based testing and even computer modeling, in addition to or instead of animal testing.

The adoption of these alternatives, already used by the drug discovery industry, can improve, speed up and cheapen the investigation of new drugs. As a result of the change, biotechnology companies are already seeing increased interest in their non-animal methods, such as organoids, organs-on-a-chip and in silico modeling.

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Nature Medicine volume 29, pages2151–2154 (2023)