Is Animal Testing Really No Longer Needed for Drug Development?

Since 1938, congressional mandate made it compulsory for the FDA to require animal testing for all new drugs/biologics before they could be tested in humans. However, in December 2022, President Biden signed the FDA Modernization Act 2.0 passed by Congress, that allows the FDA to not require animal testing of drugs if nonanimal tests are adequate. FDA has the full discretion to make the decisions on case by case basis. This mandate is also applicable to biosimilars regulated under the U.S. Public Health Service Act.

Proponents of this new law argue for the use of computer modeling, “organ chips,”organoids, etc. Organ chips are the size of computer thumb drive and the channels within are lined with living cells and tissues from major human organs, such as the brain, liver, lung, and kidney. As the fluids flow through them they mimic blood flowing through human blood vessels and tissues. This allows for the assessment of damage is in the various organs.

The proponents of animal research, argue that currently available nonclinical testing models do not allow for assessment of full impact of new drugs on all of the systems such as gastrointestinal, urinary, etc.

Although the legislation allows the agency to clear a drug for human trials without animal testing, it doesn’t require that it do so. FDA is likely to support alternative methods as long as they are backed by good science and provide all the needed data to show that the products are safe and efficacious in the in vitro models before such drugs can be tested in humans.