Toni Dimaano Science 01.13.2023 06:Jan AM EST

The FDA Removes Animal Testing Requirement For Drugs Before Human Trials Begin

The Food and Drug Administration's requirement that all new pharmaceuticals undergo animal testing will no longer apply to any new drugs, NPR says.

Following more than 80 years of medication safety regulation, the reform, which has been long awaited by animal rights organizations, may indicate a significant shift away from animal use.

President Joe Biden Has Finally Signed For The Actualization Of The Law

Pharmaceutical companies seeking FDA approval have been required to successfully subject their drugs to several animal testing before moving on to human trials since 1938.

However, long-time supporters of animal rights have lobbied for this action, and some in the pharmaceutical sector have claimed that animal research can be wasteful and expensive.

According to Gizmodo, the new FDA change is a component of a sizable package of spending legislation that President Biden signed into law on December 29.

The 2023 Consolidated Appropriations Act featured a provision on "modernizing" clinical trials in addition to setting this year's budget for the Department of Defense and other government agencies.

Instead of the 1938 requirement that new medications be evaluated for safety and effectiveness in animals, the law permits FDA to advance a medicine or biologic to human trials following either animal or non animal examinations.

Following successful rounds of "non clinical tests," new medications can now go to human trials rather than animal testing.

It is an umbrella term that covers both animal testing and the use of substitutes like organ chips, 3-D printed body parts, and computer simulations in place of animals.

Additionally, the federal budget proposal provides $5 million for FDA research to decrease the use of animals in testing and create new, better testing techniques.

Drugs Have Been Proven Ineffective And Unsafe Despite Animal Trials

The FDA Modernization Act 2.0 was co-sponsored by Kentucky Senator Rand Paul and New Jersey Senator Corey Booker.

According to NPR, last week, Senator Paul praised the appropriations bill's inclusion and passing as it will help end the needless suffering of animals.

Furthermore, he adds that by reducing unnecessary red tape, the act will speed up innovation and bring safer, more effective pharmaceuticals to market more rapidly.

The FDA has typically required that new drugs undergo toxicity studies on rodent species (such as lab rats or mice) and one non-rodent species, such as a monkey or dog.

However, the vast majority of medications that pass these testing and are then put through human trials are still found to be harmful or ineffective.

According to a 2019 study, about 95% of medications that get into human trials are rejected by the FDA, suggesting that animal testing isn't a very good filter, Gizmodo notes.

It is important to note that drug companies also use a variety of additional techniques to evaluate potential new drugs and treatments.

This includes computer modeling and "organs on a chip," which are miniature microchips that can simulate how drugs affect the function of organs.

An FDA representative told NPR that the agency will put into effect the relevant omnibus provisions and continue to collaborate with stakeholders to support the advancement of substitute testing techniques.