Congress eliminates the need for animal testing of drugs

We’re about to revolutionize how drugs are developed in the United States.

President Joe Biden has signed the FDA Modernization Act 2.0, which promises to dramatically reduce the use of animal testing in drug development by eliminating a federal mandate that new drugs be trialed on animals before the FDA approves them.

This is a big deal.

Every year, billions of dollars are spent on animal tests that suggest experimental drugs are safe. And every year, many of those drugs prove to be toxic in human trials. Why? Because animals are not identical to humans. Their organs do not always respond to drugs the same way that human organs do. 

The FDA Modernization Act 2.0, which was part of the omnibus spending bill the president signed, will allow the FDA to – for the first time – consider superior, non-animal drug testing results in weighing new medications.

Animal testing of new-drug safety has been required by the FDA since 1938. Back then, animal testing was the most reliable way to study a medicine’s side effects. Since then, however, science has developed superior tests that are more predictive of a drug’s effect on human tissue.  Alternatives, such as organ-on-a-chip technology, enable faster toxicity testing with more reliable results.

“Thanks to modern scientific innovation, the use of animal toxicity testing for experimental drugs has become increasingly obsolete,” said Senator Cory Booker (D-N.J.). “This legislation will eliminate unnecessary suffering for countless animals when scientifically reliable alternative testing methods are available.”

Animal testing has delayed the rollout of new medicines – typically to 15 years – and raised the cost of drug development, often to billions of dollars.

Research has found compounds that seem promising in preclinical studies are often proven to be ineffective or dangerous during human trials. 

A recent study published in “Nature Communications Medicine” found that organs-on-a-chip are superior to animal testing to assess the safety of drugs. The study, which represents the largest analysis to date of organs-on-a-chip, compared the performance of human liver-chips in predicting drug-induced liver injury to industry-standard animal in vivo models and primary human 3D hepatic spheroids.

They assessed 870 liver-chips and found they identified 87% of drugs that had passed animal testing but were ultimately found to cause drug-induced liver injury to patients.

Researchers estimated that improving the ability to detect hepatotoxicity with 87% sensitivity by replacing animal testing with human liver-chips could increase liver-related research and development productivity by $3 billion dollars a year for the small molecule drug development industry. They also estimated that replacing animal testing with appropriate organs-on-a-chip in the development of cardiovascular, neurological, immunological, and gastrointestinal drugs could result in an annual $24 billion improvement in research and development productivity.

Methuselah Foundation believes it is time for wider adoption of organ-chip technology. While we know it works, much remains to be done to make organ-chips the new research standard.

Earlier this year, we announced a $1 million competition to encourage innovation to enable medicine to shift away from unreliable animal testing. Our Animal Free Precision Medicine initiative is focused on:

•       Dramatically improving drug development speed and probability of success.

•       Reducing and eventually eliminating the need for animal testing.

•       Significantly reducing risks and increasing benefits to patients in clinical trials and retail medicine.

If you agree that it’s time to embrace new testing regimes to advance science, sign onto our Animal Free Precision Medicine Manifesto petition.