US drug manufacturers will no longer need to test toxicity on animals for market approval
In the US, there was a requirement that drug manufacturers needed to test their drugs for toxicity on animals before they could be used on humans in clinical trials. A new federal law has been introduced which removes thia requirement. This new law “gives drug sponsors the option to use scientifically rigorous, proven non-animal test methods”. These methods include an extensive range of alternatives as listed in the introduction to the bill itself.
The bill is S.2952 – FDA Modernization Act of 2021. It is described on the CONGRESS. GOV website as: This bill allows an applicant for market approval for a new drug to use methods other than animal testing to establish the drug’s safety and effectiveness. Under this bill, these alternative methods may include cell-based assays, organ chips and microphysiological systems, computer modeling, and other human biology-based test methods.
I guess that this is obvious, but it might be worth stating that this new law does not place an obligation on drug companies to test the toxicity of their drugs using non-animal testing before they can be used on humans. There is no obligation there. As I understand the law, it simply opens the door to drugmakers to use alternative methods and in using these methods the manufacturers will be able to apply for and obtain approval provided they can establish the drug’s safety and effectiveness.
This law, therefore, is a small step forward in animal welfare but an important one, nonetheless. It amends the Federal Food, Drug, and Cosmetic Act.
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It was sponsored by Sen. Cory Booker (D-NJ) and Rand Paul (R-KY) and passed unanimously. Nathan Winograd has reported this development to me in an email and he says that he hopes that it will be taken up and passed in the House of Representatives.
“This is the biggest policy development in Congressional history on the fight to replace animal testing with morally and scientifically superior methods”, said Dr Paul.
As I recall, animal toxicity testing for experimental drugs is not particularly reliable in any case and therefore it should be made obsolete. Sen Cory Booker said: “This legislation will eliminate unnecessary suffering for countless animals when scientifically reliable alternative testing methods are available.”
Big Pharma has resisted proposals to limit animal testing. Pfizer, on their website states that “the use of animals in research is currently an essential component of the drug discovery process”.
In the future, AI could reduce Pharma’s reliance on animal testing. My understanding is that Big Pharma is going to be reluctant to give up animal testing for toxicity of drugs, in the immediate future, that they bring to the marketplace. But this law should encourage them to find humane alternatives which are do not involve animal cruelty, a topic they tend to conveniently brush under the carpet.