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Today, the U.S. Senate passed the FDA Modernization Act 2.0, S.5002, without dissent.
Introduced by Senators Dr. Rand Paul (R-KY) and Cory Booker (D-NJ), the bill, if enacted, would curb animal testing in the coming years. A total of 10 other cosponsors backed the bill, which would end the mandate to test new drugs and biosimilars on animals.
The bill was based on S.2952, the FDA Modernization Act of 2021.
“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 in a statement. “The FDA Modernization Act 2.0 will accelerate innovation and get safer, more effective drugs to market more quickly by cutting red tape that is not supported by current science, and I’m proud to have led the charge with our fellow cosponsors.”
“Thanks to modern scientific innovation, the use of animal toxicity testing for experimental drugs has become increasingly obsolete,” said Senator Cory Booker in a statement. “This legislation will eliminate unnecessary suffering for countless animals when scientifically reliable alternative testing methods are available.”
The FDA Modernization Act 2.0 would update existing FDA regulations to allow drug developers to use new human-relevant testing methods to replace animal experiments.
The Center for Contemporary Sciences expects the new legislation to accelerate drug discovery and reduce drug development costs.
Almost 200 organizations, including several biotech companies, have lent their support to the bill. However, the generic drugmaker Teva Pharmaceutical is the only pharmaceutical company to get behind the bill.
Big Pharma companies have resisted proposals to limit animal testing. For instance, Pfizer notes on its website that the “use of animals in research is currently an essential component of the drug discovery process. Animals help us advance our scientific understanding, serve as models to study disease, help us develop and test potential new medicines and therapies.”
Companies specializing in computer models for the pharmaceutical industry, such as Cytoreason, have noted that AI could eventually reduce the pharma’s reliance on animal testing. However, it may be more challenging to replace the use of animal models in toxicology studies in the near future.
PhRMA’s website also describes animal models as an intrinsic part of drug discovery and development.
Senators Paul and Booker based their bill on the House version of the FDA Modernization Act, H.R. 2565. Representatives Vern Buchanan (R-FL) and Elaine Luria (R-VA) introduced the House bill.
The House and Senate bills have strong bipartisan support.