Senate passes bill to rework animal testing requirements for drug developers

The US Senate passed via unanimous consent on Thursday afternoon a bipartisan bill that would alter a federal mandate for animal testing on new drugs, but stops short of removing animal testing entirely.

Touted as a much-needed modernization of FDA’s rules, co-sponsor Sens. Rand Paul (R-KY) and Cory Booker (D-NJ) have said the bill will stop lots of needless suffering of animals.

Today the Senate unanimously passed my bipartisan FDA Modernization Act 2.0 to end animal testing mandates! This is an important step toward innovation and ending the needless suffering and death of animal test subjects. pic.twitter.com/vGpCCdpuOf

— Rand Paul (@RandPaul) September 29, 2022

But the FDA has made clear that although drug companies seek to use as few animals as possible and to ensure their humane and proper care, animal testing is still crucial for drug development and for determining the toxicity of experimental compounds.

“Two or more species are typically tested because a drug may affect one differently from another. Such tests show whether a potential drug has toxic side effects and what its safety is at different doses. The results point the way for human testing and, much later, product labeling,” the FDA explains.

NIH also notes that researchers try to perform toxicology tests using biochemical or cell-based (in vitro) systems instead of with animals such as mice. But “the development of in vitro tests that can reliably identify chemical hazards resulting in cancer or birth defects is more difficult because of the complexity of the biological processes involved.”

Ben Ray Luján

The text of this bill shows it would replace the term “animal” in several key sections of the FDCA, and add the term “nonclinical test,” defined as in vitro, in silico, in chemico, and other nonhuman in vivo testing that may include animal tests.

The Senate-passed bill, which comes amid monkey shortages for researchers, also includes language from another bill sponsored by Sen. Ben Ray Luján (D-NM) to amend the Public Health Service Act to remove the animal testing requirement for biosimilars too.

On the House side, the chamber previously passed its user fee reauthorization as part of a package that also included these animal-related reforms.

fda