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The U.S. House has approved the FDA Modernization Act 2.0, which would end the animal testing requirement for new drugs and biosimilars.The bill doesn’t completely ban testing on animals but enables drug developers to use alternatives when feasible.
In September, the U.S. Senate passed the FDA Modernization Act 2.0, S.5002.
The new policy, known as the Reducing Animal Testing Act, was attached to the $1.7 trillion omnibus spending bill.
Before Christmas, Biden vowed to sign the bill as soon as it reached his desk.
Section 3209 of the bill amends the Federal Food, Drug, and Cosmetics Act (FFDCA) to specify “nonclinical tests” instead of “preclinical tests.” It also swaps the term “animal” for “nonclinical tests” and adds new text identifying that “nonclinical tests” may incorporate human-relevant test…