Luján Introduces Legislation to Reduce Animal Testing
Washington, D.C. – This week, U.S. Senator Ben Ray Luján (D-N.M.) introduced The Reducing Animal Testing (RAT) Act to remove the requirement for animal studies in the approval specific biosimilar drug applications. This change reduces unnecessary animal testing, maintains patient safety, and reduces regulatory burdens of bringing lower cost, biosimilar drugs to market.
Robust scientific evidence states that animal models do not provide necessary information in the determination of safety and effectiveness for biosimilar drugs. The legislation would remove this requirement and save needless animal testing while maintaining the FDA’s ability to fully assess the safety and effectiveness of biosimilar drugs.
Biosimilars are generic versions of biologic drugs. The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was passed as part of the Affordable Care Act that President Obama signed into law on March 23, 2010. The law created an abbreviated licensure pathway for biosimilar products and requires the applicant submit three things to prove 1) analytical studies, 2) clinical studies, and 3) animal models. Scientific research has found that the first two are sufficient, and animal models are not necessary in this application process.
“Saving animals lives and getting lower-cost biosimilars to the market, while maintaining patient safety is an all-around success,” said Senator Luján. “That’s why I’m introducing the RAT Act to eliminate this testing requirement for animals and stop these needless experiments in areas that are not producing useful results. I look forward to continue working with my Senate colleagues to ensure animals are protected and respected for generations to come.”
Full text of the legislation can be found here.