FACT Act Won’t Measure Progress on Alternatives

The American Physiological Society has written to more than 60 U.S. Representatives concerning their support for the Federal Accountability in Chemical Testing Act (H.R. 816). The stated purpose of this bill is to encourage federal agencies to enhance their efforts to adopt non-animal methods of testing for toxic effects of drugs, chemicals, and other substances. H.R. 816 proposes to do this through increased monitoring of the agencies. Specifically, it would require government agencies to submit biannual progress reports with the number of animal and non-animal toxicology tests they conducted, supported, or required industry to conduct for regulatory purposes. This would affect not only regulatory testing required by agencies such as the FDA and EPA, but also discovery research conducted and/or supported by the NIH, CDC, and VA.

In the letter to the bill’s sponsor, Rep. Ken Calvert (R-CA), APS President Dennis Brown pointed out that H.R. 816 “will not promote animal welfare because researchers are already required to consider whether animal tests can be replaced by alternatives that involve less pain and distress.” Brown also made the case that tallying the number of animal tests conducted annually will not measure progress towards the adoption of alternatives since the number of tests required is also influenced by other factors. These include research funding levels; what current research priorities are; and whether validated alternatives are available to test the particular drugs or chemicals under consideration. Because there are so many confounding variables, the reports proposed under H.R. 816 will serve no useful purpose.

Requiring agencies to undertake massive and burdensome data collection that does not enhance animal welfare is the kind of administrative burden Congress sought to reduce through the 21st Century Cures Act. “This legislation would hamper efforts to assess the safety and effectiveness of new drugs not only when companies submit these compounds for regulatory approval, but even at the earliest stages of drug discovery when such research is typically funded by the National Institutes of Health,” Brown wrote. He concluded by urging Rep. Calvert and the other co-sponsors of H.R. 816 to withdraw their support for the legislation.

Related Items

APS Letter on the FACT Act

APS letter to Rep. Ken Calvert (R-CA) about the The Federal Accountability in Chemical Testing (FACT) Act, which aims to encourage non-animal methods of testing and research but would not effectively result in improved animal welfare.

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