FDA, NIH unveil new rules to reduce animal testing in drug development

Ed’s stories explore prescription drug pricing, affordability and access, as well issues surrounding patents, litigation, and legislation. He is also the author of the morning Pharmalittle newsletter and the afternoon Pharmalot newsletter.

For the second time this year, the Department of Health and Human Services announced a new set of strategies to speed a shift toward human-based research methods and reduce the use of animals in medical testing.

The Food and Drug Administration issued a final rule stating that research methods other than animal testing can be used when “appropriate” for determining the safety of drugs and biologics. Specifically, the rule replaces terms like “animal tests” and “animal studies” with “nonclinical tests” and “nonclinical studies.”

“We are moving HHS toward a new era of biomedical research that puts human biology at the center of science,” health secretary Robert F. Kennedy Jr. said in a statement. “We are modernizing outdated regulations, investing in human-based technologies, and breaking down barriers that have kept researchers dependent on animal models when better tools are available.”