End To FDA's Animal-Testing Mandate Gets Bipartisan Support In RivCo

RIVERSIDE COUNTY, CA — An end to the U.S. Food and Drug Administration's longstanding mandate of using animals for the development of human drugs may be nearing, and lawmakers from Riverside County have signed off on it.

With overwhelming bipartisan support, Wednesday night the U.S. House of Representatives passed the Food and Drug Amendments of 2022, H.R. 7667, which includes "Section 701: Animal Testing Alternatives." The section identifies other drug-testing means that manufacturers could employ to prove the safety and efficacy of their products, including cell-based assays; organ chips and microphysiological systems; computer modeling; and other nonhuman or human biology-based test methods. Animal testing would remain as an alternative, according to the legislation.

The vote on H.R. 7667 was 392 to 28. There were 215 Democrats and 176 Republicans who favored the legislation, and 28 Republicans who opposed it. All U.S. Representatives from California who cast votes were in favor, including Reps. Ken Calvert (R-Corona), Raul Ruiz (D-Coachella Valley), and Darrell Issa (R-Temecula).

The Senate Health, Education, Labor and Pensions Committee has released its own FDA reform package that includes similar language regarding alternative testing models.

“Leaders of the House and lawmakers from both parties, recognize that the United States must lift an archaic animal-testing mandate for drug development and replace that strategy with 21st-century methods grounded on human biology,” said Wayne Pacelle, president of the nonprofit Animal Wellness Action. “This is the biggest policy development in Congressional history on the fight to replace animal testing with morally and scientifically superior methods.”

According to Pacelle, the legislation has the potential in the coming years to prevent the use of millions of animals to deliver safer, more effective drugs to human patients in need of treatments.

The U.S.'s drug development paradigm, framed by the Federal Food, Drug, and Cosmetics Act of 1938, relies on animal tests for safety and efficacy evaluation. A news release from Animal Wellness Action claims the process is cruel, outdated and costly.

"Data show it typically takes 10 to 15 years and an average investment of $1 billion and up to $6 billion for a new drug," according to the release. "Animal tests are non-predictive of the human response to drugs, failing in 95 percent of cases when they go to human clinical trials. This antiquated process of pharmaceutical innovation slows delivery of palliatives and cures for patient groups, drives up drug costs, and sacrifices countless animals, including mice, rats, dogs, and non-human primates."

"Our drug development paradigm needs a reboot, and this bill moves us in that direction in one simple but meaningful way,” said Rep. Vern Buchanan, R. Fla., who was the lead author of the FDA Modernization Act, H.R. 2565, that was introduced in 2021. “Animal tests, in large part, are not predictive of the human response to drugs, with very high failure rates when the drugs go to clinical trials."

A Southern California doctor and a social welfare activist, who recently announced a $25,000 reward for the arrest and conviction of the person responsible for shooting an arrow through a Chihuahua's neck in Riverside County, weighed in on using "more predictive" models other than just animal testing.

“The most predictive technologies in existence should be available to drug sponsors to provide the safest and most effective medicines for patients,” said Gary K. Michelson, M.D., founder and co-chair, Michelson Center for Public Policy.

Rep. Nancy Mace (R-S.C.) said passing the updated legislation "is a significant step forward for not only the animal welfare community but researchers who have been forced for decades to rely on antiquated, burdensome animal testing mandates. I look forward to this landmark legislation being signed into law to reduce waste, save animals' lives, and streamline potential lifesaving medication for patients.”

The legislation will now move on to the U.S. Senate.