Groups Petition FDA to Mandate Non-Animal Testing

Washington, D.C.—California-based In Defense of Animals, (IDA) is an initiator and core member of an international coalition that filed a Citizens’ Petition with the U.S. Food and Drug Administration (FDA) this week, asking the agency to emulate the European Union regulations that require the use of existing high-tech, non-animal test methods for drug safety assessment. The Mandatory Alternatives Petition, called MAP, is also supported by over one hundred scientists, doctors, and health experts.

Modern techniques such as combinatorial chemistry, high-throughput screening, DNA microarrays and molecular modeling are used in drug development, but it is current FDA policy to require an animal testing phase before pharmaceuticals can be approved and marketed.

The FDA itself reports that 92% of drugs that tested safe in animals fail in human trials due to species differences. Statistics show that there are more than 100,000 deaths from adverse drug reactions annually in the U.S. Recently, Vioxx, a drug that successfully passed the animal testing phase, has been shown to be the likely cause of thousands of deaths in the U.S. alone.

“It’s time for the FDA to end its decades-long animal testing mandate. These tests are not only lethal to dogs, cats, monkeys, mice and other animals in laboratories, but do nothing to assure safety in humans. Along with the increasing number of new pharmaceuticals, we’re seeing an increase in human deaths.” states Dr. Elliot M. Katz, a veterinarian and President of IDA. Katz notes that the EU mandates the use of human-centered alternatives, such as microdosing, where those alternatives are available. “Every effort should be made by the FDA to advance and validate drug testing methods from archaic, cruel and unreliable animal tests to scientifically sound and humane methods.”

The 66-page Citizens’ Petition, a six-page Executive Summary and a list of supporters can be accessed at www.alternatives-petition.org. The FDA has 180 days to respond to the petition.