Congress must enact the FDA Modernization Act. Our nation cannot rescue our way out of drug-approval system that runs through a million animals a year.
Washington, D.C. — The news about the rescue of thousands of beagles abused in a breeding facility in Virginia underscores that Congress must eliminate the federal animal-testing mandate for new drugs and pass the FDA Modernization Act, S. 2952 and H.R. 2565. That bipartisan legislation, led by Senators Rand Paul, R-Ky., and Cory Booker, D-NJ, and Reps. Vern Buchanan, R-Fla. and Elaine Luria, D-Va., has passed the House as a rider to a larger FDA funding bill, and it also has been included in a similar bill passed by the Senate HELP committee. The FDA Modernization Act will enable the transition to non-animal test methods to test the safety and efficacy of new drugs and vaccines.
Every year, perhaps more than a million animals, including tens of thousands of beagles and primates, are conscripted for safety and effectiveness tests for new drugs. Even before they got to a lab, beagles were left in their own filth, underfed, ill, injured and, in some cases, dead at just one facility run by Envigo, according to a major PETA investigation. That breeding facility supplies dogs to pharmaceutical companies, universities, and other testing operators that the FDA requires them to use.
“The removal and forthcoming adoption of thousands of beagles from a testing lab is a startlingly good outcome for animals certain to face torment and doom,” said Wayne Pacelle, president of Animal Wellness Action and the Center for a Humane Economy. “But that kind of rescue is a first-ever kind of event and rarely replicable. That’s why it’s crucial for the House and Senate to complete work on a legislative package that includes a provision to eliminate an archaic animal-testing mandate that drives this trade in beagles and other animals. We will never be able to rescue more than a million animals a year conscripted into drug development protocols, and that’s why Congress must pass the FDA Modernization Act.”
The mistreatment of beagles, wild primates, and a wide range of other species is the hidden backstory for our drug development programs. The Federal Food, Drug and Cosmetics Act of 1938 mandates animal testing for every new drug development protocol. The requirement exists even though animal tests are not necessarily predictive of the human response to drugs. 95% of drugs entering human clinical trials fail after passing muster in animals. What’s more, data show that it typically takes 10 to 15 years and an investment of an average of $1 billion and up to $6 billion for a new drug. This antiquated process of pharmaceutical innovation slows delivery of palliatives and cures for patient groups, drives up drug costs, and sacrifices countless animals.
The U.S. Senate HELP Committee passed the FDA Modernization Act as a rider to a larger package of FDA-related reforms (Section 501 of S. 4348). Just days before, the U.S. House of Representatives overwhelmingly passed its FDA legislative package in a landslide vote of 392-28, and the FDA Modernization is included as a rider in that legislation, too. The FDA Modernization Act would be a transformative policy for animals and for drug approval in the United States.
Now, U.S. Senator Richard Burr, R-N.C., the ranking member of the Senate HELP committee, has introduced substitute legislation that would omit the FDA Modernization Act from the must-pass FDA funding bill — a maneuver to maintain the mandate for animal testing for drug development protocols. The substitute legislation strips all riders from the bill, leaving just the funding package for FDA. Senator Burr’s action will block key reforms of FDA and keep the status quo when it comes to animal testing. Just last week, the Congressional Budget Office estimated that the Senate version (S.4348) that passed through the HELP committee, would reduce the Federal deficit by 1.4 billion over 10 years. Senator Burr’s stripped-down version would eliminate most, if not all the cost savings.
“We can apply human biology-based test methods to better predict how humans will respond to drugs in clinical trials,” said Tamara Drake, director of research and regulatory policy at the Center for a Humane Economy. “We are already on the verge of the next phase of modern drug development, and the continued use of animals where there are better predictors of human response obstructs scientific advancement and progress for treatments for human diseases. FDA modernization will be the catalyst for this transition to modern science.”
AWA and the Center worked with key lawmakers in the House and Senate to advance the FDA Modernization, and have built a coalition of 150 medical associations, biotech companies, patient advocacy organizations, and animal welfare organizations that back the legislation. PETA is among the supporters of the FDA Modernization Act.