The FDA Modernization Act is a Key Part of the Solution
Deeply disturbing images and descriptions of ghastly tests on beagles — intentionally infecting them with parasites to test a vaccine in one experiment, cutting their vocal cords to reduce decibel levels because beagles vocalize pain in a separate laboratory exercise, and euthanizing the animals in both protocols — have prompted Congressional lawmakers to demand answers from the National Institutes of Health (NIH). Prompted by sleuthing from White Coat Waste, the lawmakers are rightfully angry about the use of government dollars to fund this needless torment of dogs.
But it’s not just that government officials are using our tax dollars in ways that undermine our values about common decency, it’s that the law requires this kind of animal sacrifice. In short, the government mandates the use of extraordinary numbers of animals — including dogs and primates — for any kind of drug development. Specifically, the U.S. Food and Drug Administration (FDA) demands that any NIH funding for preclinical pharmacology and toxicology safety and efficacy testing for drugs or vaccines involve the use of animals under the legal dictates of the Federal Food Drug and Cosmetics Act (FFDCA) of 1938.
The reality is, these poor beagles, and countless other animals, are caught up in an ossified and even barbaric legal framework that conscripts them for use as experimental tools. Our response to the crisis should not just be to condemn individuals and institutions involved in calculated abuses, but to also seek an upstream solution and to change the legal requirements that produce these sorts of outcomes.
The good news is there’s a policy solution in the waiting. We are ready to go. It’s the FDA Modernization Act.
That bill, H.R. 2565 and S. 2952, seeks to eliminate a Depression-era statutory mandate for animal testing for any new drug development protocol. And the especially good news is, we have an all-star team of lawmakers working on it. Representatives Vern Buchanan, R-Fla., Elaine Luria, D-Virg., Nancy Mace, R-S.C., Mikie Sherrill, D-N.J., and Brendan Boyle, D-Pa. introduced the House measure, and Senators Rand Paul, R-Ky., Cory Booker, D-N.J., Mike Braun, R-Ind., Ben Ray Lujan, D-N.M., and John Kennedy, R-La., pushed ahead on the companion bill.
The legislation does not seek to settle the debate over animal testing, but to apply the widely accepted view that where alternative methods exist, they should be used. It’s not a controversial notion, and it’s enshrined in the broad accept of the “3Rs” approach – Reduction, Refinement, and Replacement — developed more than a half century ago by Drs. William Russell and Rex Burch and described in their book, Principles of Humane Experimental Technique.
In recent decades, almost all major research organizations, pharmaceutical companies, academic institutions, and even government agencies have embraced the principle. But it’s the application of that principle that has been more difficult.
If you don’t want NIH to fund animal experiments, the FFDCA must be updated to allow for the use of 21st-century technology. FDA requires that this invasive and painful testing happen to “rodent” and “non-rodent” species for every single new drug submitted for review to the FDA. Beagles are often the subjects for the non-rodent phase of testing. Non-human primates are also used, but costs and supply issues prompt the experimenters to opt for beagles more frequently. Their passive, gentle dispositions means that they don’t squirm or resist as they are subjected to the agonies of the day.
The FDA’s claims that it doesn’t “require testing on dogs” doesn’t reflect the reality that dogs are the species of choice to fill the non-rodent testing requirement. According to the USDA Animal Usage Report for 2019, there were nearly 60,000 dogs used in experiments in 2019, and the use of dogs in drug development is a big chunk of that.
While their sweet disposition makes them appealing when it comes to their behavior in a laboratory, they are not particularly good “models” when it comes to human disease. An analysis of the most comprehensive quantitative database of publicly-available animal toxicity studies suggests that dogs are highly inconsistent predictors of toxic responses in humans, and that the predictions they can provide are little better than those that could be obtained by chance – like tossing a coin.
Requiring drug sponsors to submit reams of loosely relevant animal testing data before investigational drugs are used in human trials slows down the drug development process and leads to remarkable failure rates, long waits for treatments, and high drug prices.
- The data reveal that 19 out of 20 drugs found safe in animal tests then fail in human clinical trials.
- It takes an average of 10 to 15 years to bring a new drug to market and costs $1 to $6 billion.
- Estimates suggest that, relative to in vitro non-animal models, animal testing is 1.5- to 30-times as expensive.
Many drug developers don’t want to continue to operate this way, with this sort of government requirement that forbids them from using superior alternative methods that could bring more reliable results for safety and efficacy testing.
The European Parliament voted in September to phase out animal experiments and invest in Non-Animal Methods (NAMs) centered on human biological responses. The FDA Modernization Act, by eliminating an animal-testing requirement that predates World War II, would put us on a better path to adhere to the widely accepted 3Rs approach and allow government and private industry to apply anti-cruelty principles in their conduct of science and our public health imperatives.
This is our chance to end unnecessary animal testing in drug development in America. TAKE ACTION using our secure form to contact your Members of Congress and encourage them to co-sponsor the FDA Modernization Act of 2021.
Additionally, securing protections like this for animals in the halls of Congress requires significant resources. So please, donate $25, $50, $100 or whatever you can to help us get this important legislation across the finish line!