A bipartisan group of lawmakers accused the Food and Drug Administration (FDA) of “poisoning puppies to death” in an April letter obtained by the Daily Caller.
Led by Democratic Pennsylvania Rep. Brendan Boyle, the group of ten lawmakers calls for the Government Accountability Office (GAO) to conduct a study on FDA testing requirements that frequently lead to the needless abuse of animals. “We are concerned that the FDA’s failure to develop and implement clear and robust policies on the use of alternatives to animal testing continue to contribute to unnecessary animal use, wasted time and money and stymied medical progress,” the letter reads.
Around 20,000 dogs are used in medical testing each year due to an outdated FDA mandate requiring animal testing for drug approval, according to a new report from government watchdog White Coat Waste (WCW). Thousands of them are killed in the process, and critical new drugs sometimes fail the unnecessary animal testing phase despite exhibiting effectiveness in humans, the report stated.
Puppies under the age of one year are most commonly used in the disturbing tests described in the WCW report. Some of the uncovered studies involved force-feeding puppies experimental drugs and covering their mouths to prevent regurgitation. Deaths reportedly occurred due to “human error” such as incorrect dosing and reactions to drugs including dehydration, paralysis, foaming at the mouth and bleeding in the heart.
“Our first-of-its-kind analysis in Broken Bureaucracy details how century-old FDA red tape is still coercing companies to force feed thousands of puppies massive amounts of experimental drugs and, in some cases, literally tape the dogs’ mouths shut to keep them from expelling the deadly doses,” said White Coat Waste vice president of advocacy and public policy Justin Goodman.
Some lawmakers have thrown their support behind the Alternatives to Animals for Regulatory Fairness (AARF) Act, which would compel the FDA to allow for alternate trial methods that don’t involve dangerous animal testing. (RELATED: Scathing Report Reveals Numerous Safety And Sanitary Failures At Johnson & Johnson Vaccine Plant)
“Unnecessary testing on dogs and other animals is cruel and inhumane, and it’s time to stop this!” said Republican Florida Rep. Maria Elvira Salazar. “The United States has the most advanced drug testing technology in the world, and I’m supporting the bipartisan Alternatives to Animals for Regulatory Fairness (AARF) Act to provide relief to companies that want to use high-tech alternatives to fulfill FDA’s requirements.”
“It is unnecessary and cruel for the FDA to mandate animal testing on dogs when there are other, better alternatives available. I am proud to sponsor the AARF Act to put an end to needless animal testing and allow drug makers to pursue humane solutions for testing that will improve animal welfare while also saving valuable time and money,” said Republican Pennsylvania Rep. Fred Keller.
Opponents of the FDA mandate argue it isn’t only harmful to dogs. Pharmaceutical R&D costs could be reduced by as much as 26% by allowing the use of newer alternatives to animal testing, according to one study. In some instances, promising drug development is derailed by the cumbersome animal testing requirements.
“This heavy-handed bureaucracy has continued for decades even though companies would prefer to use modern alternatives that are more accurate and cost-efficient,” said Goodman.
One such example occurred when Vanda Pharmaceuticals refused to spend nearly $1 million to force-feed puppies a new drug every day for nine months, before killing and dissecting them. The FDA forced Vanda to cease trials of the drug, Tradipitant, which now shows promise as a potential COVID-19 treatment. (RELATED: FDA Has Delayed Approval Process For Promising Cancer Drug For Months Because Of COVID)
“Experiments on dogs are a massive waste of resources, especially when companies would rather use superior research technologies like human organs-on-chips to model diseases and test drugs,” said University of California San Diego professor of pathology and neurosciences Lawrence Hansen.
The government’s own data indicates that 95% of drugs that pass the animal testing phase never receive full approval. “This vast disconnect between scientific evidence and archaic FDA drug testing regulations reliably wastes billions of dollars every year, sets back medical progress, and prolongs the suffering of those desperate for relief,” said Hansen.
FDA is committed to fostering innovation. As part of this commitment, we are working to develop new regulatory tools that can help improve predictivity and potentially replace, reduce and/or refine animal testing in medical product development.
— Dr. Stephen M. Hahn (@SteveFDA) January 5, 2021
FDA leadership has committed in the past to reforming animal testing practices. For instance, several COVID-19 drugs were allowed to advance to human trials without waiting for animal testing results, according to WCW. The agency has also invested in new alternatives to animal testing.
But advocates say not enough progress has been made. “In many cases, FDA-mandated animal tests literally entail poisoning puppies to death … the FDA has made various public commitments to reduce animal testing required to fulfill drug safety requirements. Unfortunately, both then and now, government studies and other reports indicate that unclear laws, regulations, guidance and red tape have generated ambiguity in the regulated community about what animal testing is and is not required,” read the letter from lawmakers. (RELATED: Dems Pressure FDA To Loosen Restrictions On Abortion Pill, Citing ‘Deadly Pandemic’)
“We are concerned that there is not a well-defined and transparent process by which the FDA reviews and approves existing and newly developed alternative methods for regulatory use … As a result, companies often undertake needless animal testing that wastes time, money, animals’ lives and slows innovation.”
Signees of the letter include Republican Florida Rep. Bill Posey, Republican New Jersey Rep. Jeff Van Drew, Democratic Massachusetts Rep. Richard Neal, Democratic Kansas Rep. Sharice Davids, Democratic Massachusetts Rep. William Keating, Democratic Michigan Rep. Elissa Slotkin, Democratic California Rep. Karen Bass, Democratic Texas Rep. Lizzie Fletcher and Democratic Illinois Rep. Jesus Garcia.
“The FDA does not require that animals be used to demonstrate safety and efficacy,” an agency spokesperson told the Daily Caller. “The FDA is committed to doing all that it can to reduce the reliance on animal-based studies.”