13 bipartisan lawmakers demand FDA set guidelines for animal-free drug testing methods


A group of 13 bipartisan lawmakers just sent a letter of request to Robert Califf, MD, Commissioner of the Federal Food and Drug Association (FDA) of the United States. In it, lawmakers ask the FDA to establish clear guidelines for drugmakers to meet regulatory approvals using animal-free testing methods. While the FDA has made progress toward approving animal-free methods of developing new drugs, it has yet to pave the way toward regulatory approval for companies unwilling to engage in cruel testing. , obsolete and ineffective on animals.

The formal notice comes after Califf, a cardiologist, spoke before the House Appropriations Committee in May about the FDA’s 2023 fiscal budget during which he mentioned the need to reduce animal testing methods. In March, the FDA requested $8.4 billion for its operations in fiscal year 2023, including $5 million for its New Alternative Methods program, which it said would “drive the adoption of alternative methods.” for regulatory use that can replace, reduce and refine animals. test.”

And while it appears the FDA is moving toward animal-free testing methods, animal rights groups, including taxpayer watchdog group White Coat Waste Project (WCW), have found the testing to be grueling. on animals in recent years, which lawmakers point out as contradictory in the letter of formal notice. “The FDA appears to be sending mixed messages about animal testing requirements,” the letter said. “For example, the FDA has stated that it ‘does not require that human drugs be studied in dogs.’ On the other hand, the National Institutes of Health (NIH) and private companies have argued that the FDA required them to perform tests on dogs.

In the letter, the lawmakers point Califf to a statement made by the FDA in a footnote to the document that indicated its intention to work with drugmakers who choose to use non-animal testing methods, but do not have not defined how these procedures would take place to really encourage the replacement and reduction of animal testing with alternative methods.

“To eliminate unnecessary government-mandated animal testing and facilitate greater use of modern alternative methods, we call on the FDA to develop and publish guidance for industry on how alternatives to animal testing may be used to meet regulatory requirements,” the letter reads. “Further, we are asking the FDA to detail a transparent process by which sponsors can engage with the agency on this issue and obtain approval for non-animal testing methods.”

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Animal testing in the pharmaceutical industry

The notice to the FDA comes after years of campaigns and investigations by WCW. As part of its #CutFDARedTape campaign, WCW has made strides in exposing unnecessary animal testing – both in terms of wasted animal lives and taxpayer dollars – and pushing government agencies to adopt models of animal-free experiment. With its 2021 “Broken Bureaucracy” report, WCW exposed countless acts of unnecessary cruelty by drugmakers seeking FDA approval over the years, including some NIH-funded tests. which included force-feeding puppies, barking dogs while cutting their vocal cords, and injecting animals with cocaine.

The new FDA demand letter heavily references WCW verbiage regarding the need to end animal testing in the pharmaceutical industry and among its 13 signatories are Rep. Dina Titus (D-NV) and the Rep. Brian Mast (R-FL) – both WCW Waste Warrior winners who recently met Beesly, a beagle survivor of pharmaceutical industry animal testing.

“Drugmakers and taxpayer-funded federal agencies should not be forced by white coat regulators to waste time and money poisoning, barking and killing puppies in outdated tests while alternatives more efficient and cost-effective ones are available,” Justin Goodman, WCW’s senior vice president of advocacy and public policy, said in a statement. “We applaud Representatives Titus and Mast for leading bipartisan efforts to cut FDA red tape on animal testing and make it easier for companies and government agencies to avoid unnecessary animal testing.”

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Remove animals from labs for good

Over the years, WCW has helped push other agencies to reduce animal testing, including the Environmental Protection Agency (EPA) which announced in 2019 that it would cut funding for all mammalian toxicity experiments by 2035, with a 30% reduction. in funding by 2025. Instead, the organization aims to spend $4.25 million on researching and developing tests that don’t involve animals.

WCW also advocates for the protection of animals, like Beasly, who survive animal testing. In 2020, after pressure from WCW, the FDA enacted its first policy that allows animals used in lab experiments to be adopted by shelters or sanctuaries after testing is complete. Previously, all animals used for experiments were euthanized with no chance of survival. Under the new policy, the FDA will remove healthy dogs, cats, guinea pigs, rabbits and certain farm animals. A similar policy has been adopted by the Department of Veteran Affairs and the NIH.

The policy follows a 2018 rescue of 26 squirrel monkeys from nicotine testing labs, which the FDA cleared for release — marking the first time it has removed primates from its labs — after pressure from the WCW.

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