Congress Set to End FDA Mandate on Animal Testing – News

organ chip

Photo courtesy of Wyss Institute for Biologically Inspired Engineering, Harvard University

The 2022 FDA Modernization Act would eliminate the requirement that all drugs being developed for humans must first be tested on animals. Possible alternative test tools are silicon microchips that mimic the structure and function of organs. The chips are embedded in hollow tubes lined with human organ cells and through which nutrients, blood, drugs and the like can be pumped.

For nearly 84 years, federal food, drug, and cosmetic law has required that any drug intended for use in humans be tested on animals before clinical trials in humans. That mandate could be overturned this summer if Congress passes a set of reforms to the US Food and Drug Administration as planned.

The law does not prohibit animal testing. On the contrary, it allows the use of alternatives – such as organ chips that recreate the physiology of the human body in a microchip – which would be better than animal models for evaluating the safety and efficacy of drugs in humans. ‘man.

“Our drug development paradigm needs a reboot, and this bill takes us in that direction in a simple yet meaningful way,” said Rep. Vern Buchanan of Florida, lead sponsor of the Modernization Act. the FDA of 2022 in a press release. “Animal testing, for the most part, is not predictive of human response to drugs, with very high failure rates when drugs are put through clinical trials.”

Introduced in the Senate and House as stand-alone bills, the FDA Modernization Act was later added by leaders of both chambers’ health committees as amendments to larger pieces of legislation related to the FDA. These larger bills are considered inescapable because they contain provisions that update and reauthorize user fees paid by pharmaceutical companies that account for 45% of the FDA’s budget. If the charges aren’t reauthorized by mid-August, the agency could start sending furlough notices to employees. Pre-authorization expires September 30.

Strong bipartisan support carried HR 7667 to the House on June 9 by a vote of 392 to 28. The related Senate bill, S. 2952, was approved by the Senate Committee on Health, Education, work and pensions on June 14 by a vote of 13 to 9. .

“Morally and scientifically superior”

A host of animal welfare groups, biotech companies, medical associations and patient advocacy organizations have endorsed the legislation.

Wayne Pacelle, president of the advocacy group Animal Wellness Action and a supporter of the FDA Modernization Act, said the strength of the legislation is that what’s good for animals is also good for public health.

“Between 90% and 95% of drugs found to be safe in nonclinical testing fail in human clinical trials due to toxicities not predicted by animal testing or due to lack of efficacy,” Pacelle said.

These failures hamper research, prolong timelines, increase costs for drug developers, and discourage research into drugs for rare diseases. Adopting new non-animal testing methods, Pacelle said, will speed up development times, provide more reliable results and reduce failure rates.

Proponents of the bill also believe that removing the animal testing requirement will further fuel the development of human-based biological alternatives such as organ chips and foster greater acceptance of what Pacelle calls biochips. “morally and scientifically superior” testing methods.

The legislation follows developments by the FDA, which is investing more resources and continuing to research alternatives that eliminate the need for laboratory animals or reduce their numbers.

Dr. Michael Nance, a Texas zoo veterinarian, voiced his support for the decision in response to a 2019 VIN News Service report on an FDA effort to reduce animal testing, including when drugs in development courses are intended for animals of the same species.

Posting on a message board for the Veterinary Information Network, an online community for the profession and parent of VIN News, Nance wrote:

“None of us are comfortable with the idea of ​​100 green iguanas being X-rayed, monitored and evaluated for physiological and clinical response, euthanized and histologically examined, etc., to determine a drug. or a safe method to treat disease, pain, whatever, [with] [t]results apply directly only to iguanas with similar reporting and breeding [and] [s]hopefully somewhat applicable to the majority of green iguanas. And perhaps extrapolable to other iguanids, and less to other lizards, and even more to other reptiles.

“It’s better than nothing, of course, but the 100[s] (or thousands) of experimental green iguanas might have a different opinion if they could voice their opinion.

FDA’s budget request for the fiscal year that begins Oct. 1 includes funding for a comprehensive strategy for alternative methods of product testing “…to reduce animal testing through the development of qualified alternative methods and drive adoption of methods for regulatory use that can replace, reduce and refine animal testing,” also known as the 3Rs.

The 3Rs are a human framework for animal experimentation developed by William Russell, a zoologist, and Rex Birch, a microbiologist, in the 1950s, and since then widely adopted by academia, industry and government. They are:

  • replacement: avoiding or replacing the use of animals, such as by computer models
  • reduction: use as few animals as possible to obtain enough data
  • refinement: modification of husbandry and procedures to minimize pain and distress to laboratory animals

Under current FDA rules, it is impossible to completely avoid using animals.

There is no definitive count of animals used in drug testing each year, according to Pacelle. He explained that some species, such as mice and rats, should not be counted, and those that are counted are not categorized by type of test, such as drug development versus chemical or cosmetic testing.

“Estimates are made of between 50 and 100 million animals used each year worldwide, and the use of animals for drug testing is the lion’s share,” Pacelle said. “The US total could be half of that global figure.”

What is known is that in 2019, more than 58,000 dogs and 68,000 non-human primates were used in regulated animal research facilities, according to an annual report from the United States Department of Agriculture, which also counted cats, guinea pigs, hamsters, pigs, rabbits and sheep.

Given these figures, some believe that the current measure does not go far enough.

“Some people want to see a ban on animal testing,” Pacelle said. “We made the decision not to go for this because animal testing has been the construction for a long time, and regulators and drug developers must gradually move away from this strategy.He added that the expansion of human biological testing systems will go a long way to reducing the number of animals used in experiments, even without a ban.

The two FDA reform packages diverge on some provisions, so once the Senate passes its version, it will need to be reconciled with the House version. Some items may be revised or disappear from the final invoice.

Pacelle said the testing provision was unlikely to be dropped, as the wording is similar in both bills and has broad support.

VIN News Service Commentaries are opinion pieces featuring ideas, personal experiences and/or views on current issues by members of the veterinary community. To submit a comment for review, email [email protected]

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