Georgia congressman’s bill could reduce animal testing for cosmetics, drugs

Many products that Americans use every day — from makeup to sunscreens — are tested on animals for safety. But experts say the safety data can be gathered using more modern methods that don’t involve furry creatures. And they’re getting support from a bipartisan coalition in Washington D.C. led by a Georgia congressman.

U.S Rep. Earl L. “Buddy” Carter (R-St. Simons Island) is sponsoring the FDA Modernization Act 3.0, which aims to facilitate the development, qualification, and adoption of testing methods that could reduce or possibly even replace the use of animals in nonclinical testing. Carter says the bill will establish clear guidelines for non-animal test methods that hold the potential to deliver results more accurately and quickly, without harm to mice, monkeys, or beagles, which are often used in safety tests.

Animal testing made national news Monday when a company that bred beagles for medical research agreed to pay a record $35 million penalty as part of a criminal plea, admitting it neglected thousands of dogs at its breeding facility in rural Virginia. Prosecutors said Monday that the penalties were the largest ever levied in an animal-welfare case.

“The FDA Modernization Act 3.0 will allow for development of safe, effective treatments and therapies without unnecessary animal suffering,” Carter told The Atlanta Journal-Constitution. “We have a law allowing for animal-free testing methods on the books, and it’s time we put it to use by expanding testing options.”

That older bill — the FDA Modernization Act 2.0 — passed in 2022, also with bipartisan support. FDA 2.0 freed the federal Food and Drug Administration from requiring animal tests — a helpful change because the FDA’s 1938 charter has often required animal testing data before drugs and cosmetics could enter the marketplace. The updated version of the bill would go further, Carter said, by requiring FDA to establish a process to qualify the new testing methods and expedite drug applications that incorporate non-animal approaches. It would also require the FDA to report its progress in those efforts to Congress.

Carter’s co-sponsors are Nanette Barragán (D-CA), Diana Harshbarger (R-TN), and Vern Buchanan (R-FL).

Animal rights groups and companies applauded the effort, while continuing to petition the FDA to move faster in approving non-animal testing methods under the existing 2022 law. They say the new law is necessary because the older law essentially gave the FDA the option to accept non-animal tests, but didn’t explicitly require FDA to give them priority, said Dave Allen, senior director of the International Collaboration on Cosmetics Safety.

“FDA 2.0 opened up the possibility for non-animal tests to be accepted within the agency by altering a definition,” Allen said. “That was seen as a tremendous win from the animal rights community. What it didn’t do was adjust any of the regulations and guidance.” That’s where a new law could help, Allen said, by requiring that the FDA transpose the 2022 law into new regulations, and report back to Congress on its progress.

Kathleen Conlee, vice president of Animal Research Issues at the Humane Society, said animal testing raises both ethical issues and questions around data usefulness. “Animal studies will never provide information that accurately reflects human experience,” she said.

Animal Wellness Action and the Center for a Humane Economy, both of which are lobbying the FDA to adopt alternatives to animal testing, said 90-95% of drugs that pass animal tests go on to fail in human clinical trials.

Conlee hopes Carter’s bill will bring public attention to the issue — a necessary step because, she said, “We are concerned that FDA has walked back its commitment to reduce animal testing.”

The FDA said it supports industry efforts to develop and use alternative methods, but that, given the complexity of some biological tests, alternative testing methods cannot always predict side effects and safety concerns. “Scientists must do more research and validation on alternative testing methods before they can be routinely and more broadly used,” the FDA said.

Carter says the FDA 3.0 bill could see passage before the November elections. If it does, the law would help the U.S. catch up with the United Kingdom, Australia, and the European Union, which have had more limits on animal testing of cosmetics.

“Basically, we did indeed ban animal cosmetics testing in the UK and, later, EU,” Chris Magee, Head of Policy and Media at Understanding Animal Research, said. “These tests were for things like tissue damage caused by cosmetics, because that’s the sort of damage unregulated cosmetics caused — women were blinded by mascara. The tests were a reaction, hoping to prevent a repeat of real-life damage to consumers. By the late 1990s, we had new, non-animal ways to do those particular tests.”

Magee noted that in some cases, however, the EU has asked for animal tests for ingredients that seem to act as endocrine disrupters, like the sunscreen ingredient homosalate.

Still, experts told the AJC, the new, non-animal testing methods hold promise — and could eventually be a boon for Atlanta’s economy, said Shuichi Takayama, who holds the Price Gilbert, Jr. Chair in Regenerative Engineering and Medicine at Georgia Tech.

“The biotech industry is growing but still relatively small in the region,” Takayama said. “On the other hand, Georgia Tech and Emory now have the number one Biomedical Engineering departments in the nation, and there are multiple other significant biotech initiatives in Atlanta and across the state.”

Researchers at Georgia Tech have developed a method for producing organoids — a testing method that organizes cells into small 3D structures that mimic, to an extent, organs — to study breast cancer. University of Georgia’s Zeltner Lab is using a similar technique to study diseases of the peripheral nervous system and the role that stress plays in illness. Georgia Tech has developed a similar organ-on-chip method that cuts test results from hours to minutes, and could be used to study air pollution by mimicking the features of a human lung.

Two companies spun off from research conducted at Georgia Tech — Axion and Lena Biosciences — could be the first of several Atlanta startups focusing on non-animal testing methods, Takayama said. He says Carter’s bill could be helpful for the nascent industry.

“I think regulation will help but broader adoption will require the technologies to be better validated and made more user friendly,” Takayama said.