US Senate passes historic bills to curb animal-testing mandates and encourage ethical science

03 Oct 2022 --- The US Senate has passed a five-year legislation that reauthorizes the Food and Drug Administration (FDA) to federally-enforce animal testing alternatives, in what the Physicians Committee for Responsible Medicine champions as “a win for animals and consumers.” At the same time, the Senate dropped a “dangerous” provision that would have hindered state laws from banning animal-tested cosmetics.

In addition, the Senate unanimously passed the FDA Modernization Act 2.0, S.5002 on September 29, allowing for alternatives to animal testing for drug and biological product applications.

“This is the biggest policy development in Congressional history on the fight to replace animal testing with morally and scientifically superior methods,” underscores US Senator Dr. Rand Paul.

On the user-fee legislation, the Physicians Committee states: “This means that California’s groundbreaking 2018 law that bans the sale of animal-tested cosmetics – as well as similar laws in eight other states – will no longer be at risk. More importantly, other states will still be able to pass laws in the future to ban the sales of cosmetics tested on animals.”

Overall, the reauthorization gives the FDA authority to implement user-fee programs for certain drugs and devices, establish requirements to increase the diversity in clinical trials and modify provisions relating to the overall supply chain. The Physicians Committee was a co-sponsor of the first state law banning the sale of cruelty-free cosmetics, signed into law in 2018.

Physicians Committee lauds progress
The Physicians Committee for Responsible Medicine is a nonprofit organization of over 17,000 doctors. It shares that since the user-fee bill’s introduction in June, it has led a campaign to encourage the public to write, call and meet with members of Congress. This development resulted in thousands of messages to legislators urging animal testing to be removed from the FDA user-fee bill.

“Painful and unnecessary tests on animals in the cosmetics industry need to be stopped, and we must protect consumers’ rights to ban these tests in the future,” says Kristie Sullivan, MPH, VP of research policy for the Physicians Committee for Responsible Medicine.

“It is a moral imperative that we advance ethical science while protecting animals from the cruelties of animal testing,” adds Andrew Binovi, master of public policy, director of government affairs for the Physicians Committee.

“The Physicians Committee appreciates the Senate advancing the FDA bill without the provision. We look forward to working with our Congressional allies to prevent the harmful cosmetics provision from returning to the Senate floor after the election in November.”

User-fee supports alternative tests
The H. R. 7667 Act amends the “Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products and other purposes.”

Under research, development, and supply chain improvements of the H. R. 7667 Act, amendments are to be made to encourage “nonclinical tests” instead of animal-based – that means a “test conducted in-vitro, in silico, or in-chemico, or a nonhuman in-vivo test, that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug.”

Examples include cell-based assays, organ chips and microphysiological systems, computer modeling, other nonhuman or human biology-based test methods and animal tests.The amendments in H. R. 7667 Act encourages “nonclinical tests” instead of animal-based tests.

Modernization Act
Dr. Paul says that the FDA Modernization Act 2.0 will accelerate innovation and get safer, more effective products to the market by removing animal testing that is not supported by current science.

“The passage of this bipartisan bill is a step toward ending the needless suffering and death of animal test subjects – which I’m glad both Republicans and Democrats can agree needs to end.”

“[This is] a major step toward enacting a policy that could dramatically reduce testing on dogs, primates, and other animals in the years ahead,” shares Animal Wellness Action. It is expected to eliminate the federal mandate for animal testing for new drugs.

Animal testing updates
In related news, South Korea’s Ministry of Food and Drug Safety introduced an amendment to its biological standard and test method guidelines to remove the requirement for abnormal toxicity tests. Although the country banned animal testing for cosmetics in 2018, the abnormal toxicity test left loopholes open.

Meanwhile, the EU petition to ban animal testing recently closed at 1,413,383 signatures, demanding an end to animal testing.

In August, the American Chemical Society highlighted that the FDA was wholly evaluating its animal testing requirement.

By Venya Patel

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