Senate unanimously approves bill to 'replace outdated animal testing,' still awaiting House

The phaseout of animal testing in federally funded research moved one step closer to completion with the Senate's unanimous approval of the FDA Modernization Act 3.0 (S-355) on Tuesday.

The one-page bill requires the secretary of health and human services, "acting through the Commissioner of Food and Drugs, to publish a final rule relating to nonclinical testing methods" within one year, becoming "immediately effective" upon publication, that replaces "any references to 'animal' tests, data, studies, models, and research with a reference to nonclinical tests, data, studies, models, and research."

It's one of the more bipartisan bills to make it through the chamber, sponsored by Sen. Cory Booker, D-N.J., and several other Democrats and Republicans, notably the Senate's strongest libertarian-leaning Republican, Kentucky's Rand Paul. The House companion (HR-2821) hasn't left committee but had two hearings in July.

"It has been nearly three years since Congress eliminated the legal requirement that animal testing be conducted as part of the new drug development process," and the new bill will "help lock in these reforms, ensuring that FDA regulations mirror current law and reflect the best available science ... while reducing unnecessary animal suffering," Booker said in a statement circulated by Animal Wellness Action and Center for a Humane Economy. 

The bill builds on the so-called 2.0 legislation, "ensuring that modern, humane, and scientifically advanced testing methods can finally replace outdated animal testing," Paul said in the same statement. "For too long, bureaucratic inertia has delayed the implementation of these changes, which are vital to saving lives, reducing costs, and bringing life-saving treatments to patients more efficiently."

Animal Wellness Action and Center for a Humane Economy cheered the bill's passage, and the groups' praise of Food and Drug Administration Commissioner Marty Makary's "visionary leadership" stands in contrast to pro-life groups' anger at Makary for allegedly slow-walking promised research on the abortion pill's safety, with a well-funded group even calling for his firing.

"Makary’s commitment promises to position FDA as a global leader in modernizing drug evaluation and accelerating safer, more effective treatments for patients," Animal Wellness Action and Center for a Humane Economy President Wayne Pacelle said, referring to the agency's Roadmap to Reduce Animal Testing released this spring.  

Under Makary, "the FDA has embraced the most significant modernization of nonclinical science in a generation," he said. “The Senate’s action ensures that the agency’s progress is anchored in statute and regulations, giving drug sponsors clarity and maintaining momentum in reducing reliance on beagles, primates, and other animals in testing."

The FDA released draft guidance for comment purposes earlier this month, "Monoclonal Antibodies: Streamlined Nonclinical Safety Studies," which Pacelle's groups called a "new regulatory framework that allows developers to limit or waive certain animal toxicity studies when human-based scientific data provide sufficient safety insights," following up on this spring's roadmap.

The perceived progress has been uneven, with an investigation by another anti-animal testing group, the White Coat Waste Project, accusing the U.S. Navy of infecting "at-risk" monkeys with legal pathogens after HHS Secretary Robert F. Kennedy Jr. reportedly authorized the Centers for Disease Control and Prevention to end monkey research.

WCW filed a complaint with the HHS inspector general this summer against National Institutes of Health official Warren Casey for allegedly using "his federal title and NIH affiliation to contact members of WCW’s Advisory Board and attempt to dissuade their affiliation with our organization ...by promoting and distributing defamatory
content," including from an anonymous website that calls it a "hate group" that "incites violence."

The group turned on NIH Director Jay Bhattacharya after uncovering new grants for dog and primate research on his watch. "White Coat Waste has every right—and a responsibility to our donors, taxpayers, and animals—to call out" Bhattacharya "and his hand-picked 'animal testing czar', Nicole Kleinstreuer" for this "brand-new and ongoing experiments," founder and president Anthony Bellotti said this summer.