FDA plans to phase out animal testing requirements

Driving the news: The FDA said it would launch a pilot program over the next year allowing select developers of monoclonal antibodies to use a primarily non-animal-based testing strategy.

• Commissioner Marty Makary in a statement said the shift would improve drug safety, lower research and development costs and address ethical concerns about animal experimentation.
• "This initiative marks a paradigm shift in drug evaluation and holds promise to accelerate cures and meaningful treatments for Americans while reducing animal use," Makary said.

Zoom in: FDA said its roadmap envisions using computer modeling and AI to predict a drug's behavior and possible side effects, through software simulations of how a monoclonal antibody distributes through the human body.

• It also will promote the use of lab-grown human "organoids" and "organ-on-a-chip" technology that mimic the liver, heart, and immune organs to test drug safety and reveal possible toxic effects that can go undetected in animals.
• Officials said companies that submit strong safety data from non-animal tests may receive streamlined product reviews. And the FDA will begin using safety data from other countries with comparable regulatory standards to help determine a drug's efficacy.

What they're saying: "The initiative combines deregulatory themes and cutting-edge technology — all in service of the broadly popular goal of reducing animal testing," TD Cowen analyst Rick Weissenstein wrote in a note.

• PETA said the new policies were "a significant step" towards replacing the use of animals, including vaccine and other testing on monkeys at federally-funded primate centers.
• Some health tech stocks rose on the news, including Certara Inc., a maker of biosimulation software. Animal testing firms Inotiv and Charles River Laboratories fell in after-hours trading.
• PhRMA, the drug industry trade group, didn't immediately respond to a request for comment.