PCPC pushes for broader scope of US FDA animal testing phase-out
The US Food and Drug Administration (FDA) has announced a plan to phase out its animal testing requirement in developing monoclonal antibody therapies and other drugs with human-relevant alternatives. The Personal Care Products Council (PCPC) supports the proposal but urges the agency to expand the policy to include cosmetics and over-the-counter (OTC) personal care products, such as sunscreens.
“For too long, drug manufacturers have performed additional animal testing of drugs that have data in broad human use internationally,” says FDA Commissioner Martin Makary.
“By leveraging AI-based computational modeling, human organ model-based lab testing, and real-world human data, we can get safer treatments to patients faster and more reliably while also reducing R&D costs and drug prices. It is a win-win for public health and ethics.”
Moving away from animal testing
The FDA’s new roadmap emphasizes New Approach Methodologies (NAMs) — including computer simulations, lab-grown human organoids, and real-world data from international regulatory bodies — to assess safety and efficacy.
Starting with investigational new drug (IND) applications, companies will be encouraged to submit NAMs data instead of traditional animal studies.
Key components of the initiative include using AI modeling to simulate how drugs behave in the human body and human organoid testing to mimic real organ functions and detect toxic effects missed by animal models.
Furthermore, regulatory incentives such as expedited reviews for companies using non-animal test data, global data alignment, and recognition of human clinical data from other countries to avoid redundant animal tests are also part of the initiative.
Additionally, the FDA is planning a pilot program to trial non-animal-based testing strategies in monoclonal antibody development, with results predicted to inform future guidance updates.
The industry responds
The PCPC, representing more than 600 cosmetics and personal care companies, praised the FDA’s announcement but called for broader application.
“We agree with the FDA that continued reliance on outdated animal testing models is unnecessary and inefficient, and we urge the FDA to extend this ban to cosmetics and over-the-counter (OTC) drugs, such as sunscreen products,” the organization says in a statement.
The FDA is planning a pilot program to trial non-animal-based testing strategies.
The PCPC is pushing for sunscreens to be included in the FDA’s animal testing phase-out, as they currently fall under stricter regulatory requirements. EU regulators recently ordered cosmetic manufacturer Symrise to conduct animal testing on two commonly used sunscreen ingredients despite the availability of non-animal alternatives.
The PCPC has long supported the adoption of NAMs in cosmetic safety assessment and backs the Humane Cosmetics Act, which would federally ban animal testing for cosmetic products in the US.
“PCPC and our member companies have long supported an end to animal testing for cosmetics and personal care products, including OTCs,” the group states.
“We are encouraged to see positive momentum in this direction and look forward to continued engagement with the FDA to advance efficient, innovative, and safe methodologies.”
