Vanda Pharmaceuticals urges the FDA to revise its draft guidance on New Approach Methodologies, citing lack of concrete examples, scientific references, and clear pathways to replace animal testing in drug development.
Written By: Chikkula Pavan Kumar, PharmD
Reviewed By: Pharmacally Editorial Team
Vanda Pharmaceuticals has raised concerns over a newly issued draft guidance from the U.S. Food and Drug Administration (FDA) aimed at expanding the use of non-animal research tools in drug development, arguing that the document lacks the clarity and scientific detail needed to drive meaningful regulatory change.
The draft guidance, titled “General Considerations for the Use of New Approach Methodologies in Drug Development,” was released on March 18, 2026, by the FDA’s Center for Drug Evaluation and Research (CDER). It outlines the agency’s approach to integrating New Approach Methodologies (NAMs)—such as in vitro assays, organ-on-chip systems, computational models, and human cell-based platforms—into nonclinical testing frameworks to reduce reliance on traditional animal studies.
While Vanda welcomed the FDA’s commitment to improving human-relevant science and reducing animal use, the company said the current draft does not provide the practical direction needed for developers to confidently adopt these methods.
According to Vanda, the guidance does not include a single concrete example of a NAM that the FDA currently accepts as a full replacement for a required animal test. Although the document references general categories such as in vitro approaches for skin sensitization or eye irritation, it does not identify specific validated assays, case studies, or examples from regulatory submissions where animal studies were waived.
The company also highlighted the limited number of scientific references and the lack of detailed performance benchmarks, which it said leaves drug developers without clear criteria for regulatory acceptance. In addition, Vanda criticized the guidance for vague validation requirements that could create uncertainty and potentially slow the adoption of innovative testing platforms.
Vanda has previously advocated for reducing what it considers unnecessary animal testing requirements, including prolonged dog toxicity studies lasting up to nine months. The company has argued that some of these studies lack strong scientific justification and may not reliably predict human outcomes.
“While we applaud the FDA’s direction toward human-centric science, the draft guidance must strike a better balance between regulatory caution and the much-needed scientific reform that modern tools demand,” said Mihael H. Polymeropoulos, MD, President and CEO of Vanda Pharmaceuticals. He added that patients would benefit from faster access to safer medicines developed using technologies that better reflect human biology.
To improve the framework, Vanda called on the FDA to withdraw the current draft and substantially revise it with stronger scientific grounding. The company urged the agency to incorporate detailed examples of validated NAMs, including endpoints, performance data, and regulatory outcomes where such methods have replaced animal testing.
Vanda also recommended that the FDA establish clearer and faster regulatory pathways for the acceptance of NAM-based evidence and collaborate closely with industry scientists and animal welfare organizations during the public comment period.
The company said it remains willing to work with the FDA, the U.S. Department of Health and Human Services, and other stakeholders to advance regulatory policies that support innovative science while reducing animal use and improving the predictability of drug development.
Reference
Vanda Pharmaceuticals Calls for Stronger FDA Action to Accelerate Shift from Animal Testing to Human-Relevant Methods, 19 March 2026, https://vandapharmaceuticalsinc.gcs-web.com/node/16866/pdf