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Vanda Pharmaceuticals Calls for FDA Action on Testing Methods

In a recent development, Vanda Pharmaceuticals Inc. has voiced significant concerns regarding the new guidance released by the U.S. Food and Drug Administration (FDA) concerning the use of New Approach Methodologies (NAMs) in drug development. As a frontrunner in innovative drug development and a strong advocate against unnecessary animal testing, Vanda aims to push for more effective advancements in human-relevant testing methods.

On March 18, 2026, the FDA released the draft guidance titled "General Considerations for the Use of New Approach Methodologies in Drug Development." This document seeks to promote advanced testing methods like in vitro assays, organ-on-chip systems, and human cell-based platforms. However, Vanda Pharmaceuticals believes this guidance does not go far enough in addressing the urgent need for shifting away from traditional animal testing.

Vanda is well-known for its advocacy to minimize animal suffering, especially in prolonged animal studies that lack solid scientific foundations. This concern is echoed by Mihael H. Polymeropoulos, M.D., Vanda's President and CEO, who emphasized the requirement for a more balanced approach from the FDA. He articulated that patients deserve quicker access to safer drugs, which necessitates prioritizing human biology in drug testing without the undue reliance on animal models.

Current Limitations of the Draft Guidance

Several notable shortcomings have been identified in the FDA's draft guidance:
1. Lack of Specific NAM Examples: Despite discussing types of NAMs like in vitro assays, the guidance fails to provide any specific examples or case studies of validated NAMs currently accepted in place of animal tests. This lack of clarity hinders developers from knowing which methodologies might be approved for use.
2. Insufficient Citations and References: The draft includes limited scientific references, which does not provide sufficient support for the proposed methodologies. Developers are left without clear benchmarks for success in convincing regulators of the efficacy of these methods.
3. Vague Validation Requirements: There is a lack of clear pathways for the regulatory acceptance of NAMs, which could create confusion and slow the adoption of innovative testing tools.

Given the FDA’s acknowledgment of the limitations of animal testing in predicting human outcomes, Vanda believes that the agency must act decisively to facilitate the transition to more relevant methods without imposing additional barriers.

Recommendations for Improvement

In light of these concerns, Vanda Pharmaceuticals proposes several measures to enhance the FDA's guidance:

• - Revise the Draft Guidance: Withdraw the current draft and create a revised version grounded in stronger scientific evidence, including abundant references to validated NAMs.
• - Incorporate Concrete Examples: Integrate specific examples and case studies of NAMs that have successfully replaced animal tests, detailing endpoints and performance metrics.
• - Establish Clear Approval Pathways: Develop an expedited process for regulatory acceptance that favors relevance to human biology over outdated practices.
• - Collaborate with Stakeholders: Engage industry innovators, scientists, and animal welfare organizations during the public comment period to refine the guidance.

Vanda Pharmaceuticals stands willing to collaborate with the FDA, HHS, and various stakeholders to develop innovative regulatory policies that prioritize patient safety while reducing animal suffering. With a demonstrated history of advocating for ethical and scientific progress, Vanda continues to endeavor towards achieving a regulatory landscape that fully harnesses cutting-edge scientific advancements in drug development.

For further information about Vanda Pharmaceuticals and its initiatives, visit Vanda Pharmaceuticals.