Vanda files complaint against FDA seeking to lift clinical hold on study

Vanda Pharmaceuticals announced last night that it has filed a complaint against the FDA requesting that the court lift a partial clinical hold the agency “illegally imposed prohibiting Vanda from studying a new drug in humans for more than 12 weeks without conducting unnecessary and unethical animal studies.” The company explained, “Vanda has taken this legal action as it works through the FDA development process for tradipitant, a potential treatment for several human conditions including gastroparesis. During the course of drug development, animal studies are routinely conducted to identify potential toxicities in humans. FDA guidance documents outline the types of animal studies, including the appropriate species and duration, that are recommended to provide sufficient evidence of safety before a drug is studied in humans. However, the recommendations in FDA guidance documents are not legally binding on either the FDA or drug developers. If a company submits information to the FDA to show that further study in humans would be safe based on different information, the FDA is supposed to evaluate the company’s proposal and make a case-specific, science-based determination as to whether it agrees. In Vanda’s case, the FDA did not do so. It has instead treated a non-binding recommendation that nine-month non-rodent toxicity studies should be conducted before a drug is studied in humans for longer than three months as a non-negotiable requirement. Solely because Vanda has refused to conduct this study, which usually involves young beagles as the test subjects, each of which must be “sacrificed” to permit evaluation of the animal’s tissues, the FDA has placed a partial clinical hold on Vanda’s studies of tradipitant. Tradipitant studies can proceed up to 12 weeks duration. The FDA has imposed this partial hold without providing any specific scientific justification. As a matter of law, the FDA is not permitted to do that. As a result, Vanda has sued in federal court for judicial relief. ”
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