DC Judge Rules for FDA in Vanda Clinical Hold
A DC federal judge has sided with FDA in a Vanda Pharmaceuticals lawsuit that sought to remove a partial clinical hold the agency was alleged to have “illegally imposed prohibiting Vanda from studying a promising new drug in humans for more than 12 weeks without conducting unnecessary and unethical animal studies.” The affected drug is tradipitant, a potential treatment for several human conditions including gastroparesis.
Vanda had argued (see earlier story) that FDA “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.”
Judge John G. Bates found that FDA had concluded that existing tradipitant studies in nonrodents contain “sufficient troubling indications of toxicity such that — while shorter-term human studies may be safe enough to proceed — FDA needs to see if those toxicity markers increase during long-term nonrodent studies before allowing long-term human studies.” Bates’ opinion further ruled that it is not the court’s role to “second-guess the particular way the agency chooses to weigh the conflicting evidence or resolve the dispute... Vanda has not shown that FDA’s interpretation of the study is unreasonable, and so its argument fails.”
Bates also ruled on the generality of conducting animal studies, which FDA’s legal framework mandates. Bates said the framework assumes that if a drug is shown not to be toxic in animals, it is at least reasonably likely to be safe to conduct human trials. “And indeed, FDA is not free, legally speaking, to simply allow drug sponsors to proceed with human trials without adequate animal studies,” he wrote. “While Vanda is correct that FDA does not explicitly support this statement with studies, the support is implicit in the legal framework and in common sense. If Vanda has a quarrel with animal studies and their predictive power for humans in general, its fire would be more appropriately aimed at the controlling statute and regulations, not at FDA’s actions in this case.”