Post by icemandios on Mar 28, 2023 23:12:02 GMT
March 28, 2023 04:11 PM EDT
R&D
Vanda wins court case against FDA over disclosure of CRL details for sleep drug
Zachary Brennan
Senior Editor
DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.
The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.
Vanda sued last April, saying it has a right to know what else the CRL and review documents contain, and now the DC district court agrees.
While the FDA claimed that “[d]isclosing clinical and statistical reviews prepared for the evaluation of a drug application would have a chilling effect on staff communications,” the court said it is “not convinced that disclosure of reviews related to pending sNDAs would lead to the chilling effect the agency fears. As Vanda points out, the FDA currently discloses clinical and scientific reviews to the public in a variety of circumstances.”
And for other companies seeking more sunlight on why their sNDAs were rejected by the agency, the court explains:
Absent any current expectation of confidentiality, in the context of NDAs and sNDAs alike, the Court struggles to see how requiring FOIA disclosure of statistical and clinical reviews associated with pending sNDAs would in any way chill the reviewers’ frank and honest deliberations. Disclosure cannot chill deliberations if those deliberating do not reasonably expect their deliberations to remain private.