Court Orders FDA to Release Internal Deliberations on Vanda’s sNDA

A federal court has ruled the FDA must share with Vanda Pharmaceutical its internal deliberation notes on why it denied Vanda's supplemental new drug application (sNDA) for its sleep-disorder drug Hetlioz (tasimelteon) for jet lag.

In April 2022, Vanda sued the FDA in the U.S. District Court for the District of Columbia claiming the agency’s Complete Response Letter (CRL) to the company didn’t include any specifics about why the agency rejected the new indication for Hetlioz, approved since 2014 for non-24-hour sleep-wake disorder and nighttime sleep disturbances in Smith-Magenis Syndrome.

Lacking any constructive information that Vanda could use to amend its application and move the drug forward, the CRL said only, “We cannot approve this application in its present form,” Vanda alleged.

In response, the company filed a Freedom of Information Act (FOIA) request asking the FDA to release all of the documents pertaining to its no-go decision. But the agency refused, saying that the documents were “deliberative” and “pre-decisional” and thus shielded.

This week, U.S. District Judge Christopher Cooper denied FDA claims that releasing the documents to Vanda would “chill internal deliberations” and raise “public health and safety concerns.” Sponsors might pull material from the deliberations and use it to mislead doctors and consumers about a drug’s safety and efficacy, the agency argued.

Cooper ruled that the agency had not satisfied its obligation to show a foreseeable harm from publication of the documents or to “concretely explain” how their release would “chill internal agency deliberations.”

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