Vanda Pharma Sues FDA to Compel FOIA Docs on Study Requirement Waivers

On Thursday, Vanda Pharmaceuticals, Inc. filed a complaint to the D.C. District Court to compel the Food and Drug Administration to produce records to Vanda under the Freedom of Information Act (FOIA).

According to the complaint, Vanda is a Delaware corporation and a global biopharmaceutical company. The complaint states that on January 9, 2020, Vanda submitted a FOIA request to the FDA seeking information and records concerning cases in which FDA waived its putative requirement of a nine-month, non-rodent toxicity study before drugs can be tested on human patients for certain extended durations. Vanda states it requested the information to get a better understanding of the FDA’s requirements for investigational new drug applications.

The complaint states that FOIA requires an agency after receiving a proper request for records to promptly make the records available to the requestor. Additionally, the complaint states that FOIA requires to make a determination within 20 business days of receiving a FOIA request whether to comply with the request and immediately notify the requestor. 

Vanda argues that the FDA has not satisfied the requirements and deadlines under FOIA. The complaint purports that on January 14, 2020, Vanda received acknowledgement of the FOIA request, but has not otherwise responded to Vanda’s request in the intervening two years and three months. 

Additionally, the complaint purports that the FDA has failed to show exceptional circumstances exist to extend the deadline, and even if exceptional circumstances exist, the FDA would only have 30 days from its initial acknowledgement on January 14, 2020 to provide responsive documents. 

Accordingly, Vanda has filed the present lawsuit alleging that the FDA violated FOIA by failing to conduct an adequate search, to respond within the required time and to provide responsive documents. Vanda seeks a declaration that the FDA violated FOIA, a court order compelling the FDA to produce the requested documents, attorney’s fees and costs. Vanda is represented by McDermott Will & Emery LLP