Court Upholds FDA Freedom of Information Procedures
The Connecticut federal court has ruled that FDA’s procedures for expedited processing of Freedom of Information Act requests are legal. Attorney Jenifer Stach (Hyman, Phelps & McNamara) writes in her firm’s FDA Law Blog that the case involved requests from Treatment Action Group, an independent AIDS research organization, and Global Health Justice Partnership, affiliated with Yale Law School and the Yale School of Public Health. Their 2014 FOIA request was for documents of clinical trial data, communications regarding clinical trial design, and the FDA approval process for two Hepatitis C drugs — Gilead’s Sovaldi (sofosburvir) and Harvoni (sofosburvir/ledipasvir).
The court granted an FDA motion for summary judgment regarding its rules and policies for expedited processing of FOIA requests, but also ordered the agency to immediately produce all responsive documents it has gathered to date.
Stach writes that there were some interesting facts about the CDER FOIA process that came out in the decision. Between 2012 and 2014, she says, CDER received over 8,000 FOIA requests. Between 1/1/15 and 9/30/15 it received 2,522 requests and in that same period processed 2,507 requests. As of 9/30/15, CDER reported a backlog of 600 FOIA requests.
A document submitted by the agency to the court, Stach says, indicated that in addition to responding to FOIA requests, CDER also responds to document requests from Congress, the Government Accountability Office, other federal agencies, and foreign, state, and local government agencies. FDA said that responding to those other types of requests requires the attention of three employees, who are not able to respond to FOIA requests. FDA also said that CDER is burdened with production requests from litigation, and obligations imposed on it under the FDA Amendment Act of 2006. CDER currently has 40 full-time employees and one full-time contractor to deal with FOIA requests.
The court said that the law requires that expedited treatment can be given if the requester can demonstrate that failure to receive the records on an expedited basis could be expected to pose an imminent threat to life or physical safety of an individual or if the requester is primarily engaged in disseminating information and there is an urgency to inform the public about actual or alleged federal government activity.
Neither of those situations applied in this case, the court said, since the drugs may be used to treat a population of over 250,000 patients in 2015 and thus no one individual was at risk of life or safety, and because the requesters are research organizations who do not have dissemination of information as their primary mission.
FDA unsuccessfully said the case was moot because the request is now at the head of the queue. The court said the case could not be moot because the agency had not provided the requesters with any records.
The court also denied an FDA request for a stay, noting that the number of FOIA requests has decreased in recent years and that additional non-FOIA requests were not unanticipated by Congress. The court ruled that the agency is dealing with a predictable workload and is not significantly understaffed, and thus is unable to show that its resources are not adequate.
FDA was ordered to produce all responsive documents gathered to date and to report to the court 10/21 as to the documents yet to be produced with a timeframe for the remaining production.
“In sum,” Stach concludes, “the court largely adopted FDA’s arguments that the court should not give expedited treatment to this FOIA request. We expect FDA will rely on this ruling and other previous court rulings as a justification to process FOIA requests in a ‘first in-first out’ queue system, without expediting most FOIA requests. Nevertheless, there are certain portions of the court’s ruling that may encourage other organizations to sue FDA if a FOIA request is not timely answered, and perhaps even seek expedited processing of the request.”