Posted: 02 Oct 2016 03:39 PM PDT
By Jenifer R. Stach –
How often do we hear this familiar story: I submitted a request to FDA under the Freedom of Information Act (FOIA) but years later I have received no responsive records? Recently, two groups challenged FDA’s delays in processing FOIA requests. The court’s ruling in the case is quite noteworthy.
On September 20, 2016, in Treatment Action Group et. al v. Food and Drug Administration et. al, the United States District Court for the District of Connecticut granted FDA’s Motion for Summary Judgment regarding its rules and policies for expedited processing of FOIA requests. However, the court also ordered FDA to immediately produce to the FOIA requesters all responsive records that FDA has gathered to date.
Plaintiffs, Treatment Action Group (TAG) and Global Health Justice Partnership (GHJP), are seeking documents of clinical trial data, communications regarding clinical trial design, and the FDA approval process for the Hepatitis C virus drugs Sovaldi (sofosbuvir) and Harvoni (sofosburvir/ledipasvir).
TAG and GHJP are non-profit organizations. TAG is an independent AIDS research organization, while GHJP is affiliated with Yale Law School and the Yale School of Public Health. In a statement on the Yale Law School website, TAG and GHJP are seeking document production, “to make this data broadly available so that interested scientists can independently review that data and verify the drugs’ safety, efficacy, and cost-effectiveness.” FDA approved Sovaldi in December 2013, and Harvoni in October 2014.
On December 17, 2014, TAG and GHJP filed a FOIA request with FDA, including a request for expedited processing, a public interest fee waiver for duplication fees, and a fee limitation. On December 22, 2014, FDA denied the expedited processing request, stating that it would process the request in the order in which it was received. On January 26, 2015, TAG and GHJP filed an administrative appeal. On February 19, 2015, HHS sent a letter affirming the denial for expedited processing, stating that there was a failure to show a “compelling need” under 21 C.F.R. § 20.44(a). HHS stated that the FOIA request was in a queue at the Center for Drug Evaluation and Research (CDER) with an estimated processing time of 18 to 24 months. On April 1, 2015, TAG and GHJP sent a letter requesting reconsideration of the denial, to which FDA and HHS did not respond. On June 25, 2015, TAG and GHJP filed their complaint in court.
Some interesting facts about the CDER FOIA process were revealed in the court’s September 20, 2016 decision. Between 2012 and 2014, CDER received over 8,000 FOIA requests. Between January 1st and September 30th 2015, CDER received 2,522 requests. During this latter period, CDER processed 2,507 requests. As of September 30, 2015, CDER had a backlog of 600 FOIA requests.
FDA submitted a Declaration in the court case that noted that in addition to responding to FOIA requests, CDER also responds to document requests from Congress, the United States Government Accountability Office (GAO), other Federal agencies, and foreign, state, and local government agencies. FDA asserted that responding to these other types of requests requires the attention of three employees, who are not able to respond to FOIA requests. The Declaration also asserted that CDER is burdened with production requests from litigation, and obligations imposed on CDER under the Food and Drug Administration Amendment Act of 2006 (FDAAA). CDER currently employs 40 full time employees and one full time contractor to deal with FOIA requests. FDA also asserted that CDER has implemented a new review process to increase efficiency and the quality of the work under review.
Under 5 U.S.C. § 552(a)(6)(E)(i) and FDA's regulation, 21 C.F.R. § 20.44(a), a requestor may demonstrate a “compelling need” for expedited treatment of the release of records because either, 1) “[a] failure to obtain requested records on an expedited basis could be expected to pose an imminent threat to life or physical safety of an individual,” or 2) “[w]ith respect to a request made by a person primarily engaged in disseminating information” there is an “urgency to inform the public concerning actual or alleged Federal Government activity.” The Connecticut court concluded that categories of records that fit within the “compelling need” exception to normal processing of FOIA requests are “narrowly applied.” Slip Op. at 12.
The court ruled that because Sovaldi and Harvoni may be used to treat a population of over 250,000 patients in 2015, there was not an “imminent threat to the life or safety of an individual” which would warrant expedited processing. Moreover, plaintiffs did not allege that there were specific medical problems that were caused or exacerbated by Sovaldi or Harvoni that could result in harm to patients absent access to the records requested from FDA. Slip Op. at 12-14.
With regard to whether there is an urgent need to inform the public concerning actual or alleged federal government activity, the court ruled that generally a requestor must be primarily engaged in the dissemination of information, to the exclusion of other main activities. Slip Op. at 15. TAG is an independent AIDS research and policy think tank, and GHJP is a science-based, non-profit initiative dedicated to “improving health systems and justice” with a primary objective of facilitating “open science, community engagement, and public health.” The court ruled that neither TAG nor GHJP were in the business of disseminating information as their primary activity. Slip Op. at 14-17.
With respect to the urgency to inform the public, the court noted that Sovaldi and Harvoni were approved in December 2013, and October 2014, respectively, and that by the time the plaintiffs filed their FOIA request in December 2014, there was no longer a sense of urgency to inform the public. Slip Op. at 17-19.
FDA unsuccessfully asserted that the case was moot because FDA had represented that plaintiffs’ FOIA request had reached the top of the queue. The court ruled that the case was not moot because FDA had not provided plaintiffs with any records. Slip Op. at 9-11.
FDA also moved for a stay under Open America v. Watergate Special Prosecution Force, 547 F.2d 605 (D.C. Cir. 1976). FOIA requires an agency to determine whether to respond to a document request within 20 working days. The agency may also request an additional 10 working days for “unusual circumstances,” for instance when there is a need to examine a large volume of documents which are demanded in a single request. Once the agency has provided notice of the extension, if the request cannot be processed within 30 days, then the agency must notify the requestor either to limit the scope of the request or arrange an alternative time frame. Under 5 U.S.C. § 552(a)(6)(C)(i), if the Government can show that exceptional circumstances exist, and the agency is exercising due diligence, then a court may allow the agency additional time to complete a review of the records. To show exceptional circumstances, the agency must show that “(1) it is deluged with a volume of requests for information on a level unanticipated by Congress; (2) existing agency resources are inadequate to deal with the volume of the requests within the time limits established; and (3) the agency can show that it is exercising due diligence in processing the request.” Slip Op. at 21. The court noted that other courts have ruled that FDA has been unable to show a deluge of unanticipated requests. Slip Op. at 23-26. The Connecticut court concluded that the number of FOIA requests at FDA has actually decreased over the years, and that the additional non-FOIA requests were not unanticipated by Congress. As a result, the court denied the FDA motion to stay the proceedings. Because FDA “is both dealing with a predictable workload and not significantly understaffed, the court finds that the FDA is unable to show that its existing resources are inadequate.” Slip Op. at 25. However, because FDA indicated that the FOIA request was the top of its queue, the court ordered FDA to produce all responsive documents gathered to date, and report back to the court by October 21, 2016, as to the documents yet to be produced, and a timeline for the remaining production. Slip Op. at 28.
In sum, 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 treatment for the processing of the request.
How often do we hear this familiar story: I submitted a request to FDA under the Freedom of Information Act (FOIA) but years later I have received no responsive records? Recently, two groups challenged FDA’s delays in processing FOIA requests. The court’s ruling in the case is quite noteworthy.
On September 20, 2016, in Treatment Action Group et. al v. Food and Drug Administration et. al, the United States District Court for the District of Connecticut granted FDA’s Motion for Summary Judgment regarding its rules and policies for expedited processing of FOIA requests. However, the court also ordered FDA to immediately produce to the FOIA requesters all responsive records that FDA has gathered to date.
Plaintiffs, Treatment Action Group (TAG) and Global Health Justice Partnership (GHJP), are seeking documents of clinical trial data, communications regarding clinical trial design, and the FDA approval process for the Hepatitis C virus drugs Sovaldi (sofosbuvir) and Harvoni (sofosburvir/ledipasvir).
TAG and GHJP are non-profit organizations. TAG is an independent AIDS research organization, while GHJP is affiliated with Yale Law School and the Yale School of Public Health. In a statement on the Yale Law School website, TAG and GHJP are seeking document production, “to make this data broadly available so that interested scientists can independently review that data and verify the drugs’ safety, efficacy, and cost-effectiveness.” FDA approved Sovaldi in December 2013, and Harvoni in October 2014.
On December 17, 2014, TAG and GHJP filed a FOIA request with FDA, including a request for expedited processing, a public interest fee waiver for duplication fees, and a fee limitation. On December 22, 2014, FDA denied the expedited processing request, stating that it would process the request in the order in which it was received. On January 26, 2015, TAG and GHJP filed an administrative appeal. On February 19, 2015, HHS sent a letter affirming the denial for expedited processing, stating that there was a failure to show a “compelling need” under 21 C.F.R. § 20.44(a). HHS stated that the FOIA request was in a queue at the Center for Drug Evaluation and Research (CDER) with an estimated processing time of 18 to 24 months. On April 1, 2015, TAG and GHJP sent a letter requesting reconsideration of the denial, to which FDA and HHS did not respond. On June 25, 2015, TAG and GHJP filed their complaint in court.
Some interesting facts about the CDER FOIA process were revealed in the court’s September 20, 2016 decision. Between 2012 and 2014, CDER received over 8,000 FOIA requests. Between January 1st and September 30th 2015, CDER received 2,522 requests. During this latter period, CDER processed 2,507 requests. As of September 30, 2015, CDER had a backlog of 600 FOIA requests.
FDA submitted a Declaration in the court case that noted that in addition to responding to FOIA requests, CDER also responds to document requests from Congress, the United States Government Accountability Office (GAO), other Federal agencies, and foreign, state, and local government agencies. FDA asserted that responding to these other types of requests requires the attention of three employees, who are not able to respond to FOIA requests. The Declaration also asserted that CDER is burdened with production requests from litigation, and obligations imposed on CDER under the Food and Drug Administration Amendment Act of 2006 (FDAAA). CDER currently employs 40 full time employees and one full time contractor to deal with FOIA requests. FDA also asserted that CDER has implemented a new review process to increase efficiency and the quality of the work under review.
Under 5 U.S.C. § 552(a)(6)(E)(i) and FDA's regulation, 21 C.F.R. § 20.44(a), a requestor may demonstrate a “compelling need” for expedited treatment of the release of records because either, 1) “[a] failure to obtain requested records on an expedited basis could be expected to pose an imminent threat to life or physical safety of an individual,” or 2) “[w]ith respect to a request made by a person primarily engaged in disseminating information” there is an “urgency to inform the public concerning actual or alleged Federal Government activity.” The Connecticut court concluded that categories of records that fit within the “compelling need” exception to normal processing of FOIA requests are “narrowly applied.” Slip Op. at 12.
The court ruled that because Sovaldi and Harvoni may be used to treat a population of over 250,000 patients in 2015, there was not an “imminent threat to the life or safety of an individual” which would warrant expedited processing. Moreover, plaintiffs did not allege that there were specific medical problems that were caused or exacerbated by Sovaldi or Harvoni that could result in harm to patients absent access to the records requested from FDA. Slip Op. at 12-14.
With regard to whether there is an urgent need to inform the public concerning actual or alleged federal government activity, the court ruled that generally a requestor must be primarily engaged in the dissemination of information, to the exclusion of other main activities. Slip Op. at 15. TAG is an independent AIDS research and policy think tank, and GHJP is a science-based, non-profit initiative dedicated to “improving health systems and justice” with a primary objective of facilitating “open science, community engagement, and public health.” The court ruled that neither TAG nor GHJP were in the business of disseminating information as their primary activity. Slip Op. at 14-17.
With respect to the urgency to inform the public, the court noted that Sovaldi and Harvoni were approved in December 2013, and October 2014, respectively, and that by the time the plaintiffs filed their FOIA request in December 2014, there was no longer a sense of urgency to inform the public. Slip Op. at 17-19.
FDA unsuccessfully asserted that the case was moot because FDA had represented that plaintiffs’ FOIA request had reached the top of the queue. The court ruled that the case was not moot because FDA had not provided plaintiffs with any records. Slip Op. at 9-11.
FDA also moved for a stay under Open America v. Watergate Special Prosecution Force, 547 F.2d 605 (D.C. Cir. 1976). FOIA requires an agency to determine whether to respond to a document request within 20 working days. The agency may also request an additional 10 working days for “unusual circumstances,” for instance when there is a need to examine a large volume of documents which are demanded in a single request. Once the agency has provided notice of the extension, if the request cannot be processed within 30 days, then the agency must notify the requestor either to limit the scope of the request or arrange an alternative time frame. Under 5 U.S.C. § 552(a)(6)(C)(i), if the Government can show that exceptional circumstances exist, and the agency is exercising due diligence, then a court may allow the agency additional time to complete a review of the records. To show exceptional circumstances, the agency must show that “(1) it is deluged with a volume of requests for information on a level unanticipated by Congress; (2) existing agency resources are inadequate to deal with the volume of the requests within the time limits established; and (3) the agency can show that it is exercising due diligence in processing the request.” Slip Op. at 21. The court noted that other courts have ruled that FDA has been unable to show a deluge of unanticipated requests. Slip Op. at 23-26. The Connecticut court concluded that the number of FOIA requests at FDA has actually decreased over the years, and that the additional non-FOIA requests were not unanticipated by Congress. As a result, the court denied the FDA motion to stay the proceedings. Because FDA “is both dealing with a predictable workload and not significantly understaffed, the court finds that the FDA is unable to show that its existing resources are inadequate.” Slip Op. at 25. However, because FDA indicated that the FOIA request was the top of its queue, the court ordered FDA to produce all responsive documents gathered to date, and report back to the court by October 21, 2016, as to the documents yet to be produced, and a timeline for the remaining production. Slip Op. at 28.
In sum, 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 treatment for the processing of the request.
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