Case Detail
| Case Title | GOVERNMENT ACCOUNTABILITY PROJECT v. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| District | District of Columbia | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| City | Washington, DC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Case Number | 1:2007cv01702 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Date Filed | 2007-09-25 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Date Closed | 2010-03-09 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Judge | Judge Colleen Kollar-Kotelly | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Plaintiff | GOVERNMENT ACCOUNTABILITY PROJECT | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Case Description | The Government Accountability Project submitted a FOIA request to the FDA for records concerning clinical studies submitted regarding the drug Ciprofloxacin. The agency acknowledged receipt of the request, but after hearing nothing further from the agency, GAP filed an administrative appeal. The agency acknowledged receipt of the appeal, but after hearing nothing more from the agency, GAP filed suit. Complaint issues: Failure to respond within statutory time limit, Litigation - Attorney's fees | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Defendant | U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Component U.S. Food & Drug Administration (FDA) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Defendant | UNITED STATES FOOD & DRUG ADMINISTRATION | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Documents | Docket Complaint Complaint attachment 1 Opinion/Order [13] FOIA Project Annotation: The FDA has experienced consistent backlog problems for years, due in large part because of the complexity of many of the requests it receives as well as a chronic understaffing problem. Added to this are increased public and political demands on the agency to expand its regulatory role without any accompanying increase in funding or resources. To its credit, the FDA FOIA staff has made a significant dent in its backlog, but the problems that have hounded the agency for years still make it difficult to respond to complex requests in anywhere near the statutory time frame. As a result, the agency has had a string of bad luck as far as convincing district court judges to grant it an Open America stay. Two courts in New York and one in New Jersey have rejected the agency's arguments within the past year. Now Judge Colleen Kollar-Kotelly has joined those other courts in turning down the agency's pleas yet again. The case before Kollar-Kotelly was brought by the public interest group Government Accountability Project for records on the drug Cipro, which was used as a preventive measure during the anthrax scare. While Kollar-Kotelly declined to issue a stay, she did not require the agency to actually begin processing GAP's request. Instead, she noted that "although the Court concludes that Defendants have not established exceptional circumstances sufficient to warrant the eighteen-month stay they seek, the Court recognizes that Defendants are faced with a substantial backlog of pending FOIA requests and that Plaintiff's request is currently pending in the processing queue. Therefore. . . the Court shall require Defendants to file a status report with the Court on or before September 5, 2008, advising the Court as to the volume of the requested records, where Plaintiff's FOIA request currently stands in the processing queue, i.e., the date by which Defendants expect to begin processing Plaintiff's FOIA request, and how long they expect it will take to process Plaintiff's request, so that the Court can set an appropriate processing schedule." GAP submitted its request June 27 and its receipt was acknowledged by the agency June 28 and assigned to the Complex Track. After hearing nothing more, GAP filed an administrative appeal August 3, but after hearing nothing more substantive, GAP filed suit September 25. The agency filed a motion for a stay on February 19, 2008. Kollar-Kotelly first noted that "exceptional circumstances" may exist "when an agency faces an unexpected volume of requests for information and has insufficient resources to deal with those requests in the time frames set forth in the FOIA." She also pointed out that "exceptional circumstances" do not exist where "a delay. . . results from a predictable agency workload of requests under this section, unless the agency demonstrates reasonable progress in reducing its backlog of pending requests." In this case, the agency explained that the Division of Information Disclosure Policy in the Center for Drug Evaluation and Research received a high of 5,310 requests in 2003 and that its annual numbers had steadily decreased to 2,888 requests in 2007. Further, DIDP received an average of 240 requests per month in 2007, down from an average of 285 per month in 2006. GAP argued that this downward trend did not support a showing that there was a deluge of requests. Kollar-Kotelly replied by indicating that "GAP is certainly correct that the downward trend in the number of DIDP FOIA requests, at first blush, suggests that the agency is not facing an unexpected volume of requests for information." The agency pointed out that the vast majority of these requests dealt with confidential business information, personal privacy, and deliberative process information. But while Kollar-Kotelly expressed sympathy, she noted that "Defendants' arguments, however, do not suggest that the FOIA requests DIDP is processing have become increasingly or unexpectedly more complex of late." Kollar-Kotelly then gave the agency credit for its candor in bringing its recent string of defeats to her attention. But she observed that "significantly, in each case, the support for the FDA's arguments appears to have come in the form of a declaration supplied by [DIDP] that set forth the same figures for DIDP's workload that [were] proffered in this case. While those cases not are binding on this Court, they are highly persuasive in light of their overwhelming similarity to the instant case." She said she agreed with the other courts' conclusion that "DIDP's declining workload of FOIA cases does not, in and of itself, establish the type of exceptional circumstances necessary to warrant a stay." DIDP argued that there were other unanticipated demands on its resources that made it considerably more difficult to respond to requests within FOIA's time frame. These included requests from Congress, demands for production of records because of litigation, DIDP's attempts to make more information proactively available, and further demands on DIDP as part of the Food and Drug Administration Amendments Act of 2007. Responding to each concern, Kollar-Kotelly explained that the agency had faced increased congressional requests since 2004 and that "by this point, Congressional requests appear to be more of a predictable agency workload than a deluge of unanticipated responsibility." She noted the agency indicated that many of its litigation document demands had been pending for some time and were handled by five full-time employees. "Significantly, because Defendants do not provide the Court with any sense of whether DIDP faced or handled similar litigation requests in previous years, the Court cannot determine whether the 2007 litigation requests were unusual." As to its proactive disclosures, Kollar-Kotelly observed that "this argument suggests that DIDP's workload has not declined as its flow of incoming requests has declined, it does not suggest that DIDP has actually seen an increase in workload sufficient to establish exceptional circumstances." As to its increased obligations under the FDAAA, the agency admitted it was planning to hire more staff. Kollar-Kotelly pointed out that "it appears that DIDP's staffing level has increased dramatically over the past five years, and that its overall workload of incoming FOIA requests combined with other responsibilities has not." Saying that she "commends Defendants for the steps they have taken," Kollar-Kotelly indicated that "the Court cannot determine whether the decrease in DIDP's backlog is attributable to the measures Defendants have undertaken or to the decrease in incoming FOIA requests, and therefore cannot conclude that Defendants have made 'reasonable progress' in reducing their backlog of FOIA requests." She noted that the DIDP's progress in reducing its backlog was an indication it was exercising due diligence. But she pointed out that the unit's response to GAP left something to be desired. She explained that in the eight months between GAP's request and its motion for summary judgment the agency had done very little except acknowledge receipt of the organization's request and appeal. She was also bothered that the agency didn't file its motion for a stay until February. She indicated that "while Defendants are correct that neither the FOIA nor the relevant case law imposes a filing deadline for agencies seeking Open America stays, Defendants' conduct in responding to GAP's FOIA request, as opposed to FOIA requests in general, cannot be described as a model of due diligence."
Opinion/Order [26]Issues: Delay - Stay of proceedings | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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