Long under external attack for a lack of public transparency in its operations, FDA is now balking at a recommendation that it improve the transparency and accountability of its rulemaking process, according to a Government Accountability Office (GAO) report. Shown an advance draft of the report, which recommended tracking milestones in the progress of regulations submitted to the White House Office of Management and Budget (OMB), FDA objected to a GAO recommendation that it routinely report “externally” when major milestones are met. This “may result in follow-up inquiries from interested parties,” FDA objected, “and responding to such inquiries draws resources away from completing the regulation.”

FDA’s objection did not impress GAO. It “is still important to report some information externally as well as internally to improve the transparency and accountability of the agency’s rulemaking process,” the final report concluded. “Further, we believe that FDA’s concern about the impact that reporting some information externally could have on agency resources is overstated. None of the agencies we met with during this review identified responding to public inquiries as a major factor affecting resources and timeliness. Also, there is nothing that precludes agencies from providing reasons for delays when externally reporting this information to reduce the volume of public inquiries. Therefore, we kept this recommendation addressed to FDA.”

Once one of the government’s most transparent agencies, FDA’s opacity has been growing steadily since the Oklahoma City bombing in 1995 brought upgraded physical security installations to all federal buildings, and the agency used the opportunity to progressively limit public access and its own accountability. FDA’s reclusiveness reached a zenith in the Bush administration, shielding abusive management practices, such as hiding no-bid FDA contracts and cronyism with outsourced services. The secrecy even provoked review staff rebellions against concealed management-sponsor “coziness,” including interference with good science that provoked one group to open a Web site against such practices.

Lack of FDA transparency has upset many constituencies. Last December CDER Office of New Drugs director John Jenkins was moved to promise more review transparency among improvements being made in the drug review process. In January, Cleveland Clinic’s Steve Nissen called FDA’s institutional penchant for secrecy “antithetical to both good science and good government.” Most recently, journalists covering FDA have been moved to appeal to the Obama administration for relief from management policies that curb their access to key employees, who have been warned not to talk with the news media except under direct Press Office supervision.