FOIA Requires Transparency of Instructions to FDA Staff, Even When Those Instructions Are to Pause Communications with the Public
January 31, 2025During the Regulatory Freeze Pending Review and the HHS Immediate Pause on Issuing Documents and Public Communications, my thoughts turned to the principles underlying the Freedom of Information Act (FOIA). As the DOJ FOIA Guide explains in its introduction:
The United States Supreme Court has explained that “[t]he basic purpose of [the] FOIA is to ensure an informed citizenry, vital to the functioning of a democratic society, needed to check against corruption and to hold the governors accountable to the governed.”
Since its enactment, Congress has strengthened FOIA’s disclosure provisions, most recently in 2016. Among those 2016 changes were the requirement “for public inspection in an electronic format” of certain categories of documents, including two categories included in an earlier amendment: “(B) those statements of policy and interpretations which have been adopted by the agency and are not published in the Federal Register;” and “(C) administrative staff manuals and instructions to staff that affect a member of the public.” A new, third category was also added, “copies of all records, regardless of form or format – . . . (II) that have been requested 3 or more times” (bold added).
These statutory changes combined with the “foreseeable harm” standard in the FOIA exemptions, gave the statute some additional teeth. But even prior to the amendments, the text of the statute, on its face, provided real time access to government records. FOIA imposes timelines of days, not months or years, for responses. That has been significantly undermined at FDA and other agencies by administrative backlogs, and a safety valve that Congress provided for exceptional circumstances. As a result, requests to FDA routinely take a year and a half to two years. Moreover, courts generally provide the agency with more time to complete its review.
But those seeking to use FOIA to hold the Executive to the letter and spirit of the law are not without some tools. First, as a general matter, unlike many suits against the government, in a FOIA case, a district court reviews the agency’s decisions de novo and “the burden is on the agency to sustain its action.” 5 U.S.C. § 552(a)(4)(B).
Second, while the “exceptional circumstances” safety valve appears in the section of the statute regarding FOIA requests, there is no corresponding language in the section stating that an agency “shall make available for public inspection in an electronic format” certain records.
Last, given FOIA’s broad standing, jurisdiction, and venue provisions, a complainant can put the Executive to its paces, in “the district court of the United States in the district in which the complainant resides, or has his principal place of business, or in which the agency records are situated, or in the District of Columbia.” Any one of those courts “has jurisdiction to enjoin the agency from withholding agency records and to order the production of any agency records improperly withheld from the complainant.”
The Regulatory Freeze Pending Review is a standard tool of incoming administrations, and the HHS pause is, according to the memo, set to expire on February 1. The pause memo is not available on the HHS website, but hopefully incoming leadership, once settled, will take FOIA’s disclosure obligations to heart. If not, regulated industry may need to consider new ways to obtain, for example, “instructions to staff that affect a member of the public,” along with other critical information about agency policy and operations that affect it.