{"id":64346,"date":"2025-02-02T13:02:49","date_gmt":"2025-02-02T13:02:49","guid":{"rendered":"https:\/\/peraltafinancing.com\/business\/legal\/foia-requires-transparency-of-instructions-to-fda-staff-even-when-those-instructions-are-to-pause-communications-with-the-public\/"},"modified":"2025-02-02T13:02:49","modified_gmt":"2025-02-02T13:02:49","slug":"foia-requires-transparency-of-instructions-to-fda-staff-even-when-those-instructions-are-to-pause-communications-with-the-public","status":"publish","type":"post","link":"https:\/\/fivemor.com\/?p=64346","title":{"rendered":"FOIA Requires Transparency of Instructions to FDA Staff, Even When Those Instructions Are to Pause Communications with the Public"},"content":{"rendered":"<p> <br \/>\n<\/p>\n<div id=\"overview\">\n<p>During the <a href=\"https:\/\/www.whitehouse.gov\/presidential-actions\/2025\/01\/regulatory-freeze-pending-review\/\">Regulatory Freeze Pending Review<\/a> and\u00a0 the <a href=\"https:\/\/www.documentcloud.org\/documents\/25502931-acting-hhs-secretary-communications-memo-1-21-25\/\">HHS Immediate Pause on Issuing Documents and Public Communications<\/a>, our thoughts turned to the principles underlying the Freedom of Information Act (FOIA).\u00a0 As the DOJ FOIA Guide explains in its <a href=\"https:\/\/www.justice.gov\/media\/1051086\/dl?inline\">introduction<\/a>:<\/p>\n<blockquote>\n<p>The United States Supreme Court has explained that \u201c[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.\u201d<\/p>\n<\/blockquote>\n<p>Since its enactment, Congress has strengthened FOIA\u2019s disclosure provisions, <a href=\"https:\/\/www.justice.gov\/oip\/freedom-information-act-5-usc-552\">most recently in 2016<\/a>.\u00a0 Among those 2016 changes were the requirement \u201cfor public inspection in an electronic format\u201d of certain categories of documents, including two categories included in an earlier amendment: \u201c(B) those statements of policy and <strong><em>interpretations which have been adopted by the agency and are not published in the Federal Register<\/em><\/strong>;\u201d and \u201c(C) administrative staff manuals and <strong><em>instructions to staff that affect a member of the public<\/em><\/strong>.\u201d A new, third category was also added, \u201ccopies of all records, regardless of form or format \u2013 . . . (II) <strong><em>that have been requested 3 or more times<\/em><\/strong>\u201d (bold added).<\/p>\n<p>These statutory changes combined with the \u201c<a href=\"https:\/\/www.justice.gov\/oip\/oip-guidance-applying-presumption-openness-and-foreseeable-harm-standard\">foreseeable harm\u201d standard<\/a> 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.\u00a0 FOIA imposes timelines of days, not months or years, for responses.\u00a0 That has been significantly undermined at FDA and other agencies by administrative backlogs, and a safety valve that Congress provided for exceptional circumstances.\u00a0 As a result, requests to FDA routinely <a href=\"https:\/\/www.fda.gov\/regulatory-information\/freedom-information\/how-make-foia-request\">take a year and a half to two years<\/a>.\u00a0 Moreover, courts generally provide the agency with more time to complete its review.<\/p>\n<p>But those seeking to use FOIA to hold the Executive to the letter and spirit of the law are not without some tools.\u00a0 First, as a general matter, unlike many suits against the government, in a FOIA case, a district court reviews the agency\u2019s decisions de novo and \u201cthe burden is on the agency to sustain its action.\u201d <a href=\"https:\/\/www.justice.gov\/oip\/freedom-information-act-5-usc-552\">5 U.S.C. \u00a7 552(a)(4)(B)<\/a>.<\/p>\n<p>Second, while the \u201cexceptional circumstances\u201d safety valve appears in the section of the statute regarding FOIA requests, there is no corresponding language in the section stating that an agency \u201cshall make available for public inspection in an electronic format\u201d certain records.<\/p>\n<p>Last, given FOIA\u2019s broad standing, jurisdiction, and venue provisions, a complainant can put the Executive to its paces, in \u201cthe 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.\u201d\u00a0 Any one of those courts \u201chas jurisdiction to enjoin the agency from withholding agency records and to order the production of any agency records improperly withheld from the complainant.\u201d<\/p>\n<p>The Regulatory Freeze Pending Review is a <a href=\"chrome-extension:\/\/efaidnbmnnnibpcajpcglclefindmkaj\/https:\/www.govinfo.gov\/content\/pkg\/FR-2021-01-28\/pdf\/2021-01868.pdf\">standard tool of incoming administrations,<\/a> and the HHS pause is, according to the memo, set to expire on February 1.\u00a0 The pause memo is not available on the HHS website, but hopefully incoming leadership, once settled, will take FOIA\u2019s disclosure obligations to heart.\u00a0 If not, regulated industry may need to consider new ways to obtain, for example, \u201cinstructions to staff that affect a member of the public,\u201d along with other critical information about agency policy and operations that affect it.<\/p>\n<\/div>\n\n","protected":false},"excerpt":{"rendered":"<p>During the Regulatory Freeze Pending Review and\u00a0 the HHS Immediate Pause on Issuing Documents and Public Communications, our thoughts turned to the principles underlying the Freedom of Information Act (FOIA).\u00a0 As the DOJ FOIA Guide explains in its introduction: The United States Supreme Court has explained that \u201c[t]he basic purpose of [the] FOIA is to [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4302,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[97],"tags":[4845,19889,13230,2738,8311,5294,17638,8631,13293],"dealstore":[],"offerexpiration":[],"class_list":["post-64346","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-legal","tag-communications","tag-fda","tag-foia","tag-instructions","tag-pause","tag-public","tag-requires","tag-staff","tag-transparency"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.4 - 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