Seife v. FDA, No. 15-5487, 2021 WL 3542847 (S.D.N.Y. Aug. 10, 2021) (Swain, J.)

Seife v. FDA, No. 15-5487, 2021 WL 3542847 (S.D.N.Y. Aug. 10, 2021) (Swain, J.)

Re:  Request for records concerning news embargoes employed by FDA between January 2010 and May 2014

Disposition:  Granting in part and denying in part defendant's motion for summary judgment; granting in part and denying in part plaintiff's motion for summary judgment

• Exemption 5, Deliberative Process Privilege:  The court relates that "the core of the parties' dispute is whether documents that relate to the formulation of the FDA's communications strategies and decisions in connection with public announcements of certain substantive policies are covered by the Privilege and therefore exempt from disclosure."  "Courts have referred to such documents and the communications decisions to which they relate as 'messaging' documents and decisions, and this Court will do the same here."  The court further relates that "[t]he parties agree that the Second Circuit has not directly addressed whether messaging decisions are eligible for protection under the Deliberative Process Privilege . . . and courts in this District remain split over the scope of the Privilege."  "[T]he Court will first consider whether the FDA has demonstrated that the documents it has withheld are ones that relate to messaging policy matters and concern not-yet-finalized or not-yet-announced policy decisions."  "[The] Court agrees that this inquiry appropriately balances the purpose underlying the Deliberative Process Privilege, to protect 'the quality of agency decisions by preserving and encouraging candid discussion between officials' . . . with the 'basic purpose of FOIA to ensure an informed citizenry.'"  "Moreover, this approach's recognition that messaging decisions reflecting deliberations about how best to communicate a not-yet-finalized or not-yet-announced policy decision can be protected provides an appropriate threshold question for analysis of the current dispute, particularly in light of the testimony proffered by the FDA that messaging communications are central to the agency's public health mission of educating and informing the public about ongoing health concerns and the agency's responses to those concerns."
  
  The court then relates that "[t]he FDA proffers that the documents relating to the first policy event reflect OMA's 'deliberations regarding messaging decisions for the public release of the Task Force Reports' concerning preliminary recommendations for strengthening a premarket review process for medical devices."  "Because these documents would 'reveal the deliberative process' regarding 'what message to deliver, and how to go about doing so' in connection with a 'not-yet-announced policy decision,' namely the Task Force's Recommendations for improvement to the premarket review process for medical devices, the Court finds these documents are potentially eligible for protection under the Privilege."  Next, the court relates that "[t]he FDA has proffered testimony that the documents relating to the second policy event concern 'messaging decisions for the launch' of the Real Cost Campaign, 'including appropriate speakers and press invitees.'"  "Because the FDA represents that disclosure of these documents would reveal the deliberative discussions regarding the messaging decisions for the launch of the Real Cost Campaign prior to the launch of that campaign, the Court finds that they are potentially eligible for protection under the Deliberative Process Privilege."  Next, the court considers that "[t]he documents relating to the third policy event concern the April 24, 2014, announcement of the Proposed Tobacco Deeming Rule, which would extend the FDA's regulatory authority under the Tobacco Control Act."  "The FDA proffers that [one] subset of documents, created between January 24, 2014, and April 22, 2014, relates to the OMA's development of the April 24, 2014, announcement of the proposed rule 'to publicize its release and to solicit public comments' and reflects deliberations that were 'central to the FDA's mission of protecting the public health' because 'a successful announcement . . . was designed to increase public awareness and understanding of the proposed rule and encourage meaningful public comment . . . further advancing the FDA's goal of extending authority over tobacco products.'"  "On the basis of the FDA's proffer, the Court finds that the subset of documents created between January 24, 2014, and April 22, 2014, may be protected by the Privilege."  Additionally, "[t]he Court finds that [another] document is potentially eligible for protection under the Privilege because it predates the decision at issue, the announcement of the rule to the public, and the FDA proffers that its disclosure would reveal agency deliberations regarding how to make that announcement successful."  However, "[t]he Court finds that [one] entry is not eligible for protection under the Deliberative Process Privilege."  "[The] messaging document [at issue] reflects an effort to ensure that the newspaper's reporting on the proposed rule and announcement was consistent with the information the agency had provided to the public on April 24, 2014, and thus concerned an already-completed messaging policy decision."  "Withholding 'deliberations over how to spin a prior decision' or reflecting efforts to ensure a 'statement is consistent with [a] prior decision' would not advance the purposes underlying the Privilege."  Finally, the court considers "documents . . . [created] in connection with event four [that] relate to agency deliberations regarding whether and how to respond to a May 4, 2014, New York Times article regarding the proposed Tobacco Deeming Rule that was announced on April 24, 2014."  "Because these documents reflect deliberations regarding the decision to communicate with the press about an already-announced proposed rule, the Court finds that entries 64-68 are not eligible for protection by the Privilege and must be produced."  "Deliberations regarding messaging decisions seeking to clarify an already-announced version of the rule fall outside of the scope of the Deliberative Process Privilege."
  
  "Having established that the documents at issue, with the exception of [certain documents discussed above], are potentially eligible for protection under the Deliberative Process Privilege, [the court notes that] it remains the FDA's burden to demonstrate that each such document is predecisional and deliberative with regard to an identifiable decision facing the agency and therefore can properly be withheld."  "Having examined carefully these documents the Court finds that the FDA has met its burden of establishing that the remaining documents are predecisional and deliberative and therefore [are] withheld properly pursuant to Exemption 5."  "First, the FDA has met its burden of showing that the documents at issue are predecisional with respect to specific decisions facing the agency."  "Each of the documents, corresponding to these entries of the Vaughn index, predates the policy event to which it is related."  "Moreover, [defendant's] declaration provides a factual overview of each one of the events at issue and an explanation of why the documents relating to each event were significant to achieving the agency's desired outcome with respect to that particular event and also to the FDA's overall mission."  "Second, the FDA has met its burden of establishing that the documents at issue are deliberative."  "The Vaughn index entries and [defendant's] declaration indicate that many of the documents are in draft form, including draft scripts, draft key messages for press interactions, draft anticipated questions and proposed answers, draft communications plans, and a draft strategy memorandum."  "[Defendant's] declaration explains that these draft documents are created by lower-level OMA staff and therefore reflect the 'drafters' own analysis and judgment' throughout the consultative process, rather than the views of the agency."  "Moreover, [defendant's] declaration proffers that these draft documents and the views discussed in them are subject to revision, and that 'significant changes may be made to them prior to finalization[,]' depending 'on review by high-level officials and the final version of the policy being announced.'"  "The FDA has also provided sufficient information to demonstrate the documents' role in the consultative process in preparing for the events at issue."  "[Defendant's] Declaration proffers that intra-agency emails included 'communications about the risks and benefits of various proposed media options for these events, including the impact that timing, possible press invitees, possible speakers, and topics for these events have on the policy event.'"
   
• Litigation Considerations, "Reasonably Segregable" Requirements:  The court holds that "[defendant's] declaration includes affirmative statements that the documents were reviewed carefully and that all non-exempt, reasonably segregable information was disclosed."  "Plaintiff has not proffered evidence to the contrary and has not overcome the presumption of regularity that attaches to the FDA's proffer."
   
• Exemption 5, Other Considerations:  The court relates that "Plaintiff's argument that the foreseeable harm requirement applies to pre-2016 FOIA requests is inconsistent with the plain language of the [FOIA Improvement Act of 2016] and with persuasive decisions within this District holding that the [FOIA Improvement Act] imposed 'an independent and meaningful requirement' on agencies to justify withholding documents pursuant to FOIA exemptions."  "Accordingly, the [FOIA Improvement Act's] foreseeable harm standard is inapplicable to Plaintiff's FOIA request."  "The FDA has, in any event, met any applicable burden by proffering declarations identifying specific types of harm that would flow from the disclosure of the content of deliberations concerning non-final aspects of the messaging policy decisions for the announcement events that are in dispute here."