FOIA News: 2nd Circuit to consider whether FDA can withhold clinical trial info

Pending FOIA Case Has Major Implications For Trial Data Disclosure

By Beth Wang, inside Health Policy, Aug. 4, 2021

In a case with major implications for what kinds of clinical trial information can be made public, HHS and Sarepta Pharmaceuticals are asking a federal appeals court to uphold a lower court decision that FDA does not have to disclose confidential clinical trial information on Sarepta’s Duchenne muscular dystrophy drug, Exondys 51. HHS and Sarepta argue the information sought by the plaintiff, journalism professor Charles Seife, is confidential commercial information that FDA is not allowed to release under the Freedom of Information Act.

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The appeals court case is Seife v. United States Food and Drug Administration. The docket No. is 20-4072.

Read more here (accessible with free trial subscription)

Court opinions issued Aug. 3, 2021

Kowal v. DOJ (D.D.C.) -- concluding that DEA’s Vaughn indices were adequate and that agency properly withheld records under Exemptions 6, 7(C), 7(D), 7(E), and 7(F), except for its Exemption 7(E) withholdings pertaining to a law enforcement manual.

Judicial Watch v. U.S. Dep’t of State (D.D.C.) -- finding that agency performed reasonable search for Hillary Clinton’s emails and properly withheld records pursuant to Exemption 5’s deliberative process privilege.

King v. DOJ (D.D.C.) -- determining that EOUSA performed reasonable search for records concerning plaintiff’s criminal cases and denying his request to recover litigation costs because records were sought “purely for his own benefit” and litigations delays were primarily his responsibility.

Summaries of all published opinions issued since April 2015 are available here.

FOIA News: Court threatens to sanction ICE and DOJ for "unbelievable" response

During a July 29th hearing, D.C. federal judge Amit Mehta rebuked and threatened to sanction government officials for having ignored his prior ruling in Long v. ICE (D.D.C), a seven-year-old case concerning access to metadata and database schema for certain agency databases.

I am literally at a loss right now. I am at a loss. I have never, in my judicial career, had an agency respond to a judicial order in the way that ICE has responded to this order in this case.

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I'm not doing this anymore, because otherwise you all are going to get sanctioned. And I don't know how one really sanctions a federal agency. It's not like you can sanction them in a way that you sanction a party, like money is really going to matter to a federal agency.But you're going to get sanctioned unless something starts happening in this matter that is consistent with what has happened in this case. I don't understand this. You are thumbing your nose at what has happened in this case.

The judge subsequently ordered ICE and DOJ to have supervisory officials appear at a hearing on August 4, 2021.

I don't act this way with parties, I really don't, I try not to do this, but you all have really tried my patience. I don't know what more to do and I don't know what more to say other than escalating this to people who will actually understand that when a court actually rules on something, that that order should be followed. This is just unbelievable. It's unbelievable.

See full hearing transcript here.

Court opinion issued July 30, 2021

Animal Legal Defense Fund v. FDA (N.D. Cal.) -- on remand from the Ninth Circuit following the Supreme Court’s intervening Exemption 4 decision in Argus Leader, concluding that the FDA failed to establish that egg producers customarily and actually kept certain hen housing information private and confidential.

Summaries of all published opinions issued since April 2015 are available here.

Court opinions issued July 28, 2021

Bonner v. CIA (S.D.N.Y.) -- concluding that the CIA properly relied on Exemptions 1 and 3 to withhold two documents related to an al Qaeda training manual, but that Exemption 5 did not protect a draft intelligence report because because “it fails to identify any agency decision-making process in connection with which the document was created.”

The Cincinnati Enquirer v. DOJ (S.D. Ohio) -- ruling that DOJ justified withholding fewer than half of 205 pages concerning third party pursuant to Exemption 7(C), and that it was required to perform an additional search for records concerning “Operation Speakeasy.”

Summaries of all published opinions issued since April 2015 are available here.

FOIA News: Study explores affect of politicization on FOIA requests

A Hamilton University professor has published an article in the upcoming edition of Presidential Studies Quarterly that “explores the implementation of the Freedom of Information Act (FOIA) and analyzes how politicization affects aggregate federal executive branch transparency.” An abstract of the article, entitled “The Law: Government Transparency and Public Access,” is available here.

FOIA News: Reporters Committee on D.C. Circuit's ‘foreseeable harm’ standard

D.C. Circuit: FOIA’s ‘foreseeable harm’ standard has teeth

By Adam A. Marshall, Reporters Committee, July 27, 2021

In a case brought by the Reporters Committee and the Associated Press, the U.S. Court of Appeals for the D.C. Circuit issued an opinion earlier this month with its most expansive and detailed explanation of the Freedom of Information Act’s “foreseeable harm” provision to date, holding that the FBI failed to justify withholding documents regarding the agency’s impersonation of an Associated Press editor in 2007.

Read more here.

Court opinions issued July 23, 2021

Leopold v. DOJ (D.D.C.) -- holding that an agency may satisfy foreseeable harm standard on a category-by-category basis, consistent with D.C. Circuit’s July 2, 2021 decision in Reporters Committee for Freedom of Press v. FBI, and that DOJ met its burden with respect to its Exemption 5 withholdings related to Special Counsel Robert Mueller’s investigation into the 2016 presidential election.

The New York Times v. DOJ (S.D.N.Y.) -- on remand from the Second Circuit, finding that DOJ properly reprocessed memoranda concerning CIA interrogations overseas by releasing additional information previously withheld pursuant to Exemption 5 and continuing to withhold certain names pursuant to Exemptions 1 and 3.

Summaries of all published opinions issued since April 2015 are available here.

Court opinions issued July 22, 2021

The Wolk Law Firm v. NTSB (E.D. Pa.) -- determining that NTSB properly withheld certain records pertaining to aircraft accidents. including death scene photographs, autopsies, and medical case reviews, pursuant to Exemption 6 and Exemption 5’s deliberative process, attorney work-product, and attorney-client privileges.

Int’l Refugee Assistance Proj. v. USCIS (S.D.N.Y.) -- concluding that: (1) plaintiff’s lawsuit seeking access to refugee resettlement application was not moot, because: (a) disclosure of some records by non-party Department of State in response to plaintiff’s separate request did not settle whether USCIS conducted adequate search; (b) plaintiff adequately pleaded a policy-or-practice claim regarding USCIS’s alleged refusal to search a database for refugee resettlement documents; and (2) granting plaintiff’s partial summary judgment motion and finding that USCIS failed to search the relevant database for responsive agency records.

Summaries of all published opinions issued since April 2015 are available here.

Court opinions issued July 21, 2021

Chelmowski v. United States (D.D.C.) -- finding that EPA performed adequate search for records pertaining to plaintiff and that it properly withheld certain records pertaining to Exemption 5’s deliberative process privilege and Exemption 6.

Chelmowski v. United States (D.D.C.) -- finding that: (1) FCC’s search fees and its demand for advanced payment were reasonable; (2) FCC and NARA performed adequate searches concerning plaintiff; and (3) government’s withholdings under Exemptions 4, 5, 6, and 7(E) were not directly challenged or undermined by plaintiff.

Summaries of all published opinions issued since April 2015 are available here.