20-4072-cv

Seife v. FDA, et al.

UNITED STATES COURT OF APPEALS

FOR THE SECOND CIRCUIT

August Term 2021

(Argued: March 7, 2022 Decided: August 5, 2022)

Docket No. 20-4072-cv

CHARLES SEIFE,

Plaintiff-Appellant,

v.

UNITED STATES FOOD AND DRUG ADMINISTRATION,

UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES,

Defendants-Appellees,

-andSAREPTA THERAPEUTICS, INC.,

Intervenor-Defendant-Appellee.

ON APPEAL FROM THE UNITED STATES DISTRICT COURT 

FOR THE SOUTHERN DISTRICT OF NEW YORK

Before: CHIN, LOHIER, AND ROBINSON, Circuit Judges.
2

Appeal from a judgment of the United States District Court for the 

Southern District of New York (Furman, J.), entered October 6, 2020, in favor of 

two government agencies and a pharmaceutical company in this Freedom of 

Information Act ("FOIA") case. Plaintiff-appellant, a science writer and 

journalism professor, sought records from the government agencies relating to 

the pharmaceutical company's successful application for accelerated approval of 

a drug for the treatment of a neuromuscular disease. The agencies produced 

over 45,000 pages of documents, some of which were redacted under Exemption 

4 of FOIA. The district court granted summary judgment for the agencies and 

the pharmaceutical company on the basis that the redacted information fell 

within Exemption 4 and publication would either cause foreseeable harm to the 

interests protected by Exemption 4 or was prohibited by law. Plaintiff-appellant 

appeals.

AFFIRMED.

JARED CARTER (Cortelyou C. Kenney, Tyler Valeska, on 

the brief), First Amendment Clinic, Cornell Law 

School, Ithaca, NY, and Thomas S. Leatherbury, 

Vinson & Elkins LLP, Dallas, TX, and David A. 

Schulz, Media Freedom & Information Access 

Clinic, Yale Law School, New Haven, CT, for 

Plaintiff-Appellant.
3

DOMINIKA TARCYNSKA, Assistant United States 

Attorney (Benjamin H. Torrance, Assistant 

United States Attorney, on the brief), for Audrey 

Strauss, United States Attorney for the Southern 

District of New York, New York, NY, for 

Defendants-Appellees.

KRISTEN E. ITTIG (Daniel R. Bernstein, Stuart W. Turner, 

Amanda J. Sherwood, and Aime Joo, on the brief),

Arnold & Porter Kaye Scholer LLP, Washington, 

DC, and New York, NY, for Intervenor-DefendantAppellee.

CHIN, Circuit Judge:

In this case, intervenor-defendant-appellee Sarepta Therapeutics, 

Inc. ("Sarepta") obtained accelerated approval from defendant-appellee the Food 

and Drug Administration (the "FDA") for a drug Sarepta created to treat a 

neuromuscular disease. During the approval process, which spanned some nine 

years, Sarepta submitted tens of thousands of pages of documents to the FDA, an 

agency within defendant-appellee Department of Health and Human Services 

("HHS," and, together with Sarepta and the FDA, "Defendants").

Plaintiff-appellant Charles Seife, a science writer and journalism 

professor who has written about FDA practices, made a request to the FDA and 
4

HHS under the Freedom of Information Act ("FOIA"), 5 U.S.C. § 552, for 

documents submitted by Sarepta as part of the approval process. After the FDA 

constructively denied his request, Seife brought this action below.

During the course of the lawsuit, the FDA produced over 45,000 

pages of records but redacted some pages pursuant to Exemption 4 of FOIA, 

which shields from disclosure "trade secrets and commercial or financial 

information obtained from a person and privileged or confidential." 

5 U.S.C. § 552(b)(4). The district court held that the redactions were proper 

because the information fell within Exemption 4 and met the additional 

requirement set by the FOIA Improvement Act of 2016 (the "FIA"). Under the 

FIA, an agency shall withhold information under FOIA only if "the agency 

reasonably foresees that disclosure would harm an interest protected by an 

exemption" or if disclosure is "prohibited by law." 5 U.S.C. § 552(a)(8)(A). The 

principal issue presented on appeal is whether the district court correctly 

concluded that Defendants satisfied the foreseeable harm requirement. To 

answer that question, we must first discern the interests protected by Exemption 

4.
5

We hold that the interests protected by Exemption 4 are the 

submitter's commercial or financial interests in information that is of a type held 

in confidence and not disclosed to any member of the public by the person to 

whom it belongs. Because Defendants have shown as a matter of law that the 

contested information falls within Exemption 4 and that disclosure would 

foreseeably harm Sarepta's commercial or financial interests, we AFFIRM the 

district court's grant of summary judgment for Defendants and denial of

summary judgment for Seife.

BACKGROUND

A. Statutory Framework

Since 1967, FOIA has provided the public the right to request access 

to federal agency records or information. The statute reflects "a general 

philosophy of full agency disclosure unless information is exempted under 

clearly delineated statutory language." Dep't of the Air Force v. Rose, 425 U.S. 352, 

360-61 (1976). Such statutory exemptions include, inter alia, Exemption 4, which 

provides that an agency need not disclose "trade secrets and commercial or 

financial information obtained from a person and privileged or confidential." 

5 U.S.C. § 552(b)(4). The agency has the burden of "justify[ing] the withholding
6

of any requested documents." U.S. Dep't of State v. Ray, 502 U.S. 164, 173 (1991). 

"All doubts are resolved in favor of disclosure." Bloomberg, L.P. v. Bd. of Governors 

of the Fed. Reserve Sys., 601 F.3d 143, 147 (2d Cir. 2010) (quoting Local 3, Int'l Bd. of 

Elec. Workers v. Nat'l Labor Rels. Bd., 845 F.2d 1177, 1180 (2d Cir. 1988)) (cleaned 

up).

In 2016, Congress enacted the FIA out of concern that "some 

agencies [were] overusing FOIA exemptions." S. Rep. No. 114-4 (2015), as 

reprinted in 2016 U.S.C.C.A.N. 321, 322. The FIA thus further limited agency 

withholding of requested documents. This reform codified executive branch 

policies adopting "a presumption in favor of disclosure [under FOIA]." 

Memorandum on the Freedom of Information Act, 74 Fed. Reg. 4683, 4683 (Jan. 

21, 2009).1

1 When enacting the FIA, Congress explicitly referenced executive actions. A 

Senate Report explains that the FIA "codifies the policy established in January 2009 by 

President [Barack] Obama for releasing Government information under FOIA." S. Rep. 

No. 114-4 (2015), as reprinted in 2016 U.S.C.C.A.N. 321, 324. In January 2009, President 

Obama told all agencies to "adopt a presumption in favor of disclosure [under FOIA]." 

Memorandum on the Freedom of Information Act, 74 Fed. Reg. 4683, 4683 (Jan. 21, 

2009). Subsequently, on March 19, 2009, the Department of Justice ("DOJ") issued a 

memorandum that referred to President Obama's memorandum and stated that DOJ 

would "defend a denial of a FOIA request only if (1) the agency reasonably foresees that 

disclosure would harm an interest protected by one of the statutory exemptions, or (2) 

disclosure is prohibited by law." Memorandum from Eric Holder, Attorney Gen., U.S. 

Dep't of Justice, to Heads of Exec. Dep'ts & Agencies at 2 (Mar. 19, 2009) (the "2009 DOJ 

Memorandum"). The language of the FIA mirrors that of the 2009 DOJ Memorandum.
7

In relevant part, the FIA amended FOIA to provide that, for FOIA 

requests submitted after June 30, 2016, an agency could withhold information 

only if it showed that the information both fell within an exemption of FOIA and

at least one of two additional requirements was met. The requirements are that:

(I) the agency reasonably foresees that disclosure would harm an 

interest protected by an exemption described in subsection 

(b); or

(II) disclosure is prohibited by law.

5 U.S.C. § 552(a)(8)(A)(i)(I)-(II). Hence, the agency must show that disclosure of 

the requested information would foreseeably harm a protected interest or that 

disclosure is prohibited by law; otherwise, it must disclose the information, even 

if the information falls within one of the FOIA exemptions. Applicability of a 

FOIA exemption is still necessary -- but no longer sufficient -- for an agency to 

withhold the requested information. In essence, the FIA imposes an additional,

independent burden on the agency.
8

Neither the Supreme Court nor this Court nor any of our sister 

circuits has had occasion to consider the burden imposed by the FIA in an 

Exemption 4 case.2

B. The Facts

The relevant facts are drawn from the parties' affidavits and are 

undisputed.

On September 19, 2016, the FDA granted accelerated approval to 

Exondys 51, a drug developed by Sarepta to treat Duchenne muscular dystrophy 

("DMD"). DMD is a fatal neuromuscular disease that affects young and 

adolescent males. In the United States, there are approximately 9,000 to 12,000 

DMD patients.

Dystrophin is a protein, encoded by the dystrophin gene, that 

strengthens muscle fibers. DMD is caused by mutations in the dystrophin gene; 

the mutations result in a lack of dystrophin, which in turn results in loss of 

2 The only FOIA exemption to receive appellate scrutiny post-FIA is Exemption 5. 

See Machado Amadis v. United States Dep't of State, 971 F.3d 364, 371 (D.C. Cir. 2020) 

(holding that the "chilling of candid advice [from attorneys within an agency] is exactly 

what [Exemption 5] seeks to prevent."); cf. Nat. Res. Def. Council v. United States Env't 

Prot. Agency, 19 F.4th 177, 194 n.18 (2d Cir. 2021) (referencing the district court's 

determination that "the EPA 'reasonably foresees that disclosure' of these records 

'would harm an interest protected by' Exemption Five." (quoting 5 U.S.C. 

§ 552(a)(8)(A)(i)(I)).
9

muscle tissue and function. Genes are composed of sequences known as exons. 

The most common type of DMD mutation deletes exons of the dystrophin gene --

that is, parts of the dystrophin gene -- thus misaligning the remaining parts of 

the gene and causing reduced dystrophin production.3

Exondys 51 was developed to target the dystrophin gene through a 

mechanism known as "exon-skipping." "Exon-skipping" causes the cellular 

machinery to skip the mutated part or parts of the dystrophin gene. With the 

mutated parts skipped, the remaining exons in the gene are read in the correct 

alignment, resulting in a shorter but functional form of the dystrophin gene. 

Sarepta began researching possible treatments for DMD beginning in the early 

2000s and, after years of research, designed Exondys 51 -- also known as 

eteplirsen -- to skip exon 51 of the dystrophin gene. Around 13% of DMD 

mutations are amenable to exon 51 skipping, and an exon 51 mutation is the 

most common type of mutation amongst DMD patients.

3 In scientific terminology, the misalignment is caused by a "frame shift." J. App'x 

at 142. The exons -- the sequences in a gene -- are in a specific order and are read by 

ribonucleic acid ("RNA") to create proteins like dystrophin. When there is a "frame 

shift," exons are moved out of order and the RNA can no longer read the exons in the 

dystrophin gene to create dystrophin.
10

In 2007, Sarepta submitted the Exondys 51 Investigational New 

Drug application to the FDA. Sarepta then conducted Phase 1 proof-of-concept

studies on the drug. As early as 2011, Sarepta moved to Phase 2 and conducted 

two Phase 2 studies, Study 201 and Study 202. Sarepta spent over three years 

developing the clinical study procedure for the studies, in part because of 

experimentation on dosing approaches and quantifying dystrophin. Both studies 

involved the same twelve DMD patients with mutations amenable to exon 51 

skipping. Study 201 was placebo-controlled, double-blinded,4 and conducted 

over twenty-eight weeks. Study 202, a long-term Phase 2b study, followed 

approximately six months after Study 201. In Study 202, all patients received

Exondys 51.

The results of both studies were documented in clinical study 

reports. Each clinical study report was approximately 100 pages long and 

accompanied by thousands of pages of attachments with supporting data and 

background information. These clinical study reports and the study results were 

disseminated to only certain individuals within Sarepta; furthermore, Sarepta's 

4 In a double-blind clinical study, neither the patient nor the test-giver knows 

whether the patient is receiving the drug or the placebo. See, e.g., Nat'l Inst. of Health, 

Dictionary of Cancer Terms: Double-Blind Study, https://www.cancer.gov/publications/

dictionaries/cancer-terms/def/double-blind-study (last visited August 5, 2022).
11

agreements with the clinical trial site included terms of confidentiality. In June 

2015, Sarepta submitted the clinical study reports to the FDA as part of Sarepta's 

New Drug Application. The FDA received thousands of emails and calls from 

the public urging approval of Exondys 51.

On September 19, 2016, the FDA granted Exondys 51 accelerated 

approval, a special pathway for drugs treating serious conditions and providing

a meaningful advantage over existing therapy. There was, however, intense 

internal conflict within the FDA over the approval of Exondys 51. Reviewers in 

the Division of Neurology Products, the Office of Biometrics, the Office of 

Clinical Pharmacology, the Office of Drug Evaluation-I, and the Office of New 

Drugs all assessed the documents Sarepta submitted in its application. These 

reviewers unanimously recommended that Exondys 51 not be approved due to 

deficiencies in Sarepta's clinical studies. The head of the Center for Drug 

Evaluation and Research, Dr. Janet Woodcock, nevertheless overrode the

recommendation. One reviewer, the Director of the FDA's Office of Drug 

Evaluation-I, appealed Woodcock's decision to the FDA Commissioner, Dr. 

Robert Califf. Califf upheld Woodcock's decision on September 16, 2016.
12

In December 2016, Seife submitted his FOIA request to the FDA and

HHS. At the same time, he requested expedited processing. On December 21, 

2016, the FDA denied Seife's request for expedited processing. Seife appealed 

that denial administratively and, on April 25, 2017, the FDA denied his appeal.

C. The Proceedings Below

On May 25, 2017, Seife commenced this lawsuit challenging the 

denial of expedited processing and what was tantamount to a constructive denial

of his FOIA request. Soon after, Seife moved for partial summary judgment on 

expedited processing; following meet and confers, the FDA granted Seife's 

request for expedited processing. The parties also agreed to a schedule for

producing documents responsive to a narrowed FOIA request. Two of the

records Seife requested related to the clinical study reports: first, "[a]ll nonexempt portions of the narrative portion of the Clinical Study Report ("CSR") 

related to Study 201 and Study 202"; and, second, certain Study 201 and Study 

202 tables, figures, and graphs as well as "protocols and protocol amendments; 

statistical analysis plans and plan amendments." Joint App'x at 2251-52.

On July 28, 2017, the FDA sent records, including the clinical study 

reports, to Sarepta for review. Throughout August 2017, Sarepta and the FDA 
13

conducted rounds of adding or removing certain redactions. On September 15, 

2017, Sarepta moved to intervene as a defendant, and the district court granted 

Sarepta's request. Between July 24, 2017, and December 8, 2017, the FDA 

produced approximately 45,000 pages to Seife, but redacted some pages

pursuant to FOIA exemptions.

Seife challenged certain Exemption 4 redactions, including in parts 

of the clinical study reports and their appendices. The parties submitted crossmotions for summary judgment regarding those redactions, and Seife filed an 

additional motion to strike a declaration, that of Ian Estepan, submitted by 

Sarepta in connection with its motion for summary judgment. On March 27, 

2019, the district court denied Seife's motion to strike and reserved judgment on 

the cross-motions for summary judgment pending the decision in Food Marketing 

Institute v. Argus Leader Media, a case involving Exemption 4 of FOIA which the 

Supreme Court had agreed to review, see 139 S. Ct. 915 (2019). At that time, the 

district court also ordered Sarepta to re-review its redactions to make sure all 

publicly available information had been given to Seife. Defendants ultimately 

produced unredacted versions of some previously redacted records. The 

Supreme Court decided Argus Leader on June 24, 2019.
14

On October 6, 2020, the district court issued its opinion granting

Defendants' motion for summary judgment and denying Seife's motion for 

summary judgment. The district court concluded that Defendants' declarations

demonstrated that the redacted information fell within Exemption 4 and that 

disclosure either was prohibited by law or would cause foreseeable harm to the 

interests protected by Exemption 4. It did so, however, without specifying what 

those protected interests were. Judgment was entered on October 6, 2020.

This appeal followed.

DISCUSSION

FOIA cases are often resolved by summary judgment. See, e.g., 

Grand Cent. P'ship, Inc. v. Cuomo, 166 F.3d 473, 478 (2d Cir. 1999). Accordingly, 

the evidence in FOIA cases is typically limited to affidavits "in lieu of other 

documentary or testimonial evidence." Long v. Off. of Pers. Mgmt., 692 F.3d 185, 

190 (2d Cir. 2012). Summary judgment for the agency in a FOIA case is 

appropriate "when the affidavits describe the justifications for nondisclosure 

with reasonably specific detail, demonstrate that the information withheld 

logically falls within the claimed exemption, and are not controverted by either 

contrary evidence in the record nor by evidence of agency bad faith." Wilner v. 
15

Nat'l Sec. Agency, 592 F.3d 60, 73 (2d Cir. 2009) (quoting Larson v. Dep't of State, 

565 F.3d 857, 862 (D.C. Cir. 2009)).5

"We review a district court's grant of summary judgment in FOIA 

litigation de novo." See Am. Civ. Liberties Union v. Nat'l Sec. Agency, 925 F.3d 576, 

588 (2d Cir. 2019). Additionally, we review a district court's evidentiary rulings 

for abuse of discretion. See Lore v. City of Syracuse, 670 F.3d 127, 155 (2d Cir. 

2012).

As a threshold matter, Seife does not dispute on appeal that the 

redacted information falls within Exemption 4. See Pl.-Appellant's Reply Br. at 

14 (stating that "this appeal is not about whether Exemption 4 applies.").6 The 

5 Seife neither suggests there was, nor offers evidence of, agency bad faith relating 

to his FOIA request.

6 In any event, the information falls squarely within Exemption 4. Exemption 4 

provides that an agency need not disclose "trade secrets and commercial or financial 

information obtained from a person and privileged or confidential." 5 U.S.C. § 552(b)(4). 

First, Sarepta is a person for purposes of Exemption 4. See 5 U.S.C. § 551(2) (defining a 

person as "an individual, partnership, corporation, association, or public or private 

organization other than an agency" (emphasis added)). Second, the information is 

commercial or financial in nature as relates to development of a new drug. Third, the 

information is "confidential." "At least where commercial or financial information is 

both customarily and actually treated as private by its owner and provided to the 

government under an assurance of privacy, the information is 'confidential' within the 

meaning of Exemption 4." Food Mktg. Inst. v. Argus Leader Media, 139 S. Ct. 2356, 2366 

(2019). The record indicates that the information was available only to select 

individuals within Sarepta while outside parties signed a nondisclosure agreement, and 

that it was provided to the government under an assurance of privacy due to FDA 

regulations.
16

parties disagree, however, as to whether the information meets the additional 

burden imposed by the FIA. In relevant part, the FIA amended FOIA to add that 

"an agency shall withhold information under [FOIA] only if" either of the FIA's 

two prongs were met. 5 U.S.C. § 552(a)(8)(A). The two prongs are that: (1) the 

agency reasonably foresees that disclosure would result in harm to an interest 

protected by a FOIA exemption, 5 U.S.C. § 552(a)(8)(A)(i)(I), or (2) disclosure is 

prohibited by law, 5 U.S.C. § 552(a)(8)(A)(i)(II). Summary judgment for 

Defendants was thus proper if their affidavits described the justifications for the 

redactions with reasonably specific detail, disclosure would result in foreseeable 

harm to an interest protected by Exemption 4 or was prohibited by law, and Seife 

failed to present evidence to the contrary. See Wilner, 592 F.3d at 73.

We begin with the foreseeable harm requirement. Two questions

are presented: first, what are the interests protected by Exemption 4; and, 

second, did the district court err in granting summary judgment on the basis that 

disclosure would result in foreseeable harm to such an interest?

A. The Interests Protected by Exemption 4

In statutory interpretation, "a court's proper starting point lies in a 

careful examination of the ordinary meaning and structure of the law itself." 
17

Food Mktg. Inst. v. Argus Leader Media, 139 S. Ct. 2356, 2364 (2019). That includes 

"reference to the language itself, the specific context in which that language is 

used, and the broader context of the statute as a whole." Robinson v. Shell Oil Co., 

519 U.S. 337, 341 (1997). Our reading of a statute should "give effect, if possible, 

to every clause and word," Duncan v. Walker, 533 U.S. 167, 174 (2001) (internal 

quotation marks omitted), with no provision "rendered superfluous," United 

States v. Anderson, 15 F.3d 278, 283 (2d Cir. 1994).

1. Existing Interpretations

Although this is a matter of first impression for the appellate courts, 

there are two primary competing district court interpretations of the interests 

protected by Exemption 4.

First, the district court for the District of Columbia has held that the 

interests protected by Exemption 4 are "the submitter's economic or business 

interests." Ctr. for Investigative Reporting v. Customs and Border Prot., 436 F. Supp. 

3d 90, 113 (D.D.C. 2019) (cleaned up). To reach that conclusion, the court 

considered all the terms in Exemption 4, including the words "confidential," 

"commercial," and "financial." The district court also held that for an agency to 

show foreseeable harm to the submitter's economic or business interests, it has to 
18

demonstrate that disclosure would cause "genuine harm to the submitter's 

economic or business interests and thereby dissuad[e] others from submitting 

similar information to the government." Id. (cleaned up).

Second, the district court for the Northern District of California has 

taken a broader approach, holding that the interest protected by Exemption 4 is 

"the information's confidentiality--that is, its private nature." Am. Small Bus. 

League v. Dep't of Def., 411 F. Supp. 3d 824, 836 (N.D. Cal. 2019) (emphasis 

omitted). In doing so, the court limited its analysis to the word "confidential," 

concluding that "under [Argus Leader], the plain and ordinary meaning of 

Exemption 4 indicates that" confidentiality is the protected interest. Id.

Not surprisingly, the parties in this case disagree as to which 

approach we should adopt. Taking his cue from the first approach, Seife argues 

that an agency must show harm through "diminution in the economic value of a 

submitter's intangible property" calculated in the same way as monetary 

damages. Pl.-Appellant's Br. at 18-19. Defendants, however, urge us to adopt 

the American Small Business League analysis, as they argue that "the interest 

protected by Exemption 4 is the confidentiality of the information itself." Defs.-

Appellees' Br. at 26; see Intervenor-Def.-Appellee's Br. at 26 (arguing that 
19

confidentiality is "an interest protected under the exemption"). As the district 

court recognized in American Small Business League, confidentiality is a broad

interest; thus, "[d]isclosure would necessarily destroy the private nature of the 

information, no matter the circumstance." 411 F. Supp. 3d at 836.

2. Analysis

We hold that the interests protected by Exemption 4 of FOIA are the 

commercial or financial interests of the submitter in information that is of a type 

held in confidence and not disclosed to any member of the public by the person 

to whom it belongs. We examine the ordinary meaning and structure of 

Exemption 4, looking at the words themselves, the specific context in which the 

words appear, "and the broader context of the statute as a whole." Robinson v. 

Shell Oil Co., 519 U.S. at 341; see also Abuelhawa v. United States, 556 U.S. 816, 819 

(2009) (explaining that "statutes are not read as a collection of isolated phrases").

Exemption 4 covers "trade secrets and commercial or financial 

information obtained from a person and privileged or confidential." 

5 U.S.C. § 552(b)(4). For purposes of this case, Exemption 4 protects information 

that is "commercial or financial," "obtained from a person," and "confidential." 

All these clauses limit the scope of Exemption 4 and thus define its protected 
20

interests, as we must "give effect, if possible, to every clause and word." Walker, 

533 U.S. at 174.

The plain text of Exemption 4 indisputably protects confidential 

information. But it protects only certain confidential information, namely, 

confidential information that is commercial or financial in nature. The statute 

therefore contemplates harm specifically to commercial or financial interests. 

Furthermore, the confidential commercial or financial information must be 

obtained from a person. That requirement indicates the contemplated harm is to 

the person from whom the agency receives the confidential information -- that is, 

the submitter. Thus, the protected interests are the submitter's commercial or 

financial interests, and the FIA's foreseeable harm requirement refers to harm to 

the submitter's commercial or financial interests.7

7 We reject Seife's proposition that harm must be "measured by the diminution in 

the economic value of the information to the submitter," Pl.-Appellant's Br. at 27, 

because we find no support for that reading in the statutory text. Furthermore, a court 

is well-equipped, when looking at the evidence in the record, to foresee whether a 

specific identifiable harm to a submitter's commercial or financial interests will occur 

without being restricted to finding a measurable diminution in economic value. See S. 

Rep. No. 114-4 (2015), as reprinted in 2016 U.S.C.C.A.N. 321, 328 ("The standard 

mandates that an agency may withhold information only if it reasonably foresees a 

specific identifiable harm to an interest protected by an exemption.").
21

The "specific context in which that language is used" and the

"broader context of the statute as a whole" reinforce our conclusion. Robinson, 

519 U.S. at 341. The FIA amended FOIA to add an independent statutory 

requirement that an agency must meet to withhold information. The specific 

context of the language used makes clear that, at least in Exemption 4 cases, the 

FIA requirement poses an additional burden on the withholding agency. 

Congress explicitly wrote that the FIA does not apply to information withheld 

under Exemption 3. 5 U.S.C. § 552(a)(8)(B) ("Nothing in this paragraph requires 

disclosure of information that is . . . otherwise exempted from disclosure under 

[Exemption 3]."). But the statute says nothing about excluding Exemption 4.

Defendants argue that we should look only at the word 

"confidential" and hold that the interest protected by Exemption 4 is simply

"confidentiality." If we were to accept that interpretation, any and all 

confidential information would be exempt from disclosure, for disclosure "would 

necessarily destroy the private nature of the information" and confidentiality --

the interest purportedly protected by Exemption 4 -- would necessarily be 

harmed. Am. Small Bus. League, 411 F. Supp. 3d at 836.
22

Defendants' position is belied by both the structure of the statute 

and common sense. Congress expressly enacted the FIA to address situations 

where information would fall within an exemption and yet no harm would result 

from disclosure, emphasizing that in those circumstances the information must 

be disclosed. See S. Rep. No. 114-4 (2015), as reprinted in 2016 U.S.C.C.A.N. 321, 

322-24 (stating that agencies were "relying on these discretionary exemptions 

. . . even though no harm would result from disclosure"). The foreseeable harm 

requirement must be met independently from the elements of the exemption;

otherwise, the FIA adds nothing.

In arguing that the interest protected by Exemption 4 is the 

"confidentiality of the record maintained by the person who submitted that 

record to the government," Defs.-Appellees' Br. at 29, Defendants rely on Argus 

Leader. The crux of their argument is that the Supreme Court squarely held in 

Argus Leader that the interest protected by Exemption 4 is confidentiality. See id. 

at 29 ("[Argus Leader] thus makes clear that the 'interest protected by' Exemption 

4 is . . . the confidentiality of the record."). We are not persuaded.

Defendants' reliance on Argus Leader is unfounded. In Argus Leader, 

the Supreme Court answered the question whether the term "confidential" in 
23

Exemption 4 should be given its ordinary meaning. Argus Leader Media, 139 S. 

Ct. at 2363. The Supreme Court did not once mention the FIA or what interests 

Exemption 4 protects, and for good reason -- the underlying FOIA request in that 

case was filed prior to the FIA's effective date.

Here, we answer an entirely different question -- rather than 

consider the meaning of an isolated term, we consider which interests are 

protected by Exemption 4 as a whole. That is a question the Supreme Court 

neither answered nor had cause to answer in Argus Leader. At bottom, Argus 

Leader interpreted one word. While the focus on confidentiality was appropriate 

in that context -- where the only question was the definition of "confidential" -- it 

is not appropriate here, where we must read the statute in its entirety. In fact, as 

Defendants ignore, Argus Leader itself acknowledged commercial or financial 

limitations to confidentiality in the terms of Exemption 4. Compare id. at 2364 

("Exemption 4 protects information 'which would customarily not be released to 

the public by the person from whom it was obtained' such as 'business sales 

statistics' and 'customer lists'" (quoting S. Rep. No. 813, 89th Cong., 1st Sess., 9 

(1965)) (emphasis added)) with Defs.-Appellees' Br. at 29 (omitting the 

emphasized portion).
24

In conclusion, we hold that the interests protected by Exemption 4 

are the submitter's commercial or financial interests in information that is of a 

type held in confidence and not disclosed to any member of the public by the 

person to whom it belongs. An agency in a FOIA case can therefore meet the 

foreseeable harm requirement of the FIA by showing foreseeable commercial or 

financial harm to the submitter upon release of the contested information.

B. Summary Judgment

Thus, to be entitled to summary judgment, Defendants' submissions

had to "describe the justifications for nondisclosure," that is, why the release of 

the information would harm Sarepta's commercial or financial interests, in 

"reasonably specific detail." Wilner, 592 F.3d at 73 (quoting Larson, 565 F.3d at 

862). Moreover, the showing of harm to Sarepta's commercial or financial 

interests could not be controverted by contrary evidence in the record. See id.

a. Affidavits in the Record

In support of their motions for summary judgment, Defendants 

submit primarily two declarations from Ian Estepan and two declarations from 

Nancy Sager. Estepan is the Chief of Staff and Head of Corporate Affairs at

Sarepta and has experience in healthcare investing related to the development of 
25

promising drug candidates, particularly therapies for patients with DMD.8 His

declarations describe in specific detail how the information requested by Seife 

could be used by Sarepta's competitors to take research and development 

shortcuts, develop studies using Sarepta's data, or predict Sarepta's future 

moves. Sager is the Director of the Division of Information Disclosure Policy in 

the FDA. Her declarations reference Estepan's and ultimately conclude that the 

"unpublished details of Sarepta's clinical studies . . . if released, would cause 

competitive harm to Sarepta." Joint App'x at 2257.

In support of his motion for summary judgment, Seife submits three 

declarations. The first is from Dr. Peter Lurie, the President of the Center for

Science in the Public Interest and former Associate Commissioner for Public 

Health Strategy and Analysis at the FDA. The second is from Dr. Diana M. 

8 Although Seife argues that the district court should have excluded Estepan's 

declaration because it was "neither based on personal knowledge nor within [his] expert 

competence," Pl.-Appellant's Br. at 47, we disagree. Although Estepan is not a scientist 

or a doctor, his fifteen years of healthcare investigation, regular reviews of the scientific 

DMD landscape, and consultations with scientific, medical, and technical personnel 

mean that he is competent to testify about the "competitive harms that the disclosures at 

issue could cause," and does so from personal knowledge. Joint App'x at 87. 

Accordingly, we find that the district court did not abuse its discretion by considering 

the declaration.
26

Zuckerman, the President of the National Center for Health Research. The third 

is from Seife himself.

b. Foreseeable Harm

We first conclude that Defendants presented sufficient evidence, in 

reasonably specific detail, to establish foreseeable harm to Sarepta's commercial 

or financial interests. Estepan's declarations describe how the information could 

be used to develop studies for other exon-skipping drugs, used in competitors' 

head-to-head trials, or be informative as to Sarepta's future clinical endpoint 

research. Even Seife's evidence acknowledges that the information Seife seeks 

would foreseeably cause harm to Sarepta. When discussing clinical study 

results, for example, Lurie writes that the information has a "small incremental 

value to competitors." Id. at 303.

Furthermore, we do not conduct our analysis in a vacuum. The 

pharmaceutical industry is, of course, highly competitive. Development of new 

pharmaceutical drugs is a long and arduous process -- research for Exondys 51 

spanned many years, with the development of procedures for Study 201 and 

Study 202 alone taking three years, and the FDA approval process taking nine 

years. The big picture thus further supports Defendants' contentions that 
27

Sarepta's commercial or financial interests would be foreseeably harmed by 

disclosure of information it developed and gathered, Sarepta's competitors 

would benefit from disclosure, and a benefit to competitors would necessarily be 

a detriment causing harm to Sarepta.

Seife failed to present any evidence that meaningfully controverts

Defendants' showing of foreseeable harm. As a threshold matter, Seife argues 

that none of Defendants' declarations can successfully show harm because there 

is "substantially similar public information." Pl.-Appellant's Br. at 33. Thus, his 

argument goes, the similarity of the publicly available information means that 

Sarepta cannot suffer harm to its commercial or financial interests by the 

disclosure of information that is essentially the same. Seife's argument falls 

short. A FOIA decision is "evaluated as of the time it was made and not at the 

time of a court's review." Am. Civ. Liberties Union, 925 F.3d at 602 (internal 

quotation marks omitted). Seife does not specify which, if any, of the allegedly 

substantially similar data was published at the time he filed his FOIA request in 

December 2016.

Seife also contends that the declarations he submitted serve as 

contrary evidence in the record "refut[ing] Sarepta's . . . claims that disclosure of 
28

the information sought would foreseeably harm Sarepta's [protected interest]." 

Pl.-Appellant's Br. at 20.

We disagree. Only Lurie's declaration addresses foreseeable harm to 

Sarepta's commercial or financial interests, and it does not dispute that Sarepta 

would suffer foreseeable harm from disclosure of the information at issue.9 

Instead, Seife's evidence at most challenges the degree of commercial or financial 

harm to Sarepta, rather than that such harm would result.

In addition, much of Seife's evidence consists of broad, hedging 

statements. For example, Lurie writes that disclosing endpoint data is "unlikely

to be commercially appealing," Joint App'x at 301 (emphasis added), or that 

competitors who may be interested in clinical study procedures "are presumably

designing different drugs," id. at 298-99 (emphasis added). Seife thus fails to 

controvert Defendants' specific assertions that the information could be used to 

9 Zuckerman's declaration discusses only irregular aspects of Exondys 51's 

approval process and public policy reasons for releasing the information at issue. 

Seife's declaration is limited to those topics with additional testimony on redacted 

information substantially similar to public information, an argument we have already 

rejected. The dispute within the FDA over the approval of Exondys 51 is concerning. 

Defendants, however, have already produced over 45,000 pages of Seife's requested 

documents. And, as a matter of law, summary judgment for Defendants is warranted 

unless Seife's evidence controverts Defendants' claims of harm to Sarepta's business 

interests.
29

develop studies for other exon-skipping drugs, in competitors' head-to-head 

trials, or as information regarding Sarepta's future clinical endpoint direction in 

ways that would harm Sarepta's competitive interests.

In all, Defendants have shown that it was reasonably foreseeable 

that Sarepta would suffer harm to its commercial or financial interests if any of 

the information Seife seeks were released. Seife neither successfully disputes

that showing with his own evidence -- much less shows a genuine dispute of 

material fact -- nor offers evidence of bad faith in the provision of Defendants'

declarations. Seife was thus not entitled to an evidentiary hearing or additional 

discovery. See Carney v. U.S. Dep't of Justice, 19 F.3d 807, 812 (2d Cir. 1994) ("[I]f 

the agency's submissions are adequate on their face . . . the district court may 

forgo discovery and award summary judgment on the basis of affidavits." 

(internal quotation marks omitted)).

While Seife makes numerous policy arguments favoring disclosure, 

FOIA does not have an exception for cases where public health may be served by 

disclosure. See Argus Leader, 139 S. Ct. at 2366. We conclude that Defendants 

have made the requisite showing for summary judgment on the foreseeable 

harm prong of the FIA and affirm the district court's judgment on that ground. 
30

As we are satisfied that Defendants have shown the first prong of the FIA, we 

need not address the alternative prong -- whether disclosure is prohibited by 

law.

CONCLUSION

For the reasons set forth above, we hold that the interests protected 

by Exemption 4 are the submitter's commercial or financial interests in 

information that is of a type held in confidence and not disclosed to any member 

of the public by the person to whom it belongs. Defendants' declarations show

that release of the information Seife seeks would foreseeably harm Sarepta's 

interests and Seife does not raise a genuine dispute as to that showing. 

Accordingly, the district court's grant of summary judgment for Defendants and 

denial of summary judgment for Seife is AFFIRMED.