Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caDC-98-05162/USCOURTS-caDC-98-05162-0/pdf.json

Nature of Suit Code: 895
Nature of Suit: Freedom of Information Act of 1974
Cause of Action: 

---

<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued May 11, 1999 Decided August 6, 1999

No. 98-5161

Public Citizen Health Research Group,

Appellee

v.

Food & Drug Administration,

Appellant in 98-5161

Schering Corporation,

Appellant in 98-5162

Consolidated with

98-5162

Appeals from the United States District Court

for the District of Columbia

(No. 94cv00018)

Marina Utgoff Braswell, Assistant U.S. Attorney, argued

the cause for appellant Food & Drug Administration. With

USCA Case #98-5162 Document #454872 Filed: 08/06/1999 Page 1 of 21
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

her on the briefs were Wilma A. Lewis, U.S. Attorney, and

R. Craig Lawrence, Assistant U.S. Attorney.

Bruce N. Kuhlik argued the cause and filed the briefs for

appellant Schering Corporation.

Amanda Frost argued the cause for appellee. With her on

the brief was Brian Wolfman. Lucinda A. Sikes entered an

appearance.

Marjorie E. Powell was on the brief for amicus curiae

Pharmaceutical Research and Manufacturers of America.

Before: Ginsburg, Henderson, and Garland, Circuit

Judges.

Opinion for the Court filed by Circuit Judge Ginsburg.

Opinion concurring in the result filed by Circuit Judge

Garland.

Ginsburg, Circuit Judge: Pursuant to the Freedom of

Information Act, the Public Citizen Health Research Group

asked the Food and Drug Administration for documents

relating to drug applications that had been abandoned for

health or safety reasons. The FDA denied this request and

Public Citizen sued the agency in district court, where Schering Corporation, which had submitted five investigational new

drug applications (INDs) of the sort requested by Public

Citizen, intervened as a defendant. The FDA and Schering

claimed that certain of the documents in those five INDs

contained confidential commercial information and therefore

could be withheld under Exemption 4 of the FOIA, 5 U.S.C.

s 552(b)(4). Public Citizen argued that the documents could

not be withheld under that exemption and that in any event

disclosure was required under 21 U.S.C. s 355(l), which it

asserted sets a standard for nondisclosure higher than that in

Exemption 4 of the FOIA.

The district court ordered the release of all the disputed

documents on the ground that, although some could be withheld under Exemption 4, the FDA had not met the higher

USCA Case #98-5162 Document #454872 Filed: 08/06/1999 Page 2 of 21
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

standard of s 355(l). We affirm the judgment of the district

court in part, albeit on a different ground, reverse it in part,

and remand the case for further proceedings consistent with

this opinion.

I. Background

Before marketing a new drug in the United States a

manufacturer must obtain the approval of the FDA contingent upon clinical (i.e., human) tests showing that the drug is

safe and effective. See 21 U.S.C. s 355(a), (d). Before a

company may begin clinical testing, however, it must first

submit an IND describing the drug, the results of laboratory

and pre-clinical (i.e., animal) testing, and the proposed clinical

testing. See id. s 355(i). An applicant may begin the proposed clinical testing 30 days after submitting its IND; the

FDA, however, may place the testing on hold at any time.

See 21 C.F.R. ss 312.40(b), 312.42. During clinical testing

the company must update its IND with safety reports, annual

reports on the progress of the testing, any amendments to

the testing protocols, and other information. See id.

ss 312.30-312.33. After clinical testing, the company must

file a new drug application (NDA), which must include information about the results of both pre-clinical and clinical

testing; information previously submitted in the IND may be

incorporated by reference into the NDA. See 21 U.S.C.

s 355(b); 21 C.F.R. s 314.50.

This case began when Public Citizen filed a FOIA request

with the FDA for "[a]ll documents concerning pre-clinical and

clinical studies for all prescription drugs which had a discontinuance of the clinical trials because of death or serious

injury of patients or because of safety concerns from preclinical studies ... between January 1, 1990 and [July 12, 1993]."

When the agency denied the request Public Citizen filed suit

in the district court seeking release of the documents.

The FDA moved to dismiss, arguing that although a search

of its database identified 230 INDs for which the agency had

received safety reports and which were either withdrawn,

terminated, or placed on hold by the FDA, it could not

USCA Case #98-5162 Document #454872 Filed: 08/06/1999 Page 3 of 21
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

without an unduly burdensome manual search of each file

determine which of these were discontinued "because of"

health or safety concerns. The district court denied the

motion to dismiss, and the agency then determined that 14 of

the 230 INDs were responsive to the FOIA request; of those,

only portions of the five filed by Schering are at issue in this

appeal.

On cross-motions for summary judgment, the district court

first held that the disputed documents in the five INDs could

be withheld under Exemption 4, because they contain "commercial or financial information obtained from a person [that

is] privileged or confidential." 5 U.S.C. s 552(b)(4). Schering's affidavits demonstrated to the court that disclosure

would "cause substantial harm to [its] competitive position."

National Parks & Conservation Ass'n v. Morton ("National

Parks I"), 498 F.2d 765, 770 (D.C. Cir. 1974). The district

court then held that under 21 U.S.C. s 355(l)(1) the FDA

must nonetheless disclose the same documents absent "extraordinary circumstances." Finding no such circumstances

here, the court granted summary judgment for Public Citizen

and ordered the agency to release the disputed documents.

Both the FDA and Schering appealed to this court.

II. Analysis

The FDA and Schering argue that the agency may under

s 355(l) withhold any data pertaining to the safety and effectiveness of an abandoned drug that it may withhold under

Exemption 4 of the FOIA--in other words, that the standards

in the two statutes are the same. Public Citizen contends

that s 355(l) imposes a more stringent standard for nondisclosure than that in Exemption 4. We need not resolve this

dispute over the relationship between the two statutes, however, because we hold that s 355(l) does not apply to INDs.

Viewing the documents solely through the lens of Exemption

4, we conclude that the FDA has justified withholding at least

some information in four of the five INDs.

A. Section 355(l)

Section 355(l) requires the FDA, upon request, to disclose

"[s]afety and effectiveness data and information which has

USCA Case #98-5162 Document #454872 Filed: 08/06/1999 Page 4 of 21
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

been submitted in an application under subsection (b) [of

s 355] for a drug" that subsequently was abandoned by its

sponsor, "unless extraordinary circumstances are shown." 21

U.S.C. s 355(l)(1). No one disputes that an "application

under subsection (b)" is an NDA. Schering argues that

s 355(l), therefore, simply does not apply to information in an

IND, which is submitted under subsection (i), not subsection

(b). That is indeed the plain meaning of the provision, and

we cannot understand how "submitted in an application under

subsection (b)" could include anything other than information

submitted in an NDA. Public Citizen's arguments to the

contrary are not convincing.

First, Public Citizen contends that the agency applies

s 355(l) to the disclosure of material submitted in an IND

and that we should accord "substantial weight" to the FDA's

view of its regulatory structure. As Schering notes, however,

the FDA has never promulgated a regulation--nor are we

apprised of any FDA decision or other document--so interpreting s 355(l). More important, it is apparent that the

Congress has spoken to "the precise question at issue" here,

Chevron U.S.A. Inc. v. NRDC, 467 U.S. 837, 842-43 & n.9

(1984): s 355(l) by its terms applies only to "safety and

effectiveness data and information" submitted in an NDA.

Therefore, even if the agency had interpreted the phrase

"subsection (b)" in s 355 to include information submitted in

an IND, we could not defer to that interpretation.

Second, Public Citizen argues that to read s 355(l) as

applying only to NDAs is erroneous because "the IND and

NDA are not two distinct stages" in the drug approval

process. In support of this view, Public Citizen points out

that the FDA stores information related to the approval of a

drug in its IND file even after an NDA is submitted. The

fact remains, however, that NDAs and INDs are the subject

of separate subsections of s 355 and the Congress referred

only to one of them in s 355(l). We cannot help but conclude,

therefore, that the statute treats the submission of an NDA

as a discrete event in the drug approval process, regardless

how the FDA maintains its files.

USCA Case #98-5162 Document #454872 Filed: 08/06/1999 Page 5 of 21
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

Third, Public Citizen contends that a plain meaning approach to s 355(l) leads to an illogical result: data and

information submitted in an IND which later, rather than

being resubmitted in an NDA, are incorporated by reference

into the NDA would not be "submitted in an application

under subsection (b)," that is, an NDA. The FDA and

Schering offer a more sensible view, however: to incorporate

IND materials by reference into an NDA is indeed to submit

those materials as part of the NDA. By the same token, once

those materials are incorporated by reference into an NDA,

their disclosure is subject to the standard in s 355(l) even if

the FDA keeps them in an IND file.

Finally, Public Citizen argues that "[i]t makes no sense to

assume Congress enacted a statute mandating disclosure of

safety and effectiveness data only when the sponsor had filed

an NDA ..., but not when the sponsor had abandoned the

drug earlier in the process." In this regard Public Citizen

points out that the FDA accords the same treatment to such

data regardless whether they were submitted in an NDA or

an IND. Specifically, the FDA by regulation (21 C.F.R.

s 312.130(b)) provides that disclosure of information in an

IND "will be handled in accordance with" the regulation

governing disclosure of information in an NDA (21 C.F.R.

s 314.430(f)).

Nonetheless, when the Congress enacted s 355(l) it did not

mandate disclosure of information in an IND. Moreover,

Schering offers a perfectly sensible explanation why the

Congress did not do so. The Drug Price Competition and

Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98

Stat. 1585, of which s 355(l) was a part, established an

abbreviated process through which a company could obtain

approval to market the generic equivalent of a drug that the

FDA had previously approved on the basis of an NDA. See

Mova Pharm. Corp. v. Shalala, 140 F.3d 1060, 1063-65 (D.C.

Cir. 1998) (describing abbreviated new drug application process). The statute, Schering continues, does "not deal with

INDs at all, and Congress had no reason in this legislative

context to extend [s 355(l)] to them." Even if, as Public

Citizen contends, it would be more wise not to treat informaUSCA Case #98-5162 Document #454872 Filed: 08/06/1999 Page 6 of 21
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

tion submitted in an IND differently from information submitted in an NDA, a matter about which we express no

opinion, the Congress may, of course, approach matters one

step at a time. See FCC v. Beach Communications, Inc., 508

U.S. 307, 316 (1993)

In view of the above analysis, we hold that s 355(l) does

not apply to data and information submitted solely in an IND;

such information may be withheld if the agency carries its

burden under Exemption 4 of the FOIA. Schering did not

file an NDA for four of the five INDs at issue in this case

(which four we consider in Part II.B.1), but concedes that it

filed two NDAs relating to the drug at issue in IND No.

18113. We need not determine the import of Schering's

concession, however, for we conclude (in Part II.B.2) that

documents in that IND cannot be withheld under the allegedly more lenient standard in Exemption 4.

B. Exemption 4

Exemption 4 of the FOIA permits an agency to withhold

"commercial or financial information [that was] obtained from

a person [and is] privileged or confidential." 5 U.S.C.

s 552(b)(4). Information that a person is required to submit

to the Government is considered confidential only if its disclosure is likely either "(1) to impair the Government's ability to

obtain necessary information in the future; or (2) to cause

substantial harm to the competitive position of the person

from whom the information was obtained." National Parks

I, 498 F.2d at 770. In the present case the FDA and

Schering invoke only the latter standard. Meanwhile, Public

Citizen claims disclosure would prevent other drug companies

"from repeating Schering's mistakes, thereby avoiding risk to

human health," and relies upon dicta in several district court

opinions in arguing that under Exemption 4 the court should

gauge whether the competitive harm done to the sponsor of

an IND by the public disclosure of confidential information

"is outweighed by the strong public interest in safeguarding

the health of human trial participants."* See Public Citizen

__________

* Our concurring colleague is of the opinion that Public Citizen

has failed to create a genuine issue of material fact as to whether

USCA Case #98-5162 Document #454872 Filed: 08/06/1999 Page 7 of 21
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

Health Research Group v. FDA, 964 F. Supp. 413, 415

(D.D.C. 1997); see also Teich v. FDA, 751 F. Supp. 243, 253

(D.D.C. 1990); AT&T Info. Sys., Inc. v. General Servs. Admin., 627 F.Supp. 1396, 1403 (D.D.C. 1986).

We reject Public Citizen's proposal because a consequentialist approach to the public interest in disclosure is inconsistent with the "[b]alanc[e of] private and public interests" the

__________

disclosure is necessary to safeguard participants in clinical trials,

and therefore that it has not done enough to prevent summary

judgment from being entered against it, even if its view of the law

were correct. See Concur. at 2 & n.1. The record, however, makes

clear that Public Citizen has more than met its burden of raising a

dispute over this fact. The affidavit it submitted to the district

court states:

Defendants' arguments of substantial competitive harm are

disturbing from a public health standpoint because the data we

seek involve experimental drugs that were determined to pose

such serious health or safety risks that clinical testing of the

drug was stopped. ...[B]ecause the safety and effectiveness

data for this experimental drug is being withheld, we cannot

determine whether the FDA adequately protected human subjects in these clinical trials. Defendants will not be competitively harmed from the release of [this information] because

tests that reveal the hazards of a drug are simply not the type

of studies that competitors would want to copy. On the other

hand, the public will benefit significantly from their release.

Indeed, if these studies are kept secret, other drug companies

may unknowingly conduct similarly hazardous studies, potentially placing many patients needlessly at risk.

Similarly, Public Citizen's affiant states: "disclosure ... serves the

public interest in two independent ways. First, it allows the public

to scrutinize FDA's decisions concerning human testing of investigational drugs.... Second, disclosure of safety and effectiveness

data decreases the likelihood that other drug companies will replicate potentially hazardous human testing."

That the FDA claims it has another, more direct, way to prevent

exposure of human beings to this risk, see Op. at 11, merely joins

the dispute on the factual question; it does not resolve it. See

Niagara Mohawk Power Corp. v. DOE, 169 F.3d 16, 18-19 (D.C.

Cir. 1999).

Congress struck in Exemption 4. Critical Mass Energy

Project v. NRC, 975 F.2d 871, 872 (D.C. Cir. 1992) (in banc);

see also FBI v. Abramson, 456 U.S. 615, 621 (1982) (although

FOIA implements policy of broad disclosure, the Congress

also realized "that legitimate governmental and private interests could be harmed by release of certain types of information and provided nine specific exemptions under which disclosure could be refused"); see also National Parks I, 498

F.2d at 770 (legislative history of FOIA "firmly supports the

inference that [Exemption 4] is intended for the benefit of

persons who supply information"). That balance is accurately

reflected in the test of confidentiality set forth in National

Parks I, which was "known to and acquiesced in by Congress" when it enacted 5 U.S.C. s 552b(c)(4), an exemption to

the Government in the Sunshine Act that is identical to

USCA Case #98-5162 Document #454872 Filed: 08/06/1999 Page 8 of 21
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

Exemption 4 of the FOIA. CNA Fin. Corp. v. Donovan, 830

F.2d 1132, 1153 n.146 (D.C. Cir. 1987) (describing legislative

history of s 552b(c)(4)).

In other words, the Congress has already determined the

relevant public interest: if through disclosure "the public

would learn something directly about the workings of the

Government," then the information should be disclosed unless

it comes within a specific exemption. National Ass'n of

Retired Fed. Employees v. Horner, 879 F.2d 873, 879 (D.C.

Cir. 1989) (emphasis in original). Indeed, Public Citizen's

main reason for seeking this information is to "review whether the FDA is adequately safeguarding the health of people

who participate in drug trials"; the information sought, in

other words, would reveal "what the[ ] government is up to."

DOJ v. Reporters Comm. for Freedom of Press, 489 U.S. 749,

773 (1989). It is not open to Public Citizen, however, to

bolster the case for disclosure by claiming an additional public

benefit in that, if the information is disclosed, then other drug

companies will not conduct risky clinical trials of the drugs

that Schering has abandoned. That is not related to "what

the[ ] government is up to" and the Court has clearly stated

that "whether disclosure of a ... document ... is warranted

must turn on the nature of the requested document and its

relationship to the basic purpose of the Freedom of InformaUSCA Case #98-5162 Document #454872 Filed: 08/06/1999 Page 9 of 21
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

tion Act to open agency action to the light of public scrutiny

... rather than on the particular purpose for which the

document is being requested." Id. at 772. In other words,

the public interest side of the balance is not a function of the

identity of the requester, see id. at 771, or of any potential

negative consequences disclosure may have for the public,

Washington Post Co. v. HHS, 865 F.2d 320, 327-28 (D.C. Cir.

1989), nor likewise of any collateral benefits of disclosure.

In litigation seeking the release of information under the

FOIA, "the agency has the burden of showing that requested

information comes within a FOIA exemption." Niagara Mohawk Power Corp. v. DOE, 169 F.3d 16, 18 (D.C. Cir. 1999).

Even when the requester files a motion for summary judgment, the Government "ultimately [has] the onus of proving

that the [documents] are exempt from disclosure." National

Ass'n of Gov't Employees v. Campbell, 593 F.2d 1023, 1027

(D.C. Cir. 1978). The burden upon the requester is merely

"to establish the absence of material factual issues before a

summary disposition of the case could permissibly occur."

Id. Accordingly, in order to obtain a summary judgment

Public Citizen need not demonstrate that Schering would

suffer no competitive harm from the release of this information; rather, its task is to show that there is no dispute about

an issue of fact material to the FDA's burden of demonstrating that Schering would suffer substantial competitive harm

from the disclosure of its INDs. See National Parks I, 498

F.2d at 770.

1. IND Nos. 35757, 34465, 31911, and 30647

For the reasons stated in the opinion of the district court,

997 F. Supp. at 63-64, we agree with the FDA and Schering

that under Exemption 4 the agency may withhold information

in the four INDs listed above. Release of that information

would cause substantial harm to Schering's competitive position.

With respect to the first three INDs, Public Citizen contends that releasing health and safety information would only

"save Schering's competitors the time Schering spent developing and testing a dangerous drug, and thus save human

USCA Case #98-5162 Document #454872 Filed: 08/06/1999 Page 10 of 21
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

trial participants from being exposed to a dangerous drug."

According to Public Citizen, that "cannot be considered the

type of 'competitive harm' justifying withholding of the documents under Exemption 4."

Having already rejected Public Citizen's argument that any

collateral benefit from the disclosure of information--that is,

any benefit beyond learning "what the[ ] government is up

to"--must be weighed against the competitive harm that

would result from disclosure, we do not consider Public

Citizen's assertion that disclosure would in fact prevent the

exposure of human beings to a health risk. In any event, as

both the FDA and Schering point out, were a competitor to

submit an IND involving a risk known to the FDA because of

its experiences with Schering's INDs, the agency could and

presumably would refuse to permit that company to begin

clinical testing.

We turn therefore to Schering's evidence of competitive

harm from disclosure of these three INDs, all of which relate

to the same antifungal drug. According to the affidavit of its

Dr. George H. Miller, the Company "has just commenced

clinical testing on a successor [drug] which was designed

based on information learned during development of [the

drugs described in those INDs]." Further, Dr. Miller states

that "Schering's basic research revealed that the particular

type of fungal infection for which this product was designed

was not one that was relatively well-controlled by existing

products." He also states that "[t]he development and marketing of new antifungal products is ... being actively engaged in by a number of other drug companies," which could

make use of the information in the INDs in order to eliminate

much of the time and effort that would otherwise be required

to bring to market a product competitive with the product for

which Schering filed its most recent IND. This is clearly the

type of competitive harm envisioned in Exemption 4, as our

case law makes clear. See, e.g., National Parks & Conservation Ass'n v. Kleppe ("National Parks II"), 547 F.2d 673, 684

(D.C. Cir. 1976) ("Disclosure would provide competitors with

valuable insights into the operational strengths and weaknesses of a [company], while [its competitors] could continue

USCA Case #98-5162 Document #454872 Filed: 08/06/1999 Page 11 of 21
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

in the customary manner of 'playing their cards close to their

chest' "); cf. Webb v. HHS, 696 F.2d 101, 103 (D.C. Cir. 1982)

("If a manufacturer's competitor could obtain all the data in

the manufacturer's NDA, it could utilize them in its own NDA

without incurring the time, labor, risk, and expense involved

in developing them independently").

The fourth IND listed above concerned a drug "designed to

suppress allergic inflammations and subsequent symptoms of

asthma." Public Citizen concedes that Schering is now testing compounds related to the abandoned drug. Nonetheless,

Public Citizen complains that the Company does not "explain

with any specificity how the pre-clinical and clinical studies on

the old compound would lead its competitors to the new

compounds that Schering has subsequently identified."

In the affidavit Schering filed to support withholding the

documents in this IND, Dr. Francis Cuss recounts that the

Company initially believed the drug was a "leukotrine inhibitor," but that its "scientists observed certain unanticipated

effects during toxicity and clinical testing .... suggest[ing]

that the drug may have achieved its anti-inflammatory effects

through a [different] mechanism." Therefore, states the affiant, the "toxicity and clinical data together could direct a

competitor of Schering .... to pursue the the same avenues

of research and development" that Schering has pursued

since abandoning this IND. We think this explanation sufficiently specific to support Schering's argument that disclosure of information in this IND would cause it substantial

competitive harm.

Accordingly, we reverse that portion of the district court's

order requiring the agency to release the documents in these

four INDs. See Critical Mass, 975 F.2d at 880.

2. IND No. 18113

We turn now to the documents in the fifth IND, which

involved "one of four isomers making up a prescription medicine currently marketed by Schering and indicated for use in

controlling blood pressure in cases of severe hypertension."

We find that Schering's affidavit professing the extent of

USCA Case #98-5162 Document #454872 Filed: 08/06/1999 Page 12 of 21
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

competitive injury it would suffer from disclosure of the

information in this IND is not sufficient to support its motion

for summary judgment; indeed, it fails to raise a dispute as

to any material issue of fact. Summary judgment for Public

Citizen is therefore indicated.

The affidavit of Schering's Dr. Ronald J. Garutti contains

only conclusory assertions that disclosure would cause substantial competitive harm. For example, the affiant states

that disclosure "would reveal substantial basic research" as

well as "disease models ... that have been developed by

Schering at a great expense," and that "[t]oxicology data ...

have significant value beyond the compound under investigation .... [and would be applicable] to any drug product any

of whose metabolites were identical or similar to those of

IND 18113 .... [and] other drugs [of] a similar chemical

type." Dr. Garutti attests that the clinical protocols also

"have applicability beyond the specific drug being tested" and

that disclosure "would have substantial commercial value to

any company attempting to develop cardiovascular therapies

generally." The arguments in Schering's brief are even more

general: disclosure would reveal its "assessment of regulatory requirements and its experience with FDA in this area, as

well as [its] judgment as to what requirements will be necessary in order to establish the drug's safety and effectiveness."

Although a party opposing a motion for summary judgment

is entitled to every favorable inference that may fairly be

drawn from its affidavits, see Greenberg v. FDA, 803 F.2d

1213, 1216 (D.C. Cir. 1986), such "[c]onclusory and generalized allegations of substantial competitive harm ... cannot

support an agency's decision to withhold requested documents." Public Citizen Health Research Group v. FDA, 704

F.2d 1280, 1291 (D.C. Cir. 1983). Accordingly, we hold that

the agency may not withhold the disputed documents in IND

No. 18113 under Exemption 4. We therefore affirm that

portion of the district court's order requiring the agency to

release them to Public Citizen, albeit for a different reason.

C. Segregability

In view of our holding that the agency may, under Exemption 4, withhold information in four of the INDs, we turn to

USCA Case #98-5162 Document #454872 Filed: 08/06/1999 Page 13 of 21
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

Public Citizen's alternative request that we remand the case

for the district court to determine whether any non-exempt

portions of the documents that the agency may withhold can

be segregated and disclosed. Public Citizen contends that

the district court did not have occasion to make this determination because it required disclosure of all the records.

Schering responds that the district court did not do so

because Public Citizen never asked for, and therefore waived,

such relief, and that segregation would in any event be

"unreasonable" in this case.

From the record we see that Public Citizen did raise this

issue before the district court in its Reply in Support of its

Cross-Motion for Summary Judgment. In any event, on

remand it would be incumbent upon the district court on its

own initiative to address the issue of segregability. See

Trans-Pacific Policing Agreement v. United States Customs

Serv., 177 F.3d 1022, 1028 (D.C. Cir. 1999). One should

normally presume that a request for information under the

FOIA is a request for all or any, not for all or none, of the

information described. Cf. National Mining Ass'n v. Babbitt,

172 F.3d 906, 910 (D.C. Cir. 1999) (factual presumption is

reasonable when "the circumstances giving rise to the presumption ... make it more likely than not that the presumed

fact exists").

In view of the district court's disposition of this case, of

course, it had no need to address the issue of segregability

the first time around and we do not fault it for passing over

the issue then. We have now held, however, that information

in four of the five INDs at issue may be withheld. Because

"[t]he focus in the FOIA is information, not documents, and

an agency cannot justify withholding an entire document

simply by showing that it contains some exempt material," we

remand this case for the district court to determine whether

the documents the agency has withheld contain information

that can be segregated and disclosed. Schiller v. NLRB, 964

F.2d 1205, 1209-10 (D.C. Cir. 1992). In so doing, we express

no opinion upon Schering's claim that segregation is impracticable in this case.

USCA Case #98-5162 Document #454872 Filed: 08/06/1999 Page 14 of 21
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

III. Summary and Conclusion

For the foregoing reasons, we hold first that s 355(l)

applies only to information submitted in an NDA. In addition we hold that the FDA has not met its burden under

Exemption 4 with respect to, and therefore must disclose, the

information contained in IND No. 18113; and that the agency

has met its burden under Exemption 4 with respect to, and

therefore need not disclose, confidential information contained

in IND Nos. 35757, 34465, 31911, and 30647. As to the latter

four INDs, we remand the case for the district court to

determine in the first instance whether there is any nonconfidential information that can be segregated and disclosed.

So ordered.

USCA Case #98-5162 Document #454872 Filed: 08/06/1999 Page 15 of 21
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

Garland, Circuit Judge, concurring in the result: Today

the court exercises appropriate discretion in declining to

decide whether section 355(l) and FOIA Exemption 4 are

congruent, because it is unnecessary to do so to resolve the

dispute before us. I believe the court errs, however, in not

exercising similar restraint with respect to an issue regarding

the meaning of Exemption 4 itself.

My colleagues hold that in determining whether a document comes within Exemption 4, the court may not "gauge

whether the competitive harm" disclosure would cause to the

company that submitted the document "is outweighed by the

public interest in safeguarding" human health. Op. at 7-8.

This means that even if disclosure were the only way to

prevent the loss of human life, that would count for nothing

as against a showing by the company that disclosure would

cause substantial harm to its competitive position. See id. at

11 ("[W]e do not consider Public Citizen's assertion that

disclosure would in fact prevent the exposure of human

beings to a health risk."). This is an important issue, and the

kind that should be decided only after full briefing and

argument. See, e.g., Carducci v. Regan, 714 F.2d 171, 177

(D.C. Cir. 1983).

But we have not had that here. As the argument heading

of Public Citizen's brief makes clear, its core Exemption 4

argument was that the requested records "Do Not Constitute

Confidential Commercial Information." Public Citizen Br. at

31. In a single clause in a single sentence of that brief,

Public Citizen also said: "Any disadvantage to Schering is

minimal, and is outweighed by the strong public interest in

safeguarding the health of human trial participants." Id. at

34 (emphasis added). Schering replied in kind. In a single

clause in a single sentence of its reply brief (and without

citation), Schering said: "This enterprise [pharmaceutical research] has well-served the public health through the discovery and development of new medicines and should not, in

effect, be reorganized to suit Public Citizen's views through

an unprecedented and strained reading of exemption 4."

Schering Reply Br. at 6 (emphasis added). The italicized

phrases are the full extent of the argument we have heard on

USCA Case #98-5162 Document #454872 Filed: 08/06/1999 Page 16 of 21
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

this issue. The FDA did not mention the point at all; the

parties did not discuss it at oral argument; and the district

judge did not refer to it in his opinion.

Nor is this an issue we must decide in order to dispose of

this case. Even if a balancing of the public safety interest in

disclosure were an element of Exemption 4, and even if Public

Citizen had intended to raise the point, the conclusory assertion the court cites is insufficient to prevent the entry of

summary judgment in favor of the FDA. As we have said

many times before, "[i]t is well settled that [c]onclusory

allegations unsupported by factual data will not create a

triable issue of fact." Exxon Corp. v. FTC, 663 F.2d 120,

126-27 (D.C. Cir. 1980) (internal quotation omitted); see

Alyeska Pipeline Serv. Co. v. EPA, 856 F.2d 309, 313-14

(D.C. Cir. 1988); Gardels v. CIA, 689 F.2d 1100, 1106 (D.C.

Cir. 1982); Military Audit Project v. Casey, 656 F.2d 724, 749

(D.C. Cir. 1981).1

Nor is this a case where the legal conclusion the court has

reached is indisputable. To the contrary, although no party

cited the relevant precedent on this point, we have twice held

that Exemption 4 requires a balancing of the interest in

nondisclosure "against the public interest in disclosure." See

Washington Post Co. v. HHS, 690 F.2d 252, 269 (D.C. Cir.

__________

1 The court notes that in addition to the single conclusory

statement in its brief, Public Citizen also mentioned the point in an

affidavit filed in district court. Op. at 8 n.*. But as my colleagues'

recitation of statements from the affidavit makes clear, that mention

is confined to a total of three sentences in that 12-page document.

See JA 312 (opining that "the public will benefit significantly from

their release" and that "if these studies are kept secret, other drug

companies may unknowingly conduct similarly hazardous studies,

potentially placing many patients needlessly at risk") (emphasis

added); id. at 309 (alleging that disclosure "decreases the likelihood

that other drug companies will replicate potentially hazardous human testing"). As the cases cited in the text above indicate, these

conclusory statements of affiant opinion are insufficient to defeat a

motion for summary judgment. See also 10B Wright, Miller &

Kane, Federal Practice & Procedure s 2738, at 346-56 (3d ed.

1998).

USCA Case #98-5162 Document #454872 Filed: 08/06/1999 Page 17 of 21
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

1982) (Washington Post I); Washington Post Co. v. HHS, 865

F.2d 320, 326-27 (D.C. Cir. 1989) (Washington Post II).

Washington Post I involved an analysis of Exemption 4 under

the "impairment" prong of the National Parks test for confidential information.2 We held that "[t]his inquiry necessarily

involves a rough balancing of the extent of impairment and

the importance of the information against the public interest

in disclosure." Washington Post I, 690 F.2d at 269. Rather

than decide "the details of the balancing process," we remanded the case to the district court. Id. When the case

later returned to us, we concluded that the interest the

government asserted in nondisclosure--impairment of its

information-gathering ability--had not been appropriately resolved. We therefore remanded the case again, instructing

that "if the district court ultimately finds that disclosure will

impair the government's information-gathering, it will once

again be required to conduct the 'rough balancing of the

extent of impairment and the importance of the information

against the public interest in disclosure.' " Washington Post

II, 865 F.2d at 326-27 (quoting Washington Post I, 690 F.2d

at 269). And we made clear that "the only inquiry properly

before the district court was the question whether disclosure

of the financial information ... would be likely to impair the

government's ability to gather this information in the future,

and if so whether this risk outweighed the public's interest in

disclosure." Id. at 324-25 (emphasis added).3

__________

2 Under the test employed in National Parks & Conservation

Ass'n v. Morton, 498 F.2d 765, 770 (D.C. Cir. 1974), "commercial or

financial matter is 'confidential' for purposes of the exemption if

disclosure of the information is likely to have either of the following

effects: (1) to impair the Government's ability to obtain necessary

information in the future; or (2) to cause substantial harm to the

competitive position of the person from whom the information was

obtained." Nothing in the reasoning of Washington Post I suggests that the public interest balancing it requires for prong (1) is

not also required for prong (2).

3 See also Martin v. Lauer, 686 F.2d 24, 33 (D.C. Cir.1982) ("A

decision whether to release FOIA-exempt material ... requires a

considered balancing of the public's interest in disclosure of particuUSCA Case #98-5162 Document #454872 Filed: 08/06/1999 Page 18 of 21
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

None of the cases cited by the court holds that the public

safety interest in disclosure should not be weighed in applying FOIA Exemption 4. Certainly Reporters Committee does

not. See United States Dep't of Justice v. Reporters Comm.

for Freedom of the Press, 489 U.S. 749, 773 (1989). In that

case there was no question but that a balancing test was

required with respect to Exemption 7(C), id. at 776; the

question was what interests could be weighed in the balance.

The Supreme Court held that FOIA does not protect an

interest in "disclosure of information about private citizens

that is accumulated in various governmental files but that

reveals little or nothing about an agency's own conduct." Id.

at 773. But as my colleagues recognize, the Court also held

that an interest in "[o]fficial information that sheds light on

an agency's performance of its statutory duties falls squarely

within that statutory purpose" and may be weighed in the

balance. Id.

Unlike the information sought in Reporters Committee, the

information Public Citizen seeks may reveal much about "an

agency's performance of its statutory duties." All of the

records sought pertain to clinical trials that could not have

proceeded without FDA authorization, and that "were discon-

__________

lar material and the interests in nondisclosure acknowledged by the

statutory exemptions."). The Ninth Circuit has followed our approach, see GC Micro Corp. v. Defense Logistics Agency, 33 F.3d

1109, 1115 (9th Cir. 1994) ("We agree with the D.C. Circuit that, in

making our determination [of competitive harm under Exemption

4], we must balance the strong public interest in favor of disclosure

against the right of private businesses to protect sensitive information."), as has our own district court, see Public Citizen Health

Research Group v. FDA, 964 F. Supp. 413, 415 (D.D.C. 1997) (citing

Teich v. FDA, 751 F. Supp. 243, 253 (D.D.C. 1990); AT&T Info.

Sys., Inc. v. General Servs. Admin., 627 F. Supp. 1396, 1403 (D.D.C.

1986)). See also 1 James T. O'Reilly, Federal Information Disclosure s 14.12, at 14-44 (2d ed. 1990) ("In some cases the public need

for the information is factored by the court into its equation of

substantial competitive harm.... For example, public health and

safety factors may warrant more attention to the substantial harm

equation....").

USCA Case #98-5162 Document #454872 Filed: 08/06/1999 Page 19 of 21
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

tinued ... because of death or serious injury of patients."

FDA Br. at 2 (describing Public Citizen's FOIA request).

Disclosure assertedly will reveal "whether the FDA is adequately analyzing data submitted in INDs before allowing

human testing to begin and whether safety problems uncovered in clinical trials result in prompt cessation of those

trials." Public Citizen Br. at 5. That would certainly permit

the public to "learn something directly about the workings of

the Government." Op. at 9 (quoting National Ass'n of

Retired Fed. Empoyees v. Horner, 879 F.2d 873, 879 (D.C.

Cir. 1989)). Yet, in evaluating the government's Exemption 4

claims, the court makes no effort to determine how important

to the public interest learning such information would be,4 or

to weigh it against the injury Schering would suffer from

disclosure. Instead, the court ends its analysis upon finding

"that disclosure of information in this IND would cause

[Schering] substantial competitive harm." Id. at 12.

I cannot dispute my colleagues' conclusion that the briefs'

brief mention of this issue gives us the discretion to decide it.

But that is "not to say that affirmative exercise of the

discretion [is] wise." Fraternal Order of Police v. United

States, 173 F.3d 898, 903 (D.C. Cir. 1999), reconsidering

Fraternal Order of Police v. United States, 152 F.3d 998

(D.C. Cir. 1998). Deciding an issue in the absence of any

substantive briefing may later make us wish that we had

__________

4 One, but only one, of the elements of the public interest

asserted by Public Citizen is that disclosure would "save human

trial participants from being exposed to a dangerous drug" by

keeping other drug companies from replicating Schering's "hazardous human testing." Op. at 10-11, 8 n.* (quoting Public Citizen).

As noted above, on the current record this is only a conclusory

allegation. But if in fact the FDA has not already protected human

trial participants directly by barring authorization for such replicated studies, disclosure of Schering's studies will reveal that fact (to

the drug companies, trial participants, their physicians, and other

knowledgeable members of the public). By thus revealing the

FDA's failure to "perform[ ] its statutory duties," Reporters Committee, 489 U.S. at 773, disclosure may enable the public to protect

itself.

USCA Case #98-5162 Document #454872 Filed: 08/06/1999 Page 20 of 21
<<The pagination in this PDF may not match the actual pagination in the printed slip opinion>>

waited. See id. ("In retrospect, it may well have been

imprudent to address the merits on so thin an argumentative

record."). For that reason, I would "decline to resolve this

issue on the basis of briefing which consisted of [not even]

three sentences in the ... brief and no discussion of the ...

relevant case law." Railway Labor Executives' Ass'n v.

United States R.R. Retirement Bd., 749 F.2d 856, 859 n.6

(D.C. Cir. 1984) (citing Carducci, 714 F.2d at 717); see

Washington Legal Clinic for the Homeless v. Barry, 107 F.3d

32, 39 (D.C. Cir. 1997).

USCA Case #98-5162 Document #454872 Filed: 08/06/1999 Page 21 of 21