UNITED STATES COURT OF APPEALS FOR THE D.C. CIRCUIT


PUB CTZN HLTH RSRCH

v.

FDA


98-5161a

D.C. Cir. 1999


*	*	*


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
Scher- ing 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 district court ordered the release of all the disputed  documents
on the ground that, although some could be with- held under Exemption
4, the FDA had not met the higher 


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 contin- gent 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 pro- posed 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
infor- mation 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


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 discon- tinuance of the clinical
trials because of death or serious  injury of patients or because of
safety concerns from preclini- cal 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


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 


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 "com- mercial or financial
information obtained from a person [that  is] privileged or
confidential." 5 U.S.C. s 552(b)(4). Scher- ing'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 "ex-
traordinary 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


II. Analysis


The FDA and Schering argue that the agency may under  s 355(l) withhold
any data pertaining to the safety and effec- tiveness 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
nondis- closure than that in Exemption 4. We need not resolve this 
dispute over the relationship between the two statutes, how- ever,
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 


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


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 inter- preting 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


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.


Third, Public Citizen contends that a plain meaning ap- proach 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


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 pro- cess). 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


tion submitted in an IND differently from information sub- mitted 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 alleged- ly 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 disclo- sure 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




__________

n * Our concurring colleague is of the opinion that Public Citizen  has
failed to create a genuine issue of material fact as to whether 


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. Ad- min., 627 F. Supp. 1396, 1403 (D.D.C.
1986).


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


__________

n 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 


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 sub- jects in these clinical trials.
Defendants will not be competi- tively 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, poten-
tially 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 investi-
gational drugs.... Second, disclosure of safety and effectiveness 
data decreases the likelihood that other drug companies will repli-
cate 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.


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 inter- ests could be harmed by release of
certain types of informa- tion and provided nine specific exemptions
under which dis- closure 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 Con- gress" when it enacted 5 U.S.C. s
552b(c)(4), an exemption to  the Government in the Sunshine Act that
is identical to  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
wheth- er 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 Informa-


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 Mo- hawk Power Corp. v. DOE, 169
F.3d 16, 18 (D.C. Cir. 1999).  Even when the requester files a motion
for summary judg- ment, 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
informa- tion; rather, its task is to show that there is no dispute
about  an issue of fact material to the FDA's burden of demonstrat-
ing 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 posi- tion.


With respect to the first three INDs, Public Citizen con- tends that
releasing health and safety information would only  "save Schering's
competitors the time Schering spent devel- oping and testing a
dangerous drug, and thus save human 


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 docu- ments under


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 mar- keting of
new antifungal products is ... being actively en- gaged 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 & Conserva- tion
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 weak- nesses of a [company], while


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 test- ing 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 inhibi- tor," 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 affi- ant, 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 suffi- ciently specific to support Schering's argument
that disclo- sure of information in this IND would cause it


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 medi- cine 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 


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


The affidavit of Schering's Dr. Ronald J. Garutti contains  only
conclusory assertions that disclosure would cause sub- stantial
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 investiga- tion .... [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 regulato- ry requirements and its experience
with FDA in this area, as  well as [its] judgment as to what
requirements will be neces- sary in order to establish the drug's


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 general- ized allegations of substantial
competitive harm ... cannot  support an agency's decision to withhold
requested docu- ments." 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 Exemp- tion 4,
withhold information in four of the INDs, we turn to 


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 determi- nation 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 pre- sumption ... 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 impracti- cable in this


III. Summary and Conclusion


For the foregoing reasons, we hold first that s 355(l)  applies only to
information submitted in an NDA. In addi- tion 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 non- confidential
information that can be segregated and disclosed.


So ordered.


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 docu- ment 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
re- search] has well-served the public health through the discov- ery
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


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 asser- tion 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. 




__________

n 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 hu-
man 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).


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 confi- dential 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 re-
manded 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 re- solved. 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




__________

n 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 sug- gests
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


None of the cases cited by the court holds that the public  safety
interest in disclosure should not be weighed in apply- ing 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


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-




__________

n lar material and the interests in nondisclosure acknowledged by the 
statutory exemptions."). The Ninth Circuit has followed our ap-
proach, 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 informa- tion."), 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 Disclo- sure 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....").


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 ade- quately analyzing data submitted
in INDs before allowing  human testing to begin and whether safety
problems uncov- ered 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




__________

n 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 "hazard- ous 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 replicat- ed
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 Com- mittee,
489 U.S. at 773, disclosure may enable the public to protect 


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).