Court Opinion

ID: 184944
Source: CourtListenerOpinion
Date Created: 2011-02-05 02:25:59+00
Date Added: 2024-06-11T12:06:39.663269
License: Public Domain

185 F.3d 898 (D.C. Cir. 1999)
Public Citizen Health Research Group, Appelleev.Food & Drug Administration, Appellant in 98-5161Schering Corporation, Appellant in 98-5162
No. 98-5161 Consolidated with 98-5162
United States Court of AppealsFOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued May 11, 1999Decided August 6, 1999

[Copyrighted Material Omitted]
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 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:

1
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.  § 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. § 355(l), which it  asserted sets a standard for nondisclosure higher than that in  Exemption 4 of the FOIA.

2
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 standard of § 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

3
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. § 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. § 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. §§ 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.  §§ 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.  § 355(b);  21 C.F.R. § 314.50.

4
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.

5
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.

6
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. § 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. § 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

7
The FDA and Schering argue that the agency may under  § 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 § 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 § 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)

8
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  § 355] for a drug" that subsequently was abandoned by its  sponsor, "unless extraordinary circumstances are shown."  21  U.S.C. § 355(l)(1).  No one disputes that an "application  under subsection (b)" is an NDA.  Schering argues that  § 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.

9
First, Public Citizen contends that the agency applies  § 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 § 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):  § 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 § 355 to include information submitted in  an IND, we could not defer to that interpretation.

10
Second, Public Citizen argues that to read § 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 § 355 and the Congress referred  only to one of them in § 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.

11
Third, Public Citizen contends that a plain meaning approach to § 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 § 355(l) even if  the FDA keeps them in an IND file.

12
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.  § 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.  § 314.430(f)).

13
Nonetheless, when the Congress enacted § 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 § 355(l) was a part, established an  abbreviated processthrough 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 [§ 355(l)] to them."  Even if, as Public  Citizen contends, it would be more wise not to treat information 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)

14
In view of the above analysis, we hold that § 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

15
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.  § 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 HealthResearch 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).

16
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  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).

17
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. § 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 § 552b(c)(4)).

18
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 Information 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.

19
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

20
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.

21
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 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."

22
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.

23
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

24
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").

25
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."

26
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.

27
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

28
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 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.

29
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."

30
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

31
In view of our holding that the agency may, under Exemption 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 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.

32
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").

33
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.

III. Summary and Conclusion

34
For the foregoing reasons, we hold first that § 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.

35
So ordered.

Notes:

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

36
Garland, Circuit Judge, concurring in the result:

37
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.

38
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).

39
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 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.

40
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

41
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  non-disclosure "against the public interest in disclosure."  See  Washington Post Co. v. HHS, 690 F.2d 252, 269 (D.C. Cir. 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 non-disclosure--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

42
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.

43
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 discontinued ... 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.

44
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 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).

Notes:

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 § 2738, at 346-56 (3d ed.  1998).

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 particular material and the interests in non-disclosure 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 § 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....").

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.