In order to support a decision to withhold disclosure under the-"impairment" prong of the National Parks test, an agency must demonstrate that disclosure of the withheld information will result in a diminution of the "reliability" or "quality" of necessary future information. Critical Mass, 975 F.2d at 878. FDA argues that data submitted to the agency as part of its drug approval process "would not be submitted as freely" if the protocol is disclosed. (Hooton Decl. P 12). That argument is unsupported, even by an assertion of agency experience on the point. FDA's conclusory assertion of impairment does not sustain its burden of justifying nondisclosure.
2. Competitive Harm
In order to support withholding under the "competitive harm" prong, the party seeking to avoid disclosure must show (i) actual competition and (ii) likelihood of substantial competitive injury. National Parks, 498 F.2d at 770. No showing of competitive harm can be made if the information at issue is publicly available through other sources. CNA Fin. Corp. v. Donovan, 265 U.S. App. D.C. 248, 830 F.2d 1132, 1154 (D.C. Cir. 1987), cert. denied, 485 U.S. 977 (1988). An additional factor that may be considered is whether there is a strong public interest in release of the information. See Teich v. FDA, 751 F. Supp. 243, 253 (D.D.C. 1990)(benefit of releasing information about safety test results for a medical product "far outstrips the negligible competitive harm that defendants allege"); AT&T Info. Systems, Inc. v. GSA, 627 F. Supp. 1396, 1403 (D.D.C. 1986).
There are currently twenty manufacturers of oral diabetes therapies. Metformin is the leading branded therapy, holding 20% of the market share. (Rader Decl. P 3). Parke-Davis has recently obtained approval to market Troglitazone, a drug for non-insulin dependent diabetes mellitus, which will compete with BMS's Metformin. (Rader Decl. P 7). The existence of actual competition is well established and, in any case, undisputed.
The likelihood of "substantial competitive injury," however, cannot be measured, or even plainly identified, on this record. The BMS argument that disclosure of the protocol will allow competitors to raise "alarmist" safety concerns is too broad and too speculative to be credited. If critics of Metformin wanted to raise alarms, they could do so using information that is already publicly available.
The BMS assertions that disclosure of the protocol could lead to patient drop-out, bias in the results, and delays in the study's completions are likewise generalized and unsubstantiated, especially in the absence of any detailed presentation of which information in the protocol, if any, could threaten the success of the study.
BMS comes closer to stating a claim of competitive harm with its argument that disclosure of the protocol would provide "insight" into Metformin's pre-approval test results and BMS's future marketing strategies. Data resulting from pre-approval testing have been discussed by the FDA at open advisory committee meetings, however. BMS has not identified the data, if any, that are not already in the public domain. As to future marketing, the BMS theory that disclosure will let competitors know what will be in Metformin's package insert and the content of BMS' future physician education programs is simply unpersuasive. This record does not reveal how disclosure of the protocol, as opposed to the study results, would lead to such results, or explain why such results would be harmful to BMS.
The central argument put forth by BMS is that disclosure of the protocol would permit its competitors to "piggyback" -- to appropriate the study's design for their own uses. To support this argument, BMS has established that Metformin's protocol is the product of extensive research and manpower (Rohlf Decl. P 6), and that it was designed "according to FDA requirements and input to answer . . . the very specific safety questions of interest" (BMS Opp'n at 6). BMS also asserts the "uniqueness" of its protocol -- that it is designed to generate data about lesser-studied side-effects and involves a large patient base. But BMS does not answer the question posed by plaintiff's affidavits: What advantage would a competitor gain from the protocol for a study that is uniquely tailored to the characteristics of Metformin?
The record as it stands does not present a clear picture as to the competitive injury, if any, that would result from releasing the protocol. In the accompanying order, defendants are directed to submit a copy of the protocol for in camera review. To assist the in camera review, BMS may file, ex parte and under seal, a memorandum identifying precisely the portions of the protocol that contain confidential commercial information which is not already public. Further briefing may be requested following the court's receipt and review of those materials.
United States District Judge
Upon consideration of the parties' cross-motions for summary judgment, the opposition thereto, and the entire record, for reasons stated in the accompanying memorandum, it is this 24th day of February, 1997,
ORDERED that FDA submit a copy of the protocol in question for in camera review by March 6, 1997. And it is
FURTHER ORDERED that BMS may file an additional memorandum, ex parte and under seal, as described in the accompanying memorandum.
United States District Judge