v.              Civil Action No. 94-0018


  Plaintiff Public Citizen Health Research Group ("HRG") is entitled to summary judgment in this Freedom of Information Act ("FOIA") case as a matter of law. The defendants have not met their burden of demonstrating that defendant-intervenors Schering Corporation ("Schering") and Hoechst Marion Roussel, Inc. ("HMR") are likely to suffer substantial competitive harm as a result of release of records concerning four experimental drugs that posed such significant health or safety risks to patients that testing on humans was terminated. Food and Drug Administration ("FDA") regulations, as expressly codified by Congress, require that such safety and effectiveness data be made public when no work is going to be undertaken to have the drug approved and no extraordinary circumstances exist. 21 C.F.R. § 314.430(f)(1); 21 U.S.C. § 355(l)(1). Defendants attempt to nullify this strong mandate in favor of disclosure of abandoned Investigational New Drug ("IND") applications by arguing, in effect, that the "extraordinary circumstances" standard is superfluous. Yet, both FDA and Congressdetermined that abandoned INDs must be made public except in extraordinary circumstances. As discussed below, the disclosure mandate of 21 C.F.R. § 314.430(f)(1) and 21 U.S.C. § 355(l)(1) is drained of all meaning, unless defendants are required to show genuinely extraordinary circumstances -- circumstances not presented here -- in order to keep abandoned IND information secret.
  Moreover, even apart from the statutory disclosure mandate, defendants have not sustained their burden of showing that the records are "confidential" within the meaning of Exemption 4. Schering provides no new evidence to show how release of information about investigational drugs that have been abandoned for health or safety concerns will result in substantial competitive injury to Schering, but instead simply repeats the arguments advanced in its opening brief. As to HMR, it refuses even to reveal the name of its drug -- a drug currently being marketed to patients in numerous foreign countries -- because doing so would reveal that this particular drug had been the subject of an FDA clinical hold due to safety concerns. While the fact of FDA's clinical hold would be of significant interest to the doctors prescribing and patients taking HMR's drug abroad, HMR has not shown how such information would cause it substantial competitive harm.
I.     FDA Regulations, As Codified By Congress, Require Release Of The INDs.
  FDA regulations, as codified by Congress, recognize that when a drug sponsor has abandoned its efforts to have an IND approved,full safety and effectiveness reports will no longer be of competitive value to the drug's sponsor, and thus require the release of safety and effectiveness data to the public unless exceptional circumstances exist. 21 C.F.R. § 314.340(f); 21 U.S.C. § 355(l)(1); Supp. Hooton Dec. ¶ 16; Waller Dec. ¶ 19. As explained in plaintiff's opening submissions, this disclosure mandate serves a valuable public health function, by ensuring that other drug companies do not risk the health of test subjects by pursuing the same blind alleys that an abandoned IND sponsor discovered might endanger patients. Supp. Wolfe Dec. ¶ 11; see also Thomas O. McGarity & Sidney A. Shapiro, The Trade Secret Status of Health and Safety Testing Information: Reforming Agency Disclosure Policies, 93 Harv. L. Rev. 837, 840-48 (1980). To escape this strong disclosure mandate -- which exists independent of FOIA -- Schering argues that the disclosure requirement should be ignored, and HMR argues that the requirement does not apply to its may-someday-become-active IND. As demonstrated below, defendants have failed to overcome the legal presumption in favor of disclosure of abandoned INDs, and the INDs should be released.See footnote 1
A.  Schering's INDs
  Apparently acknowledging that they have not demonstrated "extraordinary circumstances" in the normal sense of the phrase, FDA and Schering ask the Court to ignore the clear language of the provision and find that a showing of competitive commercial harm is sufficient to satisfy the "extraordinary circumstances" standard. FDA Opposition Brief at 4; Schering Opposition Brief at 3. Defendants' position is at odds with the Supreme Court's oft-stated "assum[ption] 'that the legislative purpose is expressed by the ordinary meaning of the words used.'" American Tobacco Products Co. v. Patterson, 456 U.S. 63, 68 (1982)(quoting Richards v. United States, 369 U.S. 1, 9 (1962)). The term at issue here -- "extraordinary" -- is not at all ambiguous. "Extraordinary" is defined in Black's Law Dictionary as "[o]ut of the ordinary; exceeding the usual, average, or normal measure or degree; beyond or out of the common order or rule; not usual, regular, or of a customary kind; remarkable; uncommon; rare." Black's Law Dictionary (revised 4th ed. 1968). Similarly, the Webster'sdefinition of "extraordinary" is "going beyond what is usual, regular, or customary; exceptional to a very marked extent." Webster's New Collegiate Dictionary (1977).
  But defendants argue that circumstances which would apply to virtually all abandoned INDs -- i.e., that the IND data would be applicable to the development of other drugs -- meet the "extraordinary circumstances" criterion. To escape the plain meaning of "extraordinary circumstances," defendants chiefly rely on a provision in FDA's general FOIA regulations stating that "[t]he exemptions established in this subpart [including the exemption for confidential commercial information found at § 20.61] shall apply to all Food and Drug Administration records [with exceptions inapplicable here]." 21 C.F.R. § 20.60. According to defendants, the only way the agency's regulations can be interpreted consistently is for "extraordinary" in § 314.430(f) to mean competitive commercial harm as defined in § 20.61. Defendants' argument must be rejected because it violates two cardinal rules of statutory interpretation: (1) the Court has a duty to give effect to two statutes when they are capable of co- existing, and (2) a general statute will not control or nullify a specific one. See Morton v. Mancari, 417 U.S. 535, 550-51 (1974). Although these rules of interpretation were formulated in the statutory context, they are equally applicable in the regulatory context.
  Under defendants' interpretation of FDA's disclosure regulations, the specific provision mandating disclosure ofabandoned INDs except in extraordinary circumstances becomes meaningless because a determination on whether to disclose information in an abandoned IND is the same as for any other FDA document. In order to give both regulatory provisions meaning, an "extraordinary circumstances" analysis must require something different than the ordinary Exemption 4 analysis. See United States v. Borden Co., 308 U.S. 188, 198 (1939). This interpretation of the "extraordinary circumstances" standard also comports with the Supreme Court's guidance that a specific enactment not be controlled or nullified by a general one. Here, the more narrow provision (§ 314.430(f)), which applies only to drug applications that have been abandoned, should trump the more general one (§ 20.60) which applies to all FDA documents. And, in any event, the defendants' argument ignores the existence of the statutory mandate. The general regulation of § 20.60 cannot nullify Congress's command that abandoned drug applications be released. 21 U.S.C. § 355(l)(1).
  The only other authority FDA provides for its position are selected passages in the preamble to its disclosure regulations promulgated in 1974 and limited portions of the legislative history of the 1984 Waxman-Hatch Amendments to the Federal Food Drug and Cosmetic Act ("FD&C Act") which codified FDA's disclosure policy in section 505(l) of the FD&C Act, 21 U.S.C. § 355(l). FDA Opposition Brief at 6-8. However, neither the preamble nor the legislative history support such a broad reading of "extraordinary circumstances."
  In fact, as discussed in plaintiff's opening brief, FDA intended the party opposing disclosure to bear "the burden of overcoming that presumption by showing unusual circumstances that justify nondisclosure." 39 Fed. Reg. 44,602, 44,603 (1974) (promulgation of FDA's FOIA regulations) (emphasis added). The defendants' argument would swallow the FDA's rule because it eliminates the strong presumption that abandoned INDs will be released. See Plaintiff's Opening Brief at 17-19. Indeed, during the notice-and-comment period preceding the promulgation of the agency's FOIA regulations in 1974, the drug industry argued that abandonment of an IND was "irrelevant" to the issue of whether or not release of information would cause competitive harm, and pointed to circumstances strikingly similar to the ones Schering claims to justify nondisclosure here.See footnote 2 39 Fed. Reg. at 44637. FDA rejected these comments in 1974 and promulgated the rule, adopting a disclosure presumption for abandoned INDs and limiting confidentiality to genuinely "extraordinary circumstances."
  As to the legislative history, FDA relies solely on an isolated statement by Senator Hatch and testimony by then-FDA Chief Counsel Thomas Scarlett, but neglects to mention that the principalHouse sponsor of the legislation, Representative Waxman, strongly disagreed with Senator Hatch's interpretation, stating that "the Senator's statement and the FDA letter contradict the explicit language of section 104 [the disclosure provision] and my understanding of FDA's current policy." 130 Cong. Rec. E4423 (October 10, 1984) (attached as Exhibit A). As Representative Waxman then explained, in the Senate bill as it was originally introduced, "extraordinary circumstances" were defined to exist when safety and effectiveness data are found to be "trade secret or confidential commercial or financial information." Id. This description of extraordinary circumstances was deleted from the Senate bill when it passed the Senate, and was not contained in the bill that was enacted. Yet, FDA claims that the law should now be read as if it contains the language which had been deleted from the original bill. See Muscogee Nation v. Hodel, 851 F.2d 1439, 1444 (D.C. Cir. 1988) (rejecting similar argument, stating "[i]f Congress had intended the . . . provision to be identical to that in [another statute], it could have included a direct reference to [the statute] in that provision").
  The only reasonable interpretation of the "extraordinary circumstances" standard is that it is not coextensive with Exemption 4 of the FOIA, as Representative Waxman eloquently explained:
    Section 104 [the provision requiring disclosure of information except in extraordinary circumstances] was not intended to be a blanket reference to the FOIA. Section 104 creates a strong presumption that the data covered by the section will be available to the public. It recognizes that in some unusual cases, where there are extraordinary circumstances, the FDAshould be able to withhold the data. For example, when a company can show FDA that the data qualifies as a trade secret, as defined in Public Citizen Health Research Group v. FDA, 704 F.2d 1260, 1288 (D.C. Cir. 1983), then FDA can withhold it. However, since FDA would have the authority to withhold data under exemption 4 of the FOIA in the absence of section 104, the term "extraordinary" cannot and should not be read as meaning exemption 4 of the FOIA. Therefore, a company could not prevent disclosure by a simple claim or demonstration that the data were confidential, commercial information or that the data have possible commercial competitive value.
130 Cong. Rec. E4423. There would have been no reason for Congress to have included the disclosure provision in its amendment to the FD&C Act if it was simply a restatement of FOIA Exemption 4. Rather, the codification of FDA's "extraordinary circumstances" standard clarifies FDA's authority to release documents that otherwise might fall within Exemption 4. As the D.C. Circuit recently recognized, it is not FOIA itself that precludes the government from releasing information that falls within Exemption 4, but the Trade Secrets Act, 19 U.S.C. § 1905. Bartholdi Cable Co., Inc. v. FCC, 114 F.3d 274, 281 (D.C. Cir. 1997). In Bartholdi, the D.C. Circuit noted that information otherwise protected by the Trade Secrets Act may be disclosed if "authorized by law." Id., citing Chrysler Corp. v. Brown, 441 U.S. 281, 302-03 (1979). The codification of FDA's disclosure policy removes the possibility that an opponent to disclosure could argue that it was not authorized by law since the provision in fact compels its release, and thus, ensures that FDA discloses information in abandoned INDs in all but exceptional situations.
  Schering does not dispute that its five INDs at issue in this action have been abandoned. Because Schering has made no showingof extraordinary circumstances, the safety and effectiveness data in the INDs must be released.
  The regulatory and statutory disclosure mandate for abandoned INDs applies equally to HMR's IND. Indeed, perhaps recognizing the futility of Schering's argument, HMR does not dispute that abandoned INDs generally must be released, but instead argues that its IND does not fit within the provision's disclosure mandate because it has not been abandoned. In its opening submission, HMR's only support for its claim of non-abandonment was a statement that HMR is "actively considering whether and how to undertake reactivation of the IND." Waller Dec. ¶ 22 (emphasis added). To bolster its original meager declaration, HMR now adds that it "is considering the potential out-licensing of the drug for the U.S. market." Supp. Waller Dec. ¶ 3 (emphasis added). HMR does not point to any concrete steps it has taken toward reactivation or toward out-licensing the drug, nor does it claim to have even identified or begun discussions with potential licensees.
  According to defendants, an IND is not abandoned as long as a manufacturer claims that it is not. No matter how generalized the claim might be, according to defendants, the manufacturer's statement is entitled to blind deference by both the FDA and a reviewing court. If defendants are right, the public cannot successfully force disclosure of information about drug testing that has gone awry: A company's highly generalized and entirely self-serving statements about potential exploitation of a drugwould suffice to sustain claims of substantial competitive harm, even when the statements are unsubstantiated by any concrete action.
  HMR attempts to justify FDA's blind faith in its claims by pointing to FDA regulations that allow the FDA to determine that an IND has been terminated after a specified period. HMR Opposition Brief at 5. The cited regulations do not guarantee, however, that important safety data will be disclosed even after a specified period of time. The regulations allow, but do not require, the FDA to place an IND on inactive status if no subjects are entered into clinical studies for a period of two years or more, 21 C.F.R. § 312.45(a), and to terminate an IND that remains on inactive status for five years or more. 21 C.F.R. § 312.45(e). Before placing an IND on inactive status or terminating an IND, the FDA must notify the sponsor and allow the sponsor to respond as to why the actions should not be taken. 21 C.F.R. §§ 312.45(a), 312.44(a). Thus, so long as a drug sponsor claims that an IND is not abandoned, it will take no less than seven years (assuming the FDA acts quickly and the sponsor does not object) after clinical studies have been stopped due to deaths or serious injuries before the public gains access to the relevant safety data. Indeed, in this case, it appears that seven years have already passed since the last clinical tests of the drug were stopped because of safety concerns, Waller Dec. ¶ 20-21, yet the FDA has taken no action other than to rubber-stamp HMR's claim of confidentiality. In cases where embarrassing or incriminating information may be revealed, thetermination process is likely to take much longer because the sponsor will have every reason to object. Thus, while 21 C.F.R. § 312.45(e) may provide a route for eventual release of IND information, there is no lawful reason to postpone the release of safety data for seven years or more if, in fact, the IND has already been abandoned and no extraordinary circumstances exist. Because HMR's generalized statements of future intentions for development of its IND fall far short of its burden under FOIA, its IND should be released.
II.    Defendants Have Not Met Their Burden of Showing That FOIA Exemption 4 Protects Information In INDs Involving Drugs That Pose Health Or Safety Concerns.
  Even setting aside the statutory and regulatory disclosure mandate for abandoned INDs, plaintiff's motion for summary judgment should be granted because defendants have not met their burden of showing how release of the information in the INDs at issue here -- all involving drugs that pose health or safety risks to patients -- will cause Schering or HMR substantial competitive harm.
A.  Schering's INDs
  Schering has abandoned the INDs at issue in this case and does not claim to have any remaining competitive interest in the particular experimental drugs involved. Instead, Schering makes a much more attenuated claim of competitive harm, based solely on the possibility that competitors will gain advantage in their efforts to develop competing products to other Schering drugs because they will be able to use the data regarding the abandoned drug to focus and direct their own research into other drugs without any of theassociated development costs. Thus, Schering's claim of competitive harm is significantly more conjectural and remote than the claims of the drug sponsor upheld by Judge Urbina in Public Citizen Health Research Group v. FDA, No. 94-0017 (D.D.C. April 26, 1995) (Public Citizen II) (copy attached to FDA's opening brief). In Public Citizen II, the sponsor of the IND there claimed that it had not abandoned work on the IND but instead claimed that the information in the IND would be incorporated into any new IND for the same drug. Slip op. at 13; Cf. Webb v. HHS, 696 F.2d 101, 103 (D.C. Cir. 1982) (a drug sponsor has a competitive interest in keeping information in an active but not yet approved drug application secret, because otherwise a competitor could utilize the data in its own drug application for the same drug). In stark contrast, Schering has abandoned the INDs at issue here and does not claim to have any plans to develop the particular drugs for other uses; indeed, for IND 18113, Schering does not even claim that it will use the data concerning the abandoned drug to develop related drugs. Schering's Opposition Brief at 5-6. The competitive harms alleged by Schering are simply too speculative to satisfy its burden under Exemption 4 of demonstrating that disclosure of information is likely to cause substantial competitive harm. See National Parks and Conservation Ass'n v. Morton, 498 F.2d 765, 770 (D.C. Cir. 1974).
  Defendants attempt to trivialize the public health benefit from the release of the IND data by stressing that, because the INDs have been abandoned, no patients are currently receiving thedrug. FDA Opposition Brief at 17; Schering Opposition Brief at 9. However, defendants ignore two significant benefits of disclosure. First, disclosure reduces the likelihood that other drug manufacturers will needlessly put future patients at risk by pursuing the same blind alleys as Schering. That is, disclosure allows other manufacturers to learn from Schering's discovery of the toxicity of these particular drugs, and prevents other patients from being placed at risk. Supp. Wolfe Dec. ¶ 11. Second, disclosure allows the public to ensure that FDA is adequately protecting the patients who were given the abandoned drug. For example, it appears that clinical testing of the drug involved in IND 30647 was stopped because of carcinogenicity concerns. Supp. Wolfe Dec. ¶ 15. Indeed, the FDA asked Schering to ensure that annual mammograms were conducted on those patients who had taken the drug. Id. ¶ 15 & Exh. 2. Release of the safety and effectiveness data from the IND would allow HRG to determine whether FDA is adequately protecting human subjects that participated in the clinical trials. Id.
  FDA ignores these benefits when it attempts to dispute plaintiff's argument that, at a minimum, FDA must disclose information in the INDs here that is routinely disclosed by FDA once an NDA is approved -- such as extensive summaries of the safety and effectiveness data. See 21 C.F.R. § 314.430(e)(2). FDA argues that in contrast to the situation involving an approved NDA, there is no public interest in disclosing the same summary information concerning an abandoned IND. FDA Opposition Brief at16-17. As explained above, however, there are significant public health benefits to disclosing information in abandoned INDs, as both FDA and Congress have recognized. 21 C.F.R. § 314.430(f)(1); 21 U.S.C. § 355(l)(1).
  Moreover, a drug sponsor has a much more significant competitive interest in a drug on the market -- that is, in preventing competitors from introducing the same or a similar product -- than in a drug that it has decided to abandon because of its toxicity. And, competitors too would be much more interested in information concerning an approved drug than in information about the drugs here -- drugs that have been abandoned because of their health risks. See Plaintiff's Opening Brief at 26-28.
  Schering does not provide any further explanation as to why several documents that appear to provide the FDA with information about individual patient reactions have been withheld. See, e.g. Vaughn Index for IND 18113, docs. 114, 116, 193, 206, 220, 226, 233. The only response Schering provides to plaintiff's example of
document 204 from the Vaughn index for IND 18113 described as a "Letter from Schering to FDA re: patient death," is to point out that a medical summary revealing clinical data is attached. Schering Opposition Brief at 6-7 n.4. But, it is just this type of data -- data involving the adverse reaction, in this case death, of a single patient after taking Schering's drug -- that is of significant public interest and that Schering has not shown would competitively harm the company if released. Nor is Document 204 the only one involving an individual patient reaction. Anotherexample is document 206 from the Vaughn index for IND 18113 described solely as "letter from Schering to FDA describing clinical event concerning a patient"; the rationale given for the withholding is the same as was given for document 204: "[d]isclosure would reveal proprietary and commercially-valuable information regarding the safety and effectiveness in man of related chemical compounds and other compounds used in the treatment of hypertension and angina, which would guide Schering's competitors in the development and testing of new products indicated for use in the treatment of hypertension and angina, and cardiovascular diseases generally." It is difficult to imagine how reports on individual patient reactions could possibly be used to suggest additional lines of research. More likely, observation reports like these may reveal important information about patient reactions to these abandoned drugs, whether the companies fully complied with the FDA reporting regulations, and whether FDA responded adequately to these reports.See footnote 3
  HMR does not dispute that data and studies relating to the drug at issue in its IND are publicly available as a result of the drug being on the market abroad. HMR's Opposition Brief at 6-7. Recognizing that no showing of competitive harm can be made if the information at issue is publicly available through other sources, CNA Financial Corp. v. Donovan, 830 F.2d 1132, 1154 (D.C. Cir. 1987), cert. denied, 485 U.S. 977 (1988), HMR argues that it is the disclosure of the IND information in the context of an FDA clinical hold that constitutes valuable commercial information. HMR's Opposition Brief at 6-7; FDA's Opposition Brief at 13-14. Thus, according to defendants, even the name of HMR's drug must be withheld because disclosure would reveal that the particular drug had been the subject of an FDA clinical hold due to safety concerns. FDA's Opposition Brief at 14.
  Competitive harm refers to "harm flowing from the affirmative use of proprietary information by competitors," CNA Financial Corp., 830 F.2d at 1154, and not to adverse public reaction. Id. (no competitive harm in disclosure of affirmative action data, despite showing of customer and employee disgruntlement). Yet, HMR's sole concern appears to be that the public -- and its overseas market -- would learn that FDA has determined that its drug posed such significant health risks that testing of the drug had to be terminated. Release of the name of the drug does not provide competitors with any data not already available to them in the public domain, so FDA's statement that the release "would unfairly give competitors the ability to submit or use valuabledata gathered at HMR expense in support of their own INDs and subsequent NDAs, prior to approval of HMR's drug," is absurd. FDA's Opposition Brief at 14. Competitors already have the data at their disposal; release of the identity of the drug would more likely cause competitors to decide against submitting the data in support of their own drug applications.
  Defendants' position is particularly disturbing in light of the fact that the drug is being marketed in numerous countries abroad. The notion that doctors prescribing the drug abroad and the patients taking it are not entitled to the information concerning FDA's clinical hold cannot be endorsed. Exemption 4 was not intended to risk patients' health to protect corporate profits. See Teich v. FDA, 751 F. Supp. 243, 253 (D.D.C. 1990).
III.    In The Event HRG's Motion for Summary Judgment Is Denied, Plaintiff Is Entitled To Discovery.
  On the current record, defendants' claims cannot suffice as a basis for withholding the information in the Schering or HMR INDs under Exemption 4, and thus, defendants' motions for summary judgment should be denied. In two recent Exemption 4 FOIA cases concerning data from the clinical testing of an approved drug, the court denied defendants' motions for summary judgment and ordered further proceedings. In Public Citizen Health Research Group v. FDA, 953 F. Supp. 400 (D.D.C. Oct. 17, 1996) (Public Citizen III), Judge Urbina scheduled a bench trial when affidavits by FDA and two drug companies affirming that release of certain data would cause substantial harm were contradicted by an expert for HRG. 953 F. Supp. at 403. In a similar case, Judge Robertson denieddefendants' motion for summary judgment because the record "does not present a clear picture as to the competitive injury, if any, that would result from release of the protocol," and ordered in camera review. Public Citizen Health Research Group v. FDA, Civil No. 96-1650, slip op. at 7 (D.D.C. Feb. 25, 1997) (Public Citizen IV) (copy attached). Recognizing that the in camera "submission has been made ex parte and under seal the adversary process, which normally operates to assist the finder of fact in resolving complex scientific or technical issues, is partially disabled," Judge Robertson then ordered the appointment of an expert pursuant to Rule 706 of the Federal Rules of Evidence. Public Citizen IV, Civil No. 96-1650, slip op. at 1 (D.D.C. March 18, 1997) (copy attached).
  Similarly here, the record does not support the defendants' contentions of non-disclosability of the INDs. Because the defendants fail to demonstrate that the six INDs at issue in this case are properly withheld under Exemption 4 of the FOIA, defendants' motions for summary judgment must be denied and plaintiff's motion for summary judgment should be granted. However, in the event the Court is not inclined to grant summary judgment to plaintiff at this time, the Court should order further proceedings to resolve whether release of the INDs here would cause substantial competitive harm. For the reasons set forth in HRG's opening brief (at 31-34), allowing HRG to conduct discovery would give plaintiff the opportunity to further demonstrate that Schering's and HMR's claims of competitive injury are baseless.


  For the foregoing reasons, as well as those in plaintiff's earlier submissions, plaintiff respectfully submits that its motion for summary judgment should be granted.
              Respectfully submitted,
              Lucinda A. Sikes
              D.C. Bar No. 431949
              Brian Wolfman
              D.C. Bar No. 427491
               Public Citizen Litigation Group
              1600 20th Street, N.W.
              Washington, D.C. 20009
              (202) 588-1000
August 29, 1997        Attorneys for Plaintiff 


  I, Lucinda A. Sikes, hereby certify that on this 29th day of August, 1997, I served the foregoing Plaintiff's Reply In Support of Its Cross-Motion for Summary Judgment on defendant and defendant-intervenors by causing a copy of the same to be sent, via United States Mail, first-class postage prepaid, to counsel at the following address:
Marina Utgoff Braswell
Assistant United States Attorney
Judiciary Center Building, Rm. 10-820
555 4th Street, N.W.
Washington, D.C. 20001

Kinsey S. Reagan
Stacy L. Ehrlich
Kleinfeld, Kaplan and Becker
1140 Nineteenth Street, N.W.
Washington, D.C. 20036-6601

Robert P. Reznick
Hughes, Hubbard & Reed LLP
1300 I Street, N.W.
Suite 900 West
Washington, D.C. 20005

                Lucinda A. Sikes
                Attorney for Plaintiff

Footnote: 1Two of the defendants acknowledge (FDA's Opening Brief at 6-7; HMR's Opening Brief at 9 n.2) that although both the regulatory and statutory provisions refer to a New Drug Application ("NDA"), both should be applied equally to NDA and IND files. Schering disagrees, arguing that the statutory provision applies only to NDA files. Schering Opposition Brief at 4, n.2. As explained in plaintiff's opening brief, Schering's position is not supported by the regulations or legislative history. FDA regulations state that information in IND files must be treated in precisely the same fashion as information in NDA files. 21 C.F.R. § 312.130(b) (availability for public disclosure of all data and information in an IND willbe handled in accordance with provisions established
for NDAs in § 314.430). And, Congress intended 21 U.S.C. § 355(l)(1) to codify FDA's disclosure policy, and, therefore, it should be applied equally to NDA and IND files, just as FDA has always done. See, e.g., H.R. Rep. No. 857, pt. 1, 98th Cong., 2d Sess. 35, reprinted in 1984 U.S. Code Cong. & Ad. News 2647, 2668 (section 505(l) is "merely a restatement of the current regulation," and "all terms" should be given "the same meaning that they have in the regulation"); id. at 36 (Congress did not intend to change other regulations regarding the "confidentiality of IND, NDA and master file safety and effectiveness information and data").

Footnote: 2For example, claims were made that "simply knowing a process does or does not work is worth hundreds of thousands of dollars and years of research to a competitor," that "drugs subject to termination may be found to have congeners which are safer and more effective, and that initial investigations may indicate a metabolite of the drug under study is the more active form and investigational efforts may be diverted to studies of the metabolite," and that "data in an investigational file may later become essential when related drugs are being investigated." 39 Fed. Reg. 44637. 
Footnote: 3In the unlikely event that an exemption 4 claim for a portion of an adverse reaction report was valid, defendants have not explained why information on individual patient reactions cannot be segregated and released. "It has long been a rule in this Circuit that non-exempt portions of a document must be disclosed unless they are inextricably intertwined with exempt portions." Krikorian v. Dep't of State, 984 F.2d 461, 466 (D.C. Cir. 1993)(quoting Mead Data Centr., Inc. v. Dep't of Air Force, 566 F.2d 242, 260 (D.C. Cir. 1977)). FOIA requires that "[a]ny reasonably segregable portion of a record shall be provided . . . after deletion of the portions which are exempt." 5 U.S.C. § 552(b). The Court of Appeals has made clear that "[t]he 'segregability' requirement applies to all documents and all exemptions in the FOIA." Center for Auto Safety v. EPA, 731 F.2d 16, 21 (D.C. Cir. 1984).