The opinion of the court was delivered by: SIRICA
This matter comes before the Court on the plaintiff's motion for a preliminary injunction. Both sides have filed extensive memoranda concerning the issues. On June 23, 1975, the Court heard oral argument on the motion and took the matter under advisement.
This action was instituted by the plaintiff, an association of drug companies, on May 7, 1975, when a complaint seeking declaratory and injunctive relief was filed. The motion for a preliminary injunction was filed the same day seeking to prohibit the defendants, the Secretary of the Department of H.E.W. and the Commissioner of Food and Drugs, from applying and enforcing certain regulations published by the Commissioner on December 24, 1974, 39 Fed.Reg. 44601-44652 (December 24, 1974). These regulations concern the disclosure by the Food and Drug Administration (hereinafter F.D.A.) of information supplied to the F.D.A. by persons seeking approval to test and market drug products. Specifically, plaintiff seeks to require the F.D.A. to provide notice to an affected drug company of any proposed release of information pursuant to Freedom of Information Act (hereinafter F.O.I.A.) requests, in order to provide an opportunity for the affected company to consult with the F.D.A. concerning the propriety of the release of said information, and to provide an opportunity for judicial review of the F.D.A.'s decision.
In order to fulfill its important regulatory functions the F.D.A. must receive information from the manufacturers of drug products which is of a very sensitive nature. Some of the information is valuable to the drug manufacturers, and the F.D.A. freely admits that the drug manufacturers do maintain a property interest in certain sensitive information which is supplied to it. 39 Fed.Reg., 44612, P80. If such information were to be disclosed, a substantial loss could be incurred by the drug company which supplied the information.
The importance of maintaining the confidentiality of such information is reflected in two statutes which prohibit disclosure of certain information by the F.D.A. The Food, Drug and Cosmetic Act itself expressly prohibits revealing to any person outside the Department of H.E.W. or the courts "any information acquired under authority of [the F.D.A.] concerning any method or process which as a trade secret is entitled to protection." 21 U.S.C. § 331(j). Also applicable to the F.D.A. -- as well as to all federal agencies -- is 18 U.S.C. § 1905 which provides criminal punishment for any government employee who
publishes, divulges, discloses, or makes known in any manner or to any extent not authorized by law any information coming to him . . . which . . concerns or relates to trade secrets, processes, operations, style of work, or apparatus, or to the identity, confidential statistical data, amount or source of income, profits, losses or expenditures of any person, firm, partnership, corporation or association . . . .
It appears that both sides agree that the scope of coverage of the two nondisclosure statutes and the scope of exemption four are, for purposes of this suit, the same. Thus, the scope of exemption three is not at issue in this suit.
The regulations here in controversy were enacted by the F.D.A. to implement the F.O.I.A. by setting up the procedures whereby the public may obtain information from the F.D.A. and whereby the agency can deal with requests for information from the public. In promulgating these regulations the F.D.A.not only interpreted the F.O.I.A. from the standpoint of an agency obligated with implementing the legislation, but also interpreted and construed 21 U.S.C. § 331(j) which directly concerns the realm of its special expertise and administrative experience. In reviewing the merits of the case this is an important consideration.
The plaintiff argues (1) that the notice provision of the new regulations (§ 4.45) does not satisfy due process or the confidentiality requirement of the nondisclosure statutes and exemption four; (2) that § 314.14(f) which provides for the release of safety and effectiveness data in abandoned or withdrawn "N.D.A." files will deprive them of valuable property rights, absent more complete notice; (3) that the F.D.A.'s requirement that an affected drug company must help itemize and index the relevant data if there is a court challenge to the nondisclosure of allegedly confidential data (§ 4.53) is contrary to law; (4) that the F.D.A.'s objective (industrywide rather than individual practice) definition of confidential commercial or financial information (§ 4.61) is improper; (5) that the waiver provisions regarding previously disclosed information (§ 4.81) is improper; and (6) that the retroactive application of the regulations to information received by the F.D.A. before the regulations became effective violates due process. However, the principal thrust of the motion for a preliminary injunction is that the F.D.A. must provide for some notice to affected drug companies before it releases any material from its files. The temporary relief plaintiff seeks is to this effect.
In considering a motion for a preliminary injunction the Court must take into account four major factors: (1) whether the plaintiff is likely to prevail on the merits; (2) whether the plaintiff will suffer irreparable injury if the injunction is not granted; (3) whether the granting of the injunction will substantially harm other parties interested in the proceedings; and (4) whether granting the relief is in the public interest. Virginia Petroleum Jobbers Association v. F. P. C., 104 U.S.App.D.C. 106, 259 F.2d 921 (1958); See Neal-Cooper Grain Co. v. Kissinger, 385 F. Supp. 769 (D.D.C.1974).
§ 4.45. In situations where the confidentiality of data or information is uncertain and there is a request for public disclosure, the Food and Drug Administration will consult with the person who has submitted or divulged the data or information or who would be affected by disclosure before ...