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WASHINGTON LEGAL FOUND. v. KESSLER

March 9, 1995

WASHINGTON LEGAL FOUNDATION, Plaintiff,
v.
DAVID A. KESSLER, in his official capacity as Commissioner, Food and Drug Administration and DONNA SHALALA, in her official capacity as Secretary, U.S. Dept. of Health and Human Services, Defendants.



The opinion of the court was delivered by: ROYCE C. LAMBERTH

 I. Factual Background

 The FDA derives its authority to regulate various aspects of the medical and pharmaceutical industries from a complex statutory and regulatory scheme, a major portion of which is embodied in the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., and the regulations promulgated thereunder. One of the FDA's responsibilities under this scheme is to ensure that any new drug or class III medical device sought to be introduced into interstate commerce is safe and effective for each of its intended uses. 21 U.S.C. § 355(a) et seq. Another duty of the FDA is to ensure that such products are accompanied by labeling information which sets forth the uses for which the product has been found to be safe and effective. It is unlawful to introduce into interstate commerce any human drug or medical device which has not been demonstrated to be safe and effective for each of the intended uses set forth in this labeling. See 21 U.S.C. §§ 331(a) and (d). "Labeling" is defined to include all "written, printed, or graphic" materials "accompanying" a product, 21 U.S.C. § 321(m), and it is clear that supplementary or explanatory information disseminated by the producer of a drug or device may constitute "labeling," regardless of whether it physically accompanies the product. E.g., Kordel v. United States, 335 U.S. 345, 349-50, 93 L. Ed. 52, 69 S. Ct. 106 (1948).

 At issue in this case are activities of drug and medical device manufacturers which the FDA contends amount to improper labeling of medical products. Two practices in particular have attracted the attention of the FDA. The first involves the distribution by manufacturers to doctors of so-called "enduring materials" (such as medical journals, articles, and textbooks) which contain information regarding "off-label" *fn1" uses of the manufacturer's products. The distribution of enduring materials to health care professionals appears to be a common tool for manufacturers seeking to maintain good customer relations with those who purchase their products. The other practice with which the FDA has become concerned is manufacturer support of scientific or educational activities (such as medical symposia) at which off-label uses of the manufacturer's products are discussed or demonstrated. Again, sponsorship of medical symposia and the like is a common public relations practice for manufacturers of medical products.

 According to WLF, the FDA has determined that each of these activities constitutes improper labeling and/or promotion when it involves the distribution of materials or sponsorship of activities in which off-label usage of one of the manufacturer's products is discussed. WLF further contends that this determination has taken the form of a specific agency policy which the FDA has been enforcing for several years against medical product manufacturers, and which it intends to continue to enforce in the future. In support of its argument that the FDA has adopted a final agency policy, WLF includes as exhibits to its complaint letters from representatives of the FDA to manufacturers regarding the manufacturers' plans to distribute certain enduring materials to physicians. One such letter concerns a company's plans to reprint and distribute to medical specialists selected chapters from a standard oncology textbook. According to WLF, these chapters discussed, inter alia, off-label uses of many different manufacturers' products besides those of the company seeking to distribute the reprints. In the letter, the FDA representative told the company that the planned distribution was "unacceptable," but that "the entire unaltered textbook could possibly be distributed as a 'service' of [the company,] assuming that discussions of uses of [the company's] drugs do not constitute a major portion of the book." Compl. Att. 1, Ex. B.

 As further support for its contention that the FDA has adopted final policy concerning distribution of off-label usage information, WLF cites a letter written by Ronald Johnson, Director of the FDA's Office of Compliance, Center for Devices and Radiological Health, to a company which had helped sponsor a program entitled "Pedicle Fixation of the Lumbar Spine and Other Advanced Techniques." In this letter, Mr. Johnson stated that "the Food and Drug Administration has reviewed promotional materials showing that" the company "promoted" off-label uses for its products at the program. Compl. Att. 1, Ex. E. Mr. Johnson appears to have made this determination based on the contents of a promotional brochure which purportedly showed that an individual "associated with" the company had provided information and devices used during the "hands on" training portion of the program. In the letter to the manufacturer, Mr. Johnson states that "supporting such programs and providing devices for the purpose of hands-on training in the use of the devices for this unapproved use constitutes promotion of the devices for such use." Id. The letter goes on to state that the "FDA requests that [the company] cease sponsoring promotional programs which detail the use of your devices for this unapproved use, and that [the company] cease supplying devices to programs which include information and 'hands on training' for the use of your devices in this procedure." Id. The letter closes with Mr. Johnson's request for "a written response detailing your plans to correct these violations, and your intentions to comply with this Warning Letter." Id. (emphasis supplied).

 The FDA maintains that it has not adopted a final agency policy regarding manufacturer distribution of information concerning off-label usage. In support of this argument, FDA describes its standard procedure for formulating final agency policy and notes that this procedure has not yet been completed. FDA contends that so long as the agency has not released a formal policy statement or instituted an enforcement action against a manufacturer, there is no "final agency action" reviewable in this court. Def.'s Mem. Supp. M. Dis. at 28. The FDA is quite mistaken. Nevertheless, because the procedure by which the FDA formulates agency policy is relevant to this case, a brief description of that procedure is warranted.

 The FDA claims that it is in the process of revising its policies on industry-supported promotion of off-label uses of medical products. As part of this process, the FDA published a "Draft Policy Statement on Industry-Supported Scientific and Educational Activities" ("Draft Policy Statement") in the Federal Register in November of 1992. 57 Fed. Reg. 56412 (Nov. 27, 1992). By its terms, this Draft Policy Statement represents a tentative agency position concerning how the FDA intends to distinguish between manufacturer-supported activities "that are otherwise independent from the promotional influence of the supporting company [and are therefore permissible] and those that are not [and therefore violate the Federal Food, Drug and Cosmetic Act]." Id. The Draft Policy Statement sets forth a number of criteria that the FDA considers useful in distinguishing between independent and impermissibly manufacturer-influenced activities. Central to the scheme proposed in the Draft Policy Statement is FDA'S recommendation that companies wishing to support activities involving discussion of off-label uses enter into written agreements with the "providers" of the activities. Such a written agreement should "reflect that the company and provider agree that the activity is to be educational and nonpromotional and that the company has taken steps to ensure that it has no role in the design or conduct of the program that might bias the treatment of the topic." Id. at 56413. The FDA maintains that the policies and procedures described in the Draft Policy Statement have not yet been adopted as official FDA policy, and that the agency is still in the process of formulating its final policy statement.

 In October of 1993, plaintiff WLF filed a Citizen Petition *fn2" with the FDA pursuant to 21 C.F.R. § 10.30. In its petition, WLF claims that the FDA has "a strong aversion to the dissemination of information regarding off-label uses of drugs and medical devices," Citizen Petition at 2; that the FDA has attempted to act beyond the ambit of its statutory powers in regulating such activities; and that the FDA, through its Draft Policy Statement, warning letters, and other means, has successfully intimidated manufacturers into not distributing off-label usage information. According to WLF, the FDA's actions, in the aggregate, amount to a formal agency policy which impermissibly trammels the First Amendment rights of manufacturers and doctors to disseminate and receive, respectively, this information. Id. at 12-15. The petition requests that the FDA formally withdraw its Draft Policy Statement and adopt a policy which

 
recognizes the important role played by off-label uses of approved drugs and medical devices...and that declares that FDA will not interfere in non-labeling activities of drug and medical device manufacturers whose effect is to promote--through the dissemination of truthful medical information--off-label uses of approved drugs and medical devices.

 Id. at 3.

 FDA regulations provide that the agency must respond to a Citizen Petition within 180 days. 21 C.F.R. § 10.30(e)(2). The FDA may respond in one of three ways: it may 1) grant the petition; 2) deny the petition; or 3) provide a "tentative" response informing the petitioner that the agency requires additional time to respond. Id. WLF maintains that FDA offered no response at all to WLF's petition until July 14, 1993--some 270 days after WLF filed its petition, and several weeks after WLF filed the present lawsuit. The FDA's response to WLF's petition was a statement of its intention to publish the petition in the Federal Register for public comment, with the indication that it would act on the petition after reviewing those comments. *fn3" At oral argument on the present motion, counsel for FDA indicated that the administrative review process is on-going and that the agency will require at least one more year to complete this process and release a final agency position on the off-label usage issue. Despite FDA's claims to the contrary, WLF maintains that FDA has in fact been enforcing a clearly defined policy concerning manufacturer support of off-label uses since. 1992. WLF alleges that this policy is unconstitutional and seeks an order from this court pursuant to the Administrative Procedure Act, 5 U.S.C. § 701 et seq., declaring that the policy violates the First Amendment rights of WLF's members and enjoining the FDA from continuing to enforce the policy.

 II. Motion to Dismiss

 Defendants move to dismiss WLF's suit on a number of grounds. First, defendants argue that the doctors who are members of WLF and who claim to have been harmed by the alleged FDA policy do not have standing to maintain this lawsuit. According to FDA, the doctors have not experienced any direct harm as a result of FDA's action, therefore no "case or controversy" exists as between these doctors and the FDA. FDA also argues that, in addition to WLF's lack of standing, its claims are not ripe for judicial review. Finally, FDA asserts that this court does not have jurisdiction to order the relief sought by WLF. Because each of these contentions is without merit, defendants' motion to dismiss will be denied.

 In resolving a motion to dismiss, the plaintiff's factual allegations must be presumed true and liberally construed in favor of the plaintiff. Phillips v. Bureau of Prisons, 192 U.S. App. D.C. 357, 591 F.2d 966, 968 (D.C. Cir. 1979) (citing Miree v. Dekalb County, Georgia, 433 U.S. 25, 27 n.2, 53 L. Ed. 2d 557, 97 S. Ct. 2490 (1977)). In addition, the plaintiff must be given every favorable inference that may be drawn from his allegations of fact. Scheuer v. Rhodes, 416 U.S. 232, 236, 40 L. Ed. 2d 90, 94 S. Ct. 1683 (1974). Dismissal is only appropriate if it appears beyond doubt that no set of facts proffered in support of plaintiff's claim would entitle him to relief. Haynesworth v. Miller, 261 U.S. App. D.C. 66, 820 F.2d 1245, 1254 (D.C. Cir. 1987).

 A. Standing

 Defendants' contention that WLF lacks standing to maintain this suit is insubstantial, and it need not detain the court long. An organization may have "representational" standing to sue on behalf of its members provided there is an injury-in-fact to at least one of the organization's members. Hunt v. Washington State Apple Advertising Comm'n, 432 U.S. 333, 53 L. Ed. 2d 383, 97 S. Ct. 2434 (1977). The Supreme Court has set forth the following three-part test for determining whether an organization may assert representational Standing:

 
An association has standing to bring suit on behalf of its members when: (a) its members would otherwise have standing to sue in their own right; (b) the interests it seeks to protect are germane to the organization's purpose; and (c) neither the claim asserted nor the relief ...

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