Although the defendants do not allege that WLF's complaint fails the second prong of the Hunt test, the court notes that standing questions are jurisdictional and can therefore be raised at any time and are never waived. It seems prudent, then, to note that plaintiff's complaint alleges that Washington Legal Foundation "devotes a substantial portion of its resources to defending the rights of individuals and businesses to go about their affairs without undue interference from government regulators." Compl. P 5. As such, the court finds that the interests sought to be protected in the present suit are "germane to" WLF's organizational purpose. Hunt, 432 U.S. at 343.
3. Participation of Individual Members
The third prong of the Hunt test requires that neither the claim asserted nor the relief requested require the participation of individual members of the organization. Id. Nothing in the filings or arguments of the parties suggests that this lawsuit would require WLF's member-doctors to participate individually, and the court finds no reason to conclude otherwise. Accordingly, the court finds that WLF's suit meets each of the three representational standing requirements established by the Supreme Court in Hunt and accordingly rejects defendants' motion to dismiss for lack of standing.
B. Finality, Ripeness, and Exhaustion
At the heart of the motion to dismiss is defendants' contention that WLF's dispute is not yet ripe for judicial review. Specifically, FDA asserts that 1) because FDA is still considering how to respond to WLF's Citizen Petition, WLF's suit is "premature"; 2) this dispute is not ripe for review, inasmuch as FDA has not adopted an official policy concerning manufacturer-supported distribution of off-label usage information; and 3) resolution of the dispute in its present posture would improvidently require the court to step into the FDA's role as a formulator of public health policy. The court is mindful of the serious concerns raised by these arguments. However, after a careful consideration of the filings and arguments of counsel, and the applicable case law, the court is convinced that this dispute is ripe for judicial review at this time.
Defendants' argument that WLF's suit is "premature" seems to be an attempt to invoke the requirement that a party challenging the action of an administrative agency exhaust its remedies through the administrative process before turning to the courts. Although FDA does not explicitly style this issue as an "exhaustion" question, the tenor of FDA's filings and the cases it cites make clear that this is the thrust its argument. FDA notes that WLF's Citizen Petition is still pending before the agency and argues that WLF should therefore be required to wait until FDA has definitively ruled on the petition.
This argument is unpersuasive.
First, as described above, with regard to WLF's Citizen Petition, the FDA failed to follow the procedures set forth in its own regulations whereby the agency must respond to such petitions within 180 days of receiving them. FDA did not respond to WLF's petition for 270 days, and then only several weeks after the filing of the present lawsuit. At oral argument, counsel for the defendants explained that WLF's petition had "slipped through the cracks," and that the agency's failure to respond to the petition within the 180 day time period was wholly inadvertent. The court accepts this explanation, and also agrees with FDA that the agency's failure to respond timely to WLF's petition should not itself constitute a formal denial of the petition, for purposes of determining whether there has been final agency action. At the same time, however, the FDA's handling of WLF's Citizen Petition, as well as the statements in its filings and at oral argument, evidence a somewhat less vigilant concern for the doctors' First Amendment rights than this court would hope to see.
Furthermore, there does not seem to be any explicit statutory or regulatory requirement that WLF pursue any administrative remedy at all. The D.C. Circuit has noted that the exhaustion doctrine serves four primary purposes: 1) it ensures that persons do not flout legally established administrative processes; 2) it protects the autonomy of agency decisionmaking; 3) it aids judicial review by permitting factual development of issues relevant to the dispute; and 4) it serves judicial economy by avoiding repetitious administrative and judicial factfinding and by resolving sole claims without judicial intervention. Public Citizen Health Research Group v. Commissioner, Food & Drug Administration, 238 U.S. App. D.C. 271, 740 F.2d 21, 29 (D.C. Cir. 1984). The Public Citizen Court went on to observe that "the exhaustion doctrine is not jurisdictional in nature...and should not be applied blindly when the interests that the doctrine protects would not be served...." Id. (citations omitted). Application of the factors set forth in Public Citizen makes clear that WLF's suit should not be dismissed on exhaustion grounds.
First, it is clear that WLF has already attempted to resolve this dispute through the administrative process. While the court accepts that FDA's failure to respond within the 180 day time frame established under FDA's regulations was inadvertent, the court finds that in light of the two and one-half year time period that FDA estimates will be required to resolve WLF's dispute,
WLF's decision to seek judicial review cannot be described as an attempt to "flout" any "established administrative process." Second, the "autonomy of agency decisionmaking" is not implicated here, given the court's determination, set forth more fully below, that plaintiff's complaint does allege that the FDA has in fact adopted a firm agency policy concerning off-label usage information. Next, while it is possible that some additional facts would be developed in the course of the FDA's resolution of WLF's citizen petition, any additional benefit this would provide is more than outweighed by the gravity of WLF's allegations concerning the impairment of its members' constitutional rights. Cf. Califano v. Sanders, 430 U.S. 99, 109, 51 L. Ed. 2d 192, 97 S. Ct. 980 (1976) (noting that "constitutional questions obviously are unsuited to resolution in administrative hearing procedures and, therefore, access to the courts is essential to the decision of such questions"). Finally, given plaintiff's allegations that FDA has not only promulgated, but has also sought to enforce (albeit somewhat informally) a final agency policy, the court doubts very much that WLF is likely to "successfully vindicate [its] claims" in an administrative proceeding before the FDA. In light of these conclusions, the court finds that WLF is not barred by the exhaustion doctrine from maintaining the present suit.
The strongest argument raised by FDA is its assertion that WLF's claims are not ripe for judicial review. FDA maintains that it has not yet adopted an official policy concerning manufacturer-supported off-label usage information, and therefore an attempt by this court to resolve the dispute at this stage would be premature and would usurp the FDA's role as a formulator of administrative policy. The court is mindful of the serious prudential concerns raised by FDA's ripeness argument. However, after balancing these concerns against the harm inflicted by the constitutional violations alleged in the plaintiff's complaint, the court concludes that it may exercise its powers of review and entertain this dispute now.
The ripeness doctrine has been explained by the D.C. Circuit this way:
The ripeness doctrine, which requires a court to evaluate the fitness of issues for judicial review and the hardship to the parties from withholding review, "prevent[s] the courts, through avoidance of premature adjudication, from entangling themselves in abstract disagreements over administrative policies and...protect[s] the agencies from judicial interference until an administrative decision has been formalized and its effects felt in a concrete way by the challenging parties."
Public Citizen, 740 F.2d at 30 (quoting Abbott Laboratories v. Gardner, 387 U.S. 136, 148, 18 L. Ed. 2d 681, 87 S. Ct. 1507 (1967)). In determining whether a dispute is ripe for review, a court should balance in a flexible and pragmatic manner the hardship to the parties from withholding review and the desire not to interfere with agency policymaking. Ciba-Geigy Corp. v. U.S. Environmental Protection Agency, 255 U.S. App. D.C. 216, 801 F.2d 430, 434 (D.C. Cir. 1986). Furthermore, "courts confronted with close questions of ripeness are appropriately guided by the presumption of reviewability, especially when the affected person is confronted with the dilemma of choosing between disadvantageous compliance or risking imposition of serious penalties." Id. When deciding whether a dispute is fit for judicial review, a court must examine several factors including 1) whether the issue presented is purely legal; 2) whether consideration of that issue would benefit from a more concrete setting; and 3) whether the agency's action is "sufficiently final." Id. at 435. These factors must, in turn, be balanced against the harm suffered by the party affected by the agency action. See Public Citizen 740 F.2d at 30.
The question of the "finality" of FDA's off-label usage policy is the linchpin of this case. As noted above, the parties are in complete disagreement on this fundamental issue. The FDA maintains that it has not yet formulated a final agency policy, while WLF contends that the FDA has not only promulgated such a final policy, but that it has been enforcing the policy for several years. At the outset, the court notes that "the label an agency attaches to its action is not determinative." Continental Airlines, Inc. v. CAB, 173 U.S. App. D.C. 1, 522 F.2d 107, 124 (D.C. Cir. 1974) (en banc). "In particular, we look Primarily to whether the agency's position is definitive and whether it has a direct and immediate effect on the day-to-day business of the parties challenging the action." Ciba-Geigy, 801 F.2d at 435-36. As set forth below, plaintiff's complaint does allege the existence of such a policy.
First, it is clear that the FDA has not officially promulgated a final agency policy concerning dissemination of off-label usage information. The FDA Published a Draft Policy Statement concerning "industry-supported scientific and educational activities" in the Federal Register on November 19, 1992. 57 Fed. Reg. 56412. In addition to the Draft Policy Statement, FDA has also Published in the Federal Register a "notice and request for comment" pertaining to WLF's Citizen Petition. 59 Fed. Reg. 59820 (Nov. 18, 1994). This request for comment contains a summary of FDA's regulatory role vis-a-vis drug and medical device manufacturers, an explanation of the Draft Policy Statement regarding industry-supported promotion of off-label uses, and a description of WLF's Citizen Petition. FDA contends that the Draft Policy Statement and the request for comment demonstrate that the FDA is still in the process of formulating a final agency policy.
Whether FDA has officially adopted a final policy, however, is not determinative. In the context of a ripeness inquiry, it is the effect of the agency's conduct which is most important in determining whether an agency has adopted a final policy. And this case illustrates why this must be so: If an agency's own characterization of the finality of its policy were determinative, that agency could effectively regulate industry without ever exposing itself to judicial review. A powerful agency such as FDA could achieve this result through the simple expedient of 1) never formally declaring the policy to be "final," and 2) threatening (but never actually initiating) enforcement procedures against companies which failed to comply with the agency's de facto policy. Indeed, this is precisely what plaintiff has alleged.
WLF's complaint alleges that the FDA has sought to enforce a final agency policy concerning manufacturer-supported dissemination of off-label usage information. With regard to manufacturers' distribution of "enduring materials" containing such information, WLF describes a number of different instances in which representatives of the FDA sent warning letters and followed up with telephone calls to manufacturers which had planned to distribute medical textbooks and other enduring materials to doctors. In one such instance, WLF alleges that a pharmaceutical company which planned to distribute a standard oncology textbook. (which included references to off-label uses of some of the company's products) to doctors was informed by a representative of the FDA that the company would have to include package inserts from each of the company's drugs that were mentioned in the textbook. In subsequent telephone calls, however, the FDA allegedly rescinded even this limited approval and stated that pharmaceutical companies would no longer be permitted to have any involvement in the distribution of medical textbooks in which off-label uses of their drugs were discussed. Compl. at PP 45-47. Companies attempting to support scientific and educational activities by providing information or samples of their products encountered similar warnings from representatives of the FDA. E.g., Compl. PP 50-58.
In addition to sending warning letters to individual companies, high-ranking officers of the FDA are alleged to have made general remarks which plaintiff contends reveal the existence of a definitive agency position concerning off-label usage information. The Commissioner of the FDA himself, defendant David Kessler, allegedly made the following statement in June of 1991: "I would urge all members of the pharmaceutical industry to take a long hard look at their promotional practices. I do not expect companies to wait until this guidance becomes final to put their advertising and promotional houses in order." Compl. P 53. More recently, David Adams, Director of the Policy Development and Coordination Staff in Commissioner Kessler's office is alleged to have written the following statement regarding the FDA's Draft Policy Statement:
Although this document was published as a draft policy statement with an invitation to submit comments, it reflects actual agency policy. It tells you how the agency makes decisions from day to day in determining whether activities are subject to regulation and are potentially illegal under the Food, Drug and Cosmetic Act.
Pl.'s Opp. to Def.'s M. Dis. at 26 (quoting David Adams, "New Initiatives in FDA Advertising Policies," in The Changing Face of FDA Advertising and Marketing Rules: An Executive Report, (David Swit, ed. 1994)) (emphasis supplied). Other FDA officials are alleged to have made similar comments at various times. Id. at 26.
FDA maintains that these letters and comments do not amount to "final agency action." According to FDA, the "regulatory letters" described above merely "reflect views of particular individuals, not the institutional decision of the agency." Def's Mem. Supp. M. Dis. at 23. As such, defendants argue that this "informal advice given by specific employees of FDA" should not suggest the existence of any formal agency policy. Id. at 26. Likewise, because neither the Draft Policy Statement nor the comments of Commissioner Kessler constitute "coercive imperatives" which the FDA is bound to adhere to, id. at 23, these are not evidence of a final policy either, according to FDA. Unfortunately, by focusing exclusively on the individual trees, FDA appears to have lost sight of the forest. The question here is not whether any single act on the part of the FDA signifies the existence of a final agency policy; rather, the aggregate effect of these acts must be analyzed to determine whether the agency by its conduct has objectively demonstrated the existence of such a policy. Once the agency "publicly articulates an unequivocal position...and expects regulated entities to alter their primary conduct to conform to that position, the agency has voluntarily relinquished the benefit of postponed judicial review." Ciba-Geigy, 801 F.2d at 436. The allegations in the complaint suggest that FDA has done exactly this.
Although the FDA characterizes the "regulatory letters" and other statements of FDA officials as merely "advisory," the court must not be blind to the practical effects of these letters and other statements. As alleged in plaintiff's complaint, the collective effect of FDA's conduct has been to discourage manufacturers from disseminating information that they would otherwise have chosen to distribute. The result is that doctors, including WLF's member-doctors, have been prevented from receiving information which they claim to have an interest in receiving. Contrary to FDA's protestations, the plaintiff's allegations clearly set forth a causal connection between FDA's conduct and the decision of various companies to stop disseminating certain kinds of information and to stop supporting certain scientific and educational activities.
It may be true, as FDA argues, that a company which disagrees with the "advice" contained in FDA's regulatory correspondence may disregard this advice, go ahead with its planned activities, and then challenge the constitutionality of any adverse FDA action in an enforcement proceeding. However, the reality of the situation, as alleged by plaintiff, is that few if any companies are willing to directly challenge the FDA in this manner. In the first instance, the company must expose itself to the FDA's power to seize an entire product line if the FDA finds the products to be "misbranded." Although the company can then litigate the validity of the seizure (and therefore the policy pursuant to which the seizure was made), the prospect of lost sales and protracted litigation is understandably discouraging to these companies. In addition, the FDA wields enormous power over drug and medical device manufacturers through its power to grant or deny new product applications. It is evident that manufacturers are most reluctant to arouse the ire of such a powerful agency. The result, according to plaintiff, is that "FDA has been able to effectuate its policies without having to resort regularly to formal rulemaking." Pl.'s Opp. to Def.'s M. Dis. at 29. As evidence of this, the complaint describes a substantial reduction in the distribution of enduring materials to doctors and in the willingness of manufacturers to sponsor scientific and educational activities since the alleged implementation of FDA's off-label usage policy. These allegations portray the sort of "direct and immediate effect" which the Ciba-Geigy court found to be a useful indication of the finality of an agency position. Ciba-Geigy, 801 F.2d at 436.
Thus, the predicament faced by manufacturers wishing to sponsor activities or distribute educational materials is a perfect example of a situation in which "the affected person is confronted with the dilemma of choosing between disadvantageous compliance or risking imposition of serious penalties." Ciba-Geigy, at 434. Under such circumstances the presumption of reviewability attaches with particular force. Id. The fact that this suit is being brought by doctors who have been prevented from receiving information rather than the with whose conduct the FDA policy primarily interferes lends further credence to plaintiff's contention that the FDA's power over industry is such that it is able to implement de facto regulatory policies without formally adopting final agency positions. As a general proposition, the court finds the possibility of such a practice disturbing; in the context of the plaintiff's constitutional allegations, the court finds the possibility of such a practice intolerable. Thus, the court concludes that the allegations contained in the plaintiff's amended complaint clearly raise a question of fact as to whether the FDA has been enforcing a de facto policy concerning manufacturer-supported distribution of off-label usage information.
In light of this conclusion, the court finds that the other two ripeness factors set forth in Ciba-Geigy, namely, whether the question presented is a purely legal one and whether consideration of the issue would benefit from a more concrete setting, support the court's determination that this dispute is ripe for review. First, although a determination on the merits will involve a factual inquiry as to whether plaintiff's allegations concerning FDA's conduct are true, it seems likely that the primary issues at to be decided will be 1) whether the FDA adopted a de facto policy concerning off-label usage; and 2) whether such policy was unconstitutional. These are primarily legal rather than factual issues. With regard to the second factor, it is hard to imagine a dispute that would not benefit from a more concrete setting; however, the court is not persuaded that this particular dispute is likely to become significantly more focused with time. Any marginal benefit which might be obtained by waiting for the FDA to officially adopt an off-label usage policy is more than offset by the serious First Amendment harms alleged by plaintiff. The court is confident that the dispute presented by WLF is fit for judicial review under the standard set forth in the case law of this circuit; accordingly, defendants' motion to dismiss on ripeness grounds will be denied.
Finally, FDA makes the curious argument that even if it has promulgated a policy which violates the First Amendment rights of manufacturers and doctors, this court lacks the power to declare such a policy unconstitutional or to enjoin defendants from enforcing it. FDA contends that WLF's suit "in essence" requests this court to enjoin future FDA enforcement actions, something the courts do not have jurisdiction to do. Again, the FDA is mistaken. WLF's complaint alleges that the FDA has adopted a final agency policy, and that this policy interferes with the constitutional rights of its members. The Supreme Court's decision in Abbott Laboratories v. Gardner, 387 U.S. 136, 140-41, 148, 18 L. Ed. 2d 681, 87 S. Ct. 1507 (1967) clearly establishes that the courts have jurisdiction to review final agency policy and to order suitable relief in the event such policy is determined to be unlawful. FDA's argument that the court is without jurisdiction to order the relief sought by WLF is therefore rejected as well.
For the reasons set forth herein, defendants' motion to dismiss will be denied. A separate Order shall issue this date.
Royce C. Lamberth
United States District Judge
For the reasons set forth in the accompanying Memorandum Opinion, defendants' motion to dismiss is hereby DENIED.
Royce C. Lamberth
United States District Judge