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Ass'n of Am. Physicians & Surgeons, Inc. v. Food & Drug Admin.

March 4, 2008

ASS'N OF AM. PHYSICIANS & SURGEONS, INC., ET AL., PLAINTIFFS,
v.
FOOD & DRUG ADMIN., ET AL., DEFENDANTS, AND
DURAMED PHARMACEUTICALS, INC., INTERVENOR-DEFENDANT.



The opinion of the court was delivered by: John D. Bates United States District Judge

MEMORANDUM OPINION

In August 2006, the United States Food and Drug Administration ("FDA") approved Barr Pharmaceuticals, Inc.'s ("Barr") supplemental new drug application ("SNDA") for Plan B, an emergency contraceptive drug currently marketed by Duramed Research, Inc. ("Duramed"), a wholly owned subsidiary of Barr. The approval of the SNDA allowed Plan B to be marketed without a prescription to consumers age 18 and over and retained the prescription requirement for consumers under the age of 18. Plaintiffs Association of American Physicians & Surgeons, Inc. ("AAPS"), Concerned Women for America ("CWA"), Family Research Council ("FRC"), and Safe Drugs for Women ("SDW") bring this action challenging the FDA's approval of the SNDA and the procedures the FDA employed as being in violation of the Federal Food, Drug, and Cosmetic Act ("FDCA") and the Administrative Procedures Act ("APA"). Plaintiffs assert claims against the FDA and its Commissioner, Dr. Andrew C. von Eschenbach, in his official capacity and in his individual capacity (the "federal defendants").

Currently before the Court are motions to dismiss filed by the federal defendants and Duramed, the intervenor-defendant, pursuant to Fed. R. Civ. P. 12(b)(1) for lack of subject-matter jurisdiction and pursuant to Fed. R. Civ. P. 12(b)(6) for failure to state a claim upon which relief can be granted. Upon careful consideration of the motions, the parties' memoranda, the arguments advanced at the motions hearing held on February 15, 2008, the applicable law, and the entire record, and for the reasons set forth below, the Court will grant the federal defendants' and Duramed's motions to dismiss.

BACKGROUND

I. Statutory and Regulatory Background

Under the FDCA, a drug's sponsor must first submit a new drug application ("NDA") to the FDA for approval before a new drug may be marketed in the United States. 21 U.S.C. § 355(a)-(b). The new drug application must contain a wealth of information such as investigative reports demonstrating the drug's safety and effectiveness, a statement of the drug's components, and specimens of proposed labeling for the packaging of the new drug. Id. § 355(b)(1). The FDA must reject a NDA if several conditions are not met. For example, a NDA will be rejected if inadequate testing was conducted, if the testing data show that a "drug is unsafe for use under such conditions [as prescribed, recommended, or suggested in the proposed labeling]," if there is "a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling," or if "based on a fair evaluation of all material facts, such labeling is false or misleading in any particular." Id. § 355(d).

Some NDAs are approved with the restriction that the drug may be dispensed by prescription only ("Rx-only"). The Rx-only requirement applies when, "because of [the drug's] toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, [it] is not safe for use except under the supervision of a practitioner licensed by law to administer such drug." Id. § 353(b)(1)(A). A Rx-only drug may later be approved for over-the-counter ("OTC") use when the agency finds that the prescription requirements "are not necessary for the protection of the public health by reason of the drug's toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, and [the agency] finds that the drug is safe and effective for use in self-medication as directed in proposed labeling." 21 C.F.R. § 310.200(b); see also 21 U.S.C. § 353(b)(3), 355(c)-(d).

II. Factual Background

On July 28, 1999, the FDA approved a new drug application submitted by Women's Capital Corp. ("WCC") -- now a wholly owned subsidiary of Duramed -- for prescription Plan B. Am. Compl. ¶ 66. In April 2003, WCC submitted a supplemental new drug application seeking to make Plan B available to all consumers over the counter in what is commonly referred to as a Rxto-OTC switch. Id. ¶ 68. Several months later, Barr acquired WCC, and thereafter Barr and Duramed continued to advocate for OTC approval of Plan B. Id.

After the Center for Drug Evaluation and Research ("CDER") completed its review of the application, the Acting Director issued a "not approval" letter to Duramed. Id. ¶ 69. The CDER cited concerns about the ability of consumers under the age of 16 to use Plan B without professional supervision by a practitioner licensed to administer the drug. Id. The Acting Director suggested that Duramed could: (1) provide data to demonstrate that consumers under the age of 16 could safely use Plan B as an over-the-counter drug, or (2) seek over-the-counter status solely for consumers over the age of 16. Id.

Duramed elected to pursue the second option and submitted an amended SNDA seeking to retain the prescription requirement for consumers under the age of 16 and seeking an OTC switch only for consumers age 16 and older. When the FDA responded on August 26, 2005, the Commissioner informed Duramed that CDER found Plan B to be safe for over-the-counter use for consumers age 17 and older. Id. ¶ 70. Nevertheless, the FDA did not approve this distribution scheme. Instead, the FDA indicated that it would first have to resolve whether it could approve the distribution of the same pharmaceutical drug to different populations for OTC and Rx use, and if so, how to proceed with such an approval. Id. ¶ 70. The FDA thereafter published an Advance Notice of Proposed Rulemaking ("ANPR") seeking public comment on these issues. Id. ¶ 71 (citing 70 Fed. Reg. 52,050 (Sept. 1, 2005)). After receiving approximately 47,000 comments, the FDA determined that it was unnecessary to proceed by rulemaking. Id. ¶¶ 72, 74.

In August 2006, Duramed submitted yet another amended SNDA -- this time requesting OTC availability of Plan B for consumers age 18 and older. Fed. Defs.' Exs. 9 & 10. In its application, Duramed proposed a single package for Plan B to be used for the Rx and OTC populations. Duramed also indicated that it would only make Plan B available for purchase at licensed pharmacies and health care clinics and would direct pharmacies to keep the product "behind the counter." Fed. Defs.' Exs. 9 at 4-7 & 10 at 36-46; see also Am. Compl. ¶ 78. In August 2006, the FDA approved this amended SNDA. Am. Compl. ¶ 78. As approved by the FDA, Plan B's current labeling contains the legend "Rx only for age 17 and younger." Id. ¶ 79.

III. Procedural Background

Almost eight months later, on April 12, 2007, plaintiffs AAPS, CWA, FRC and SDW filed this action seeking to vacate the FDA's August 2006 SNDA approval decision for Plan B. Plaintiff AAPS is a not-for-profit membership organization of physicians who practice in all areas and specialties. Id. ¶ 3. Plaintiff CWA is a nonprofit corporation that represents approximately 500,000 men and women across the nation advancing their interests before Congress and other governmental bodies. Id. ¶ 4. Plaintiff FRC is a nonprofit corporation dedicated to "valuing human life from conception until natural death and upholding the institution of the family, including parental oversight of children's health care." Id. ¶ 5. And Plaintiff SDW is a nonprofit corporation whose members consist of physicians and pharmacists. Id. ¶ 6.

After the federal defendants and Duramed filed motions to dismiss arguing that plaintiffs lacked standing to sue, plaintiffs filed an amended complaint in an attempt to cure any pleading deficiencies. In their amended complaint, plaintiffs allege: (1) that the FDA's approval was unlawful because the SNDA failed to demonstrate that Plan B was safe for OTC use by consumers age 18 and older, (2) that the FDA's approval violated the FDCA by allowing Plan B to be marketed as both a prescription and an OTC drug, (3) that the FDA's age-based decision violated the FDCA, (4) that the FDA has created a "third class" of drugs in violation of the FDCA, (5) that the FDA violated the APA by failing to conduct a rulemaking, (6) that the FDA violated the FDCA by failing to conduct a rulemaking, (7) that the federal defendants were improperly influenced by political pressure, and (8) that the FDA is not authorized to impose administrative exhaustion requirements.

In response to the amended complaint, the federal defendants and Duramed (collectively the defendants) again filed motions to dismiss arguing that plaintiffs' allegations are insufficient to establish the elements of standing and that plaintiffs have failed to exhaust their administrative remedies. Defendants also argue that plaintiffs' theories underlying Counts II, IV, V, and VI are incorrect as a matter of law. Finding the jurisdictional argument of defendants persuasive, the Court will grant the motions to dismiss.

STANDARD OF REVIEW

"[I]n passing on a motion to dismiss, whether on the ground of lack of jurisdiction over the subject matter or for failure to state a cause of action, the allegations of the complaint should be construed favorably to the pleader." Scheuer v. Rhodes, 416 U.S. 232, 236 (1974); see Leatherman v. Tarrant Cty. Narcotics and Coordination Unit, 507 U.S. 163, 164 (1993); Phillips v. Bureau of Prisons, 591 F.2d 966, 968 (D.C. Cir. 1979). Therefore, the factual allegations must be presumed true, and plaintiff must be given every favorable inference that may be drawn from the allegations of fact. Scheuer, 416 U.S. at 236; Sparrow v. United Air Lines, Inc., 216 F.3d 1111, 1113 (D.C. Cir. 2000). However, the Court need not accept as true "a legal conclusion couched as a factual allegation," nor inferences that are unsupported by the facts set out in the complaint. Trudeau v. Federal Trade Comm'n, 456 F.3d 178, 193 (D.C. Cir. 2006) (quoting Papasan v. Allain, 478 U.S. 265, 286 (1986)).

Under Rule 12(b)(1), the parties seeking to invoke the jurisdiction of a federal court --plaintiffs here -- bear the burden of establishing that the court has jurisdiction. See US Ecology, Inc. v. U.S. Dep't of Interior, 231 F.3d 20, 24 (D.C. Cir. 2000); see also Grand Lodge of Fraternal Order of Police v. Ashcroft, 185 F. Supp. 2d 9, 13 (D.D.C. 2001) (a court has an "affirmative obligation to ensure that it is acting within the scope of its jurisdictional authority."); Pitney Bowes, Inc. v. United States Postal Serv., 27 F. Supp. 2d 15, 19 (D.D.C. 1998). "'[P]laintiff's factual allegations in the complaint . . . will bear closer scrutiny in resolving a 12(b)(1) motion' than in resolving a 12(b)(6) motion for failure to state a claim." Grand Lodge, 185 F. Supp. 2d at 13-14 (quoting 5A Charles Alan Wright & Arthur R. Miller, Federal Practice and Procedure § 1350 (2d ed. 1987)). Additionally, a court may consider material other than the allegations of the complaint in determining whether it has jurisdiction to hear the case, as long as it still accepts the factual allegations in the complaint as true. See Jerome Stevens Pharmaceuticals, Inc. v. FDA, 402 F.3d 1249, 1253-54 (D.C. Cir. 2005); EEOC v. St. Francis Xavier Parochial Sch., 117 F.3d 621, 624-25 n.3 (D.C. Cir. 1997); Herbert v. Nat'l Acad. of Scis., 974 F.2d 192, 197 (D.C. Cir.1992).

In reviewing a motion to dismiss pursuant to Rule 12(b)(6), the Court is mindful that all that the Federal Rules of Civil Procedure require of a complaint is that it contain "'a short and plain statement of the claim showing that the pleader is entitled to relief,' in order to 'give the defendant fair notice of what the . . . claim is and the grounds upon which it rests.'" Bell Atl. Corp. v. Twombly, 550 U.S. ___, 127 S.Ct. 1955, 1964 (2007) (quoting Conley v. Gibson, 355 U.S. 41, 47 (1957)); accord Erickson v. Pardus, 551 U.S. ___, 127 S.Ct. 2197, 2200 (2007) (per curiam). "A Rule 12(b)(6) motion tests the legal sufficiency of a complaint." Browning v. Clinton, 292 F.3d 235, 242 (D.C. Cir. 2002). Thus, the complaint's "[f]actual allegations must be enough to raise a ...


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