The opinion of the court was delivered by: Ellen Segal Huvelle United States District Judge
Plaintiff ViroPharma Incorporated ("ViroPharma") brings this action against the Food and Drug Administration ("FDA") and the Department of Health and Human Services, seeking review under the Administrative Procedure Act ("APA"), 5 U.S.C. §§ 701-706. Specifically, ViroPharma claims that that FDA failed to conduct notice-and-comment rulemaking prior to what plaintiff claims was a decision by the FDA to change its regulations regarding the permissible methods by which an applicant for an Abbreviated New Drug Application ("ANDA") can demonstrate that the drug is the "bioequivalent" of a previously approved drug. Defendants has moved to dismiss pursuant to Federal Rules of Civil Procedure 12(b)(1) and 12(b)(6) on the grounds that this Court has no subject matter jurisdiction because of lack of standing and ripeness and that plaintiff has failed to state a claim upon which relief can be granted. For the reasons explained herein, the Court will grant defendants' motion on the basis of a lack of standing.
I. STATUTORY AND REGULATORY FRAMEWORK
Under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., a "pioneer" or "innovator" drug may not be marketed until the FDA has approved a new drug application ("NDA") that includes, inter alia, reports from clinical studies establishing the safety and effectiveness of the drug. 21 U.S.C. § 355(b)(1). An applicant may obtain FDA approval to market generic copies of an FDA-approved brand-name drug, known as the "reference listed drug" ("RLD"), by submitting an Abbreviated New Drug Application ("ANDA"). 21 U.S.C. § 355(j). In order to rely upon a RLD's record of safety and effectiveness for approval, an ANDA must include information demonstrating that the generic drug is the same as the RLD in a number of specified ways. 21 U.S.C. § 355(j)(2)(A). Of particular relevance here, the ANDA must demonstrate that the generic is the "bioequivalent" of the RLD, and is therefore absorbed into the body at the same rate and to the same extent as the innovator drug. 21 U.S.C. § 355(j)(2)(A)(iv). Where, as here, "a drug . . . is not intended to be absorbed into the bloodstream, the Secretary may establish alternative, scientifically valid methods to show bioequivalence if the alternative methods are expected to detect a significant difference between the drug and the [RLD] in safety and therapeutic effect." 21 U.S.C. § 355(j)(8)(C).
Depending on the circumstances and the particular drug in question, the FDA may require an applicant use one or more of a variety of different methodologies in order to demonstrate bioequivalence. In general, however, methodologies for demonstrating bioequivalence may be classified as either in vivo (i.e., through human testing) or in vitro (i.e., laboratory testing). The requirements for demonstrating bioequivalence are the subject of a number of regulations, the correct interpretation of which is at the crux of the parties' dispute. According to ViroPharma, 21 C.F.R § 320.21(b) sets forth a general requirement that bioequivalence be demonstrated through in vivo testing, unless the drug product meets one of the waiver criteria set forth in 21 C.F.R. § 320.22. (Compl. ¶¶ 35-37.) The FDA, however, argues that there is no such "default requirement for in vivo data to establish bioequivalence." (Reply at 15.) Instead, the FDA relies on language in 21 C.F.R. § 320.24, which states that "FDA may require in vivo or in vitro testing, or both, to . . . establish the bioequivalence of specific drug products." FDA therefore asserts that it has discretion to determine, on a case-by-case basis, whether it will require in vivo testing, in vitro testing, or both in order to establish the bioequivalence of a drug product. According to ViroPharma, however, 21 C.F.R. § 320.24 merely lists the various methods for establishing either in vivo or in vitro bioequivalence, depending on which of those two types of testing is otherwise required by the regulations. (Compl. ¶ 39.)
On November 9, 2007, Cobalt Laboratories Inc. and Cobalt Pharmaceuticals (collectively, "Cobalt") submitted a citizen petition and petition for stay of action regarding the bioequivalence requirements for generic versions of the locally acting GI drug Precose (acarbose). (Id. ¶ 49 & Ex. 1.) This petition asked FDA to require all ANDAs for generic acarbose to include in vivo bioequivalence studies. (Id.) FDA responded to Cobalt's petitions on May 7, 2008, denying the request for a stay of action. (Id. ¶ 50.) In its to the acarbose petition, FDA asserted that under "§ 320.24 of the regulations, FDA has the discretion to accept in vitro studies for a nonsystemically absorbed drug product such as acarbose when such studies are determined to be a scientifically valid method of determining bioequivalence." (Id. ¶ 51 & Ex. 2.) ViroPharma claims that this response "effectively amended [FDA] regulations" by "interpret[ing] the list of bioequivalence methods provided in 21 C.F.R. § 320.24 as a separate and sufficient regulatory basis for waiving in vivo bioequivalence requirements independent of 21 C.F.R. § 320.22." (Id. ¶ 52.)
ViroPharma, a small pharmaceutical company headquartered in Exton, Pennsylvania, acquired the exclusive right to the prescription drug Vancocin in the United States from Eli Lilly and Company in 2004. (Id. ¶¶ 7, 13.) Vancocin is the trade name for the FDA-approved drug vancomycin hydrochloride capsules ("vancomycin") and is used to treat life-threatening gastrointestinal infections such as C. difficile ("CDI"). (Id. ¶¶ 14, 15.) Vancocin is one of only two drugs that ViroPharma markets and is the primary source of ViroPharma's revenue. (Id. ¶ 20.)
In 1996, FDA recommended that ANDA sponsors submit a clinical in vivo study to demonstrate bioequivalence of generic vancomycin. (Mot. at Ex. 5.) FDA revised these bioequivalence recommendations in early 2006 to include data generated by in vitro methods for demonstrating bioequivalence. (Id.; Compl. ¶ 23.) In March 2006, ViroPharma filed a petition for stay of action challenging FDA's revised recommendation. (Compl. ¶ 59.) The FDA has yet to complete its response to this petition. (Mot. at 12.) In December 2008, FDA revised its draft recommendation for the appropriate bioequivalence methodology for vancomycin, requesting public comment on the most recent version. (Id. at Ex. 5.) FDA continues to accept comments from the public on the draft guidance document (id.), and has not yet finalized it. (Id. at 12).
ViroPharma alleges that the FDA has received at least eleven ANDAs for vancomycin. (Compl. ¶ 72), but FDA has yet to ...