United States District Court, District of Columbia
ROYCE C. LAMBERTH, Judge.
Plaintiff Spectrum Pharmaceuticals, Inc. ("Spectrum") has brought this action against Sylvia Mathews Burwell, in her official capacity as Secretary of the U.S. Department of Health and Human Services ("HHS"), and Stephen Ostroff, M.D., in his official capacity as acting Commissioner of food and drugs for the U.S. Food and Drug Administration ("FDA"). Sandoz, Inc. ("Sandoz") has intervened as a defendant. Spectrum manufactures a pharmaceutical product under the brand name FUSILEV®. On March 9, 2015, the FDA approved Sandoz's request to market a generic version of this product. Spectrum seeks to enjoin the FDA to withdraw or stay its approval of Sandoz's abbreviated new drug application ("ANDA") on the grounds that both the approval and the process by which it issued violate the requirements of the Food, Drug, and Cosmetic Act ("FDCA") and its implementing regulations. 21 U.S.C. §§ 301 et seq. Spectrum also argues that the FDA's approval of Sandoz's ANDA constitutes arbitrary and capricious agency action in violation of the Administrative Procedure Act. 5 U.S.C. § 706.
Before the Court is Plaintiff's Motion for summary judgment , Defendants' Supplemental Brief in Support of Judgment for Defendants , and Intervenor-Defendant's Cross-Motion for summary judgment . Upon consideration of Plaintiff's Motion and Memorandum in Support thereof , Defendants' Supplemental Brief in Support of Judgment for Defendants, Intervenor-Defendant's Cross-Motion and Opposition , the arguments made in open court on April 29 and May 18, 2015, the entire record in this case, and the applicable law, the Court will DENY Plaintiff's Motion  for summary judgment and GRANT summary judgment for Defendants and Intervenor-Defendant . The Court will explain its reasoning in the following analysis.
A. Statutory and Regulatory Framework
1. Orphan Drug Exclusivity, New Drug Applications, and Abbreviated New Drug Applications
Congress passed the Orphan Drug Act ("ODA") to encourage the development of "orphan drugs, " drugs that treat diseases or disorders affecting only a small number of people. Pub. L. No. 97-414, 96 Stat. 2049 (1983). When a company develops a drug that the FDA has designated an "orphan drug, " the Act gives that developer seven years of market exclusivity, during which time the FDA may not approve any other entity's application "for such drug for such disease or condition, " barring certain exceptional circumstances not applicable here. 21 U.S.C. § 360cc(a).
Under the FDCA, pharmaceutical companies seeking to market "pioneer" or "innovator" drugs must first obtain FDA approval to do so by filing a new drug application ("NDA"). 21 U.S.C. § 355(a)-(b). The NDA must contain extensive scientific data and other information, including 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 drug. 21 U.S.C. § 355(b)(1).
The Drug Price Competition and Patent Term Restoration Act of 1984 ("Hatch-Waxman Amendments"), codified at 21 U.S.C. § 355 and 35 U.S.C. §§ 156, 271, and 282, lets generic versions of already-NDA-approved drug products bypass the lengthy NDA process and proceed instead via abbreviated new drug applications ("ANDAs"). 21 U.S.C. § 355(j). The Hatch-Waxman Amendments were intended to balance encouraging innovation in drug development with accelerating the availability of lower-cost generic alternatives to innovator drugs. See H.R. Rep. No. 98-857 (Part I), 98th Cong., 2d Sess. at 14-15 (1984), reprinted in 1984 U.S.C.C.A.N. 2547-48; see also Tri-Bio Labs., Inc. v. United States, 836 F.2d 135, 139 (3d Cir. 1987). Though an entity submitting an ANDA must still obtain FDA approval, the ANDA need not include clinical evidence establishing the safety and effectiveness of its proposed generic drug. Instead, the ANDA may point to the already-approved innovator drug that their generic drug mimics, known as the reference listed drug ("RLD"), and rely instead on the FDA's previous finding that the RLD is safe and effective. See 21 U.S.C. 355 § (j)(2).
To use this shortcut, the ANDA applicant must show that its proposed drug is the "same as" the RLD in all key respects (including active ingredient, dosage form, strength, route of administration, and, with certain exceptions, labeling), and is bioequivalent to the RLD. 21 U.S.C. § 355(j)(2)(A)(ii)-(v). The statute also requires that an ANDA contain "information to show that the conditions of use prescribed, recommended, or suggested in the labeling proposed for the new drug have been previously approved for a [listed drug]." 21 U.S.C. § 355(j)(2)(A)(i). The FDA must approve an ANDA unless it finds, among other things, that the ANDA has not provided sufficient evidence of the foregoing. 21 U.S.C. § 355(j)(4).
FDA regulations allow for a labeling "carve-out, " whereby a generic drug's labeling may differ from the RLD's to omit those parts of the RLD's labeling that "are protected by patent, or by exclusivity." 21 C.F.R. § 314.127(a)(7). Such carve-outs are allowed, however, only where the omissions "do not render the proposed drug product less safe or effective than the listed drug for all remaining, non-protected conditions of use." Id. When a proposed labeling carve-out renders the generic product less safe than the RLD, the FDA may not approve the ANDA. Id. The FDA has acknowledged that this language reflects Congress's intent that the generic drug be safe and effective for each "condition of use" prescribed, recommended, or suggested in the generic drug labeling. See FDA Letter to Dexmedetomidine Hydrochloride Injection NDA Holder/ANDA Applicant, Docket No. FDA-2014-N-0087 (Aug. 18, 2014) at 7, available at http://www.regulations.gov/#!documentDetail;D=FDA-2014-N-0087-0025.
B. Factual Background
1. FUSILEV ®
The name of Spectrum's innovator drug product at issue in this case is FUSILEV®. FUSILEV® contains levoleucovorin, a variant of leucovorin, a drug that has been used to treat the toxic effects of the cancer medicine methotrexate. A.R. 183-84.
a. The Methotrexate Indications
On March 7, 2008 the FDA approved FUSILEV® for injection, in the form of a freeze-dried powder single-use vial containing the equivalent of 50 mg levoleucovorin (the "small vial"), for the following medical uses ("indications"): (1) Rescue after high-dose methotrexate therapy in osteosarcoma, and (2) Diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. A.R. 135-38. These indications are referred to collectively herein as the "Methotrexate Indications." Before the drug contained in the small vial can be injected intravenously it must first be reconstituted through mixture with another chemical, and once reconstituted becomes unsafe for use after twelve hours. ...