VELOXIS PHARMACEUTICALS, INC., Plaintiff, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, et al., Defendants.
Civil Action No. 14-2126 (RBW)
United States District Court, District of Columbia.
Signed June 12, 2015
Heide L. Herrmann, Department of Justice, Washington, DC, for Defendants.
MEMORANDUM OPINION
REGGIE B. WALTON, United States District Judge
The plaintiff, Veloxis Pharmaceuticals, Inc., filed this civil suit against the defendants—the United States Food and Drug Administration (FDA); Margaret Hamburg, the Commissioner of the FDA; the United States Department of Health and Human Services (DHHS); and Sylvia Burwell, the Secretary of the DHHS—seeking declaratory and injunctive relief to redress the FDA‘s decision to delay complete and final approval of Envarsus XR, which is the plaintiff‘s anti-rejection medication for kidney transplant recipients. Complaint for Declaratory and Injunctive Relief (Compl.) ¶ 1. Without such approval from the FDA, the plaintiff cannot market Envarsus XR until July 2016. Id. ¶ 7. The plaintiff alleges that the FDA‘s decision violates the Administrative Procedure Act (APA),
I. BACKGROUND
A. Statutory Background
1. The Hatch-Waxman Amendments
The Food, Drug, and Cosmetic Act (FDCA) governs the pharmaceutical drug approval process for both new and generic drugs. See
The length of a pioneer drug‘s marketing exclusivity varies. See Allergan, 398 F.Supp.2d at 17 (“Because Congress still wanted to provide incentives for new drug development, alongside the [Abbreviated New Drug Application] process that eased the marketing of generic drugs, [the] Hatch-Waxman [Amendments] entitle[d] [a New Drug Application] applicant to a period of market exclusivity ([three] or [five] years, depending on the degree of innovation reflected in the NDA).“). For example, certain provisions in the Hatch-Waxman Amendments provide three years of marketing exclusivity (“three-year exclusivity“). See
Under the Hatch-Waxman Amendments, sponsors seeking to market new or generic drugs can obtain FDA approval for their drug products through one of three pathways: (1) a full New Drug Application (“NDA“), see
The full NDA process requires the [sponsor] to submit detailed safety and efficacy data for the drug, including, among other things, “full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use” (i.e., clinical trials); all components of the drug; the methods used for the drug‘s manufacture, processing, and packing; [and] examples for proposed labeling for the drug.... This path is used by [sponsors] for “new branded drugs,” which are sometimes called “pioneer” or “innovator” drugs. A [sponsor] may also choose to file an ANDA.... The ANDA process facilitates efficient approval of generic versions of pioneer drug products that have already been determined to be safe and effective. Rather than requiring generic [sponsors] to conduct expensive and time consuming clinical trials, the ANDA process allows the [sponsors] to rely on the clinical trials already performed in connection with the approval of the previously approved drug, provided that the generic [sponsor] can show that its drug has the same relevant characteristics (including, inter alia, the same labeling, active ingredient, route of administration, dosage form, strength, and bioequivalence). In other words, an ANDA does not attempt to demonstrate safety or effectiveness; instead, the [sponsor]‘s only goal is to establish that the generic product is equivalent to another drug that is already known to be safe and effective. Thus, this path is used by [sponsors] “for the introduction of generic versions of previously approved branded drugs.”
The Section 505(b)(2) NDA is a sort of hybrid of the other two pathways. Like the full NDA, a 505(b)(2) NDA must directly demonstrate that the proposed drug product is safe and effective; however, like the ANDA, a 505(b)(2) [spon-
sor] can rely on clinical studies that were previously submitted to [the] FDA in support of another drug and that were not conducted or licensed by the 505(b)(2) [sponsor]. The drug for which the borrowed studies were conducted is referred to as the “Reference Listed Drug” (RLD), and the RLD-related clinical studies that a Section 505(b)(2) [sponsor] relies upon may be proffered to satisfy the [sponsor]‘s entire burden of proving safety and effectiveness, or they may only support some of the necessary findings; in the latter case, the [sponsor] can supplement with studies of its own. This means that a Section 505(b)(2) NDA may include the [sponsor]‘s own research supporting the basic safety and efficacy of the drug in addition to the research studies related to the RLD, or it may rely entirely on the RLD, but, in any event, the Section 505(b)(2) [sponsor] must present information that bears upon the safety and effectiveness of its drug product in light of the difference between the pioneer drug product and the [sponsor]‘s modification of that drug product. The 505(b)(2) NDA pathway is often used when the new drug differs only slightly from the pioneer drug, and this pathway is often favored by [sponsors] seeking to market drugs that are neither “entirely new” nor “simply a generic version of a branded drug.”
Takeda Pharms., 78 F.Supp.3d at 71-72, 2015 WL 252806, at *4 (alteration, citations, footnote, and internal quotation marks omitted).
2. The Food and Drug Administration Modernization Act of 1997
The Food and Drug Administration Modernization Act of 1997 (“FDAMA“), Pub.L. No. 105-115, 111 Stat. 2296, further amended the FDCA. ViroPharma, Inc. v. Hamburg, 898 F.Supp.2d 1, 6 (D.D.C.2012). Leading up to the passage of the FDAMA,
“antibiotic” drugs were approved under Section 507 of the [FDCA] and non-antibiotic drugs were approved under Section 505. This difference had a long history, dating back to the development of penicillin, the first drug to have the capacity to kill microbes, i.e., be “antibiotic.” ... Two key consequences arose from these different treatments. [Sponsors] for generic versions of antibiotic drugs were only requested to show conformance with statutorily-mandated, published standards of identity, strength, quality, and purity for the antibiotic substance, as reflected in antibiotic “monographs” published by [the] FDA. [Sponsors] did not have to submit the safety and efficacy data that was required for pioneer and generic non-antibiotic drugs. Therefore, generic antibiotics were developed and marketed fairly readily. However, antibiotic drugs did not receive the ... marketing exclusivity benefits available to pioneer and non-antibiotic drugs after enactment of the [Hatch-Waxman Amendments].... In 1997, with the enactment of the FDAMA, Congress extended Hatch-Waxman to antibiotics by repealing Section 507 of the [FDCA] and requiring that all applications for antibiotic drugs be submitted under Section 505.... However, ... [in] eliminat[ing] the separate approval pathway for antibiotics, [Congress only] made antibiotics approved after the statute‘s effective date, but not [o]ld [a]nti-biotics,4 eligible for exclusivity....
Allergan, 398 F.Supp.2d at 18.
B. Factual Background
1. Kidney Transplant Patients
When a kidney is transplanted from a donor to a recipient, the immune system of the recipient will try to reject the kidney. A.R. at FDA 00006. At the time the kidney is transplanted, the recipient is generally referred to as a “de novo patient.” Id.
To prevent rejection, the de novo patient must take “drugs that suppress the immune system ... at the time the [kidney] is transplanted....” Id. An immunosuppressive drug regimen usually contains a combination of three or four drugs. Id. at FDA 00007. The recipient must be on the regimen from the time the kidney is transplanted, and continue to be on it as long as the kidney is “viable.” Id. at FDA 00006. The “intensive level of immunosuppression administered” to a de novo patient, which lasts “until early after the [transplant] surgery,” is called “induction.” Id. at FDA 00006-7. After the transplant surgery, “the [recipient]‘s regimen of ... immunosuppressants is carefully and frequently monitored ... and may be adjusted to minimize the development of adverse reactions while keeping the [recipient]‘s immune system from rejecting the kidney.” Id. at FDA 00007. “The goal is to customize the regimen to find the optimum balance between the efficacy and the toxicity of the immunosuppressive regimen.” Id. Once the de novo patient achieves the optimum balance, the recipient is referred to as a “maintenance patient.” Id. Thereafter, one of the three to four immunosuppressive drugs the patient had been receiving can be discontinued and replaced with another drug. Id. at FDA 00008. This replacement process is called “conversion.” Id.
2. Tacrolimus
i. Prograf
Tacrolimus is an immunosuppressant approved for use in preventing organ rejection. Id. at FDA 00009. Astellas Pharma US, Inc. (“Astellas“) submitted, and the FDA approved, a Section 505(b)(1) NDA for a tacrolimus formulation in 1994, under the trade name Prograf (“Prograf NDA“). Id. Prograf is a twice-daily, immediate release capsule that is used for the “prophylaxis of organ rejection in patients receiving,” among other organ transplants, “kidney ... transplants.” Id.
Tacrolimus is also considered an antibiotic drug by statute. See id. (citing
ii. Astagraf XL
In 2005, Astellas submitted a Section 505(b)(1) NDA for a different tacrolimus formulation under the trade name Astagraf XL (“Astagraf XL NDA“). A.R. at FDA 00010. For this formulation, it sought approval for a once-daily, extended release capsule for the “prophylaxis of organ rejection following,” again among other organ transplantations, a “kidney transplantation.” Id. at FDA 00010. In 2009, Astellas withdrew the Astagraf XL NDA after the FDA identified some deficiencies in the NDA. See id. at FDA 00011-12; id. at FDA 00874. Astellas submitted a new
3. Envarsus XR
The plaintiff submitted a Section 505(b)(2) NDA for a tacrolimus formulation, under the trade name Envarsus XR in December 2013 (“Envarsus XR NDA“). Id. at FDA 00016. Envarsus XR is a once daily, extended-release tablet, used for the “prophylaxis of organ rejection in both de novo and conversion kidney transplant patients.” Id. at FDA 00018. The Envarsus XR NDA relies on its own independent clinical studies, as well as clinical studies relied upon for the approval of the Prograf NDA. Id. at FDA 00016. The FDA tentatively approved Envarsus XR in October 2014. Id. at FDA 00018. That same month, however, the FDA determined that Astagraf XL‘s three-year exclusivity prevented the FDA from fully approving Envarsus XR in all respects. Id. at FDA 00019. Specifically,
[the] FDA concluded that the [three-year] exclusivity for Astagraf XL cover[ed] [the Envarsus XR extended release] dosage form and its once-daily dosing regimen [for de novo patients], both of which were changes from the previously approved tacrolimus drug, Prograf, and were supported by new clinical investigations essential to the approval of Astagraf XL. Because Envarsus XR is also an [extended release] dosage form of tacrolimus with a once-daily dosing regimen [for de novo patients], [the] FDA determined ... that Envarsus XR shares Astagraf XL‘s exclusivity-protected conditions of approval.
Id. Because the FDA withheld final approval of Envarsus XR for the prophylaxis of organ rejection in de novo kidney transplant patients, the plaintiff cannot market Envarsus XR for this use. See id.
C. Procedural Background
In November 2014, the plaintiff met with the FDA and expressed its belief that the FDA had erred for several reasons in delaying complete and final approval of Envarsus XR on the basis of Astagraf XL‘s three-year exclusivity. Id. at FDA 00019-20; see also id. at FDA 01588-90, 1592-1622, 1623-25, 1626-43. Thereafter, in December 2014, the plaintiff provided additional arguments to the FDA as to why its delay of complete and final approval was erroneous. Id. at FDA 01739-42. Upon review of the plaintiff‘s submissions to the FDA, the FDA proposed a compromise: “it could [fully] approve Envarsus
II. STANDARD OF REVIEW
In cases involving review of final administrative actions, the summary judgment standard of review set forth in
“The scope of review under the ‘arbitrary and capricious’ standard is narrow and a court is not to substitute its judgment for that of the agency.” Motor Vehicle Mfrs. Ass‘n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983). The agency must show that it “examine[d] the relevant data and articulate[d] a satisfactory explanation for its action including a rational connection between the facts found and the choice made.” Id. (internal quotation marks omitted). “Under the APA, it is the role of the agency to resolve factual issues to arrive at a decision that is supported by the administrative record, whereas the function of the district court is to determine whether or not as a matter of law the evidence in the administrative record permitted the agency to make the decision it did.” Hi-Tech Pharmacal Co. v. FDA, 587 F.Supp.2d 13, 18 (D.D.C.2008) (internal quotation marks and citation omitted). “[T]here is a presumption in favor of the validity of the administrative
III. ANALYSIS
All of the plaintiff‘s arguments are premised on the allegation that the FDA incorrectly interpreted and applied various portions of the FDCA, as amended. See, e.g., Compl. ¶¶ 7-9. The Court must review the FDA‘s interpretations of the FDCA under the two-step framework outlined in Chevron, U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837 (1984). This is a staged analysis that requires the [C]ourt to consider, first, “whether Congress has spoken to the precise question at issue. If the intent of Congress is clear, that is the end of the matter; for the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress.” If there is no clear answer, however, the [C]ourt must proceed to the second step, which involves giving deference to FDA‘s interpretation of the statute so long as FDA‘s reading of the statute is “based on a permissible construction.” Takeda, 2015 WL 252806, at *22 (quoting Chevron, 467 U.S. at 842-43); see also Pharm. Research & Mfrs. of Am. v. Thompson, 251 F.3d 219, 224 (D.C.Cir.2001) (explaining that under the first step of Chevron, the Court must exhaust the “traditional tools of statutory construction,” such as analyses of the “text, structure, purpose, and legislative history” of the statute“). ”Chevron deference is frequently given to the FDA‘s interpretation of the FDCA, as well as its own regulations.” Teva Pharms., Indus., 355 F.Supp.2d at 116 (internal quotation marks omitted).
A. The QI Program Supplemental Funding Act
The plaintiff contends that the FDA should not have granted three-year exclusivity to Astagraf XL because the Astagraf XL NDA was submitted and pending before October 2008, and the QI Act conferred three-year exclusivity on an old antibiotic only if the NDA was submitted after October 2008. See Pl.‘s Summ. J. Mem. at 40-43. Although the FDA concedes that the Astagraf XL NDA was submitted and pending before October 2008, it nevertheless maintains that Astagraf XL was properly awarded three-year exclusivity because the Astagraf XL NDA was withdrawn in 2009, and then a new Astagraf XL NDA was submitted in 2012. See Defs.’ Summ. J. Mem. at 22-23; see also A.R. at FDA 00031-33.
Under the FDCA, as amended by the QI Act, the Court agrees with the
To the extent that Congress did not address the precise conflict presented here, i.e., the FDCA is silent as to the withdrawal and “resubmission” of an old antibiotic NDA that was pending on or before October 2008,7 the FDA‘s interpretation of the statute to allow three-year exclusivity for an old antibiotic that is the subject of a withdrawn and resubmitted NDA is reasonable. The FDA granted three-year exclusivity for Astagraf XL because its NDA demonstrated “a significant new use for an [o]ld antibiotic....” A.R. at FDA 00033; see also Pl.‘s Reply at 14 (the plaintiff concedes that Astagraf XL is a new antibiotic drug in that it is a once daily, extended release capsule—as opposed to a twice-daily, immediate release capsule like Prograf—for use in ”de novo kidney transplant patients treated without induction“). The FDA‘s decision to afford the benefit of three-year marketing exclusivity to Astagraf XL is consistent with congressional intent in passing the QI Act—to “balance the need to encourage development of new antibiotic drugs to combat the growing number of disease-resistant bacterial infections and the desire to ensure access to previously approved antibiotics through approval of generic versions of such antibiotics.” ViroPharma, 898 F.Supp.2d at 20 (internal quotation marks omitted); see also id. (QI Act was “an important step forward to help spur research on new antibiotics” (internal quotation marks omitted)). “While [the plaintiff] may argue with that interpretation on policy grounds and present alternative readings of the provision‘s purpose and legislative history, such [arguments] fail in the face of the agency‘s carefully considered decision.” Id. (internal quotation marks omitted). This is especially so where the limitation advanced by the plaintiff would discourage, rather than “encourage[,] [the] development of new antibiotic drugs,” id. as a sponsor of a 505(b) NDA would abandon and forever lose the costs associated with its research and development efforts where its drug products were the subjects of a previously-submitted and withdrawn NDA.8 In short, the
B. 21 U.S.C. § 355(c)(3)(E)(iii)
Once an old antibiotic, such as tacrolimus, is eligible for marketing exclusivities, the FDCA entitles those antibiotics to limited marketing exclusivities. In pertinent part, the FDCA states:
If an application submitted under subsection (b) of this section for a drug, which includes an active ingredient (including any ester or salt of the active ingredient) that has been approved in another application approved under subsection (b) of this section, is approved after September 24, 1984, and if such application contains reports of new clinical investigations (other than bioavailability studies) essential to the approval of the application and conducted or sponsored by the applicant, the Secretary may not make the approval of an application submitted under subsection (b) of this section for the conditions of approval of such drug in the approved subsection (b) application effective before the expiration of three years from the date of the approval of the application under subsection (b) of this section if the investigations described in clause (A) of subsection (b)(1) of this section and relied upon by the applicant for approval of the application were not conducted by or for the applicant and if the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted.
1. “Relied Upon”
The parties’ conflicting interpretations of the term “relied upon” in
The term “relied upon” is not defined in the FDCA. Nevertheless, the statutory provision is clear as to how three-year exclusivity operates and can be unambiguously parsed into essentially two components: entitlement to exclusivity and scope of that exclusivity. See, e.g., Goldstein v. SEC, 451 F.3d 873, 878 (D.C.Cir.2006) (“The lack of a statutory definition of a word does not necessarily render the meaning of a word ambiguous....“). Under the plain language of this provision, entitlement to three-year exclusivity requires: (1) submission of a 505(b) NDA10; (2) a drug that contains an active ingredient approved after September 1984; and (3) at least one new clinical investigation, excluding bioavailability studies, that is essential to the conditions of approval for the 505(b) drug. See
may not make the approval of an application submitted under subsection (b) of this section for the conditions of approval of such drug in the approved subsection (b) application effective before the expiration of three years from the date of the approval of the application under subsection (b) of this section if the investigations described in clause (A) of subsection (b)(1) of this section and relied upon by the applicant for approval of the application were not conducted by or for the applicant and if the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted.
The plaintiff goes to great lengths to avoid the plain meaning of
Second, the plaintiff insists that the “importance of reliance” is confirmed by the “FDA‘s implementing regulation, which provides that a [second-in-time] 505(b)(2) [NDA] will be blocked by three-year exclusivity [only] to the extent that it ‘relies on the information supporting the conditions of approval of an original new drug application.‘” Pl.‘s Summ. J. Mem. at 18-19 (quoting
(4) If an application:
(i) Was submitted under section 505(b) of the act;
(ii) Was approved after September 24, 1984;
(iii) Was for a drug product that contains an active moiety that has been previously approved in another application under section 505(b) of the act; and
(iv) Contained reports of new clinical investigations (other than bioavailability studies) conducted or sponsored by the applicant that were essential to approval of the application, the agency will not make effective for a period of [three] years after the date of approval of the application the approval of [1] a 505(b)(2) application or [2] an abbreviated new drug application for the conditions of approval of the original application, or [3] an abbreviated new drug application submitted pursuant to an approved petition under section 505(j)(2)(C) of the act that relies on the information supporting the conditions of approval of an original new drug application.
Third, the plaintiff implores the Court to examine other provisions of the FDCA because “[h]ad Congress simply intended to describe a 505(b)(2) application [in
Fourth, the plaintiff asserts that the FDA‘s decision to delay complete and final approval of Envarsus XR for the prophylaxis of organ rejection in de novo kidney transplant patients “upends the balance sought to be achieved by Congress” under the Hatch-Waxman Amendments. Pl.‘s Summ. J. Mem. at 22. Specifically, the Hatch-Waxman Amendments were enacted to, among other objectives, incentivize pharmaceutical companies and reward them for researching and developing innovative drugs. See id. at 20-23. But here, according to the plaintiff, it is “reap[ing] no reward for its own innovation and investment, while Astagraf XL is inappropriately shielded from competition against an innovative product....” Id. at 23. The Court is not persuaded.13 As the Court will explain below, Envarsus XR is not innovative to the extent that it is a once-daily, extended release tacrolimus formulation for the prophylaxis of organ rejection in de novo kidney transplant patients, as these were conditions of approval for Astagraf XL. And to the extent that Envarsus XR‘s innovation is its once-daily, extended release formulation for use in conversion kidney transplant patients, the plaintiff has voluntarily declined to market Envarsus XR for only this use, see A.R. at FDA 01751-52 (the plaintiff refusing to accept the FDA‘s proposal for final approval of Envarsus XR in use in conversion kidney transplant patients), and is not in a position to complain that the FDA‘s interpretation of
2. “Conditions of Approval”
The parties agree that the scope of Astagraf XL‘s marketing exclusivity is limited to the “conditions of approval” based upon the “new clinical investigations” that were conducted in support of the Astagraf XL NDA. Pl.‘s Summ. J. Mem. at 29, 35; Def.‘s Summ. J. Mem. at 24-25. They also agree that Envarsus XR should be excluded from the marketplace only to the extent that Astagraf XL and Envarsus XR “share ‘conditions of approval.‘” Pl.‘s Summ. J. Mem. at 35 (citing
Because the parties agree that the term “conditions of approval” is undefined in the FDCA and that no FDA implementing regulation clarifies the meaning of that term, Pl.‘s Summ. J. Mem. at 35; Defs.’ Reply at 18, the parties essentially concede that the term is ambiguous, and the Court thus proceeds to step two of the Chevron test to assess whether the FDA‘s interpretation of the FDCA is reasonable and entitled to deference, which the Court concludes it is. The FDCA sets up a “logical
There is no dispute that the new clinical investigations that were essential to the FDA‘s approval of Astagraf XL and that led to three-year exclusivity for Astagraf XL were Study 158 and Study 12-03. E.g., Pl.‘s Summ. J. Mem. at 30; Defs.’ Summ. J. Mem. at 30. There is also no dispute that Study 158 examined “Astagraf XL in de novo kidney transplant patients with induction” and Study 12-03 investigated “Astagraf XL in de novo kidney transplant patients without induction.” Pl.‘s Summ. J. Mem. at 30 (citing A.R. at FDA 00035); see also A.R. at FDA 00034-35 (FDA finding that both studies demonstrated the safety and efficacy of Astagraf XL for the prophylaxis of organ rejection in de novo kidney transplant patients). In light of the results adduced from these new clinical investigations, the FDA concluded that Astagraf XL was entitled to three-year exclusivity for those innovations that distinguished it from Prograf—a once-daily, extended release tacrolimus formulation for prophylaxis of organ rejection in de novo kidney transplant patients. See AstraZeneca Pharms., 872 F.Supp.2d at 80, 83, 85. It follows that because Astagraf XL and Envarsus XR share these conditions of approval, complete and final approval of the Envarsus XR NDA must be delayed until the expiry of Astagraf XL‘s three-year exclusivity.16
3. “New Clinical Investigations”
The plaintiff has devoted substantial effort to explain why the FDA erroneously identified Study 158 as a “new clinical investigation” pursuant to
“Simple fairness to those who are engaged in the tasks of administration, and to litigants, requires as a general rule that courts should not topple over administrative decisions unless the administrative body not only has erred but has erred against objection made at the time appropriate under its practice.” United States v. L.A. Tucker Truck Lines, Inc., 344 U.S. 33, 37 (1952). The District of Columbia Circuit has consistently held that courts “are bound to adhere to the ‘hard and fast rule of administrative law, rooted in simple fairness, that issues not raised before an agency are waived and will not be considered by a court on review.‘” Coburn v. McHugh, 679 F.3d 924, 929 (D.C.Cir.2012) (quoting Nuclear Energy Inst. v. EPA, 373 F.3d 1251, 1297 (D.C.Cir.2004) (per curiam)); see also CSX Transp., Inc. v. Surface Transp. Bd., 584 F.3d 1076, 1079 (D.C.Cir.2009) (acknowledging the “well-established doctrine of issue waiver, which permits courts to decline to hear arguments not raised before the agency where the party had notice of the issue“). This principle applies to legal, as well as factual, arguments. See Nuclear Energy Inst., 373 F.3d at 1290 (“To preserve a legal or factual argument, ... [a] proponent [must] have given the agency a ‘fair opportunity’ to entertain it in the administrative forum before raising it in the judicial one.” (quoting Wash. Ass‘n for Television & Children v. FCC, 712 F.2d 677, 681 (D.C.Cir.1983))). And the Circuit has clarified that the standard for waiver in administrative law cases focuses on whether the “specific argument” put forth by the plaintiff was raised before the agency. See Koretoff v. Vilsack, 707 F.3d 394, 398 (D.C.Cir.2013). Under this standard, the Circuit “require[s] ‘the argument [the plaintiff] advances here’ to be raised before the agency, not merely the same general legal issue.” Id. (quoting Nuclear Energy Inst., 373 F.3d at 1291).
On November 17, 2014, the FDA sent the plaintiff the “FDA Exclusivity Summary for Astagraf XL.” Plaintiff‘s Motion for Preliminary Injunction (“Prelim.Inj.Mot.“), Exhibit (“Ex.“) 4 (Declaration of Jennifer L. Bragg (“Bragg.Decl“)) ¶ 6; see also A.R. at FDA 0108289. The FDA Exclusivity Summary for Astagraf XL (“Astagraf XL Summary“) identified Study 158 as a “new clinical investigation” that was essential to the approval of Astagraf XL and that supported the three-year exclusivity for the drug.19 A.R. at FDA 01086-87. After receiving the Astagraf XL Summary and having notice that the FDA relied on Study 158 for granting Astagraf XL‘s three-year exclusivity, the
C. The Plaintiff‘s Motion to Supplement the Administrative Record
The plaintiff seeks to supplement the administrative record with “the FDA‘s own Statistical Review and Evaluation from the [Prograf] supplemental New Drug Application” (“Prograf Review and Evaluation“) and the “FDA‘s minutes of a June 17, 1997 meeting between FDA and the sponsor of Duoneb” (“Douneb Meeting Minutes“).21 Pl.‘s Supplement Mot. at 1. The plaintiff
Supplementation of the administrative record is only appropriate in exceptional or “unusual” circumstances. City of Dania Beach v. FAA, 628 F.3d 581, 590 (D.C.Cir.2010) (“[W]e do not allow parties to supplement the record ‘unless they can demonstrate unusual circumstances justifying a departure from this general rule.‘” (quoting Tex. Rural Legal Aid v. Legal Servs. Corp., 940 F.2d 685, 698 (D.C.Cir.1991))); see also Cape Hatteras Access Pres. Alliance v. U.S. Dep‘t of Interior, 667 F.Supp.2d 111, 112 (D.D.C.2009) (“A court that orders an administrative agency to supplement the record of its decision is a rare bird.“). This is because “[t]here is a strong presumption that the agency properly compiled the administrative record.” Ivy Sports Med., LLC v. Sebelius, No. 11-cv-1006(RLW), 2012 WL 5248176, at *1 (D.D.C. Oct. 24, 2012). Thus, “[s]upplementation of the administrative record is the exception, not the rule.” Id. (internal quotation marks omitted).
To rebut the strong presumption of regularity afforded to the administrative record compiled by the agency, the party seeking supplementation must “put forth concrete evidence that the documents it seeks to ‘add’ to the record were actually before the decisionmakers.” Marcum v. Salazar, 751 F.Supp.2d 74, 78 (D.D.C.2010). Conclusory statements will not suffice; rather, the plaintiff “must identify reasonable, non-speculative grounds for its belief that the documents were considered by the agency and not included in the record.” Id. at 78 (quoting Pac. Shores Subdivision Cal. Water Dist. v. U.S. Army Corps of Eng‘rs, 448 F.Supp.2d 1, 6 (D.D.C.2006)) (internal quotation marks omitted). “Therefore, absent clear evidence to the contrary, an agency is entitled to a strong presumption of regularity, that it properly designated the administrative record.” Ivy Sports Med., 2012 WL 5248176, at *1 (internal quotation marks omitted).
The District of Columbia Circuit has recognized three narrow instances where supplementation of an administrative record may be appropriate: “(1) if the agency ‘deliberately or negligently excluded documents that may have been adverse to its decision,’ (2) if background information was needed ‘to determine whether the agency considered all the relevant factors,’ or (3) if the ‘agency failed to explain administrative action so as to frustrate judicial review.‘”22 City of Dania Beach, 628 F.3d at 590 (quoting Am. Wildlands v. Kempthorne, 530 F.3d 991, 1002 (D.C.Cir.2008)).
Here, the strong presumption of regularity has not been rebutted by the plaintiff for several reasons. First, the plaintiff relies on conclusory allegations that the FDA negligently or deliberately omitted these documents, as opposed to concrete evidence. See Pl.‘s Supplemental Mot. at 5, 7. Second, the documents are not adverse to the FDA‘s decision to delay final approval of Envarsus XR until the expiry of Astagraf XL‘s three-year exclusivity. The argument that Study 158 was not a “new clinical evaluation” has been waived by the plaintiff, and thus the Prograf Review and Evaluation is irrelevant. And the Douneb Meeting Minutes are cumulative, as the FDA has already included its substance in the administrative record. Compare Pl.‘s Supplemental Mot., Ex. B (June 17, 1997 Meeting Minutes (“Duoneb Meeting Minutes“)) at 6 (FDA “expressed opinion that ... [the Duoneb NDA] could not be approved pending expiration of ... exclusivity for Combivent NDA even if ... [the Duoneb NDA] does not reference the Combivent NDA and even if [the Duoneb NDA] provides data in support of the combination product from the literature ....“); with A.R. at FDA 00047-48 (explaining how FDA “concluded that it likely would not be able to fully approve Duoneb‘s 505(b)(2) NDA ... due to Combivent‘s existing exclusivity,” not-
IV. CONCLUSION
For the foregoing reasons, the Court concludes that the FDA‘s decision to delay final approval of Envarsus XR for the prophylaxis of organ rejection in de novo kidney transplant patients was neither arbitrary and capricious nor in excess of the FDA‘s statutory authority.23
SO ORDERED
REGGIE B. WALTON
United States District Judge