Full opinion text
MEMORANDUM OPINION BERYL A. HOWELL, United States District Judge A subsidiary of the plaintiffs, Ranbaxy Laboratories, Ltd. and Ranbaxy, Inc. (collectively, “Ranbaxy” or the “plaintiffs”), paid, in 2013, what was then the “largest drug safety settlement” in history, amounting to $500 million, in connection with criminal charges for falsifying data and manufacturing adulterated drugs at two of its facilities in India. U.S. Dep’t of Justice, “Generic Drug Manufacturer Ran-baxy Pleads Guilty and Agrees to Pay $500 Million to Resolve False Claims Allegations, cGMP Violations and False Statements to the FDA,” May 13, 2013, available at http://www.justice.gov/opa/pr/ generic-drug-manufacturer-ranbaxy-pleads-guilty-and-agrees-pay-500-million-resolve-false. During the course of the investigation into the plaintiffs’ (now) admitted wrongdoing, the Federal defendants in this case — the Secretary of Health and Human Services, the Commissioner of the U.S. Food and Drug Administration (“FDA”), and the FDA — granted “tentative approval” to five Abbreviated New Drug Applications (“ANDAs”) submitted by -the plaintiffs for the manufacture of certain generic drugs at the same facilities involved in the plaintiffs’ subsidiary’s criminal case. See Defs.’ Mem. Opp’n Pis.’ Mot. Prelim. Inj. and Supp. Defs.’ Mot. Summ. J. (“Defs.’ Mem.”) at 10-17, ECF No. 52. Years after the grant of those ANDAs, when two of these tentative approvals were preventing other drug manufacturers from coming to market with generic versions of costly medications, the FDA reexamined and revoked two of those five tentative approvals, for esomeprazole and valganciclovir, stating the approvals had been granted “erroneously.” Defs.’ Mem. at 3; Compl. ¶ 38, ECF No. 1; Administrative Record (“AR”) at 1 (Letter from FDA to plaintiffs regarding esomeprazole and valganciclovir ANDAs, Nov. 4, 2014 (the “Rescission Letter”)). This agency action prompted the plaintiffs to file the instant suit, contending that the Federal defendants had no authority, statutory or otherwise, to correct their egregious error and rescind the tentative approvals. See generally Compl. Now pending before the Court is the plaintiffs’ Motion for Preliminary Injunction (the “Pis.’ Mot.”), ECF No. 41; the Federal defendants’ Motion for Summary Judgment (the “Defs.’ Mot.”), ECF No. 51; and the Motions for Summary Judgment from four other generic drug manufacturers, Dr. Reddy’s Laboratories (“Dr.Reddy’s”), Endo Pharmaceuticals, Inc. (“Endo”), Ivax Pharmaceuticals, Inc. (“Ivax”), and Teva Pharmaceuticals USA, Inc. (“Teva”), which have each been granted leave to intervene in this matter as defendants, ECF Nos. 53 and 73. Although the FDA’s practices, which apparently led to these errors, raise grave concerns, the Federal defendants’ interpretation of the relevant portions of the Food, Drug, and Cosmetics Act (the “FDCA”) as permitting the rescission of the erroneously issued tentative approvals is reasonable. Consequently, the Federal defendants’ and defendant-intervenors’ motions are granted and the plaintiffs’ motion is denied. I. BACKGROUND The statutory regime under which generic drug applications, such as those at issue here, are approved, is complex. Thus, a brief summary of the regulations governing ANDAs and their approval is provided before turning to the history of the plaintiffs’ applications, the concurrent investigations into the plaintiffs’ manufacturing processes by the FDA, and the procedural background of the instant matter. A. The Statutory Regime All pharmaceutical manufacturers wishing to sell their products in interstate commerce must first seek approval from the FDA in compliance with 21 U.S.C. § 355. New drug applications (“NDAs”) are subject to rigorous application protocols under which the applicant must prove the drug is safe and effective. See 21 U.S.C. § 355(b); Defs.’ Opp’n Pis.’ Mot.. Temp. Restraining Order (“Defs.’ TRO Opp’n”) at 5, ECF No. 22-1. The applicant must also provide information about patents used in the drug, or for using the drug, “to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug.” 21 U.S.C. § 355(c)(2). 1. The Hatch-Waxman Amendments Between 1962 and 1984, companies wishing to manufacture generic versions of drugs already approved for use had to follow the same rigorous steps as in a new drug application before the drug could be approved and sold, even though the generic equivalent was effectively identical to a brand name drug. H.R Rep. No. 98-857, pt. 1, (Report of the House Committee on Energy and Commerce on Drug Price Competition and Patent Term Restoration Act) at 14-15 (1984). In 1984, Congress passed the Drug Price Competition and Patent Term Restoration Act, codified in 21 U.S.C. § 355. Colloquially known as the “Hatch-Waxman Amendments,” the amendments created a process by which generic drugs could be approved on the basis of an “abbreviated” new drug application, an ANDA, by “piggy-back[ing]” on the studies already completed by the pioneer drug manufacturer. FTC v. Actavis, Inc. (Actavis), — U.S. —, 133 S.Ct. 2223, 2228, 186 L.Ed.2d 343 (2013); see Mylan Labs, Inc. v. Thompson, 389 F.3d 1272, 1274-75 (D.C.Cir.2004). This statutory change removed a major expense for generic drug manufacturers, since “[ujnlike an NDA, an ANDA need not contain clinical evidence of the safety or efficacy of the drug.” See Teva Pharm. Indus. Ltd. v. Crawford, 410 F.3d 51, 52 (D.C.Cir.2005). Its purpose is “to speed the introduction of low-cost generic drugs to market,” Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S (Caraco), — U.S. —, 132 S.Ct. 1670, 1676, 182 L.Ed.2d 678 (2012), thus increasing competition and, theoretically, lowering prices, Teva Pharms. USA Inc. v. Sebelius, 595 F.3d 1303, 1305 (D.C.Cir.2010). To further this goal, the Hatch-Waxman Amendments included the “so-called paragraph IV certification.” Carneo, 132 S.Ct. at 1677. Since “the FDA cannot authorize a generic drug that would infringe a patent,” id. at 1676, Congress required ANDA applicants, in 21 U.S.C. § 355(j)(2)(A)(vii), to certify that the generic drug would not infringe upon any valid patents. 2. Paragraph IV Certification Relevant to the instant matter, one of the bases on which an ANDA applicant may certify that its product will not infringe any valid patents is by certifying that some or all of the patents used in the making of the pioneer drug are invalid. 21 U.S.C. § 355(j)(2)(A)(vii)(IV). Known as a paragraph IV certification, this course of action entails significant risk since it will almost inevitably “provok[e] litigation” and, indeed, the mere filing of a paragraph IV certification is deemed to be “an act of infringement, which gives the [pioneer drug manufacturer] an immediate right to sue.” Carneo, 132 S.Ct. at 1677; see 35 U.S.C. § 271(e)(2)(A). Assuming the pioneer drug manufacturer timely files suit, the FDA may not approve the ANDA, “usually for a 30-month period,” while the patent dispute is litigated. Actavis, 133 S.Ct. at 2228. To incentivize manufacturers to take advantage of paragraph IV certifications, despite the considerable expense and difficulties, the Hatch-Waxman Amendments included a provision allowing the first generic manufacturer to file an ANDA predicated on this certification to “enjoy a period of 180 days exclusivity (from the first commercial marketing of its drug).” Id. at 2228- 29 (citing 21 U.S.C. § 355(j)(5)(B)(iv)); Teva Pharms. USA Inc., 595 F.3d at 1305 (noting exclusivity provision designed to “compensate [generic] manufacturers for research and development costs as well as the risk of litigation from patent holders” (internal quotation marks and citation omitted; alteration in original)). This exclusivity functions as a mini-generic monopoly for the generic drug manufacturer, providing a 180-day period in which only the first generic manufacturer may compete with the pioneer drug. Actavis, 133 S.Ct. at 2229. This incentive can be worth “several hundred million dollars,” but it can “belong only to the first generic to file.” Id. (citations omitted). 3. Forfeiture Triggers While the 180-day exclusivity period holds out the promise of substantial monetary compensation for first-to-file generic manufacturers, it is not guaranteed. The exclusivity is forfeited if any statutorily defined “forfeiture event” occurs. 21 U.S.C. § 355(j)(5)(D)(i). . An applicant forfeits any 180-day exclusivity by (1) failing timely to market the drug after certain specified events have occurred, id. § 355(j)(5)(D)(i)(I); (2) withdrawing the ANDA, either itself or constructively by the agency, “as a result of a determination by the Secretary that the application does not meet the requirements, for approval under [21 U.S.C. § 355®(4) ],” id. § 355(j)(5)(D)(i)(II); (3) amending or withdrawing the applicant’s paragraph IV certifications, id. § 355(j)(5)(D)(i)(III); (4) failing to obtain tentative approval “within 30 months after the date on which the application is filed, unless the failure is caused by a change in or a review of the requirements for approval of the application imposed after the date on which the application is filed,” id. § 355(j)(5)(D)(i)(IV); (5) entering into an agreement “with another applicant, the listed drug application holder, or a patent owner” found to be in violation of antitrust laws, id. § 355(j)(5)(D)(i)(V); or (6) expiration of the valid patents that would otherwise be infringed if the ANDA applicant marketed its drug, id. § 355(j)(5)(D)(i)(VI). The forfeiture triggers were added to § 355(j) as an amendment to the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (the “MMA”). 108 Pub.L. 173, 117 Stat.2066, 2448-64. One of the amendment’s primary sponsors noted during the final floor debate that the forfeiture triggers’ purpose was to “ensure that the 180-day exclusivity period enjoyed by the first generic to challenge a patent cannot be used as a bottleneck to prevent additional generic competition.” 149 Cong. Rec. S15746 (daily ed. Nov. 24, 2003) (statement of Sen. Schumer). The amendment was prompted by some “brand and generic companies ... abusing this [180-day] exclusivity period-both through collusive agreements and use of other tactics” that prevented the timely appearance of generic drugs in the marketplace. Id The amendments were intended to “end this abuse because the generic company forfeits its exclusivity if it doesn’t go to market in a timely manner.” Id In short, the amendments were viewed as “important, pro-consumer cost containment provisions.” Id; see also id at 15761 (statement of Sen. Frist) (“The [amendments] also take[ ] additional steps to reduce or eliminate the delays in the movement of generic drugs to the marketplace.”). Although Congress’ stated goal with the 1984 and 2003 amendments to the FDCA was to bring generic drug products to market faster, the Act still requires ANDA applicants to fulfill myriad statutory requirements before receiving approval to market a generic version of a pioneer drug. This approval process is discussed below, since the transition from one stage to the next, and whether those transitions are irrevocable, are the key questions at issue in the instant matter. B. The ANDA Approval Process The Federal defendants describe three significant “milestones” in the ANDA process: (1) when the ANDA may be “received” by the FDA because it is “substantially complete” such that the agency may conduct a “substantive review,” Defs.’ Mem. at 5; (2) when an ANDA receives “tentative approval,” id at 6; and (3) when an ANDA receives final, or “effective,” approval, id Each milestone is described in further detail below. 1. Substantially Complete An ANDA does not require the submission of the results of human clinical trials, as is required for NDAs, but the application materials are substantial and governed by statute. See 21 U.S.C. § 355(j)(2)(A). An ANDA must contain, inter alia, “information to show” the bioe-quivalence of the proposed generic drug to the pioneer drug, id § 355(j)(2)(A)(ii), id § 355(j)(2)(A)(iv); a certification regarding any potential patent infringement, including, if applicable, the aforementioned paragraph IV certification, id § 355(j)(2)(A)(vii); and “the items specified in clauses (B) through (F) of’ 21 U.S.C. § 355(b)(1), which is the section of the FDCA governing the contents of NDAs, 21 U.S.C. § 355©(2)(A)(vi). By cross-referencing and incorporating certain clauses of § 355(b)(1), Congress required AND As to contain (B) a full list of the articles used as components of such drug; (C) a full statement of the composition of such drug; (D) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (E) such samples of such drug and of the articles used as components thereof as the Secretary may require; (F) specimens of the labeling proposed to be used for such drug. 21 U.S.C. § 355(b)(1). Thus, ANDAs must contain all the elements required for NDAs under § 355(b)(1) except for “full reports and investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective for use” and “assessments required under [21 U.S.C. § 355c].” Id. The agency “may not require that an abbreviated application contain information in addition to that required by” the statute. Id. § 355(j)(2)(A). The Federal defendants summarize that § 355(j)(2)(A) requires, in essence, that the ANDA applicant “demonstrate that its proposed generic drug product is the same as the previously approved-innovator drug in several respects and that the ANDA sponsor can reliably manufacture the drug product.” Defs.’ Mem. at 4. FDA regulations mandate that “within 60 days after FDA receives an application, the agency will determine whether the application may be filed.” 21 C.F.R. § 314.101(a)(1). In reviewing the application, the FDA determines if the ANDA complies with the terms of § 355(j)(2)(A) and any applicable agency regulations so that the “application is sufficiently complete to permit a substantive review.” Id. § 314.101(b)(1). The same regulation lists the acceptable reasons for the agency to refuse to “receive! ]” an ANDA and the procedure to perfect the application. Id. § 314.101(d), (e). Once this “threshold determination” has been made, the ANDA proceeds to the next phase of its review. 2. Tentative Approval The substantive review of an ANDA “involves reviews by many disciplines of various aspects of an application, including bioequivalence, chemistry, labeling, and manufacturing,” and, according to the Federal defendants, “often requires multiple ‘review cycles’ before an application is ready for approval.” Defs.’ Mem. at 5; see Admin. Rec. (“AR”) at 312-14 (routing slip for tentative approval of generic ANDA, showing review by at least twelve FDA employees). The purpose of this review is to determine whether an ANDA meets the statutory requirements for approval such that the drug can be sold in interstate commerce. See 21 U.S.C. § 355(j). Since an ANDA is, by definition, based on a drug that has already been approved for marketing and, consequently, has been found to be safe and effective, an ANDA “shall” be approved by the FDA unless the ANDA fails to meet certain conditions, including if “the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of the drug are inadequate to assure and preserve its identity, strength, quality, and purity.” Id. § 355(j)(4)(A). As the Federal defendants point out, however, “[t]he timing for ANDA approval depends, in part, on statutory patent protections afforded to the innovator drug.” Defs.’ Mem. at 6. In other words, an ANDA may meet all the requirements for approval, but the FDA may be barred by statute from approving the application until such time as certain patents for elements of the pioneer drug expire; in such cases, the agency may grant the ANDA “tentative approval.” 21 U.S.C. § 355Cj)(5)(B)(iv)(II)(dd)(AA). “Tentative approval,” according to the statute, “means notification to an applicant by the Secretary that an application under this subsection meets the requirements of paragraph (2)(A), but cannot receive effective approval because the application does not meet the requirements of this subpara-graph . Id. Tentative approval is often an intermediate step between the submission of a substantially complete application and “effective approval” allowing the marketing of a generic drug, but the practical importance of tentative approval is limited. “A drug that is granted tentative approval ... is not an approved drug and shall not have an effective approval until the Secretary issues an approval after any necessary additional review of the application.” 21 U.S.C. § 355(j)(5)(B)(iv)(II)(dd)(BB); 21 C.F.R. § 314.1 OT(b)(3)(v) (“Tentative approval of an application does not constitute ‘approval’ of an application and cannot, absent a final approval letter from the agency, result in an effective approval... .”). Nevertheless, tentative approval does affect the eligibility of an ANDA applicant for the 180-day exclusivity period provided in 21 U.S.C. § 355(j)(5)(B)(iv). As previously noted, the first ANDA applicant to file an ANDA with a paragraph TV certification is eligible for the 180-day exclusivity period, so long as none of the forfeiture triggers added to the law in 2003 apply. Supra Part I.A.3. One of those six forfeiture triggers,, described as “forfeiture events” in the statute, is the failure of the ANDA applicant “to obtain tentative approval of the application within 30 months after the date on which the application is filed.... ” 21 U.S.C. § 355(j)(5)(D)(i)(rV). Thus, while tentative approval, standing alone, does not provide any tangible benefit to the ANDA applicant, if an ANDA applicant becomes eligible for the 180-day generic marketing exclusivity, the securing of tentative approval is necessary within a set time period in order to avoid forfeiting that exclusivity. Id. Importantly for the present dispute, the FDA maintains that its “policy ... has always been, and remains, that an ANDA is not eligible for tentative approval absent a satisfactory showing of CGMP compliance.” Defs.’ Mem. at 29. 3. Final Approval The eleven reasons allowed by statute for declining to provide final approval to an ANDA are set forth in 21 U.S.C. § 355(j)(4). Among these multiple reasons for the FDA to deny approval of an ANDA are that (1) the agency finds a drug’s manufacturing process to be “inadequate to assure and preserve [a drug’s] identity, strength, quality, and purity,” id. § 355(j)(4)(A); (2) the generic drug is not shown to be sufficiently similar to the pioneer drug, id. § 355(j)(4)(C); id. § 355(j)(4)(F); (3) the drug’s inactive ingredients “are unsafe for use under the conditions prescribed,” id. § 355(j)(4)(H); (4) the approval of the pioneer drug has been revoked, id. § 355(j')(4)(I); (5) “the application does not meet any other requirement of paragraph (2)(A),” id. § 355(j)(4)(J); and (6) “the application contains an untrue statement of material fact,” id. § 355(j')(4)(K). Final approval does not follow by operation of law from a tentative approval letter. See Ranbaxy Labs Ltd. v. FDA, 307 F.Supp.2d 15, 21 (D.D.C.2004) (noting tentative approval does not convert to final approval “automatically” upon the cessation of patent litigation and expiration of a patent that previously prevented final approval). Rather, as expressly contemplated in § 355Cj)(5)(B)(iv)(II)(dd)(BB), final approval accrues only after “any necessary additional review of the application” by the FDA after the impediments to final approval that necessitated a grant of tentative approval have been removed. Once final approval is requested, the agency once again reviews the ANDA and determines whether final approval should issue. See Abbreviated New Drug Application Regulations; Patent and Exclusivity Provisions, 59 Fed.Reg. 50,338, 50,352 (Oct. 3, 1994) (stating the “agency will examine the application to determine whether there have been any changes in the conditions under which the application was tentatively approved” before sending notice of final approval). Once an ANDA has been granted final approval, the manufacturer may begin selling the drug in interstate commerce. See 21 U.S.C. § 355(a). Even after a drug has been marketed, however, the agency retains the ability to revoke that final approval. Id. § 355(e). The agency “shall, after due notice and opportunity for hearing to the applicant, withdraw approval of an application with respect to any drug under this section,” when it makes one or more of five findings: (1) that “such drug is unsafe for use under the conditions of use upon the basis of which the application was approved;” (2) that “new evidence of clinical experience,” indicates the drug is no longer safe for use; (3) that new evidence indicates the drug is not effective; (4) that appropriate patent information was not filed in a timely manner; or (5) “that the application contains any untrue statement of a material fact.” Id. If the Secretary determines that “there is an imminent hazard to the public health,” the application may be suspended “immediately,” with an expedited hearing to be held after such suspension. Id. The agency “may also, after due notice and opportunity for hearing to the applicant, withdraw the approval of an application” if the Secretary finds that (1) “the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain such records ...;” (2) that new information “evaluated together with the evidence before him when the application was approved, [shows that] the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to assure and preserve its identity, strength, quality, and purity;” or (3) that new information combined with knowledge previously available to the Secretary shows that “the labeling of such a drug ... is false or misleading.” Id. To sum up, an ANDA typically passes through three distinct phases of FDA review on the generic drug’s way to the marketplace. A generic drug manufacturer must first perfect an application before that application is reviewed on the merits. If the ANDA could be approved, except for the presence of blocking patents or other periods of exclusivity, the ANDA may be tentatively approved, which approval does not allow the marketing of the drug but may serve to preserve eligibility for a 180-day generic marketing exclusivity period by eliminating a potential forfeiture event. After any patent impediments are removed, the ANDA may be granted final approval, at which point the drug may be marketed in interstate commerce. Post-final approval, an ANDA’s approval must be revoked, after due notice and hearing, pursuant to certain statutory requirements, and may be revoked in certain other circumstances. As context for the treatment of the ANDAs at issue in this litigation, the Court turns next to a review of the recent history of enforcement actions against the plaintiffs as a result of rampant compliance problems at the plaintiffs’ production facilities in India where the generic drugs at issue were to be manufactured. C. The Plaintiffs’ Repeated Compliance Failures The history of the plaintiffs’ compliance — or lack thereof — with Current Good Manufacturing Practice (CGMP) at their' facilities in India, where the plaintiffs planned to manufacture the generic drugs at issue in this litigation, is extensive. These compliance problems were apparently ongoing before, during, and even after the Federal defendants gave tentative approval to the ANDAs at issue. The Federal defendants now admit that granting tentative approval to these ANDAs was egregious error, which the FDA rectified, in November 2014, by rescinding the tentative approvals. These are the agency actions challenged by the plaintiffs in this lawsuit. 1. The 2006 Inspection The plaintiffs’ manufacturing facility in Simour District, Himanchal Pradesh, India (“Paonta Sahib”), was inspected by the FDA between February 20 and 25, 2006 in connection with certain of the plaintiffs’ pending NDAs and ANDAs, including for antiretroviral drugs on the list of PEP-FAR approved medications that were manufactured at the facility. AR at 1488 (Establishment Inspection Report, Ranbaxy Laboratories, Ltd. Simour District, India facility for inspection beginning Feb. 20, 2006 and ending Feb. 25, 2006 (the “2006 Inspection Report”)). At the time of the 2006 Inspection Report; the plaintiffs [redacted] Id. at 1491. As reported in the 2006 Inspection Report, [radaeted], id. at 1498-1506; [redacted] id. at 1507; [redacted] id.; [redacted] id.; [redacted], id. at 1507-08; id. at 1508-09; [redacted] id. at 1509; and [redacted], id. The plaintiffs discounted these observations in three letters filed with theFDA. AR at 1478-83 (Letter from plaintiffs to FDA, Mar. 20, 2006); id. at 1475-77 (Letter from plaintiffs to FDA, Apr. 20, 2006); id. at 1469-74 (Letter from plaintiffs to FDA, May 25, 2006). In each letter, the plaintiffs addressed one or more of the FDA’s observations, either offering an explanation for the observation, see, e.g., id. at 1481 (noting [radacted]), or noting that the plaintiffs had adopted new practices in response to the observations, see, e.g., id. at 1477 (noting new [radacted]). 2. The 2006 Warning Letter Despite these explanations and implemented changes, the FDA issued a “Warning Letter” to the plaintiff on June 15, 2006, noting that the inspection of the Paonta Sahib facility “revealed significant deviations from U.S. Current Good Manufacturing Practice (CGMP) Regulations ... in the manufacture of drug products.” Id. at 1462 (Letter from FDA to plaintiff, June 15, 2006 (the “2006 Warning Letter”)). The 2006 Warning Letter acknowledged the plaintiffs’ “actions to restructure the stability group and institute a Management Review Committee to oversee the stability program,” but noted that the agency “still [had] concerns regarding the observations.” Id. Even with the changes, the FDA stated that “[t]here is no assurance that the stability sample test intervals for each attribute examined have been met to assure valid estimates of stability.” Id. at 1463. Perhaps foreshadowing later problems that would develop with the plaintiffs’ reports to the FDA, the agency noted that the plaintiffs had averred that “a hard copy handwritten master list ... identifies all the samples placed in each of the stability chambers” at the facility. Id. at 1464. The FDA investigators, however, did not see any such master list, “nor was it mentioned or provided to the investigative team when they initially requested the sample logbook or throughout the inspection.” Id. The 2006 Warning Letter required the plaintiffs to submit a print-out of another log pertaining to stability sampling that the FDA investigators also failed to observe on their inspection, and further noted that certain of the plaintiffs’ explanations were self-contradictory. See id. (noting “samples cannot be for both ‘investigational purposes’ only and ‘impurity profile trending/deviations’ because impurity testing is part of the drug product stability program”); id. at 1466 (“the purpose of these ‘stand-by’ samples remains unclear .... [p]lease clarify if these samples are for ‘investigational’ purposes, ‘impurity profile’ trending, or for ‘regulatory global filings’ and explain the rationale for storage of these samples at [redacted] for up to [redacted] months.”). Additionally, the 2006 Warning Letter contained details of the FDA’s own studies finding that certain drugs from the Paonta Sahib facility “show much lower potencies in these batches within approximately three to six months of release, and well before their expiration dates,” as well as findings of “several abnormalities” among antiretroviral drugs shipped by the plaintiff to African nations under the PEPFAR program. See id. at 1467. As a result, the 2006 Warning Letter advised the plaintiffs that “[u]ntil FDA has confirmed correction of the deficiencies observed during the most recent inspection and compliance with CGMPs, this office will recommend withholding approval of any new applications listing your Paonta Sahib facility as the manufacturer of finished pharmaceutical drug products.” Id. In late August 2006, the plaintiffs responded to the 2006 Warning Letter by reaffirming their intention “to improve our quality programs and to enhance [their] operational performance at the Paonta Sahib facility.” Id. at 1436 (Letter from plaintiffs to FDA, Aug. 29, 2006). As part of that commitment, the plaintiffs advised that they had retained a consulting firm “to verify that [their] stability laboratory program improvements are effective and systemic, and to verify the effectiveness of [their] commitments made in response to the Warning Letter.” Id. This consulting team’s assessment began in early July 2006' and was still ongoing as of August 29. Id. The plaintiffs also included a detailed response to the 2006 Warning Letter, identifying changes made to their policies and procedures in response to the FDA’s observations, including some additional documentation. See id. at 1438-69. A month later, and of particular importance for the instant ANDAs, the agency requested [redacted] Id. at 1434 (Letter from FDA to plaintiffs, Sept. 27, 2006). The promised audit results proved to be a sticking point between the agency and the plaintiffs. In response to the FDA’s request, the plaintiffs noted that “it was our and PAREXEL’s understanding that it is FDA’s policy not to review or copy any reports or records that result from such audits” and, consequently, the plaintiffs believed that turning over the report would “affect the candor with which personnel would approach future audits, and make them a far less valuable tool for senior management and for the company as a whole.” Id. at 1431 (Letter from plaintiffs to FDA, Oct. 13, 2006). The plaintiffs offered to work with the agency to provide “other relevant materials” while stopping short of producing the audit report. Id. On November 29, 2006, a team from the plaintiffs, including the plaintiffs’ CEO, President, counsel, and a Vice-President from the plaintiffs’ consulting firm, met with twelve FDA staff regarding the 2006 Warning Letter. Id. at 1424 (FDA’s Meeting Minutes, Nov. 29, 2006). The agency expressed concern at the meeting “that there appeared to be a lack of global corrective actions” in response to the 2006 Warning Letter and peppered the plaintiffs’ representatives with questions. See id. at 1425-28. In response to at least one of the concerns, the plaintiffs’ consultant noted that certain “information was not provided” to the consultant “when requested” and believed that certain discrepancies between the plaintiffs’ recollection of certain events and the inspectors’ memories was “due mainly to communication barriers.” Id. at 1427. The PAREXEL audit report was a specific topic of discussion. “The Agency clarified that FDA’s policy of not requesting company audits does not apply to third party audits,” such as that conducted by the plaintiffs’ consultant. See id. at 1428. The plaintiffs’ consultant averred that “disclosing results of audits to the Agency would be destructive to the company’s audit program and be destructive to [the plaintiffs’] quality improvement goals for fear of disclosure of audits to the FDA.” Id. The agency dismissed those concerns, noting that “audits are routinely received and reviewed by [the agency], and requested to see any information that could be provided by Parexel.” Id. The plaintiffs agreed to “consider the request.” Id. As to the scope of the audit, the plaintiffs’ consultant stated that the consultant was “doing a retrospective verification of stability samples” and that a review of the accuracy of “all current and future ANDA filings” and that the results for the pending ANDAs “will be completed ... and provided to the Agency in December, 2006.” Id. Finally, the FDA reiterated to the plaintiffs that the “hold on Ranbaxy’s application[s]” instituted as part of the 2006 Warning Letter “would not be removed until the facility is reinspected to ensure that updated procedures have been implemented and global issues have been addressed.” Id. Although the plaintiffs appeared to push for a re-inspection as soon as possible, the agency noted that it “would be difficult to schedule a re-inspection in January, 2007, as this does not allow for sufficient preparation time.” Id. Nevertheless, the FDA agreed to “work to schedule the re-inspection as soon as it is possible” after the additional information the plaintiffs’ promised the agency in December 2006 was received. Id. at 1429. The FDA conducted its re-inspection between January 26 and February 1, 2007, finding the Paonta Sahib “site acceptable for APIs.” AR at 1374 (Memo of Teleconference between FDA and plaintiffs’ counsel, Apr. 5, 2007). The plaintiffs admitted in an April 2007 teleconference with the FDA that “Ranbaxy had not yet addressed all of [the FDA’s] concerns from the June 2006 Warning Letter,” and that the audit of “stability raw laboratory data” was still ongoing. Id. at 1375. The FDA informed plaintiffs that until they “reviewed the audit report,” which the FDA had requested during the November 2006 meeting, “FDA could not complete its CGMP compliance assessment” necessary to lift the hold on processing the plaintiffs’ ANDAs. See id. 3. The Plaintiffs Seek Withdrawal Of FDA’s Compliance Hold Two days before the plaintiffs’ would lose their 180-day generic marketing exclusivity for a drug, tamsulosin hydrochloride — which is not at issue in this litigation — due to the plaintiffs’ failure to obtain tentative approval within thirty months of the ANDA’s submission, the plaintiffs notified the agency that “the retrospective stability verification promised during the November 29, 2006 meeting between Ran-baxy and FDA has been completed, and that the company’s ANDA submissions are being updated today to reflect changes identified in the course of the review.” Id. at 1371 (Letter from plaintiffs to FDA, June 18, 2007). The plaintiffs averred that with the completion of this retrospective review, the agency should be able to “lift the application hold related to Ran-baxy’s finished dosage facility at Paonta Sahib, India” in time to grant tentative approval to the plaintiffs’ tamsulosin ANDA so as to preserve the potential for 180-day exclusivity. Id. The plaintiffs summarized the review’s findings, noting that three categories of errors were found and updates made to correct those errors, but, significantly, “in no case did the corrections affect the previous conclusions about the stability of the sample.” Id. at 1373. Shortly after the submission of the corrections occasioned by the retrospective review, the FDA requested further information, including access to the plaintiffs’ consultant’s stability verification audit reports. See id. at 1366 (Letter from plaintiffs’ counsel to FDA, July 27, 2007 referring to “meeting with FDA on June 26, 2007”). In late July 2007, the plaintiffs’ counsel provided the reports due to “the importance of resolving the hold,” even though they “were initially prepared under privilege.” Id. The plaintiffs’ counsel summarized the reports as showing a tiny proportion of errors discovered during a review of a sample of the plaintiffs’ stability tests, and averred that the plaintiffs had “taken exhaustive steps to assure the accuracy of data contained in its stability reports and ANDA submissions.”- Id. at 1370. At the same time that the plaintiffs were advocating for the FDA to lift the compliance hold on products manufactured at Paonta Sahib, a Federal criminal investigation into the plaintiffs was ongoing. See id. at 1362 (Email chain between plaintiffs’ counsel and FDA, Dec. 27-28, 2007, referring to “implications for the criminal case of providing the audits”). Despite the FDA’s persistent requests to review the audit reports from PAREXEL, the plaintiffs insisted that these audits were privileged and would not be produced. See id. The failure to submit the audits resulted in the withdrawal of an ANDA for clarithro-mycin, a drug for which the plaintiffs did not have 180-day exclusivity but would otherwise have been able to market at the beginning of 2008. See id. at 1365. The compliance hold continued. See id. 4. The 2008 Inspection Between March 3 and March 7, 2008, FDA inspectors returned to the plaintiffs’ facilities in India, this time to inspect a “new” plant, called “the Batamandi plant,” which was [redacted] See AR at 1316 (Establishment Inspection Report, issued Apr. 16, 2008). The inspection had three goals: (1) [redacted] (2) [redacted] and (3) [redacted] Id. at 1314. The inspection revealed [redacted] (1) [redacted] (2) [redacted] (3) [redacted]. Id. at 1314-15. In the course of the inspection, the FDA personnel discovered [redacted]. See id. at 1336-49. [redacted]. See id. at 1349. Regarding the relationship between the Batamandi plant and the Paonta Sahib plant, the inspectors discovered that [redacted] inspectors discovered that [redacted] Id. at 1351. The inspectors noted that [redacted] Id. at 1351. As one inspector was leaving, [redacted] Id. at 1353. As one inspector was leaving, [redacted] Id. at 1353. in response to the damaging findings from this inspection, the plaintiffs [redacted] See AR at 1275 (Letter from plaintiffs to FDA, May 1, 2008); but see id. at 1356 (noting that [redacted]). he plaintiffs also admitted that [redacted] Id. at 1273. [redacted] See id. at 1277. 5. The 2008 Warning Letter Following the 2008 inspection and after reviewing the plaintiffs’ response to the inspectors’ observations, the FDA issued another Warning Letter to the plaintiffs. AR at 1266 (FDA Warning Letter to plaintiffs, Sept. 16, 2008 (the “2008 Warning Letter”)). Similarly to the 2006 Warning Letter, the 2008 Warning Letter alerted the plaintiffs to “significant deviations from U.S. Current Good Manufacturing Practice” at both parts of the Paonta Sahib plant, and that “[t]hese CGMP deviations cause [the plaintiffs’] drug products to be adulterated within the meaning of’ the FDCA. Id. Since the Batamandi plant was determined to be a mere extension of the Paonta Sahib facility, not a new, separate facility as the plaintiffs had claimed, “the violations observed during the March 2008 inspection [were] indications of continuing CGMP deficiencies in the quality systems at the Paonta Sahib facility, including the failure of production and quality management to prevent such deficiencies.” Id. By 2008, the FDA’s inspectors were “concerned that these instances of discrepancies observed during the March 2008 inspection, are indications of continuing, systemic CGMP deficiencies at the Paonta Sahib facility.” Id. at 1267. For instance, the 2008 Warning Letter opines that the plaintiffs’ “response regarding Employee I [who signed off on operations for which he was not present] demonstrates a lack of knowledge by the employee regarding the fundamental purpose of independent verification under CGMP, and the failure of [the plaintiffs] to ensure that employees conducting and recording these checks understood these essential requirements.” Id. at 1268. Such independent checks are “an essential part of U.S. CGMP regulations” and the failure to perform the checks was cited as an “important example of the necessary steps [the plaintiffs] need to implement to ensure product quality.” Id. After detailing multiple instances of deficiencies in the plaintiffs’ Paonta Sahib plant’s quality systems, the 2008 Warning Letter stated in no uncertain terms that if the plaintiffs “wish to continue to ship [their] products to the United States, it is the responsibility of [the plaintiffs] to assure compliance with all U.S. standards for Current Good Manufacturing Practices.” Id. at 1270. While the 2006 Warning Letter indicated that the FDA would recommend denial of any applications for drugs manufactured at Paonta Sahib, the 2008 Warning Letter enhanced this sanction by instituting a “refusal of admission” prohibiting the plaintiffs from exporting drugs manufactured at Paonta Sahib to the United states because “the methods and controls used in their manufacture do not appear to conform to current good manufacturing practice.” Id. at 1271. 6. The 2009 Letter By 2009, with the criminal investigation proceeding and the FDA’s Center for Drug Evaluation and Research (“CDER”) still concerned with the plaintiffs’ practices, the FDA issued a letter informing the plaintiffs that it had “determined that Ranbaxy Laboratories Limited ... submitted untrue statements of material fact in abbreviated and new drug applications filed with the Agency.” AR at 1254 (Letter from FDA to plaintiffs, Feb. 25, 2009 (the “2009 Letter”)). Citing the observations at Paonta Sahib in 2006 and 2008 as well as the responses given by the plaintiffs to those inspections, the agency determined that “[t]hese and other findings indicate a pattern and practice of submitting untrue statements of material fact and other wrongful conduct, which raise significant questions regarding the reliability of the data and information contained in applications (pending and approved) ... filed with the Agency.” Id. at 1258. Consequently, the FDA informed the plaintiffs that, pursuant to FDA policy, the agency would begin assessing “the validity of the data and information in all of Ranbaxy’s affected applications” and that the FDA did “not intend ordinarily to conduct or to continue its normal substantive scientific review (including review of data and labeling) of any such pending application or supplement, or of any new application or supplemental applications” until the review was complete. Id. Among the applications affected by the 2009 Letter were the two ANDAs at issue here: ANDA 77830 (for esomeprazole magnesium) and ANDA 78078 (for valganciclovir hydrochloride). Id. at 1263. In essence, as of February 25, 2009, the FDA had frozen all of the plaintiffs’ applications containing data from Paonta Sahib and would take no further steps toward approving those applications until the review of the plaintiffs’ data was complete. 7. The Consent Decree And Criminal Plea Three years later, the United States filed a Complaint for Permanent Injunction against the plaintiffs in the U.S. District Court for the District of Maryland. AR at 1232 (Complaint for Permanent Injunction, Case No. 12-cv-250 (JFM), Jan. 25, 2012). On the same date, the plaintiffs and the government filed a consent decree requiring the plaintiffs to, inter alia, establish new practices and offices to ensure compliance, AR- at 1180-81 (Consent Decree of Permanent Injunction, Case No. 12-cv-250 (JFM), Jan. 25, 2012); withdraw certain ANDAs, id. at 1185; submit other ANDAs to new audits, id. at 1187-89; and ensure compliance with CGMP at the plaintiffs’ Paonta Sahib and Dewas, India facilities, id. at 1189-90. The extensive requirements in the Consent Decree supplanted the 2009 Letter’s requirements, such that “the provisions of [the] Decree with respect to [the Paonta Sahib] facilities constitute the full requirements that [the plaintiffs] must satisfy to address FDA’s concerns.” Id. at 1224. Sixteen months later, one of the plaintiffs’ subsidiaries, Ranbaxy USA, Inc., pleaded guilty to seven criminal counts of fraud and introduction of adulterated drugs into interstate commerce. See Pis.’ TRO Reply at 18, ECF No. 28 (referring ■ to guilty plea and stating plaintiffs “paid a very heavy price from which it will take years to recover”). The combination of criminal fines, criminal forfeitures, and a civil settlement levied against the plaintiffs’ subsidiary amounted to $500,000,000. U.S. Dep’t of Justice, “Generic Drug Manufacturer Ranbaxy Pleads Guilty and Agrees to Pay $500 Million to Resolve False Claims Allegations, cGMP Violations and False Statements to the FDA,” May 18, 2013, available at http://www.justice. gov/opa/pr/generic-drug-manufacturer-ranbaxy-pleads-guilty-and-agrees-pay-500-million-resolve-false. As previously noted, this guilty plea was touted as the “largest drug safety settlement” in history. Id. Yet, even this massive fine and the Consent Decree do not appear to have resolved the plaintiffs’ compliance problems. Due to newly observed CGMP deficiencies at two of the plaintiffs’ other plants in India, the Consent Decree has been expanded and currently “prohibits Ranbaxy from distributing in interstate commerce drug products, including APIs, manufactured at the Paonta Sahib, Dewas, Mohali, and Toansa facilities until Ranbaxy demonstrates its CGMP compliance at those facilities.” Defs.’ TRO Opp’n at 17. Having provided context for the FDA’s evolving understanding of the breadth and depth of the plaintiffs’ compliance failures, culminating in a criminal conviction, an import ban, and hundreds of millions of dollars in fines, the Court now turns to the two ANDAs at issue in this litigation and the errors by the FDA that led to their tentative approval. D. The Plaintiffs’ANDAs Five of the plaintiffs’ ANDAs affected by the problems at Paonta Sahib are of particular relevance to the instant litigation, including three ANDAs approved in 2007 and 2008, immediately prior to the tentative approval of ANDA 77830 for eso-meprazole magnesium, and ANDA 78078 for valganciclovir hydrochloride tablets, which are the two ANDAs at issue here. The three prior ANDAs are addressed first before turning to the two ANDAs at issue in the instant litigation. 1. Tentative Approval For Three Of The Plaintiffs’ ANDAs Despite Compliance Problems At Paonta Sahib The AR shows that the plaintiffs received five tentative approvals despite their Paonta Sahib facility failing to comply with CGMP. The first of these ANDA exceptions was the application for tamsulo-sin, for which the plaintiffs would have forfeited any claim to 180-day exclusivity if they did not obtain tentative approval by June 20, 2007. See supra Part I.C.3. Despite the compliance hold preventing any tentative approvals for generic products manufactured as the Paonta Sahib facility, the plaintiffs launched a multi-pronged initiative to get this ANDA approved by approaching two FDA components, ODER and Office of Generic Drugs (“OGD”), with different arguments. See AR at 1371. In one approach, the plaintiffs alerted the FDA’s ODER component that the stability verification audits the FDA had requested were complete and showed Paonta Sahib was following CGMP, thus negating the need for the compliance hold. See AR at 1371. As a second approach, the plaintiffs’ counsel threatened the FDA’s OGD component with a lawsuit if the agency did not immediately “confirmf ] that Ranbaxy will not forfeit on June 20, 2007 its right to 180-day exclusivity.” AR at 1868 (Letter from plaintiffs’ counsel to FDA’s OGD, June 18, 2007). In a June 18, 2007 letter to the OGD, plaintiffs’ counsel raised the same argument the plaintiffs press here: that 21 U.S.C. § 355(j) “does not authorize FDA to withhold tentative approval, and thereby deprive an ANDA applicant of its 180-day exclusivity, based on the adequacy of the methods, facilities, or controls used for the manufacture of the drug product.” Id. at 1873. The letter left no doubt that if OGD did not grant tentative approval by June 20, 2007, just two days after the date of the letter from the plaintiffs’ counsel, the FDA would find itself embroiled in lawsuit because, in the plaintiffs’ view, failure to do so “would be arbitrary and capricious,” and because “there is no factual basis” to conclude that the conditions of the 2006 Warning Letter had not been resolved. See id. at 1874. Under this threat of litigation and while ODER was processing the results of the stability studies submitted by the plaintiffs, though without the oft-requested independent audit reports from PAREXEL, see supra Part I.C.3, the OGD tentatively approved the plaintiffs’ ANDA for tamsu-losin. AR at 1858 (OGD Approval Routing Summary). Included in the routing summary for the tentative approval is an email chain from ODER employees to OGD, noting that, [redacted] In other words, the agency’s compliance staff apparently believed, [redacted] See id. ODER noted that [redacted] M With this caveat, ODER [redacted] OGD’s grant of tentative approval. Id. at 1860. The process by which the FDA considered four more of the plaintiffs’ other AN-DAs for tentative approval is reminiscent of a child’s game of telephone, where the initial message becomes distorted upon repetition. A second ANDA from the plaintiffs, for valsarían, was reactivated by agency staff the day after tentative approval was granted to the tamsulosin ANDA because the plaintiffs were [redacted] AR at 1856 (email chain between FDA employees, June 21-July 10, 2007). Review of this ANDA was, similarly to the ANDA for tamsulosin, urgent, since the plaintiffs would lose their eligibility for the 180-day generic marketing exclusivity if the ANDA were not tentatively approved in short order. An intervening change in the drug’s monograph, however, resulted in a several month delay from the OGD’s resuming review of the ANDA to its tentative approval. See id. at 1854-55. [redacted] By October 2007, OGD asserted that the [redacted]” Id. at 1838 (email chain between Edwin Rivera Martinez and William P. Rickman, Oct. 25, 2007). This rationale never appeared in communications from ODER prior to October 2007 and, indeed, [redacted]. See generally AR. Nevertheless, the valsarían ANDA was given tentative approval shortly thereafter. See id. at 1834-35 (OGD Approval Routing Summary). Thus, by late 2007, the FDA had violated its own policy not to grant tentative approval to ANDAs when a compliance hold was in place three times, for the plaintiffs’ tamsulosin, galantamine, and val-sarían ANDAs. Also, by late 2007, the ODER and OGD employees involved in making these decisions were apparently no longer considering why an exception to the plaintiffs’ compliance hold should be granted, but were merely cutting-and-pasting language from previous emails pertaining to other ANDAs recommending that OGD issue tentative approval despite the compliance hold, [redacted] The two ANDAs at issue in this litigation, for esomeprazole and valganciclovir, were issued after this game of telephone had progressed for six months. 2. The Plaintiffs’ Esomeprazole ANDA The plaintiffs filed their ANDA for eso-meprazole, including their paragraph IV certification, by letter dated August 4, 2005. AR at 1792 (ANDA Checklist for Completeness and Acceptability of an Application). The ANDA was noted as the first generic product application received and was approved for filing as substantially complete on September 30, 2005 by personnel in OGD. Id. [redacted] [redacted] Based on CDER’s recommendation, OGD granted tentative approval for the plaintiffs esomeprazole ANDA 77830, on February 5, 2008, noting [redacted] Id. at 1771-72 (OGD Approval Routing Summary). As part of the 2012 Consent Decree, the plaintiffs were required to [redacted] Id. at 1768 (letter from FDA to plaintiffs, May 4, 2012 (internal quotation marks omitted)). CDER notified the plaintiffs that the eso-meprazole ANDA [redacted] when it was initially filed, allowing the FDA, under the terms of the consent decree, to proceed in its audit of the esomeprazole ANDA. Id. at 1769. This audit was designed to determine if the application contained any “untrue statements of material fact” or “a pattern or practice of data irregularities affecting approval,” as provided for in the Consent Decree. AR at 1766 (letter from FDA to plaintiffs, Nov. 4, 2014). The plaintiffs were notified on November 4, 2014, that there did not appear to be any “untrue statements of material fact” or “data irregularities” preventing the FDA from resuming its review of the ANDA. Id. Since the 2009 Letter and the Consent Decree had frozen all action on any of the plaintiffs’ NDAs or ANDAs, completing this audit did not guarantee final approval, but rather allowed the FDA to resume considering whether the ANDA was eligible for such approval. See id. 3. The Plaintiffs’ Valganciclovir ANDA The plaintiffs filed their ANDA for val-ganciclovir, including their paragraph IV certification, by letter dated December 22, 2005. AR at 1820 (ANDA Checklist for Completeness and Acceptability of an Application). This ANDA, number 78078, was the first generic product application received for this drug and was approved for filing as substantially complete on February 27, 2006. Id. [redacted] [redacted] Id. [redacted] Based in part on this recommendation, OGD granted the plaintiffs tentative approval for valganciclovir on June 20, 2008. Id. at 1807 (OGD Approval Routing Summary). Pursuant to the 2012 Consent Decree, the ANDA was reviewed and. found to have been substantially complete when submitted. Id. at 1802-03 (letter from FDA to plaintiffs, May 15, 2012). Also pursuant to the consent decree, the ANDA was audited and found not to “appear to contain any untrue statements of material fact ... nor does it appear to contain a pattern or practice of data irregularities affecting approval,” thus allowing FDA to resume reviewing the ANDA on August 10, 2012. Id. at 1798-99 (letter from FDA to plaintiffs, Aug. 10, 2012). E. The Instant Litigation Despite the intensive investigation the FDA conducted of the plaintiffs’ manufacturing facilities — and the parallel criminal investigation — the FDA did not revisit any of the ANDAs tentatively approved in 2007 and 2008, including the valganciclovir and esomeprazole ANDAs, until 2014. Defs.’ Mem. at 37. The Federal defendants explain that “[i]t was only in 2014, when applications from two other sponsors were ready for approval, that FDA had reason to determine whether Ranbaxy was entitled to exclusivity for this drug and, at that time, the agency recognized that Ranbaxy’s claim to exclusivity was predicated on an erroneous decision.” Id. When two other generic drug manufacturers, defendant-intervenors Dr. Reddy’s and Endo, sought final approval for their own ANDAs for valganciclovir, the FDA reexamined the two ANDAs at issue here. See id. After review, the agency “determined that FDA erred in tentatively approving” the plaintiffs’ two ANDAs because tentative approval was granted “while the compliance status of one or more of the facilities referenced in the applications was unacceptable to support tentative approval.” Rescission Letter at 1. Consequently, the FDA revoked the tentative approval for the plaintiffs’ val-ganciclovir and esomeprazole ANDAs and determined that the rescission meant the plaintiffs had forfeited any eligibility for 180-day exclusivity for the valganciclovir ANDA by failing to obtain tentative approval within thirty months of the date of the ANDA’s submission. Id. at 1-2. The same day, November 4, 2014, the agency granted final approval to defendant-inter-venors Dr. Reddy’s and Endo for their own valganciclovir ANDAs. Compl. ¶ 41. Ten days later, the plaintiffs filed the instant suit for declaratory and injunctive relief, Compl. at 1, and a motion for a temporary restraining order, ECF No. 2. A hearing on the TRO was held on November 19, 2014, by which time defendant-intervenors Dr. Reddy’s and Endo had moved for and been granted leave to intervene. Minute Order, Nov. 17, 2014 (setting hearing date); Minute Order Nov. 17, 2014 (granting defendant-intervenor Endo’s Motion to Intervene); Minute Order, Nov. 17, 2014 (granting defendant-intervenor Dr. Reddy’s Motion to Intervene). After oral argument at the November 19, ■ 2014 hearing, the Court denied the plaintiffs’ motion for a temporary restraining order “because the plaintiffs have not made a clear showing that this Court has subject matter jurisdiction over this matter or a likelihood of irreparable harm ... let alone satisfy the other factors for the extraordinary relief of a TRO.” Hrg. Tr. 91:20-25, ECF No. 61. Specifically, the plaintiffs had not shown at the time of the November 19, 2014 hearing that the plaintiffs “can take advantage of that [180-day] exclusivity” for valganciclovir that had been rescinded, “or that they will suffer any imminent harm as a result of the loss of that exclusivity.” Id. 92:21-24. As for the plaintiffs’ esomeprazole ANDA, the plaintiffs failed to show “that the FDA has taken any final agency action regarding the plaintiffs’ eligibility for 180-day exclusivity,” since the Rescission Letter stated that the FDA, “consistent with its longstanding policy ... ‘has not made any determination regarding Ranbaxy’s eligibility for 180-day exclusivity for this ANDA.’ ” Id. 93:6-16 (quoting Rescission Letter at 1 n.3). In light of the plaintiffs’ stated intention to move for a preliminary injunction and the proposed briefing schedule submitted by the parties, consideration of the plaintiffs’ preliminary injunction motion and the defendants’ and defendant-intervenors’ motions for summary judgment was consolidated. Minute Order, Nov. 21, 2014 (citing Fed. R. Civ. P. 65(a)(2)). After receiving extensive briefing from the parties, the preliminary injunction hearing was vacated “to conserve the parties’ and judicial resources.” Minute Order, Jan. 7, 2015 (citing LCvR 7(f)). After the motions were fully briefed, the defendants notified the Court that FDA had “forfeited its eligibility for 180-day exclusivity for esomeprazole because it failed to obtain tentative approval of its ANDA within 30 months after the date on which thé ANDA was submitted” and approved an ANDA filed by defendant-inter-venor Ivax for the same medication. Defs.’ Not. Admin. Action at 1, ECF No. 67. Three days later, defendant-interve-nors Ivax and Teva moved for and were granted leave to intervene. Minute Order, Jan. 30, 2015. Defendant-intervenors Ivax and Teva moved for summary judgment on February 2, 2015, which motion became ripe for decision on February 5, 2015. II. LEGAL STANDARD A. Summary Judgment Pursuant to Federal Rule of Civil Procedure 56, summary judgment may be granted when the court finds, based upon the pleadings, depositions, affidavits, and other factual materials in the record, “that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a), (c); see Tolan v. Cotton, — U.S. —, 134 S.Ct. 1861, 1866, 188 L.Ed.2d 895 (2014) (per curiam); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). “A genuine issue of material fact exists if the evidence, ‘viewed in a light most favorable to the nonmoving party,’ could support a reasonable jury’s verdict for the non-moving party.” Muwekma Ohlone Tribe v. Salazar, 708 F.3d 209, 215 (D.C.Cir.2013) (quoting McCready v. Nicholson, 465 F.3d 1, 7 (D.C.Cir.2006)). In APA eases such as this one, “the district judge sits as an appellate tribunal. The ‘entire case’ on review is a question of law.” Am. Bioscience, Inc. v. Thompson, 269 F.3d 1077, 1083 (D.C.Cir.2001) (collecting cases). Accordingly, this Court need not and ought not engage in lengthy fact finding, since “[generally speaking, district courts reviewing agency action under the APA’s arbitrary and capricious standard do not resolve factual issues, but operate instead as appellate courts resolving legal questions.” James Madison Ltd. by Hecht v. Ludwig, 82 F.3d 1085, 1096 (D.C.Cir.1996); see also Sierra Club v. Mainella, 459 F.Supp.2d 76, 90 (D.D.C.2006) (“Under the APA ... the function of the district court is to determine whether or n