Full opinion text
UNDER SEAL MEMORANDUM OPINION KETANJI BROWN JACKSON, United States District Judge Table Of Contents I.BACKGROUND ... 69 A. Colchicine: A Drug For The Treatment Of Gout ... 69 B. FDA’s Drug Approval Framework: The Hatch-Waxman Amendments ... 71 1. NDAs, ANDAs, and 505(b)(2) NDAs ...71 2. The Patent Certification Requirement ...72 3. The Labeling Requirements ... 73 C. FDA’s Approval Of Colcrys (A Col-chicine Tablet) ... 74 1. Mutual Relies On ColBenemid, Published Literature, And Its Own Clinical Studies To Support The Colcrys Application For Acute Flares Of Gout ... 74 2. Mutual Relies on ColBenemid and Published Literature To Support The Col-crys Application For Prophylactic Treatment of Gout ... 76 3. FDA Takes Enforcement Action Against Unapproved Oral Colchicine Products Because Their Labels Do Not Reflect The Most Current Data ... 76 D. FDA’s Approval Of Mitigare (A Colchicine Capsule) ... 77 1. Mutual Files A Citizen Petition Protesting West-Ward’s Application And FDA Responds ... 77 2. FDA Approves Mitigare Capsule For Prophylaxis Of Gout Flares Based On Col-Probenecid, Published Literature, and West-Ward’s Own Studies ... 79 3. West-Ward Launches Mitigare, Alerting Takeda To The Existence Of Mitigare ...80 E. Procedural History ... 80 II. LEGAL STANDARDS ... 83 III. DISCUSSION ... 84 A. FDA’s Approval Of Mitigare Without A Colcrys Reference And Related Certifications To The Colcrys Patents Did Not Violate The Agency’s Rules Or The FDCA ...84 1. FDA’s Procedural Rules Did Not Require West-Ward To Reference Colcrys Because West-Ward Did Not Rely On Col-crys Data To Support West-Ward’s Application For FDA Approval Of Mitigare ... 85 a. No FDA Policy Establishes That FDA’s Reliance — As Opposed To That Of The Section 505(b)(2) Applicant — Gives Rise To Patent Certification Obligations ... 86 b. Even If Agency Reliance On Third-Party Data Is Relevant, FDA Did Not Approve Mitigare In Reliance On Mutual’s Information ... 90 2. Under FDA’s Procedural Rules, An Applicant — Not FDA — Has The Right To Choose The “Most Appropriate” Or “Most Similar” Reference Drug For Its 505(b)(2) Application ... 92 3. The FDCA Unambiguously Requires A Section 505(b)(2) Applicant To Certify Only To Patents Associated With The Reference Listed Drug ... 95 B. FDA’s Approval Of Mitigare Was Not An Unreasoned Change Of The Agency’s Prior Position Regarding Single-Ingredient Oral Colchicine Products ... 103 C. FDA’s Decision To Approve Miti-gare With A Label That Contains Safety Information That Differs From Colcrys Was Not Arbitrary And Capricious ... 107 IV. CONCLUSION ..: 108 The Hatch-Waxman Amendments to the Food-, Drug, and Cosmetic Act (“FDCA”), Pub. L. No. 98-417, 98 Stat. 1585 (1984), “balance two competing interests in the pharmaceutical industry: (1) inducing pioneering research and development of new drugs and (2) enabling competitors to bring low-cost, generic copies of those drugs to market.” Janssen Pharmaceutica, N.V. v. Apotex, Inc., 540 F.3d 1353, 1355 (Fed.Cir.2008) (internal quotation marks and citation omitted). Hatch-Wax-man achieves this balance, in part, by allowing new applicants for drug approval to rely on research and data that an innovator company generates so long as the new applicant “references” the innovator’s drug and “certifies” to the innovator’s patents. See infra Part I.B.2; see also 21 U.S.C. § 355(b)(2)(A). Plaintiffs Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”) and Elliott Associates, L.P., Elliott International, L.P., and Knollwood Investments, L.P. (collectively, “Elliott”) allege that the Food and Drug Administration (“FDA”) upset Hatch-Waxman’s careful balance when the agency approved an application that Hik-ma Pharmaceuticals PLC (“Hikma”) submitted through its U.S. agent West-Ward Pharmaceuticals Corp. (“West-Ward”) for a gout medication named Mitigare. Miti-gare is a single-ingredient '0.6 milligram (“mg”) oral colchicine drug product that is substantially similar to Plaintiffs’ colchi-cine drug, Colcrys, which FDA approved five years prior to Mitigare based in part on research studies that Takeda’s predecessor Mutual Pharmaceutical Company, Inc. (“Mutual”) conducted. In seeking approval for Mitigare, West-Ward neither referenced Colcrys nor certified to the Col-crys patents, and Hikma has now authorized West-Ward to market a generic version of Mitigare that will compete with— and cost less than — Plaintiffs’ Colcrys. In the separate but consolidated complaints that Takeda and Elliott have filed in this Court against Defendants Sylvia Mathews Burwell (in her official capacity as Secretary of the Department of Health and Human Services) and Margaret Hamburg (in her official capacity as head of the FDA), Plaintiffs maintain that FDA’s approval of Mitigare without a Colcrys reference or the related patent certifications violates the Administrative Procedure Act (“APA”) because that approval was inconsistent with the agency’s procedural rules and the certification provisions of the FDCA. Plaintiffs also claim that FDA’s approval of Mitigare was arbitrary and capricious because Mitigare’s label lacks certain safety information that is on the Colcrys label — information that is related to Mutual’s research and that FDA previously suggested should be on the label of future colchicine drug products. The lawsuits that Takeda and Elliott have filed (and in which Hikma and West-Ward have now intervened) request a stay or rescission of FDA’s approval of Mitigare as a remedy for these alleged violations. Before this Court at present are four cross-motions for summary judgment that the Plaintiffs, the Defendants, and the Defendant-Intervenors have submitted in the context of the two pending actions. This Court has considered these dispositive motions, the oppositions thereto, the supplemental briefing, and the arguments made orally at the two hearings that this Court has held in relation to this matter. Because this Court agrees with Defendants and D efendant-Intervenors that (1) no statute, regulation, or policy required FDA to reject West-Ward’s application for Miti-gare because the application did not reference Colcrys or certify to the Colcrys patents; (2) FDA’s scientific judgment that Mitigare is safe as labeled is well-reasoned and entitled to deference; and (8) FDA did not make an unreasoned change in policy when it approved Mitigare, Takeda’s Motion for Summary Judgment in Takeda Pharmaceuticals U.S.A., Inc. v. Burwell, No. 14-1668-KBJ (D.D.C.), is DENIED; Elliott’s Motion for Summary Judgment in Elliott Associates, L.P. v. Burwell, No. 14-1850-KBJ (D.D.C.), is DENIED; and Defendants’ and Defendant-Intervenors’ cross-motions for summary judgment in Elliott Associates, L.P. v. Burwell, No. 14-1850-KBJ (D.D.C.), are GRANTED. This Court issued a separate order consistent with this opinion on January 9, 2015. 1. BACKGROUND The instant dispute involves two drug products, both of which have the active ingredient colchicine, which is a pharmacological substance that has been used historically for the treatment of gout. Plaintiffs have a financial interest in Colcrys— an FDA-approved 0.6 mg single-ingredient oral colchicine tablet — and they have brought this challenge to Defendant FDA’s recent approval of Intervenors’ Mitigare, which is a 0.6 mg single-ingredient oral colchicine capsule. In order to understand the Plaintiffs’ challenge fully, some background information about both colchicine itself and FDA’s prior approval of Plaintiffs Colcrys, is necessary. The underlying facts are not in dispute. A. Colchicine: A Drug For The Treatment Of Gout Doctors have used colchicine — an agent derived from the Colchicum Autumnale plant — to treat gout for centuries. {See Admin. R. (hereinafter, “AR”) at 3 (“The first use of colchicine as a selective treatment for gout is attributed to the Byzantine physician Alexander of Tralles in 6 A.D.”).) Colchicine can be used both for the targeted treatment of gout flares (“acute treatment”) and for longer-term maintenance treatment that is aimed at preventing flares (“prophylaxis”). (See id. at 4, 116-17, 157, 204.) However, there is a relatively small window of doses in which colchicine provides therapeutic benefits without causing severe complications. (See AR at 202.) This “narrow therapeutic index” means that minor dosing changes can have a grave effect on patient outcomes because toxic levels of colchicine can be reached relatively quickly and “can result in serious life-threatening adverse events and death.” (Id.; see also id. at 117 (noting that, although colchicine is therapeutic “at doses of approximately 0.015 mg/kg,” the drug is “toxic in doses greater than 0.1 mg/kg, and typically lethal at doses of approximately 0.8 mg/kg”).) Even doses of colchicine that are within the normal therapeutic range can be toxic if colchicine is used concomitantly with certain other drugs called “CYP3A4 and P-gp inhibitors.” (Id. at 202.) Consistent with colchicine’s long history, drug manufacturers in the United States marketed a variety of forms and dosages of colchicine for decades prior to Congress’s 1962 enactment of amendments to the FDCA that required FDA to “approve” a drug — i.e., to make findings that a drug is safe, effective, and properly labeled — prior to marketing. (See AR at 50, 255); see also Peter Barton Hutt, et al., Food and Drug Law 577 (3rd ed.2007). After Congress passed the 1962 amendments that established a premarket approval requirement, FDA reviewed a number of drugs that were already on the market, including ColBenemid, which is a combination tablet that contains both 0.5 mg of colchicine and 500 mg of probenecid. (See AR at 4, 668.) FDA determined that ColBenemid was “effective for the treatment of chronic gouty arthritis when complicated by frequent, recurrent acute attacks of gout,” 37 Fed.Reg. 15189-02 (July 28,1972) (see also AR at 50), and approved that product for, “essentially, prophylactic treatment of gout flares” (AR at 668). It subsequently approved a generic version of ColBenemid — known as Col-Probenecid— that is also a tablet with 0.5 mg of colchi-cine and 500 mg of probenecid and is still on the market today. (See id. 4, 349, 353.) Other drug manufacturers have relied upon FDA’s findings that colchicine and probenecid effectively treat gout in the context of the agency’s approval of Col-Benemid and Col-Probenecid, including the two drug companies that have sponsored the colchicine drug products at issue in the instant case. (See id. at 4, 8). Just as combination colchicine products were legally marketed and sold for many years in the pre-approval era, “[s]ingle-ingredient colchicine tablets” — tablets that contain only colchicine and are not combined with another drug — “were available for decades as marketed but unapproved products, in 0.6 mg strength.” (Id. at 668.) The practice of marketing single-ingredient colchicine products as an unapproved drug continued even after Congress required premarket approval of drugs (see id. at 421), and it persisted until at least 2006, when “FDA announced a new drug safety initiative to remove unapproved marketed drugs from the market” (id. at 349). FDA undertook this initiative with the knowledge that “[f]or historical reasons, some drugs are available in the United States that lack required FDA approval for marketing[,]” FDA Ctr. For Drug Evaluation & Research, Guidance for FDA Staff and Indus.: Marketed Unapproved Drugs — Compliance Policy Guide Sec. 440.100: Marketed New Drugs Without Approved NDAs & ANDAs 2 (June 2006, as revised Sept. 2011), and with the intent to bring all prescription drug products into compliance with an FDA approval process that Congress had adopted in 1984, as part of a statute that is formally named the “Drug Price Competition and Patent Term Restoration Act of 1984” and is commonly referred to as the “Hatch-Waxman Amendments.” Pub. L. No. 98-417, 98 Stat. 1585 (1984), codified at 21 U.S.C. § 355. B. FDA’s Drug Approval Framework: The Hatch-Waxman Amendments In brief, Hatch-Waxman requires drug manufacturers seeking to market a new drug to first obtain FDA approval via one of three different application pathways: (1) a full New Drug Application (“NDA”); (2) an Abbreviated New Drug Application (“ANDA”); or (3) an intermediate process known as a Section 505(b)(2) NDA. See 21 U.S.C. § 355; see also, e.g., Ethypkarm S.A. France v. Abbott Labs., 707 F.3d 223, 226-27 (3d Cir.2013) (describing the three different approval methods). 1. NDAs, ANDAs, and 505(b)(2) NDAs The full NDA process, see 21 U.S.C. § 355(b)(1), requires the manufacturer 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” (ie., clinical trials); all components of the drug; the methods used for the drug’s manufacture, processing, and packing; examples for proposed labeling for the drug; and any patents claimed in relation to the drug. See 21 U.S.C. §§ 355(b)(1)(A), (B), (D), (F), (G). This path is used by drug manufacturers for “new branded drug[s],” Ethypkarm S.A. France, 707 F.3d at 226, which are sometimes called “pioneer” or “innovator” drugs. A drug manufacturer may also choose to file an Abbreviated New Drug Application (“ANDA”) pursuant to 21 U.S.C. § 355(j). 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 manufacturers to conduct expensive and time consuming clinical trials, the ANDA process allows the manufacturer to rely on the clinical trials already performed in connection with the approval of the previously approved drug, provided that the generic manufacturer 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 bioequivalency). See 21 U.S.C. § 355(j)(2)(A). In other words, an ANDA does not attempt to demonstrate safety or effectiveness; instead, the applicant’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 drug manufacturers “for the introduction of generic versions of previously approved branded drugs.” Ethypkarm S.A. France, 707 F.3d at 227. 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) applicant can rely on clinical studies that were previously submitted to FDA in support of another drug and that were not conducted or licensed by the 505(b)(2) applicant. See 21 U.S.C. § 355(b)(2). 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) applicant relies upon may be proffered to satisfy the applicant’s entire burden of proving safety and effectiveness, or they may only support some of the necessary findings; in the latter case, the applicant can supplement with studies of its own. This means that a Section 505(b)(2) NDA may include the applicant’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) applicant 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 applicant’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 drug manufactures seeking to. market drugs that are neither “entirely new” nor “simply a generic version of a branded drug.” Ethypharm S.A France, 707 F.3d at 227. 2. The Patent Certification Requirement Because development of a new drug product is notoriously “expensive and time-eonsuming[,]” Pfizer Inc. v. Shalala, 182 F.3d 975, 976 (D.C.Cir.1999), Congress has concluded that the statutory scheme should include effective incentives for innovation such as patent protection for the substantial “investments necessary to research and develop new drug products” that pioneering companies undertake, Mylan Pharm., Inc. v. FDA, 454 F.3d 270, 272 (4th Cir.2006) (internal quotation marks omitted). With property rights comes the potential for price manipulation, however; and Congress is also perpetually concerned about drug manufacturer monopolies and the rising prices of prescription drugs. The Hatch-Waxman Amendments to the FDCA are aimed at “strik[ing] a balance between [creating] incentives ... for innovation,” on the one hand, and “quickly getting lower-cost generic drugs to market[,]” on the other. Teva Pharm. Indus. Ltd. v. Crawford, 410 F.3d 51, 54 (D.C.Cir.2005). This balance is reflected in statutory process for the FDA’s approval of new drugs. Specifically, the Hatch-Waxman Amendments mandate that the FDA must record patent information about approved drug products in a publication entitled “Approved Drug Products with Therapeutic Equivalence Evaluations,” which is generally called the “Orange Book,” after the color of its cover. If a drug product is the first-approved innovator of its kind, FDA will designate the product as an RLD that other products may later rely upon. Additionally, any 505(b)(2) NDA that is submitted to FDA for approval must identify the previously approved drug that the applicant is relying upon for approval, see 21 C.F.R. § 314.54, and must contain certain statements (“certifications”) regarding any “product patents” (patents covering a drug product or the drug substance that is a component of the drug product) and “method-of-use patents” (patents covering approved methods of using a drug product) that are listed in the Orange Book for the referenced drug, see 21 U.S.C. § 355(b)(2)(A). Notably, patent certifications are essentially promises that relate to the status of the drug product’s patents, as known or understood by the applicant: (I) no such patents exist, (II) any such patents have expired, (III) the proposed drug will not be marketed before the patents expire, or (IV) any such patents are invalid or will not be infringed by the proposed drug. See id. § 355(b)(2)(A)(i)-(iv). This last requirement — often referred to as a “Paragraph IV certification” — is particularly relevant here because Mutual and its affiliates received numerous patents directed to colchicine. Seventeen of these patents are listed in FDA’s Orange Book for Col-crys, and the earliest of the Colcrys patents expires on October 6, 2028. In addition to the obligation to reference the drug upon which the 505(b)(2) application relies and certify to its patents, a 505(b)(2) applicant must also provide notice of any Paragraph IV certification to owner of the RLD and each patent owner, explaining the factual and legal basis for the applicant’s opinion that the patent is invalid or not infringed. See 21 U.S.C. § 355(b)(3)(C)-(D). This notice enables the owners of the RLD and its related patents to litigate the patent issue before FDA approves the 505(b)(2) NDA applicant’s new drug product. To this end, upon the filing of a Paragraph IV certification, FDA is required to stay any approval for at least 45 days, and up to 30 months, in order to permit any potential patent litigation to proceed. See 21 U.S.C. § 355(c)(3)(C), (j)(5)(B)(iii). Thus, Congress has permitted new drug applicants to piggyback on the approved research of prior drug manufacturers— and thus forgo costly and time-consuming studies aimed at proving the safety and effectiveness of drug substances that have already been approved — in exchange for requiring those applicants to notify the owners of the drug that the new applicant relies upon so that the drug owner has an opportunity to take steps to protect its patent rights. See Abbott Labs. v. Young, 920 F.2d 984, 985 (D.C.Cir.1990) (“Facing the classic question of the appropriate trade-off between greater incentives for the invention of new products and greater affordability of those products, Congress struck a balance [in the Hatch-Waxman Amendments] between expediting generic drug applications and protecting the interests of the original drug manufacturers.”). 3. The Labeling Requirements In addition to selecting an approval path, as part of the Hatch-Waxman drug approval process drug sponsors must submit to FDA for approval the “proposed text of labeling,” 21 C.F.R. § 314.50(c)(2)©; see also 21 U.S.C. § 355(b)', including “adequate directions for use,” 21 U.S.C. § -352(f)(1). The labeling must contain all material facts and adequate warnings, and the product must be safe for the uses indicated in the labeling. Id. §§ 321(n), 352(f), and 352(p). FDA evaluates the information included in the text of the proposed labeling and has the authority to deny a drug application if it finds that the labeling information is not adequate or is false or misleading. See 21 U.S.C. § 355(d); 21 C.F.R. §§ 314.125(b)(6) and (b)(8). C. FDA’s Approval Of Colcrys (A Colchicine Tablet) When FDA finally undertook vigorous enforcement of Hatch-Waxman’s drug approval protocol in 2006, colchicine drug products that had previously been marketed as prescription drugs but had not gone through the new approval process were among the many types of pharmaceuticals that were forced to exit the market. (See AR at 5, 349.) The two drug companies that are at odds in the instant dispute— Takeda (previously Mutual) and Hikma (in conjunction with its U.S. agent WestWard) — had both previously marketed col-chicine products as prescription drugs in the U.S., and both companies sought to have those products approved for re-entry into the marketplace. On July 31, 2006, Mutual met with FDA to discuss the new regulatory requirements and to get information regarding what would be necessary to bring Mutual’s colchicine drug product into compliance with the statutory and regulatory scheme. (See id. at 5.) Because of the wealth of pre-existing information concerning the use of colchicine for the treatment of gout and FDA’s prior approval of combination colchicine products like ColBenemid and Col-Probenecid, Mutual discovered that it did not need to submit full NDAs supporting the safety and effectiveness of Colcrys for the treatment of gout. (See id. at 5-9.) Instead, Mutual submitted two successive 505(b)(2) NDAs in order to have its 0.6 mg single-ingredient oral colchicine tablet Col-crys approved for two indications: the treatment of acute gout flares and the prophylaxis of gout flares. (See id. at 668.) The contents of Mutual’s abbreviated new drug applications provide important context for understanding Plaintiffs’ challenge to FDA’s subsequent approval of Mitigare. 1. Mutual Relies On ColBenemid, Published Literature, And Its Own Clinical Studies To Support The Colcrys Application For Acute Flares Of Gout Mutual’s first Section 505(b)(2) application for Colcrys, which requested approval of a 0.6 mg single-ingredient oral colchi-cine tablet for treatment of acute gout flares, identified the combination drug product ColBenemid as the reference listed drug. (See id at 7.) In addition, Mutual’s application cited FDA’s earlier finding that ColBenemid is effective for the chronic treatment of gout, and also relied on published literature about the use of col-chicine. Mutual also conducted its own research; specifically, it sponsored two sets of studies that contributed to the existing body of knowledge about the potential toxicity of colchicine. Mutual’s Acute Gout Flare Receiving Colchicine Evaluation trial (“the AGREE trial”) was a “randomized, double-blind, placebo-controlled clinical trial” that evaluated “the efficacy, safety, and tolerability of colchicine in patients with an acute gout flare[.]” (Id. at 6.) “The AGREE trial was necessary for approval of colchicine for the treatment of acute gout flares because only a single randomized, controlled clinical trial of colchicine in this indication existed in the medical literature.” (Id. at 22.) The AGREE trial showed that a low-dose regimen of colchicine for the treatment of acute gout- flares reduced the number of adverse events that patients experienced but was still as effective at treating gout flares as a higher dose regimen. (Id. at 6-7.) This new data “improve[d] the safety profile of colchicine when used to treat acute gout flares” and permitted Mutual to develop a new, low-dose regimen for the use of colchicine for the treatment of acute gout flares. (Id. at 7.) Mutual also conducted certain drug-drug interaction studies (“DDI studies”) comparing colchicine administered alone with colchicine administered in conjunction with other drugs. (Id.) Such drugs included cytochrome P4503 (“CYP3A4”) inhibitors and Pglycoprotein (“P-gp”) inhibitors— pharmaceuticals that can affect the mechanisms that the body uses to metabolize colchicine, and thus were already known to have the potential of leading to toxic col-chicine blood levels. (Id. at 50, 58-60, 668.) As a result of its DDI studies, Mutual developed a new dosing regimen for concomitant use of Colcrys with certain CYP3A4 inhibitors and P-gp inhibitors. Thus, although the potential for adverse reactions from the interaction of certain drugs with colchicine was already well-known prior to Mutual’s research, Mutual’s DDI studies “allowed for a more precise quantitative assessment of the interactions.” (Id. at 668; see also id. at 50 (summarizing dose modifications developed by Mutual).) FDA approved Mutual’s 505(b)(2) NDA for Colcrys for the treatment of acute gout flares on July 30, 2009. (See AR at 6.) On that same day, based on Mutual’s AGREE trial and DDI studies, FDA issued a related drug safety communication for healthcare providers (an “FDA Alert”). See FDA, Information for Healthcare Professionals: New Safety Information for Colchicine (marketed as Colcrys) (July 30, 2009). This FDA Alert informed healthcare professionals of the results of the Mutual colchicine studies, namely that “a substantially lower dose of colchicine was as effective as the traditional higher dose in treatment of acute gout flares” and that colchicine could have dangerous “drug interactions with P-gp inhibitors or strong CYP3A4 inhibitors[.]” (AR at 7.) FDA purportedly took this action to combat “outdated assumptions of what is safe and effective for treatment with oral colchi-cine” and to ensure that patients would not “suffer from adverse reactions such as severe gastro-intestinal complications — and even death — needlessly.” (Id. at 8 (internal quotation marks omitted.) The FDA Alert also “referred healthcare professionals to the dosing recommendations and additional drug interaction information in Colcrys product labeling.” (Id. at 7.) 2. Mutual Relies on ColBenemid and Published Literature To Support The Colcrys Application For Prophylactic Treatment of Gout Approximately three months after the FDA Alert was issued, on October 16, 2009, FDA approved a second Colcrys application, this time for the prophylaxis of gout flares. (See id. at 8.) Unlike Mutual’s application for approval of Colcrys for the treatment of acute gout flares, Mutual’s application for Colcrys for the prophylaxis of gout flares did not include new studies in support of the safety and efficacy of the drug product. (Id.) Instead, Mutual’s assertion that Colcrys is a safe treatment for the prophylaxis of gout flares was based on “an assessment of adverse events from the worldwide literature and postmarketing adverse event databases” and “cross-reference to Mutual’s earlier colchicine NDAs.” (Id.) Mutual’s assertion that Colcrys is an effective treatment for the prophylaxis of gout flares “was based entirely on the published literature, including published reports of two randomized, controlled trials of colchicine for this indication and the DESI finding for ColBenemid” (id. at 22-23 (footnote omitted)). 3. FDA Takes Enforcement Action Against Unapproved Oral Colchicine Products Because Their Labels Do Not Reflect The Most Current Data On September 30, 2010 — nearly one year after Colcrys was approved for prophylaxis of gout flares — “FDA announced its intention to take enforcement action against unapproved single-ingredient oral colchicine products and persons who manufacture or cause the manufacture of such products or their shipment in interstate commerce.”. (Id. at 9.) This action was part of the broader initiative that the agency had launched in 2006 against unapproved marketed drugs generally, and with respect to colchicine products in particular, FDA remarked that “the labeling for unapproved single-ingredient oral col-chicine products listed with FDA ... does not reflect the most current data regarding the safety and effectiveness of single-ingredient oral colchicine.” See Single-Ingredient Oral Colchicine Products; Enforcement Action Dates; Notice, 75 Fed. Reg. 60768 at 60769-70 (effective October 1, 2010); see also FDA News Release, “FDA orders halt to marketing of unapproved single-ingredient oral colchicine” (Sept. 30, 2010). Notably, the agency expressed a particular concern with how the labels of unapproved colchicine products dealt with the use of colchicine for the treatment of acute gout flares and potential drug-drug interactions — the two areas that Mutual had studied and had specifically addressed in the Colcrys label. Unlike Colcrys, the labels of unapproved colchicine products generally used vague warnings suggesting “avoidance when possible and caution when necessary, with vigilant monitoring of clinical signs of toxicity.” (AR at 668.) By contrast, consistent with the findings of Mutual’s DDI studies and AGREE trial, the Colcrys label contained both: (1) a two-page table of dose modifications intended to help mitigate the risk of colchi-cine toxicity for patients taking Colcrys in combination with the drug products listed in the table (see Compl. Ex. 5 at 5-6), and (2) a low dose regimen of colchicine for treatment of acute gout flares that occur while colchicine is already being used to treat prophylaxis (see id. at 3). FDA suggested that it was important that similar information appear on the labels of all colchicine products, calling Mutual’s findings about lower dosing for acute gout flares “the standard of care” at the time, and also noting that “awareness regarding colchicine interactions may not be widespread in the healthcare community.” 75 Fed.Reg. 60769. D. FDA’s Approval Of Mitigare (A Colchicine Capsule) West-Ward removed its unapproved single-ingredient 0.6 mg colchicine tablet from the market in response to FDA’s enforcement announcement, just as Mutual had done. (AR at 50.) West-Ward had been marketing its 0.6 mg single-ingredient oral colchicine tablet since the early 1970s. (Id.). In an attempt to comply FDA’s new approval scheme and announced enforcement measures, WestWard submitted a Section 505(b)(2) application to FDA for approval of its preexisting colchicine tablet. (Id. at 50-51.) Before filing its application, however, West-Ward specifically inquired of FDA whether the agency would entertain a 505(b)(2) application for a colchicine tablet that referenced and relied upon Col-Pro-benecid, rather than Mutual’s recently-approved Colcrys, and the agency answered in the affirmative. (See id. at 6.) It is undisputed that Westward wanted to cite Col-Probenecid instead of Colcrys because, unlike Colcrys, Col-Probenecid is not tied to any patents that would require West-Ward to submit a Paragraph IV certification that would delay the approval and re-marketing of West-Ward’s colchi-cine product. West-Ward filed the aforementioned Section 505(b)(2) application for approval of a colchicine tablet that referenced Col-Probenecid in August 2010. (See AR at 50.) Athough FDA’s new drug approval process is confidential, Mutual learned of West-Ward’s application through public sources while approval was pending. (Compl., Takeda Pharms. U.S.A., Inc. v. Burwell, No. 14-1668-KBJ (D.D.C. Oct. 6, 2014), ECF No. 1, ¶ 35.) 1. Mutual Files A Citizen Petition Protesting WestAWard’s Application And FDA Responds On November 26, 2010, Mutual filed a “citizen petition” with FDA regarding the agency’s requirements for ANDAs and Section 505(b)(2) NDAs for colchicine tablets. Mutual specifically requested that FDA take, or refrain from taking, a number of actions; as relevant here, Mutual asked the agency to: (1) “[rjefrain from filing or approving any application for a 0.6 mg oral colchicine tablet with a proposed indication already approved for Colcrys (i.e., a “duplicate” of Colcrys) that is not submitted as an ANDA”; (2) “[rjefrain from filing or approving any ANDA or 505(b)(2) application for a single-ingredient oral colchicine product that does not reference Colcrys and include certifications to the patents listed in FDA’s [Orange Book] for Colcrys;” and (3) “[r]equire the labeling for any single-ingredient oral colchicine product to include all information related to drug-drug interactions that is in the Colcrys labeling, including relevant dose adjustments needed to prevent unnecessary toxicity[.]” (AR at 1.) In other words, Mutual asked FDA to mandate that every single-ingredient oral colchicine product submitted to the agency for approval both reference Colcrys and have the same safety information and dose adjustments that are on Colcrys’s label; and also that FDA reject any application for a drug product exactly like Colcrys that is submitted through the 505(b)(2) pathway. On May 25, 2011, FDA responded to Mutual’s Citizen Petition, granting the petition in part and denying it in part. (See id. at 2.) For present purposes, FDA made three significant decisions. First, the Colchicine Citizen Petition Response sustained Mutual’s objections to WestWard’s 505(b)(2) application for a 0.6 mg single-ingredient colchicine tablet that was identical to Colcrys. FDA acknowledged that it had previously advised West-Ward that West-Ward could submit an application for its 0.6 mg single-ingredient colchi-cine tablet via the 505(b)(2) pathway and without referencing Colcrys, but admitted in the Response that the agency had been “incorrect” about that, and added that “FDA regrets that [] advice to WestWard.” (Id. at 17.) Thus, FDA granted Mutual’s request that the agency require any application for a single-ingredient oral colchicine product that was identical to Colcrys “be submitted as an ANDA that cites Colcrys as the RLD and complies with applicable regulatory requirements.” (Id. at 2-3.) FDA also stated that the West-Ward application needed to be withdrawn and resubmitted as an ANDA (see id. at 11-16). Second, FDA’s Citizen Petition Response addressed Mutual’s broader contention that any single-ingredient colchi-cine product — not just a 0.6 mg tablet such as the one submitted by West-Ward— “must necessarily cite Colcrys as its listed drug, irrespective of whether the proposed product shares the same strength, phar-macokinetic (PK) profile, or other characteristics such as dosage form or conditions of use.” (Id. at 3.) FDA denied this request. (See id.) The agency explained that a drug product that differs from Col-crys in one of the above listed ways is not a “duplicate” of Colcrys and therefore presents a different set of circumstances than West-Ward’s admittedly incorrect 505(b)(2) application for a 0.6 mg single-ingredient oral colchicine tablet that did not reference Colcrys. (See id. at 12-13.) FDA stressed that, although requiring duplicate products to be approved through the ANDA pathway “ensures that duplicate products are marketed with the same or similar labeling that FDA has determined contains the scientific information necessary for the safe and effective use” (id. at 13), a 505(b)(2) NDA must directly demonstrate that the proposed drug product is safe and effective. (See id. at 3 (noting that “any 505(b)(2) application for a proposed single-ingredient colchicine product must meet the statutory approval standard for safety and effectiveness”).) The agency also remarked that, “in light of the significant amount of non-product-specific published scientific literature on col-chicine and additional non-product-specific scientific literature that may become available over time, FDA declines to speculate on whether a 505(b)(2) applicant for a non-pharmaceutieally equivalent product could submit adequate safety and effectiveness data to support approval without reference to Colcrys.” (Id. at 21.) Thus, although FDA promised that it would reject an application for a duplicate of Colcrys that did not reference Colcrys, FDA also anticipated that the agency might approve a single-ingredient oral colchicine product that did not cite Colcrys, so long as the new drug product differed from Colcrys in some way and the new drug product’s 505(b)(2) application made the requisite showing of safety and effectiveness. Third, FDA’s Citizen Petition Response described what type of information FDA would require for the label of a single-ingredient oral colchicine product. With respect to label information about concomitant use of colchicine with other drugs, FDA commented that “Mutual’s drug-drug interaction studies [had] provided new, quantitative information about the extent of changes in exposure that can occur with co-administration of certain drugs with col-chicine.” (Id. at 19.) Thus, the label “for any single-ingredient oral colchicine product needs to include adequate information on drug-drug interactions, including relevant dose adjustments needed to prevent unnecessary toxicity.” ■ (Id. at 3.) As for the use of colchicine to treat the acute flares of patients who were already taking colchicine for prophylaxis, FDA stated that “the labeling for a single-ingredient colchi-cine product seeking approval for prophylaxis of gout flares must inform healthcare providers that the lower dose colchicine regimen evaluated in the AGREE trial is adequate to treat an acute gout flare that may occur during chronic colchicine use[.]” (Id. at 3.) 2. FDA Approves Mitigare Capsule For Prophylaxis Of Gout Flares Based On Col-Probenecid, Published Literature, and West-Ward’s Own Studies After FDA determined that it was unacceptable for West-Ward to submit a Section 505(b)(2) application for á colchicine tablet that was a duplicate of Colcrys, as explained above, West-Ward reformulated its product, and submitted a new 505(b)(2) application for a colchicine capsule named Mitigare. West-Ward’s application for Mitigare relied on published literature about colchicine, FDA’s findings of safety and effectiveness from Col-Probenecid, and new clinical pharmacology studies West-Ward conducted. (See AR at 108.) This application differed from WestWard’s earlier application for a single-ingredient colchicine product in at least two significant ways. First, Mitigare is a capsule, not a tablet. Like Colcrys, Mitigare contains 0.6 mg of colchicine administered orally, but the difference in dosage form means that Miti-gare is not a duplicate of Colcrys, and as a result, FDA permitted West-Ward to file its application for Mitigare using the 505(b)(2) pathway rather than the ANDA pathway. (See Ex. 11 to Takeda Compl., ECF No. 1-1, at 217-32, FDA Ctr. for Drug Evaluation & Research, Guidance for Indus.: Appls. Covered By Sec. 505(b)(2), Draft Guidance (Oct. 1999) at 6 (noting that “[a]n application that is a duplicate of a listed drug and eligible for approval under section 505(j)” “can’t be submitted as 505(b)(2) application”).) Second, West-Ward conducted new DDI studies to support its application. In an effort to produce a single-ingredient oral colchicine product that did not reference Colcrys or rely upon Mutual’s data, WestWard commenced a development program that FDA recommended in which WestWard sponsored DDl studies similar to Mutual’s but involving a different set of CYP3A4 and P-gp inhibitor drugs. (AR at 118, 669.) Per FDA’s advice, West-Ward chose to study the same classifications of drugs that Mutual studied; however, contrary to expectations, the results of WestWard’s studies differed substantially from the results of Mutual’s studies. (See id. at 669-70.) Mutual’s studies had indicated that colchicine dosing regimens should be modified when colchicine is co-administered with certain types of drugs, but West-Ward’s results indicated that dose modifications are “not warranted” when 0.6 mg colchicine is administered concomitantly with certain CYP3A4 inhibitors and P-gp inhibitors. (Id. at 670.) When West-Ward submitted its research as part of the Mitigare application, FDA wrestled with these unexpected results, comparing Mutual’s data with West-Ward’s data and attempting to understand the differing results. (See id. at 667-711.) FDA ultimately reached the conclusion that Mitigare is safe and effective for the prophylaxis of gout, and approved WestWard’s 505(b)(2) application on September 26, 2014. (See id. at 28.) As approved, Mitigare not only differs from Colcrys in dosage form, it also has a substantially different label than Colcrys. In contrast to the Colcrys label, the Mitigare label does not include the lower dose colchicine regime for the treatment of acute gout flares that Mutual evaluated in its AGREE trial; rather, the Mitigare label states under the “[ljimitations of use” section that “[t]he safety and effectiveness of Mitigare for acute treatment of gout flares during prophylaxis has not been studied.” (id. at 32 (Mitigare label)). Furthermore, instead of the detailed dose modifications for preventing drug-drug interaction toxicity that the Colcrys label contains, the Mitigare label warns generally that patients taking certain drugs in combination with Mitigare should avoid the combination entirely, or if avoidance is not possible, adjust the dose of Mitigare “by either reducing the daily dose or reducing the dose frequency, and the patient should be monitored carefully for colchicine toxicity.” (AR at 141 (citation omitted).) 3. West-Ward, Launches Mitigare, Alerting Takeda To The Existence Of Mitigare FDA’s evaluation of West-Ward’s application for Mitigare was undertaken confidentially, in accordance with FDA rules and regulations. See 21 C.F.R. § 314.430(b) (“FDA will not publicly disclose the existence of an application or abbreviated application before an approval letter is sent to the applicant under § 314.105 or tentative approval letter is sent to the applicant under § 314.107[J”). Moreover, because West-Ward neither cited Colcrys as the RLD nor certified to any Colcrys patents in West-Ward’s 505(b)(2) application for Mitigare, Westward did not inform Takeda of West-Ward’s application for Mitigare. Consequently, Plaintiffs did not know about West-Ward’s application for Mitigare until September 30, 2014, when West-Ward issued a press release regarding FDA’s approval of its new single-ingredient colchicine product. (See Confidential Deck Matthew Woods, Takeda Pharms. U.S.A., Inc. v. Burwell, No. 14-1668-KBJ, ECF No. 3-6 ¶ 33.) Moreover, Takeda only discovered that WestWard' intended to market an authorized generic version of Mitigare that will compete with — and cost less than — Takeda’s Colcrys, on October 1, 2014. (See id. ¶ 34.) E. Procedural History On October 6, 2014, Takeda filed a two-count complaint and a Motion for a Preliminary Injunction against Defendants Burwell and Hamburg. (See Compl., Takeda Pharms. U.S.A., Inc. v. Burwell, No. 14-1668-KBJ (D.D.C. Oct. 6, 2014), ECF No. 1 (“Takeda Compl.”); Mot. for TRO or Prelim. Inj., Takeda Pharms. U.S.A., Inc. v. Burwell, No. 14-1668-KBJ (D.D.C. Oct. 8, 2014), ECF No. 9, see also Mem. Supp. Pl.’s Confidential Mot. for TRO or Prelim. Inj., Takeda Pharms. U.S.A, Inc. v. Burwell, No. 14-1668-KBJ (D.D.C. Oct. 8, 2014), ECF No. 10 (“Takeda PI Mem.”).) In its complaint, Takeda alleges that FDA acted wrongfully in three respects: (1) “FDA acted arbitrarily and capriciously in approving [West-Ward’s] Section 505(b)(2) application for Mitigare without requiring the label to contain critical safety information that FDA previously stated was necessary for single-ingredient oral colchicine products[;]” (2) “FDA’s approval of [West-Ward’s] application for Mitigare was unlawful, arbitrary and capricious because, as approved, Mitigare is not safe in light of the defects in its label[;]” and (3) “FDA’s failure to require [West-Ward] to reference Takeda’s own colchicine drug, Colcrys, in its application interfered with Takeda’s rights to participate in the administrative process, including the Paragraph IV certification process under Hatch Waxman and the Citizen Petition process.” (Takeda Compl. ¶ 1.) Takeda initiated a patent infringement action against West-Ward in the United States District Court for the District of Delaware shortly before it brought this action against FDA. (See Compl., Takeda Pharms. U.S.A., Inc. v. West-Ward Pharm. Corp., No. 14-1268-SLR, 2014 WL 5241780 (D.Del. Oct. 3, 2014), ECF No. 1.) On October 9, 2014, the Delaware court entered a Temporary Restraining Order enjoining West-Ward from marketing Mitigare pending further proceedings in the patent litigation. (See Memorandum Order, Takeda Pharms. U.S.A, Inc. v. West-Ward Pharm. Corp., No. 141268-SLR, 2014 WL 5088690 (D.Del. Oct. 9, 2014, ECF No. 21.) The Delaware court eventually denied Takeda’s Motion for a Preliminary Injunction, but “given the significance of this dispute to both parties” issued an order maintaining the status quo — that is, prohibiting West-Ward from marketing Mitigare — pending Takeda’s appeal of that court’s decision regarding the preliminary injunction. (Memorandum Opinion at 16, Takeda Pharms. U.S.A., Inc. v. West-Ward Pharm. Corp., No. 14-1268-SLR, 72 F.Supp.3d 539, 2014 WL 5780611 (D.Del. Nov. 4, 2014), ECF No. 78, 2014 WL 5088690; see also Order, Takeda Pharms. U.S.A., Inc. v. WestWard Pharm. Corp., No. 14-1268-SLR, 72 F.Supp.3d 539, 2014 WL 5780611 (D.Del. Nov. 4, 2014), ECF No. 79.) Meanwhile, in the instant District of Columbia case,. West-Ward moved to intervene in Takeda’s suit against FDA, and' this Court granted that request. (See Unopposed Mot. to Intervene, Takeda Pharms. U.S.A., Inc. v. Burwell, No. 14-1668-KBJ (D.D.C. Oct. 9, 2014), ECF No. 11; Minute Entry dated Oct. 9, 2014, Takeda Pharms. U.S.A, Inc. v. Burwell, No. 14-1668-KBJ.) West-Ward and the Government then filed oppositions to Takeda’s Motion for a Preliminary Injunction. (See Hikma and West-Ward’s Opp’n to Mot. for TRO (“West-Ward Opp. Mem.”), Takeda Pharms. U.S.A., Inc. v. Burwell, No. 14-1668-KBJ (D.D.C. Oct. 17, 2014), ECF No. 16; Burwell and Hamburg’s Resp. to Mot. for TRO (“FDA Opp. Mem.”), Takeda Pharms. U.S.A., Inc. v. Burwell, No. 14-1668-KBJ (D.D.C. Oct. 17, 2014), ECF No. 15.) Takeda field a reply on October 20, 2014. (See Reply to Opp’n to Mot. for, TRO (“Takeda Reply Mem.”), Takeda Pharms. U.S.A., Inc. v. Burwell, No. 14-1668-KBJ (D.D.C. Oct. 20, 2014), ECF No. 21.) On November 4, 2014, this Court heard argument from Takeda, FDA, and WestWard on Takeda’s Motion for a Preliminary Injunction. (See Minute Entry dated Nov. 4, 2014, Takeda Pharms. U.S.A., Inc. v. Burwell, No. 14-1668-KBJ). However, in light of the stay that was issued in the Delaware patent litigation, this Court consolidated Takeda’s Motion for a Preliminary Injunction with the resolution of the merits of Takeda’s' complaint and, with Takeda’s consent, construed the merits arguments in Takeda’s preliminary injunction motion as a motion for summary judgment. (See Order, Takeda Pharms. U.S.A., Inc. v. Burwell, No. 14-1668-KBJ (D.D.C. Nov. 5, 2014), ECF No. 40.) The parties subsequently filed supplemental briefs on Takeda’s converted motion. (See Burwell and Hamburg’s Supplemental Mem. (“FDA Suppl. Mem.”), Takeda Pharms. U.S.A., Inc. v. Burwell, No. 14-1668-KBJ (D.D.C. Nov. 14, 2014), ECF No. 43; Takeda’s Supplemental Mem. (“Takeda Suppl. Mem.”), Takeda Pharms. U.S.A., Inc. v. Burwell, No. 14-1668-KBJ (D.D.C. Nov. 14, 2014), ECF No. 44; Hikma and West-Ward’s Supplemental Mem., (‘West-Ward Suppl. Mem.”), Takeda Pharms. U.S.A., Inc. v. Burwell, No. 14-1668-KBJ (D.D.C. Nov. 14, 2014), ECF No. 45.) On the same day that this Court heard argument on Takeda’s then-pending preliminary injunction motion (November 4, 2014), Elliott Associates, L.P., Elliott International, L.P., and Knollwood Investments, L.P. (collectively, “Elliott”) filed a two-count complaint against Defendants Burwell and Hamburg that is substantially similar to Takeda’s action. (See Compl. Elliott Assocs. v. Burwell, No. 14-1850-KBJ (D.D.C. Nov. 4, 2014), ECF No. 1 (“Elliott Compl.”).) Elliott “owns a legally-enforceable right tied to the Colcrys patents to receive a percentage of the royalties from the sale of Colcrys,” and because Elliott expects that Mitigare will compete directly with Colcrys, these plaintiffs allege that FDA’s failure to require West-Ward to certify to the Colcrys patents has injured them. (Elliott Compl. ¶ 7.) The Elliott complaint specifically alleges that FDA acted wrongfully in two respects: (1) that “FDA’s decision to approve Mitigare without requiring that [West-Ward] certify to the patents covering the use of colchicine for the prophylaxis of gout flares violates the plain text of Section 505(b)(2)(A) of the FDCA[;]” and (2) that “FDA acted in an arbitrary and capricious manner by approving [WestWard’s] 505(b)(2) application without requiring a certification as to the Colcrys patents.” (IdA 9-11.) Elliott filed a motion for summary judgment on November 17, 2014. (See Mot. for Summ. J, Elliott Assocs. v. Burwell, No. 14-1850-KBJ (D.D.C. Nov. 17, 2014), ECF No. 14, see also PL’s Mem. Supp. Mot. for Summ. J., Elliott Assocs. v. Burwell, No. 14-1850-KBJ (D.D.C. Nov. 17, 2014), ECF No. 14-1 (“Elliott MSJ Mem.”).) Just as they had in Takeda v. Burwell, Hikma and WestWard moved to intervene in Elliott v. Burwell. (See Consent Mot. to Intervene, Elliott Assocs. v. Burwell, No. 14-1850-KBJ (D.D.C. Nov. 18, 2014), ECF No. 47.) This Court granted the motion. (See Minute Entry dated Nov. 21, 2014, Elliott Assocs. v. Burwell, No. 14-1850-KBJ.) In light of the overlap between the parties, facts, and allegations in Takeda v. Burwell and Elliott v. Burwell, this Court that the two cases should be considered in tandem. (See Minute Entry dated Nov. 18, 2014, Elliott Assocs. v. Burwell, No. 14-1850-KBJ.) On November 19, 2014, this Court held a second motions hearing in which the parties in both cases participated. (See Minute Entry dated Nov. 19, 2014, Takeda Pharms. U.S.A., Inc. v. Burwell, No. 14-1668-KBJ.) After the hearing, West-Ward and FDA filed cross-motions for summary judgment in Elliott v. Burwell. (See Cross Mot. for Summ. J. by Hikma and West-Ward, Elliott Assocs. v. Burwell, No. 14-1850-KBJ (D.D.C. Dec. 9, 2014), ECF No. 60; Mem. in Opp. by Hikma and West-Ward, Elliott Assocs. v. Burwell, No. 14-1850-KBJ (D.D.C. Dec. 9, 2014), ECF No. 61 (“West-Ward XMSJ Mem.”); Cross Mot. for Summ. J. by Burwell and Hamburg (“FDA XMSJ Mem.”), Elliott Assocs. v. Burwell, No. 14-1850-KBJ (D.D.C. Dec. 9, 2014), ECF No. 62; Mem. in Opp by Burwell and Hamburg, Elliott Assocs. v. Burwell, No. 14-1850-KBJ (D.D.C. Dec. 9, 2014), ECF No. 63 (“FDA XMSJ Mem.”).) Elliott filed a reply to both Cross-Motions on December 13, 2014. (See Reply to Opp’n and Cross Mot. for Summ. J. (“Elliott MSJ Reply Mem.”), Elliott Assocs. v. Burwell, No. 14-1850-KBJ (D.D.C. Dec. 13, 2014), ECF No. 64.) The motions for summary judgment in Takeda v. Burwell and Elliott v. Burwell are now ripe. II. LEGAL STANDARDS Under Federal Rule of Civil Procedure 56, summary judgment is appropriate when the moving party demonstrates “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. However, in a case involving review of final administrative action — such as FDA’s approval of a new drug — the standard set forth in Rule 56 does not apply. See, e.g., ViroPharma, Inc. v. Hamburg, 916 F.Supp.2d 76, 79 (D.D.C.2013). Instead, “FDA’s administrative decisions are subject to review under the Administrative Procedure Act (‘APA’), 5 U.S.C. § 706, which requires the reviewing court to set aside an agency action that is ‘arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.’ ” ISTA Pharm., Inc. v. FDA 898 F.Supp.2d 227, 230 (D.D.C.2012). “Summary judgment thus serves as a mechanism for deciding, as a matter of law, whether the agency action is supported by the administrative record and is otherwise consistent with the APA standard of review.” Hill Dermaceuticals, Inc. v. FDA No. 11-1950, 2012 WL 5914516, at *7 (D.D.C. May 18, 2012) (citing Richards v. INS, 554 F.2d 1173, 1177 & n. 28 (D.C.Cir.1977)); see also Am. Bioscience, Inc. v. Thompson, 269 F.3d 1077, 1083-84 (D.C.Cir.2001) (collecting cases). In reviewing agency action, a court must be mindful of the division of labor between the court and the agency. “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 Pharmacol Co. v. FDA 587 F.Supp.2d 13, 18 (D.D.C.2008) (internal quotation marks and citation omitted). Accordingly, a reviewing court cannot “substitute its judgment for that of the agency,” Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43, 103 S.Ct. 2856, 77 L.Ed.2d 443 (1983), especially when the agency’s scientific expertise informs its judgment. See Balt. Gas & Elec. Co. v. Natural Res. Def. Council, Inc., 462 U.S. 87, 103, 103 S.Ct. 2246, 76 L.Ed.2d 437 (1983) (holding that “[w]hen examining ... [a] scientific determination ... a reviewing court must generally be at its most deferential”). Moreover, given that “[t]he scope of review under the ‘arbitrary and capricious’ standard is narrow[,]” State Farm, 463 U.S. at 43, 103 S.Ct. 2856, the agency action under review is “entitled to a presumption of regularity!,]” Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 415, 91 S.Ct. 814, 28 L.Ed.2d 136 (1971), overruled on other grounds by Califano v. Sanders, 430 U.S. 99, 97 S.Ct. 980, 51 L.Ed.2d 192 (1977). In sum, the court performs “only the limited, albeit important, task of reviewing agency action to determine whether the agency conformed with controlling statutes[,]” Balt. Gas, 462 U.S. at 97, 103 S.Ct. 2246, and/or whether the agency has committed “a clear error of judgment!,]” Overton Park, 401 U.S. at 416, 91 S.Ct. 814. III. DISCUSSION Although the instant cross-motions for summary judgment focus on the alleged impropriety of one agency action — FDA’s approval of Mitigare — Plaintiffs make myriad arguments in an attempt to support their claim that FDA’s approval of that drug product was wrongful and should be rescinded. First, both Takeda and Elliott steadfastly maintain that FDA should not have approved Mitigare without requiring West-Ward to certify to the Col-crys patents that cover the use of colchi-cine for the prophylaxis of gout flares, with Takeda asserting that the agency relied on Colcrys’s data to approve Mitigare and thus FDA’s failure to require West-Ward to reference Colcrys and certify to the Colcrys patents violated the agency’s own procedural rules (see Takeda Reply Mem. at 19-22; Takeda Suppl. Mem. at 6-13), and Elliott arguing additionally that the agency’s failure to require West-Ward to certify to the Colcrys patents without regard- to any reliance on Colcrys contravened both the agency’s longstanding policies and the FDCA itself (see Elliott MSJ Mem. at 23-46). In addition, Takeda takes issue with Mitigare’s label, arguing that “[t]he Mitigare label contains neither the FDA-approved low-dose-treatment notation for acute gout nor the drug-drug interaction dosing adjustments, both of which FDA expressly required in light of the severe safety concerns it identified during the Colcrys review process.” (Takeda PI Mem. at 32 (citation omitted).) Consequently, Takeda contends that Miti-gare is unsafe as labeled, and also that FDA’s approval of Mitigare constitutes an unreasoned change in the agency’s position regarding the requirements for the labeling of single-ingredient oral colchicine products. (See id. at 26-36.) Takeda also argues that “FDA’s failure to enforce its own labeling requirements allowed [Westward] to circumvent the statutory directive that it file a Paragraph IV certification to Takeda’s patents[.]” (Id. at 36.) For the reasons explained below, this Court concludes that Plaintiffs are wrong to characterize FDA’s actions with respect to Mitigare as unauthorized, unsafe, or unreasoned; to the contrary, it is clear on the record presented that FDA’s approval of Mitigare was consistent with the FDCA, the regulations the agency has promulgated pursuant to the FDCA, the Citizen Petition Responses FDA has issued, and the policies and practices under which the agency operates. Furthermore, the record clearly reveals the reasonableness of FDA’s expert determination that Mitigare is safe and effective as labeled, and it supports the agency’s conclusion that Miti-gare’s labeling best reflects current scientific information regarding the risks and benefits of Mitigare-a conclusion that, in any event, is entitled to a high degree of deference. Consequently, Plaintiffs have failed to establish that summary judgment should be entered in their favor on their APA claims, and this Court finds that Defendants are entitled to summary judgment as a matter of law. A. FDA’s Approval Of Mitigare Without A Colcrys Reference And Related Certifications To The Colcrys Patents Did Not Violate The Agency’s Rules Or The FDCA Both Plaintiffs contend that, when FDA approved Mitigare without a Paragraph IV certification to the Colcrys patents, FDA permitted West-Ward to “circumvent” the agency’s own Hatch-Waxman directives regarding the filing of patent certifications, in a manner that was arbitrary, capricious, an abuse of discretion, and otherwise not in accordance with law. (See Takeda PI Mem. at 36; Takeda Compl. ¶¶ 1, 56; Elliott MSJ Mem. at 29; Elliott Compl. ¶ 14); see also 5 U.S.C. § 706(2)(A). It bears noting at the outset that the assertion that FDA should have required West-Ward to reference Colcrys and to certify to the Colcrys patents is, from a broad perspective, the same argument that Takeda’s predecessor Mutual made to FDA in its 2010 Citizen Petition (see supra Part I.D.l), when Mutual specifically asked that the agency refrain from approving any future Section 505(b)(2) application for a single-ingredient oral colchicine product that does not reference Colcrys and include certifications to the Colcrys patents. (See AR at 1.) As explained above, FDA specifically rejected that request in its Col-chicine Citizen Petition Response, stating, inter alia, that a Section 505(b)(2) application for a single-ingredient oral colchicine product might not need to cite Colcrys as its reference listed drug if the new drug •does not share the same dosage form. (See AR at 3; see also supra Part I.D.l.) The agency also emphasized that “[w]hether another 505(b)(2) application for a single-ingredient colchicine product that does not cite Colcrys as a listed drug could ever be appropriate will depend on the facts and circumstances of the particular appli-eation[.]” (AR at 21.) Plaintiffs argue now th