JAMES C. FRANCIS IV, United States Magistrate Judge.
Plaintiffs Natural Resources Defense Council, Inc. ("NRDC"), Center for Science in the Public Interest, Food Animal Concerns Trust, Public Citizen, and Union of Concerned Scientists brought this action against the various government defendants seeking to compel the United States Food and Drug Administration (the "FDA") to initiate proceedings to withdraw its approval of the use of certain antibiotics in livestock for non-therapeutic purposes.
The March 22 Order requested additional briefing on the issue of a schedule under which the FDA must act. (March 22 Order at 152 n. 19). In the midst of that briefing, the Government appealed the March 22 Order (Notice of Appeal dated May 21, 2012) and filed a motion requesting that this Court stay the March 22 Order pending resolution of the appeal or, in the alternative, impose an interim stay pending disposition of the Government's not-yet-filed stay application in the United States Court of Appeals for the Second Circuit (Memorandum of Law in Support of the Government's Motion for a Stay Pending Appeal ("Gov't Stay Memo.") at 1). The plaintiffs, for their part, filed a motion to strike documents that the Government submitted in connection with its motion for summary judgment on the third claim for relief. (Plaintiffs' Motion to Strike Non-Record Material ("Motion to Strike")).
Upon Judge Katz' retirement, this case was reassigned to me. Before me now, then, are the parties' briefs regarding timing, the Government's motion for a stay, and the plaintiffs' motion to strike, and I held oral argument on these issues on July 18, 2012. For the reasons that follow, the plaintiffs' motion to strike is granted in part; the Government's proposed schedule for compliance with the March 22 Order is adopted; and the Government's motion for a stay is denied.
The facts of the case are set out in the March 22 and June 1 Orders, with which I assume familiarity. Nevertheless, some background will be helpful in understanding the following discussion.
In the 1950s, the FDA approved the use of antibiotics "to stimulate growth and promote feed efficiency in food-producing animals" and issued permissions (by approving new animal drug applications or abbreviated new animal drug applications) for penicillin and tetracyclines to be used for such purposes. (March 22 Order at 131-32). By the mid-1970s, however, the FDA, concerned with the public health risk to humans and animals of antibiotic resistance caused by such uses, issued a regulation "providing that the agency would propose to withdraw approval of all [non-therapeutic] uses of antibiotics in animal feed unless drug sponsors and other interested parties" presented data resolving the agency's concerns. (March 22 Order at 132-33). Thereafter, the FDA's Bureau of Veterinary Medicine (the "BVM") (which has since been renamed the Center for Veterinary Medicine (the "CVM")), along with a subcommittee of the FDA's National Advisory Food and Drug Committee (the "NAFDC") reviewed the data submitted. (March 22 Order at 133 & n. 5). In 1977, the NAFDC adopted the report and recommendations of its subcommittee, which advised the FDA to "withdraw approval for the [non-therapeutic] uses of penicillin" and "discontinue the[] use [of tetracyclines] for growth promotion and/or feed efficiency in all animal species for which effective substitutes are
Later in 1977, after review of the NAFDC recommendations, the Director of the BVM issued notices of an opportunity for hearing ("NOOHs") on proposals to withdraw approval of all non-therapeutic uses of penicillin in animal feed and most non-therapeutic uses of tetracyclines in animal feed. (March 22 Order at 133-34). The FDA issued the NOOHs pursuant to a subsection of the provision of the FDCA governing "New Animal Drugs":
21 U.S.C. 360b(e)(1)(B). In response, "approximately twenty drug firms, agricultural organizations, and individuals requested hearings," at which, pursuant to the statutory and regulatory scheme, they would have the burden of proving that the relevant uses of the drugs were safe. (March 22 Order at 134).
The Commissioner of the FDA granted the hearing requests, but no hearings were ever scheduled. (March 22 Order at 134-35). Instead, the FDA continued to research the risks connected with the non-therapeutic uses of antibiotics in the feed of food-producing animals, contracting with various agencies to study the problem. (March 22 Order at 135-36). Three reports released in the 1980s — by the National Academy of Sciences, the Seattle-King County Department of Public Health, and the Institute of Medicine-were unable to conclude that the non-therapeutic use of antibiotics in animal feed was safe, instead finding support for the FDA's concerns. (March 22 Order at 135-36).
In June 2010, the FDA released a non-binding Draft Guidance, which reviewed recent studies on the risks of non-therapeutic uses of antibiotics in animal feed and concluded that the evidence supported the conclusion "that using medically important [antibiotic] drugs for production purposes is not in the interest of protecting and promoting the public health." (March 22 Order at 136 (internal quotation marks omitted)). The FDA recommended restricting the use of antibiotics in food-producing animals to uses necessary for ensuring medical health and uses including veterinary oversight or consultation. (March 22 Order at 136).
The plaintiffs filed this action in May 2011 "alleging that the FDA's failure to withdraw approval of the [non-therapeutic] use of penicillin and tetracyclines pursuant to the 1977 NOOHs constituted an agency action unlawfully withheld or unreasonably delayed in violation" of the APA and the FDCA. (March 22 Order at 137). In December 2011, the FDA rescinded the 1977 NOOHs, explaining that it continued to be concerned about antibiotic resistance, but that it was "engaging in other regulatory strategies ... and that if [it] were to move forward with the NOOHs it would need to update [them] to reflect current data, information, and policies and prioritize any withdrawal proceedings."
In the March 22 Order, Judge Katz held, first, that § 360b(e)(1) and its accompanying regulations require the FDA to take a series of "discrete actions" upon a "finding" that a new animal drug has not been shown to be safe, thus bringing this case under the rubric of § 706(1) of the APA, which the Supreme Court has held applies only when "an agency failed to take a discrete action that it is required to take." Norton v. Southern Utah Wilderness Alliance, 542 U.S. 55, 64, 124 S.Ct. 2373, 159 L.Ed.2d 137 (2004); (March 22 Order at 138-40). He then held that the FDCA unambiguously requires the Secretary of Health and Human Services to begin proceedings to withdraw approval of a drug by issuing notice and providing an opportunity for a hearing once "[s]he finds that a new animal drug is not shown to be safe," rejecting the Government's position that the "finding" that triggers mandatory withdrawal proceedings occurs only after the opportunity for a hearing. (March 22 Order at 140-45). As a consequence of the conclusion that the statute's meaning is plain, the opinion unsurprisingly holds that the FDA's contrary interpretation does not deserve deference under Chevron, U.S.A., Inc. v. Natural Resources Defense Council, 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984), and its progeny. (March 22 Order at 143-45). Moreover, Judge Katz found that (1) the Commissioner of the FDA, who has been delegated with the authority vested in the Secretary under the FDCA, authorized the Director of the BVM "to make the findings on which such notices of withdrawal are based" (March 22 Order at 146-47); (2) in the 1977 NOOHs, the Director of the BVM made such findings requiring the FDA to proceed with the withdrawal of penicillin and tetracyclines (March 22 Order at 147-48); and (3) these findings were later adopted by Commissioner (March 22 Order at 148-49). The March 22 Order therefore held that the Government violated the APA and the FDCA by failing to begin the withdrawal of approval for non-therapeutic uses of penicillin and tetracyclines in animal feed after it had made the findings resulting in the NOOHs. In addition, Judge Katz held that, because the Government's duty was triggered by the Director's findings, and not by the issuance of the NOOHs, the 2011 rescission of the NOOHs did not moot this claim. (March 22 Order at 149-51).
The June 1 Order rejected the Government's argument that the FDA's denials of the citizen petitions were unreviewable "decisions not to enforce," Heckler v. Chaney, 470 U.S. 821, 827, 105 S.Ct. 1649, 84 L.Ed.2d 714 (1985), and held that the denials were judicially reviewable because they were not "`action[s] committed to agency discretion by law'" pursuant to the APA. (June 1 Order at 330 (quoting 5 U.S.C. § 701(a)(2))). Specifically, Judge Katz found that "[t]he process of withdrawing approval of a new animal drug is more analogous to informal rulemaking than to traditional enforcement actions," and thus
The plaintiffs ask that the Court strike a statement issued by the Animal Health Institute ("AHI")
The "focal point" of judicial review of agency action is the administrative record upon which the agency made its decision, "not some new record made initially in the reviewing court." Camp v. Pitts, 411 U.S. 138, 142, 93 S.Ct. 1241, 36 L.Ed.2d 106 (1973); IMS, P.C. v. Alvarez, 129 F.3d 618, 623 (D.C.Cir.1997) ("It is a widely accepted principle of administrative law that the courts base their review of an agency's actions on the materials that were before the agency at the time its decision was made."); New York v. Shalala, No. 93 Civ. 1330, 1996 WL 87240, at *5 (S.D.N.Y. Feb. 29, 1996) ("Shalala") ("Judicial review of agency action is generally limited to review of the full administrative record that was before the agency at the time it rendered its decision."). Thus, it is established that a court may strike documents from the record that were not before the agency at the time of its decision.
The Government contends that the AHI Statement is properly included as "background information about the animal drug industry's current stance toward the FDA's plans to regulate." (Strike Opp. Memo. at 2). Some courts have held that information outside of the administrative record may be reviewed as background to help the court understand the relevant issues. See Rochester-Genesee Regional Transportation Authority v. Hynes-Cherin, 531 F.Supp.2d 494, 518 (W.D.N.Y. 2008) (collecting cases from the Sixth and Ninth Circuits, the District of the District of Columbia, and the Western District of New York). According to the defendants, the AHI Statement shows that the animal drug industry "appears now to support the FDA's approach."
However, the Government has not explained how an expression of support from the animal drug industry that post-dates the FDA's decision on the citizen petitions is relevant — even as background — to the question of whether the FDA's denial violated the FDCA or the APA. To be sure, the AHI Statement could be used as evidence that the FDA's voluntary compliance program might succeed (although as noted in the footnote, this is something of a stretch), but the Government has expressly disavowed the notion that the FDA's confidence in the program is relevant to its defenses, stating that the premise that the Court's determination might "depend[] on the strength of the FDA's asserted faith or professed confidence in the voluntary compliance program" is "incorrect." (Strike Opp. Memo. at 2 (internal quotation marks and ellipses omitted)). Indeed, at oral argument, the Government admitted that AHI's public statements "have very little relevance" to the FDA's decisions. (Tr. at 13). Moreover, it is clear that Judge Katz did not find the AHI Statement useful or relevant, as he never alluded to it in the June 1 Order.
Because the AHI Statement was not part of the administrative record before the FDA at the relevant time and it is not "useful" to the Court as background information, the plaintiffs' motion to strike is granted to the extent that it requests that the AHI Statement be stricken from the record.
The plaintiffs also asked the Court to disregard three other documents submitted with the Government's motion papers. (Motion to Strike at 3; FDA Draft Guidance for Industry # 209 dated April 13, 2012 ("Draft Guidance # 209"), attached as Exh. A to 3d Barcelo Decl.; Draft Text for Proposed Regulation dated April 5, 2012 ("Draft Regulation"), attached as Exh. B to 3d Barcelo Decl.; FDA Guidance for Industry #213 dated April 13, 2012
In compliance with the March 22 Order, the parties have submitted briefs on the issue of a schedule for the FDA's withdrawal proceedings. The Government asks that I refrain from imposing any deadlines, stating that "subject to any future direction by the appellate courts, it intends to abide by the orders of the Court." (Brief in Support of the Government's Position on the Issue of Timing ("Gov't Timing Br.") at 1-2). In the alternative, the Government proposes a timeline — derived from an "analysis to estimate the time and resources that would be required" (1st Flynn Decl., ¶ 6) — that requires reissuance of the NOOHs within 11 to 17 months, with an additional period of years to complete the withdrawal process, including administrative appeals. (Gov't Timing Br. at 10-11; 1st Flynn Decl., ¶¶ 6, 11-15, 18-21, 23-24). NRDC, in contrast, asserts that a schedule is essential, and that the Government's "protracted" timing estimate should be slashed so that the NOOHs are required to be issued within 125 days of commencement of the process and withdrawal proceedings are complete in an additional two years. (Plaintiffs' Opposition to the Government's Brief Concerning a Schedule for Compliance with the Court's Order ("Pl. Timing Br.") at 21, 24).
Even in the area of administrative law, district courts have "broad equitable powers" to order "any appropriate relief" that is not prohibited by Congress. Cobell v. Norton, 240 F.3d 1081, 1108 (D.C.Cir.2001). However, a court must be careful not to intrude "into the domain which Congress has set aside exclusively for the administrative agency," Federal Power Commission v. Transcontinental Gas Pipe Line Corp., 423 U.S. 326, 333, 96 S.Ct. 579, 46 L.Ed.2d 533 (1976) (internal quotation marks omitted), by "control[ling] the operations" of the agency, Sierra Club v. U.S. Army Corps of Engineers, 701 F.2d 1011, 1042 (2d Cir.1983). For example, in the absence of "extremely compelling circumstances," a court oversteps its bounds if it dictates the procedures an agency must follow in performing its statutory duties, see Vermont Yankee Nuclear Power Corp. v. Natural Resources Defense Council, 435 U.S. 519, 543-45, 98 S.Ct. 1197, 55 L.Ed.2d 460 (1978); or retains jurisdiction to oversee an agency's compliance with the court's orders, see Sierra Club, 701 F.2d at 1042-49 (vacating district court's order appointing special master with "highly intrusive" mandate and requiring agency itself to make required investigations and analyses, among other things); Baystate Medical Center v. Leavitt, 587 F.Supp.2d 37, 41 (D.D.C.2008) (refusing to retain jurisdiction to oversee agency's compliance with court order). However, it is clear that if an agency has unreasonably delayed dispatching its duty, it is permissible for a court to impose a timetable for compliance. See Cobell, 240 F.3d at 1107 (affirming district court's order imposing timetable when agency had unreasonably delayed fulfilling its duty);
The Government asserts that this is not a situation in which the FDA has unreasonably delayed action. (Gov't Timing Br. at 1; Reply Brief on Support of the Government's Position on Timing ("Gov't Timing Reply") at 6). It is true that NRDC did not argue that the FDA's failure to complete withdrawal proceedings was action "unreasonably delayed" under the APA, but rather that it was "unlawfully withheld." (Memorandum of Law in Support of Plaintiffs' Motion for Summary Judgment at 10-13). In granting NRDC's motion for summary judgment, Judge Katz did not make an explicit finding that the FDA unreasonably delayed action. However, he did mark the agency's "prolonged inaction" and repeatedly referred to its decades-long failure to commence withdrawal proceedings. (March 22 Order at 130-31, 136, 150 n. 16). Similarly, in its brief regarding timing, NRDC focuses on the agency's delay. (Pl. Timing Br. at 2, 8, 10-11). The fact that the March 22 Order lacks a discussion of unreasonable delay does not indicate, as the Government would have it, that it is "[not] present here" as a factual matter. (Gov't Timing Reply at 6). Nor does it mean that I cannot consider the whether the agency has in fact unreasonably delayed institution of withdrawal proceedings in deciding how to exercise the court's "broad equitable powers" to order relief.
To decide whether there has been unreasonable delay meriting the imposition of a schedule or deadline, I am guided by "six principles that have helped courts determine when mandamus is an appropriate remedy for agency delay":
In re Barr Laboratories, Inc., 930 F.2d 72, 74-75 (D.C.Cir.1991) (internal quotation marks omitted) (citing Telecommunications Research & Action Center v. FCC, 750 F.2d 70, 80 (D.C.Cir.1984)). "[A] finding that delay is unreasonable does not, alone, justify intervention." Barr Laboratories, 930 F.2d at 75 (internal quotation marks omitted). Instead, a court should weigh the effect on the agency of the contemplated order, as well as the effect of the delay on other interests involved.
The Government complains that imposing a timetable will impermissibly re-order its priorities, citing Barr Laboratories. In that case, a drug manufacturer sought a writ of mandamus compelling the FDA to act on its generic drug applications. Barr Laboratories, 930 F.2d at 73. Although the law required action within 180 days of receipt of the applications, the FDA admitted that action on such applications took significantly longer and estimated that in the future, it could take almost two years. Id. at 74. Nonetheless, the court refused to issue the writ, explaining that "a judicial order putting Barr at the head of the queue simply moves all others back one space and produces no net gain." Id. at 75.
This case is easily distinguishable. In Barr Laboratories, the writ of mandamus would have effectively controlled the agency's generic drug approval process, benefitting one enterprise at the expense of others, failing to improve the efficiency of the process of approving (or disapproving) generic drugs, and having no effect on human health and welfare. Here, the FDA has utterly failed in its duty to initiate congressionally-mandated withdrawal proceedings. Requiring it to do so promptly is not reordering the FDA's priorities; it is correcting the agency's misprision of its duty. In Barr Laboratories, the court found that the contemplated order would have no effect on human health and welfare. Here, in contrast, compelling the FDA to timely fulfill its obligations will speed adjudication on the issue of whether the non-therapeutic use of certain antibiotics in animal feed threatens human health and, if the sponsors or other interested parties cannot demonstrate the drugs' safety, accelerate their compulsory withdrawal. See 21 U.S.C. § 360b(e)(1) (mandating withdrawal proceedings when the evidence demonstrates that the "drug is not shown to be safe"); 21 C.F.R. § 514.115(b)(3) (same); Tetracycline (Chlortetracycline and Oxytetracycline)-Containing Premixes; Opportunity for Hearing, 42 Fed.Reg. 56264 (Oct. 21, 1977) (stating that "the tetracycline-containing products have not been shown to be safe for widespread subtherapeutic use"); Penicillin-Containing Premixes; Opportunity for Hearing, 42 Fed.Reg. 43772 (Aug. 30, 1977) (stating that "the penicillin-containing products have not been shown to be safe for subtherapeutic use").
The Government repeatedly asserts that a schedule should not Gov't Timing Br. be imposed because the FDA did not believe it had "a legal duty to proceed with hearings." (Gov't Timing Br. at 1, 5, 8; Gov't Timing Reply at 2; Declaration of William T. Flynn dated May 15, 2012 ("1st Flynn Decl."), ¶ 5). However, as the District of Columbia Circuit makes clear, "the court need not find any impropriety lurking behind agency lassitude in order to hold that agency action is unreasonably delayed." Barr Laboratories, 930 F.2d at 75. The FDA's asserted belief that neither the FDCA nor its regulations required further action once the 1977 NOOHs were issued, then, does not make this delay any less unreasonable. Moreover, the FDA seems to have a pattern of attempting to avoid instituting proceedings to withdraw approval of the non-therapeutic use of antibiotics in animal feed. As detailed in the
The Government has conducted an analysis to determine the likely amount of time it will take to perform each of the tasks required to comply with the March 22 Order and supports the schedule with a declaration from Dr. William T. Flynn, the CVM's Deputy Director for Science Policy. (1st Flynn Decl., ¶¶ 1, 6, 11-15, 18-21, 23-24). NRDC objects to the proposed time estimates as "protracted" (Pl. Timing Br. at 1), "leisurely" (Pl. Timing Br. at 14), "vague" (Pl. Timing Br. at 14, 16), "excessive" (Pl. Timing Br. at 14, 18), and "generous" (Pl. Timing Br. at 15), and suggests a significantly abbreviated schedule (Pl. Timing Br. at 21). While the Government's position draws on its expertise, including experience with prior withdrawal proceedings (Gov't Timing Br. at 13; 1st Flynn Decl., 23; Declaration of William T. Flynn dated June 1, 2012 ("2d Flynn Decl."), ¶ 4; Tr. at 57), the plaintiffs' arguments are largely speculative.
Look, for example, at the plaintiffs' complaints about the amount of time it will take for the agency to search CVM's files for information relevant to reissuance of the NOOHs. Dr. Flynn estimates it will take "10 to 14 employees ... approximately 60 days," with each employee devoting "a substantial amount of time" to the project. (1st Flynn Decl., ¶ 11). NRDC argues that, because Dr. Flynn does not specify the amount of time each employee will spend on each task, the "estimate allows for tremendous variation." (Pl. Timing Br. at 14). It then spins out two variations, one of which assumes that the task would take 10 employees 86 work-hours each.
NRDC's support for its abbreviated schedule consists of a declaration by Dr. Lance Price, an associate professor who directs the Center for Microbiomics and Human Health and the Center for Food Microbiology and Environmental Health at the Translational Genomics Research Institute, a nonprofit biomedical research institute. (Declaration of Lance Price, Ph.D. dated May 23, 2012 ("Price Decl."), ¶ 1). Professor Price estimates that it would take one graduate-level research assistant working full-time sixty days to complete the review or two such research assistants thirty days. (Price Decl., ¶ 6). However, these estimates do not appear to take into account the purposes of the review. Moreover, the fact that such a review could be performed by research assistants working full-time on the project in an academic environment says little about the time requirements for civil servants in a federal agency who have other responsibilities. Indeed, NRDC's two-week estimate appears to rely on the unfounded assumption that agency personnel will be able to devote their undivided time-and attention to this project.
Similarly, NRDC's insistence that any hearings can be completed within 21 months of issuance of the revised NOOHs (Pl. Timing Br. at 24) is unsupported and, as the Government points out, completely speculative. (Gov't Timing Reply at 9). For example, it does not appear to take into account the potential number of requested hearings that the FDA will have to hold.
The agency is in the best position to analyze the issue and propose a realistic schedule that is not based on unsupported assumptions, but rather on its expertise, and it has done so. See International Chemical Workers Union, 958 F.2d 1144, 1150 (D.C.Cir.1992) (accepting agency's estimate of time needed to complete rulemaking); Brock, 823 F.2d at 629 (adopting agency's proposed timetable even though target date was "disappointing"); cf. Qwest Communications International v. Federal Communications Commission, 398 F.3d 1222, 1239 (10th Cir.2005) (declining to impose "arbitrary" deadline where agency did not propose schedule for compliance). Therefore, I adopt the Government's proposed schedule, which requires issuance of revised NOOHs for penicillin and tetracyclines in 17 months, and provides an additional 41 months for the hearing process. (1st Flynn Decl., ¶¶ 16, 25).
The Government has requested a stay of the March 22 Order pending the Second Circuit's decision on its appeal or, in the alternative, a stay pending the Second Circuit's resolution of the Government's planned application for a stay in that court. (Gov't Stay Memo. at 1). "A stay is not a matter of right, even if irreparable injury might otherwise result. It is instead an exercise of judicial discretion, and the propriety of its issue is dependent upon the circumstances of the particular
Id. at 434, 129 S.Ct. 1749 (internal quotation marks omitted). "The first two factors... are the most critical," id., and these factors have typically been evaluated on a sliding scale, so that a strong showing that the applicant is likely to succeed excuses a weaker showing of irreparable injury. Nevertheless, the Supreme Court has recently emphasized that the applicant must demonstrate that both factors are satisfied, so that even if a party makes a robust showing that it is likely to succeed on appeal, it still must also show that "irreparable injury is likely." Winter v. Natural Resources Defense Council, 555 U.S. 7, 22, 129 S.Ct. 365, 172 L.Ed.2d 249 (2008).
Although the oft-repeated standard indicates that an applicant must "ma[ke] a strong showing that he is likely to succeed on the merits," Hilton v. Braunskill, 481 U.S. 770, 776, 107 S.Ct. 2113, 95 L.Ed.2d 724 (1987), if "a serious legal question is involved," a stay may issue when the movant "present[s] a substantial case on the merits ... and show[s] that the balance of the equities weighs heavily in favor of granting the stay," LaRouche v. Kezer, 20 F.3d 68, 72-73 (2d Cir.1994); see also Sutherland v. Ernst & Young LLP, 856 F.Supp.2d 638, 640-41 (S.D.N.Y.2012); cf. Citigroup Global Markets, Inc. v. VCG Special Opportunities Master Fund Limited, 598 F.3d 30, 38 (2d Cir.2010) (holding, in preliminary injunction context, that Winter does not foreclose a "flexible standard" of "assessing a movant's likelihood of success on the merits").
The Government argues, as it did in its motions for summary judgment, that (1) "the plain meaning of [21 U.S.C. § 360b(e)(1) ] provides that the Commissioner's statutory finding comes only after [a] hearing or after a sponsor opts not to request a hearing" (Gov't Stay Memo. at 8); (2) to the extent the statute is ambiguous, the FDA's interpretation that the
Judge Katz' thorough opinion in this case addressed each of these contentions and rejected them. See Schwartz v. Dolan, 159 F.R.D. 380, 384 (N.D.N.Y.1995) ("Mere repetition of arguments previously considered and rejected cannot be characterized as a `strong showing' [of likelihood of success on the merits]."); see also International Equity Investments, Inc. v. Opportunity Equity Partners, Ltd., No. 05 Civ. 2745, 2006 WL 1116437, at *3-4 (S.D.N.Y. April 26, 2006) (holding that applicant had failed to show a likelihood of success on the merits when it presented only arguments that the court had already rejected); Shays, 340 F.Supp.2d at 45-47 (same).
However, neither party denies that this case involves serious legal questions regarding the FDA's responsibilities under the APA, the FDCA, and the pertinent regulations. The issues presented, perhaps most particularly the proper identification of the "finding" that triggers the commencement of withdrawal proceedings under 21 U.S.C. § 360b(e)(1)(B) and the consequences that follow, are difficult. Moreover, the appeal will likely present only questions of law, which the Second Circuit will review without deference. The Government's arguments, although largely regurgitated from its summary judgment papers, are far from frivolous. Although the Government may not have made a strong showing of likelihood of success on appeal, it has presented a "substantial case on the merits." LaRouche, 20 F.3d at 72. Therefore, the success of its stay application depends on whether it can "show that the balance of the equities weighs heavily in favor of granting the stay." Id. at 72-73.
To support a stay pending appeal, the applicant must show "injury that `is neither remote nor speculative, but actual and imminent and cannot be remedied by an award of monetary damages.'" RxUSA Wholesale, Inc. v. Department of Health and Human Services, 467 F.Supp.2d 285, 301 (E.D.N.Y.2006) (quoting Rodriguez v. DeBuono, 175 F.3d 227, 234 (2d Cir.1999) (per curiam)). The potential for irreparable injury should be evaluated taking into account the possibility that the ruling sought to be stayed is erroneous. See National Immigration Project of the National Lawyers Guild v. U.S. Department of Homeland Security, 842 F.Supp.2d 720, 733 (S.D.N.Y.2012) ("Thus, failure to stay the disclosure required by the Order would cause the Government irreparable injury if the ruling [were] erroneous.").
The Government contends that it will suffer irreparable injury if a stay is not granted because the significant resources the FDA will be required to expend in order to commence withdrawal proceedings will "compromise FDA's ability to pursue its goals with respect to antimicrobial resistance and animal drug licensing by diverting resources away from those programs." (Gov't Stay Memo. at 15-18). This argument does not demonstrate irreparable harm sufficient for the imposition of a stay.
Moreover, the argument "that potentially wasted and diverted staff resources constitutes irreparable harm" has been held "meritless." Shays, 340 F.Supp.2d at 48; see also Graphic Communications Union v. Chicago Tribune Co., 779 F.2d 13, 15 (7th Cir.1985) (holding that costs incurred as consequence of compliance with court order do not show irreparable harm). This is a sensible rule. As NRDC points out, accepting the Government's argument would almost always result in a finding of irreparable harm whenever an agency was required to comply with a court order. (Plaintiffs' Opposition to the Government's Motion for a Stay Pending Appeal ("Pl. Stay Memo.") at 16). As a consequence, stays pending appeal would become routine, conflicting with the rule that such relief should be "extraordinary." Shays, 340 F.Supp.2d at 41; cf. Graphic Communications, 779 F.2d at 15 (noting that if costs imposed by compliance with court order constituted irreparable harm, every such order "would be deemed to create irreparable harm, and it would be easy to get such orders stayed").
The Government attempts to distinguish Shays, asserting that in that case, "not only did the [agency] not make any claim that its ability to fulfill its mission would be compromised without a stay, but it did not even claim that any specific programs would be harmed at all. Rather the [agency] made a general (and unsupported) claim of diversion of resources from other agency priorities." (Gov't Stay Reply at 7). The Government cites nothing — no document or brief — that supports its position
The additional cases the defendants marshal as support fare no better. The Government cites James River Flood Control Association v. Watt, 680 F.2d 543 (8th Cir.1982) (per curiam), and Arkansas Peace Center v. Arkansas Department of Pollution, 992 F.2d 145 (8th Cir.1993) to bolster its position that diversion of agency resources is irreparable harm sufficient to merit a stay. In James River, the district court issued a preliminary injunction prohibiting the Department of the Interior from acquiring land on which it intended to build a pumping station, "pending the outcome of proceedings ... regarding the inadequacy of the Environmental Impact Statement." 680 F.2d at 544. In Arkansas Peace Center, the district court preliminarily enjoined the defendant agencies from incinerating certain hazardous wastes based on allegations that "the incineration was proceeding in violation of certain federal and state regulations regarding incinerator performance." 992 F.2d at 146. In both cases, the court found that preventing the actions would irreparably harm the agencies. Id. at 147; James River, 680 F.2d at 544. However, in neither case did the Eighth Circuit suggest that the enjoined activities were statutorily mandated, as Judge Katz found here. Nor did the appellate court suggest that redistribution of agency resources motivated staying the preliminary injunctions. These cases are therefore of doubtful relevance.
Finally, the Government's argument is, at its base, an economic one: that the opportunity cost of compliance with the March 22 Order will irreparably harm the FDA. But the Government has not demonstrated that compliance would seriously threaten its mission or operations. Rather, it asserts that the diversion of resources will "compromise" the FDA's pursuit of goals relating to antimicrobial resistance. (Gov't Stay Memo. at 15; Gov't Stay Reply at 6; 2d Flynn Decl., ¶ 4). As support, it cites concerns such as a "drain [of] resources" from certain other FDA programs (1st Flynn Decl., ¶ 26), the possibility of delay in certain programs (1st Flynn Decl., ¶ 27), and difficulty fully staffing both the voluntary withdrawal project and the formal withdrawal proceedings at all times (2d Flynn Decl., ¶ 8). This evidence does not show that compliance with the March 22 Order will substantially endanger the CVM's or the FDA's mission to "protect the public health by ensuring that ... human and veterinary drugs are safe and effective." 21 U.S.C. § 393(b)(2)(B).
In short, the Government has not shown that it will be irreparably harmed if a stay pending appeal is not granted.
The Government recognizes, and NRDC does not appear to dispute, that the plaintiffs "are in the same position as members of the public." (Gov't Stay Memo. at 19). In this case, then, the last two factors are best discussed together. (Gov't Stay Memo. at 18-20; Pl. Stay Memo. at 20-22).
The Government asserts that the public interest supports a stay because the FDA "has determined that the public health concerns regarding production uses of antibiotics in animal feed would be most quickly addressed by finalizing and implementing"
The Government fails to take into account the fact that the March 22 Order held that the FDCA requires the FDA to initiate withdrawal proceedings. "When administrative agencies fail to follow statutory procedures, the public suffers." Apotex, Inc. v. U.S. Food & Drug Administration, 508 F.Supp.2d 78, 88 (D.D.C.2007).
In addition, for all its insistence that the voluntary program will succeed, the Government has presented "no hard evidence that the drug sponsors have agreed or will agree [] to the proposed measures." (June 1 Order at 340). The single piece of evidence it submitted (which has been struck from the record) expressed tepid support, at best, from the affected community. At oral argument, the Government was not able to articulate any more convincing reason for its confidence. (Tr. at 46-49). As the plaintiffs note, the voluntary program is passive insofar as it requires drug sponsors to approach the FDA if they are interested in taking part in the program. (Pl. Stay Br. at 21; Final Response to Citizen Petition dated Nov. 7, 2011, attached at Exh. A to Declaration of Mitchell S. Bernard dated Feb. 21, 2012, at 4). Although the Government may hold fast to its "hope and belief ... that everyone will move together at the same time" (Tr. at 20), insufficient buy-in by the drug sponsors will likely result, ultimately, in the same formal withdrawal procedures required under the both the March 22 Order and now this order. (Gov't Stay Brief at 16-17; 2d Flynn Decl., ¶ 5).
On the other hand, engaging in the mandated withdrawal procedures promptly will allow drug sponsors the opportunity to show that the challenged drug uses are safe. If they are shown to be safe, the public interest is likely served by allowing their continued use. If, however, they are not shown to be safe, the FDA will be required to withdraw approval, thus safeguarding the public's (and the plaintiffs') health and welfare. Moreover, as Judge Katz observed, "nothing prevents the [FDA] from seeking voluntary cooperation from the drug industry[] in tandem" with withdrawal proceedings. (June 1 Order at 340). Even if both projects might not be "adequately staffed at all times" (2d Flynn Decl., ¶ 8), simultaneous engagement will have less deleterious effects during the relatively short pendency of the appeal. Finally, the argument that the voluntary program is a better solution because it addresses drugs in addition to penicillin and tetracyclines is a straw man. As the Government concedes, the FDA is not prohibited in this process from issuing amended NOOHs addressing the extended range of drugs covered by the voluntary program. (Tr. at 31).
It is clear, then, that the plaintiffs are at risk of harm if a stay is imposed and that the public interest favors enforcement of the March 22 Order. Indeed, given the substantial harm that further delay of withdrawal proceedings could visit on the plaintiffs and the public, the balance of the equities would not "weigh heavily in favor" of a stay even if the Government had shown irreparable harm. LaRouche, 20 F.3d at 72-73. The Government's request for a stay pending decision on the appeal of the March 22 Order is therefore denied.
As noted, the defendants ask in the alternative that I grant an interim stay pending resolution of the Government's anticipated stay application in the Second
For the foregoing reasons, the plaintiffs' motion to strike (Docket no. 79) is granted in part, and Document no. 78-6 is stricken from the record. The Government's motion for a stay pending appeal, or, in the alternative, for an interim stay pending resolution of the Government's planned application for a stay in the Second Circuit (Docket no. 92), is denied. Furthermore, the Government is ordered to comply with the Court's order of March 22, 2012, according to the schedule included in paragraphs 11 through 25 of the Declaration of William T. Flynn dated May 15, 2012 (Docket no. 86).
SO ORDERED.
