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Astrazeneca Pharmaceuticals LP v. Burwell

United States District Court, District of Columbia

July 11, 2016



          RANDOLPH D. MOSS United States District Judge.

         This action arising under the Administrative Procedure Act("APA"), 5 U.S.C. § 701 et seq., is before the Court on the plaintiffs' motion for a temporary restraining order. Dkt. 22. The plaintiffs, AstraZeneca Pharmaceuticals LP and IPR Pharmaceuticals, Inc. ("AstraZeneca"), allege that the Food and Drug Administration ("FDA") "is poised to grant final approval to several Abbreviated New Drug Applications (ANDAs) for generic versions of AstraZeneca's drug Crestor" on the basis of an interpretation of its pediatric-labeling and general carve-out authority that is contrary to law. Id. at 1. AstraZeneca seeks a temporary restraining order ("TRO") enjoining the FDA from approving these AND As "pending a hearing on a motion for preliminary injunction and/or expedited review on the merits." Dkt. 22-1 at 8. AstraZeneca also suggests, alternatively, that the Court exercise its authority under the All Writs Act, 28 U.S.C. § 1651, to retain jurisdiction over the case and to preserve the possibility of meaningful judicial review. See Dkt. 46 at 14-15. Six generic drug manufacturers, each of which asserts that it has received tentative approval of an ANDA for a generic version of Crestor, have intervened as defendants. See Dkts. 6, 9, 15, 21, 35, 47. The FDA, along with the intervenors, oppose AstraZeneca's motion. See Dkts. 42, 43. The Court held a hearing on AstraZeneca's motion on July 7, 2016.

         In its opposition brief and at the motion hearing, the FDA argued that the Court currently lacks jurisdiction over this matter because the agency has yet to issue a final decision and, in fact, has yet to decide whether to permit the manufacturers of the generic form of Crestor to enter the market. Dkt. 43 at 17-30. Although the FDA concedes that it is likely to issue decisions in the near future, it argues that as the record now stands, there is nothing for the Court to review. In response, AstraZeneca argues that existing FDA precedent, and the preparations that the intervenors assert that they are making for "an imminent launch of [their] produces], " leaves little doubt that the FDA has already decided to approve the AND As. Dkt. 46 at 6. AstraZeneca argues, in addition, that it can obtain meaningful judicial consideration of its motion for a TRO only before the ANDAs are approved because "there is every reason to believe" that the generic manufacturers will "flood the market immediately with at least six months' worth of generic product, " causing "AstraZeneca's market share [to] drop precipitously." Dkt. 22-1 at 45.

         As the Court noted at the hearing, there is merit to portions of both the FDA's and AstraZeneca's arguments. As the FDA correctly observes, AstraZeneca has submitted a citizen petition to the agency, see 21 U.S.C. § 355(q), which among other things raises the same substantive arguments AstraZeneca makes in this case. The Federal Food, Drug, and Cosmetic Act, however, provides that where a citizen petition remains pending before the Secretary and raises an issue that the petitioner also seeks to raise in a civil action, the district court "shall dismiss without prejudice the action for failure to exhaust administrative remedies." 21 U.S.C. § 355(q)(2)(B). Moreover, even if AstraZeneca had not submitted a citizen petition, it would still face a substantial ripeness problem: the FDA contends that its evaluation of the pending AND As "is ongoing, and it is possible that the agency would agree with AstraZeneca on one or more of the issues it has raised or find another basis for non-approval." Dkt. 43 at 34.

         At the same time, AstraZeneca is correct that the FDA's position leaves both the parties and the Court "in an awkward bind." Teva Pharmaceuticals USA, Inc. v. Sebelius, 595 F.3d 1303, 1311 (D.C. Cir. 2010). Because generic manufacturers are at times poised to ship their products within hours of approval, see Dkt. 22-2 at 7-8, and because the FDA maintains that there is nothing for the Court to review until it issues such an approval, the window for review is not only small, but "more or less instantaneous[]" with the FDA's issuance of its decision. Teva, 595 F.3d at 1311. For this reason, "[district courts in this circuit routinely reach the merits of. . . claims to exclusivity before the FDA has granted final approval to any ANDA concerning the drug at issue." Id. But to do so, a court must first conclude that such a pre-enforcement action is ripe for judicial review. Putting aside the "hardship" prong to that test for present purposes, the plaintiff must show that the dispute is "fit" for review-that is, that the issue presented is "purely legal, " that "consideration of the issue would [not] benefit from a more concrete setting, " and that "the agency's action is sufficiently final." Id. at 1308. (internal quotation marks omitted). Here, however, the FDA contends that its consideration of AstraZeneca's legal argument is intertwined with a factual inquiry relating to the safety of the proposed labels for the generic versions of Crestor and that its consideration of the citizen petition and AND As is ongoing. See Dkt. 43 at 13.

         The fact that this case may fall short of the mark for pre-enforcement review, however, does not mean that AstraZeneca and other manufacturers in similar circumstances are simply without recourse to prevent an asserted loss of six months or more of exclusivity. Rather, as AstraZeneca suggests in its reply brief, the Court is authorized under the All Writs Act, 28 U.S.C. § 1651, to issue those orders necessary to preserve the availability of meaningful judicial review. The All Writs Act authorizes federal courts to issue "all writs necessary or appropriate in aid of their respective jurisdictions and agreeable to the usages and principles of law." 28 U.S.C. § 1651(a). The Act has long been recognized to encompass a federal court's power "to preserve [its] jurisdiction or maintain the status quo by injunction pending review of an agency's action through the prescribed statutory channels." FTC v. Dean Foods Co., 384 U.S. 597, 604 (1966) (quoting Arrow Transp. Co. v. SouthernRR Co., 372 U.S. 658, 671 n.22 (1963)). The D.C. Circuit has further explained that, "[i]f the court may eventually have jurisdiction of the substantive claim, the court's incidental equitable jurisdiction, despite the agency's primary jurisdiction, gives the court authority to impose a temporary restraint in order to preserve the status quo pending ripening of the claim for judicial review." Wagner v. Taylor, 836 F.2d 566, 571 (D.C. Cir. 1987); see also Nat'l Treasury Employees Union v. King, 961 F.2d 240, 245 (D.C. Cir. 1992).

         Against this background, the Court concludes-as it suggested at the July 7 hearing-that it is appropriate to devise some mechanism to ensure that three goals are satisfied: First, AstraZeneca should have some opportunity to present its arguments to the Court before it suffers an irretrievable loss of six months or more of exclusivity. Second, that mechanism should not deprive the intervenors of their right to market generic versions of Crestor as soon as lawfully allowed to do so. Third, the Court should not unnecessarily or unduly interfere with the usual operation of the administrative process.

         Rather than simply impose such a mechanism on the parties, at the July 7 hearing the Court invited the parties to meet and confer to determine whether they could reach an agreement regarding how best to proceed. Pursuant to the Court's direction, the parties have now filed a status report addressing two aspects of this issue, along with two additional issues raised by AstraZeneca. See Dkt. 49. The four issues are (1) whether the FDA should be required to provide advance notice to the Court or to the parties before issuing its decision on the citizen petition; (2) whether the FDA should issue a decision on the citizen petition before issuing decisions on the pending AND As; (3) whether the intervenors should be required to produce copies of their draft labels to AstraZeneca in order to expedite any further briefing or argument on AstraZeneca's motion for a TRO; and (4) when the Court should require the FDA to file the administrative record. Id. The Court will address each of these issues in turn.

         1. Advance Notice

         As an initial matter, AstraZeneca requests that the Court order that the FDA provide the parties with 48 hours' notice before issuing a decision on AstraZeneca's citizen petition "in order to ensure the availability of lead counsel for the hearing." Dkt. 49 at 2. The FDA and the intervenors "strenuously oppose" this request. Id. They argue that AstraZeneca has sought emergency relief from the Court and that the company should be able to "assemble attorneys in time for a hearing." Id. And although not raised by AstraZeneca in this context, they argue that "no further briefing is necessary." Id.

         As explained further below, the Court will set a further hearing on this matter in due course. Given the need to ensure immediate review of the FDA's final decision on AstraZeneca's citizen petition and the need to ensure that the effect of that decision is not unnecessarily or materially delayed, lead counsel for all parties should be prepared to appear in Court on two hours' notice. Although the Court may provide the opportunity for further briefing at or following the hearing, for the reasons discussed below, there will be no need for further briefing in advance of the hearing.

         2.Timing and Procedures for Release of the FDA's Decision

         The most substantial disagreement among the parties involves the procedures for the release and review of the FDA's decision on AstraZeneca's citizen petition. AstraZeneca argues that the Court should order the FDA to issue its decision on the citizen petition 48 hours before final approval of any of the AND As at issue. It contends that this delay will provide the parties with an opportunity to review the decision and will provide the Court with an opportunity to conduct a hearing and to render a decision on AstraZeneca's (renewed) motion for a TRO. See Dkt. 49 at 3-4. Alternatively, AstraZeneca seems to suggest that the FDA be permitted to issue its AND A decisions at the same time that it issues a decision on the citizen petition but that the Court stay any approvals for 48 hours. See Id. at 4.

         The FDA disagrees. It argues that it "is bound by its statutory mandate not to delay approval of an ANDA once it determines that the approval criteria have been met." Id. at 5. It does, however, point to three approaches taken by other judges in order to "provide for timely review of final agency action on AND As." Id. First, it points to Teva Pharmaceutical Industries, Ltd. v. Sebelius, Civ. No. 14-0786 (D.D.C. May 9, 2014), where Judge Huvelle dismissed an action as unripe but required the FDA to provide the Court-and only the Court- with advance notice that a decision on an ANDA was imminent so that the Court could be prepared to rule promptly in the event the ANDA was challenged. Dkt. 49 at 5; Dkt. 49-1 at 112-13. Second, it points to Otsuka Pharmaceutical Co., Ltd v. Burwell, C\v. No. 15-852 (D. Md. Apr. 29, 2015), where Judge Hazel retained jurisdiction over the matter pending issuance of a final FDA decision on the AND As and, according to the FDA, required the FDA to provide notice to the Court-and only the Court-with 24 hours' advance notice that a decision was imminent so that the Court could be prepared promptly to rule on the pending motion for a TRO. Judge Hazel did not enjoin issuance of the ANDA decisions but held a hearing within an hour-and-a-half of the agency's final action. Dkt. 49 at 5-6. Third, the FDA discusses, but does not endorse, Judge Bates's approach in Hi-Tech Pharmacal Co. Inc. v. FDA, Civ. No. 08-1495 (D.D.C. Oct. 10, 2008), where the Court retained jurisdiction over the matter pending the FDA's issuance of its ...

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