                              UNITED STATES DISTRICT COURT
                              FOR THE DISTRICT OF COLUMBIA


 ASTRAZENECA PHARMACEUTICALS
 LP; IPR PHARMACEUTICALS, INC.,

                Plaintiffs,

        v.

 SYLVIA MATHEWS BURWELL, Secretary
 of Health & Human Services; ROBERT
 CALIFF, Commissioner of Food and Drugs;
 FOOD AND DRUG ADMINISTRATION,

                Defendants,                           Civil Action No. 16-cv-1336 (RDM)

        and

 PAR PHARMACEUTICAL, INC.; APOTEX
 CORP.; APOTEX INC.; SANDOZ INC.;
 SUN PHARMA GLOBAL FZE; SUN
 PHARMACEUTICALS INDUSTRIES INC.;
 GLENMARK PHARMACEUTICALS INC.,
 USA; GLENMARK PHARMACEUTICALS,
 LTD.;

                Intervenor-Defendants.


                                MEMORANDUM AND ORDER

       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 ANDAs “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] product[s],” leaves

little doubt that the FDA has already decided to approve the ANDAs. 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



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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

ANDAs “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, “[d]istrict 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



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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 ANDAs 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. Southern R.R. 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



                                                  4
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 ANDAs; (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.



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       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 ANDAs 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 ANDA 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 ANDAs.” 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—



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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, Civ. 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 ANDAs 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 final decision and directed that the FDA provide at least 12 hours’ notice to the

Court—and to the parties—that the issuance of its decision on exclusivity was imminent. Then,

at a previously scheduled status conference, the FDA issued its decision in the courtroom, where,

according to the FDA, Judge Bates ordered that the decision “not be publicly disclosed.” Dkt. 49

at 6.

        Finally, some of the intervenors agree with the FDA that the approach taken in Ostuka is

appropriate, while others argue that the Court should require the FDA to file its decision on the

citizen petition by 8 a.m. on the day it issues and that the agency postpone issuance of its

decision on the ANDAs until the earlier of 4 p.m. that day or an order of the Court denying

AstraZeneca’s motion for a TRO. Id. at 7.

        The Court appreciates the parties’ efforts to find a workable solution to the dilemma

described above and, exercising its authority under the All Writs Act, 28 U.S.C. § 1651, will



                                                 7
adopt a variation on the parties’ competing proposals. As an initial matter, the Court agrees with

the FDA and intervenors that the 48-hour delay proposed by AstraZeneca is more than is

necessary to provide a window for judicial review. As explained above, the Court’s goal is to

impinge as little as possible on the FDA’s normal practices and the normal operation of the

statute and regulations, while protecting AstraZeneca’s right to be heard before it is too late to

avoid significant injury. For this same reason, the Court will also reject AstraZeneca’s proposal

(and the similar, although more limited proposal raised by some of the intervenors) that the FDA

issue its decision on the citizen petition before it renders decisions on the ANDAs. The FDA

represents that it lacks statutory authority to agree to this approach, although it does not suggest

that the Court would lack authority to order the agency to proceed in this manner. But it is

evident that doing so would constitute a substantial break with FDA practice, and the Court will

not require that the agency depart from its usual practice in this area, which is fraught with the

risk of consequences that may be unforeseen by the Court.

       At the same time, however, the Court is unconvinced by the FDA’s suggestion that the

Court merely require that the FDA provide it with advance notice of the agency’s impending

action. The FDA states that it “understand[s] that litigation involving challenges to the approval

process for generic drugs can be grueling,” and it expresses its “sympath[y]” to the Court. Dkt.

49 at 5. But that observation, and the FDA’s proposed solution, both misperceive the Court’s

concern. The Court’s worry is that the APA, and general principles of administrative law, favor

the availability of judicial review of agency action and that the FDA’s proposed approach would

permit up to a half-dozen manufacturers each to ship a supply of six months or more of the

generic form of Crestor into the marketplace before AstraZeneca has an opportunity to be heard




                                                  8
on the legality of the agency’s action in approving the ANDAs—if, in fact, that is what the

agency decides to do.

       This, then, leaves a version of the approach Judge Bates applied in Hi-Tech Pharmacal,

which the FDA does not endorse but seems to favor over the approaches that AstraZeneca and

some of the intervenors recommended. The Hi-Tech Pharmacal approach permits the FDA to

issue its decisions on the citizen petition and the ANDAs at the same time—as the agency

favors—and permits the expeditious resolution of AstraZeneca’s motion for a TRO. As the FDA

explains, this “approach would allow the court to preserve the status quo while doing the least

damage to the integrity of FDA’s approval and decision-making processes and be most

consistent with the statutory authority.” Id. at 7. The FDA does request, however, that “in the

event the Court proceeds in this manner, any required notice and any subsequent proceedings

should be under seal” in order to avoid adverse consequences on the stock market. Id.

       As set forth in greater detail below, the Court will adopt a variation on this approach in

order to provide a brief window for judicial review while imposing the smallest possible effect

on the FDA’s usual processes and the rights and expectations of all of the parties to the

proceeding. The Court will require that the FDA provide the Court—and the Court alone—with

24 hours’ notice before issuing its decision on AstraZeneca’s citizen petition. The Court will

then schedule a closed hearing at which all counsel of record may appear, and the FDA will be

required to issue its decision on the citizen petition and any decision that it may have reached on

any of the ANDAs at that closed hearing.

       3.      Production of Draft Labeling

       AstraZeneca also requests that the Court issue an order directing the intervenors to

provide it with copies of their draft labeling, subject to a protective order, by midnight on July 8,



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2016. Dkt. 49 at 7–8. In particular, AstraZeneca argues that access to the draft labeling will

assist it in preparing any further briefing and will assist it and the Court in their preparation for

the hearing. Id. at 8. The FDA and the intervenors disagree, arguing that the final labeling will

be included in the administrative record and that the FDA is precluded from disclosing the draft

labeling. Id.

        AstraZeneca seeks the draft labeling as a window into the FDA’s tentative assessment of

the issue presented in AstraZeneca’s citizen petition and in this litigation. Draft labeling that

includes the type of information that the FDA is authorized to require on certain pediatric carve-

out labels under 21 U.S.C. § 355a(o)(2), for example, might reasonably inform AstraZeneca’s

arguments. But the Court is unconvinced that this type of discovery is appropriate in this APA

case. Receiving the requested information might assist AstraZeneca in preparing for the

upcoming hearing, but the company has not established any right to it and, as discussed below, it

will have the opportunity to review the final labeling at the hearing.

        The Court, accordingly, will not require the intervenors to produce their draft labeling to

AstraZeneca. The Court will, however, promptly enter a protective order to govern future

proceedings. To the extent the FDA or the intervenors have any comments on the proposed

protective order submitted by AstraZeneca, see Dkt. 50, they shall file their comments with the

Court by 2 p.m. on July 11, 2016. As explained below, the Court contemplates that the FDA will

provide copies of the final labeling, if any, at the hearing on AstraZeneca’s motion for a TRO,

along with any other essential material.

        4.      Preparation of the Administrative Record

        Finally, AstraZeneca asks that the Court order the FDA to produce the administrative

record at the time it issues its decision on AstraZeneca’s citizen petition—which, as noted above,



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will occur at the hearing to be scheduled by the Court. Dkt. 49 at 8. The FDA and intervenors

oppose this request, noting that “[i]t will take some time to assemble and properly redact the

[a]dministrative [r]ecord to protect confidential commercial information” and arguing that “the

underlying [a]dministrative [r]ecord is not necessary for the Court to rule on any motion for a

TRO.” Id. at 9. The Court recognizes that it may take several days for the FDA to assemble and

to redact the administrative record and will not order that the agency produce the record at the

hearing. It will, however, order that the FDA bring to the hearing fifteen copies of the

administrative decision on the citizen petition, the administrative decisions on the intervenors’

ANDAs, the final labels for those ANDAs (if they are approved), and any other documents or

record material that the FDA intends to rely on at the hearing in support of its position.

                                          CONCLUSION

       For the reasons discussed above, the Court orders that (1) the FDA shall provide the

Court with 24 hours’ notice before issuing a decision on the pending citizen petition; (2) the

FDA may issue decisions on any or all of the pending ANDAs simultaneously with its decision

on the citizen petition but shall not issue a decision on any of the pending ANDAs before it

issues a decision on the citizen petition; (3) the FDA shall issue its decision on the citizen

petition at a hearing before the Court, which the Court will promptly schedule upon receiving

notice from the FDA that the decision is forthcoming; (4) all counsel shall be prepared to appear

for a hearing on two hours’ notice; (5) neither the FDA’s decision on the citizen petition nor its

decision on any of the pending ANDAs shall be disclosed or released prior to their issuance at

the hearing before the Court, and they shall not otherwise be disclosed or released without prior

authorization from the Court at the hearing; (6) the hearing will be closed and those proceedings

shall be sealed pending further order from the Court; (7) the FDA is authorized to contact the



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Court’s deputy clerk ex parte for purposes of notifying the Court of an impending decision of

AstraZeneca’s pending citizen petition; (8) if the FDA requests, the Court will issue its order

setting the hearing under seal; (9) the Court will not require that the intervenors produce copies

of their draft labeling to AstraZeneca in advance of the hearing, but the FDA should bring fifteen

copies of any final, approved labeling to the hearing; (10) the FDA should also bring fifteen

copies of its decision on the citizen petition to the hearing, fifteen copies of any final decisions

respecting the intervenors’ ANDAs, and fifteen copies of any other documents or record material

that the agency intends to rely upon at the hearing; and (11) the Court will otherwise address the

timing of production of the administrative record at the hearing.

       SO ORDERED.



                                                               /s/ Randolph D. Moss
                                                               RANDOLPH D. MOSS
                                                               United States District Judge

Date: July 11, 2016




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