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
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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
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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
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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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