United States District Court, District of Columbia
ASTRAZENECA PHARMACEUTICALS LP; IPR PHARMACEUTICALS, INC., Plaintiffs,
SYLVIA MATHEWS BURWELL, Secretary of Health & Human Services; ROBERT CALIFF, Commissioner of Food and Drugs; FOOD AND DRUG ADMINISTRATION, Defendants, 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
RANDOLPH D. MOSS United States District Judge.
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.
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.
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.
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.
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).
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
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.
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
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.
and Procedures for Release of the FDA's Decision
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.
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 ...