Case 1:12-cv-01936-RBW Document 9 Filed 12/03/12 Page 1 of 6

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
—————————————————–
ENDO PHARMACEUTICALS INC.,
)
)
Plaintiff,
)
)
v.
)
)
UNITED STATES FOOD AND DRUG
)
ADMINISTRATION, et al.,
)
)
Defendants.
)
—————————————————–

Civil Action 12-1936 (RBW)

DEFENDANTS’ RESPONSE TO THE COURT’S
NOVEMBER 30, 2012 ORDER
On November 30, 2012, Endo Pharmaceuticals Inc., (“Endo”) filed a complaint and
motion for preliminary injunction against the U.S. Food and Drug Administration, Commissioner
Hamburg, and the U.S. Department of Health and Human Services Secretary Sebelius
(hereinafter, “FDA”). 1 The case concerns the drug product oxymorphone HCl, extended-release
tablets, marketed by Endo since 2006 under the brand-name Opana ER. On the same day the
case was filed, and before setting a briefing schedule or hearing date, this Court ordered FDA to
respond to two questions. This filing is FDA’s response to that Court order.
I.

Does the Court have jurisdiction to entertain the plaintiff’s motion prior to the date
on which FDA is required to act under 21 U.S.C. § 355(j)(6) and 21 C.F.R.
§ 314.161(a)?
The Court has jurisdiction to entertain Endo’s motion for preliminary injunction to the

extent it claims that FDA has unreasonably delayed rendering a decision whether, under 21

1

FDA notes that Endo failed to satisfy its duty to confer under LCvR 7(m). Counsel
first notified FDA of this matter Friday afternoon at 3:56 pm and did not attempt to confer with
agency counsel prior to filing its complaint or motion for preliminary injunction.

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U.S.C. § 355(j)(6) and 21 C.F.R. § 314.161, the original Opana ER product was removed from
the market for safety or effectiveness reasons. However, that claim fails under Federal Rule of
Civil Procedure 12(b)(6) because FDA has no duty to act before December 31, 2012, despite
Endo’s arguments to the contrary.
Endo filed a citizen petition with FDA dated August 10, 2012, 2 that asks FDA to take
several actions including, as relevant to the Court’s jurisdictional question, making a
determination, under 21 C.F.R. § 314.161, that the original Opana ER was removed from the
market for safety reasons. 3 A recent amendment to the Federal Food, Drug, and Cosmetic Act
gives FDA 270 days from the date of submission to respond substantively to a citizen petition
requesting such a determination. See 21 U.S.C. § 355(w). Mention of this statutory deadline is
conspicuously absent from Endo’s filings. Yet, despite a statutory deadline for FDA’s response
that is many months away, Endo nonetheless argues that FDA has unreasonably delayed
responding to its citizen petition. This claim is subject to dismissal under Fed. R. Civ. P.
12(b)(6) because Endo has not shown that FDA has a duty to act prior to May 10, 2013 -- 270
days after Endo’s citizen petition was submitted to FDA.
Endo’s unreasonable delay claim fails not only because of the statutory 270-day deadline,
but also because it is far from unreasonable for FDA to take sufficient time to make the
requested determination. Endo does not suggest that the withdrawn product is less safe than the
2

Endo filed a second citizen petition with FDA, dated August 31, 2012, but that petition
does not involve application of 21 U.S.C. § 355(j)(6) or 21 C.F.R. § 314.161 and is therefore not
relevant to the Court’s questions.
3

On August 30, 2011, FDA determined, in response to a citizen petition from a generic
manufacturer, that two strengths of the original Opana ER (7.5 mg and 15 mg) were not
withdrawn from the market for reasons of safety or effectiveness. See 76 Fed. Reg. 53908 (Aug.
30, 2011). This determination was made before Endo’s new formulation of Opana ER was
approved in December 2011. Endo’s citizen petition requesting a 314.161 determination is not
limited to any particular strengths of the original Opana ER.
2

 Case 1:12-cv-01936-RBW Document 9 Filed 12/03/12 Page 3 of 6

new formulation for the intended user. Instead, Endo’s request that FDA make a section 314.161
determination raises inter alia complex and novel legal issues concerning: (1) whether a product
that was previously considered safe and effective must now be found unsafe or ineffective
because a manufacturer claims that a safer or more effective product has been introduced to the
market; and (2) whether the potential for misuse of a drug product by a population other than the
intended user constitutes a safety concern under 21 U.S.C. § 355(j)(6) and 21 C.F.R. § 314.161
that requires FDA to conclude the drug was withdrawn for safety or effectiveness reasons. In
addition, if FDA were to conclude that Endo’s original Opana ER product was removed from the
market for safety or effectiveness reasons, FDA would then have to decide what process is
required to withdraw approval of previously approved products.
To determine these issues, FDA must also resolve the complex scientific question
whether Endo’s new formulation for Opana ER is safer or more effective than Opana’s old
formulation, particularly in light of the fact that FDA has approved no labeling for Opana’s new
formulation that suggests a reduced potential for abuse exists. Compare new Opana ER label
(available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201655lbl.pdf) with old
Opana ER label (available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021610s013lbl.pdf)
(the only relevant difference between the labels is the description of the tablets’ shape (round vs.
octagonal); the “abuse potential” sections of the labels are identical). Because FDA needs
adequate time to consider and analyze the relevant legal and factual issues, including analysis of
data relating to the alleged safety advantage of the new formulation (which Endo submitted just
weeks ago, on November 13), the agency has not yet determined whether all strengths of the
original Opana ER were removed from the market for safety reasons, and is not likely to reach
such a determination by December 31, as Endo desires. In these circumstances, any alleged

3

 Case 1:12-cv-01936-RBW Document 9 Filed 12/03/12 Page 4 of 6

“delay” on FDA’s part is eminently reasonable. Endo’s urgent desire to block previously
approved generics from competing in the marketplace, which competition Endo believes will
begin on January 1, 2013, does not translate into a mandatory requirement that FDA reorder its
priorities and respond to Endo’s citizen petition by December 31, 2012.
Apart from the 270-day deadline that governs FDA’s response to Endo’s citizen petition
in this case, neither 21 U.S.C. § 355(j)(6) nor 21 C.F.R. § 314.161(a) establish a deadline by
which FDA must determine whether Endo’s product was removed from the market for safety
reasons. Endo reads into both the statutory provision and the regulation a requirement that FDA
act by December 31, 2012. There is no statutory or regulatory support for Endo’s claim. Indeed,
the December 31 date is a function of Endo’s own creation necessitated by its own commercial
decision-making. In settlement of patent litigation, Endo granted a license to a generic
manufacturer, Impax Laboratories Inc. (“Impax”), that permits Impax to begin marketing a
generic version of the original Opana ER on January 1, 2013. But a different generic version of
two strengths of the original Opana ER, marketed by Actavis South Atlantic (“Actavis”), was
introduced in July 2011, see http://www.actavis.us/en/oxymorphone.htm, and it is FDA’s
understanding that those strengths continue to be marketed today. Endo’s self-inflicted
December 31 deadline is a thinly-veiled attempt to maintain its market-share and block generic
competition from Impax. 4

4

Notably, Endo has patent protections on its new formulation of Opana ER that have the
potential to prevent generic competition until approximately 2029. See
http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=201655&Product
_No=007&table1=OB_Rx (Orange Book entry showing the drug substance patent that is listed
only for the new formulation of Opana ER, patent number 7,851,482, expires on July 10, 2029).
4

 Case 1:12-cv-01936-RBW Document 9 Filed 12/03/12 Page 5 of 6

II.

Would the FDA authorize the marketing of a generic drug that has already been
approved prior to reaching a determination under 21 U.S.C. § 355(j)(6) and 21
C.F.R. § 314.161(a) whether the plaintiff’s product was withdrawn from the market
for safety reasons?
FDA does not authorize the marketing of generic drugs separately from approving those

products. Once FDA issues a final approval under 21 U.S.C. § 355(j), which is a finding by
FDA that the generic product meets all the requirements for generic approval and therefore the
product is safe and effective, the manufacturer can immediately begin marketing the approved
product. As Endo noted in its Memorandum Of Points And Authorities In Support Of Plaintiff’s
Motion For Preliminary Injunction (“PI Mem.”), two abbreviated new drug applications
(“ANDAs”) for generic versions of the original Opana ER were approved in December 2010,
before Endo removed its product from the market. PI Mem. at 2. Those ANDAs belong to
Impax and Actavis. As noted above, Actavis began marketing two strengths of its generic
product on July 15, 2011. See http://www.actavis.us/en/oxymorphone.htm. In FDA’s view,
Impax was also permitted to begin marketing its product immediately upon approval. Impax,
however, is apparently blocked by a patent license agreement with Endo from marketing until
January 1, 2013. See PI Mem. at 13, n.20. FDA was not, and is not, a party to that licensing
agreement.
FDA assures the Court that it will not approve any other ANDAs that reference the
original Opana ER without first determining whether the product was removed from the market
for reasons of safety or effectiveness, in accordance with 21 U.S.C. § 355(j)(6) and 21 C.F.R.
§ 314.161(a). However, products that have already been approved (including Impax’s product,
Actavis’ product, and Endo’s own original product) may continue to be lawfully marketed unless
and until FDA determines that Endo’s original Opana ER was in fact removed from the market
for reasons of safety and effectiveness. Indeed, Endo itself could resume marketing its original
5

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Opana ER tomorrow should it choose, because FDA’s finding that Endo’s product is safe and
effective remains, as of this date, unchanged. The fact that Endo’s own labeling for the new
Opana ER product is largely identical to the original Opana ER label except for the description
of the tablets’ shape, as explained above, confirms that Endo’s true interest in expedited FDA
consideration stems from business concerns rather than protection of the public health.
* * *
Because Endo has no likelihood of success on its ill-conceived, eleventh-hour motion for
exigent relief, the Court should deny it on that basis alone. Alternatively, FDA requests that the
Court set a reasonable, non-expedited briefing schedule on Endo’s motion for preliminary
injunction together with the government’s anticipated motion to dismiss Endo’s unreasonable
delay claim.
Respectfully submitted,
OF COUNSEL:
WILLIAM B. SCHULTZ
Acting General Counsel
ELIZABETH H. DICKINSON
Associate General Counsel,
Food and Drug Division
ERIC M. BLUMBERG
Deputy Chief Counsel, Litigation
SHOSHANA HUTCHINSON
Associate Chief Counsel
U.S. Department of Health & Human Services
Office of the General Counsel
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
301-796-8566

STUART F. DELERY
Principal Deputy Assistant Attorney General
MAAME EWUSI-MENSAH FRIMPONG
Deputy Assistant Attorney General
MICHAEL S. BLUME
Director
/s/
ANDREW E. CLARK
Assistant Director
Consumer Protection Branch
Civil Division
Department of Justice
P.O. Box 386
Washington, DC 20044
202-307-0067
andrew.clark@usdoj.gov

December 3, 2012

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