Complaint Challenges FDA’s Unlawful Efforts to Retroactively Restrict
the Promotion of EXPAREL Despite Its Broad Indication
PARSIPPANY, N.J.--(BUSINESS WIRE)--Sep. 8, 2015--
Pacira
Pharmaceuticals, Inc. (NASDAQ: PCRX) today filed a lawsuit against
the U.S. Food and Drug Administration (FDA) seeking to exercise its
lawful rights to communicate truthful and non-misleading information
about its flagship product, EXPAREL® (bupivacaine liposome
injectable suspension). EXPAREL was approved
in 2011 for administration into the surgical site to produce
postsurgical analgesia.
The complaint outlines the Company’s belief that the FDA has violated
the Administrative Procedure Act (APA), Fifth Amendment, and its own
guidance materials and precedent by threatening enforcement action for
promoting EXPAREL consistent with its approved indication. Additionally,
the lawsuit alleges that the FDA violated the First Amendment rights of
Pacira and the co-plaintiffs by restricting the exchange of truthful and
non-misleading speech. The complaint, which was filed in
the United States District Court for the Southern District of New York,
can be accessed here: http://phx.corporate-ir.net/phoenix.zhtml?c=220759&p=irol-lawsuit.
Dave Stack, president, chief executive officer, and chairman of Pacira,
remarked, “EXPAREL is an effective alternative to opioid-based
postsurgical pain management, which is critically important to patient
care as our nation battles an opioid addiction epidemic. In filing this
lawsuit, we aim to restore our lawful right to communicate truthful and
non-misleading information about EXPAREL consistent with the broad
indication, for administration into the surgical site for postsurgical
analgesia, granted by the FDA in 2011. It is unfortunate that the
Agency’s unwillingness to respond to repeated requests for discussion
around these issues have left us with no choice but to take legal
action.”
Background on the Complaint
In September 2014, the FDA issued Pacira a Warning
Letter related to certain promotional materials. At FDA’s
insistence, Pacira took certain actions to address the immediate FDA
concerns and minimize further disruption to its business, but at the
same time presented the Agency with evidence in defense of its marketing
practices and requested multiple follow-up discussions.
Over the last year, Pacira repeatedly sought a dialogue with the FDA to
address points of misunderstanding and disagreement, and repeatedly was
denied. Six weeks ago, while continuing to deny the Company’s requests
for a meeting, and declining to offer further insight into its
interpretation of the EXPAREL label, the Agency issued a close-out
letter, indicating that it regarded the matter of the Warning Letter to
be closed.
Pacira brings three counts in its complaint:
1. The unilateral attempt by the FDA to narrow the approved broad
indication for EXPAREL without observing the procedure required by law
for modifying a drug’s label violates The Administrative Procedure Act
(APA).
2. The FDA regulations as applied to Pacira are vague, deprive the
company of fair notice of what is prohibited, and operate as a
retroactive, ex post facto penalty, all in violation of the Due Process
Clause of the Fifth Amendment.
3. FDA’s actions attempting to forbid Pacira from sharing truthful and
non-misleading information regarding both the efficacy and the
administration of EXPAREL violate the Company’s First Amendment right to
engage in truthful and non-misleading speech.
Pacira seeks declaratory relief as well as a preliminary and/or
permanent injunction preventing the FDA and other defendants from taking
any action to violate the Company’s aforementioned rights. The Company’s
motion for an injunction, which will be filed subsequent to the
complaint, will be supported by several key declarants, including Larry
Goldkind, MD, a former Deputy Director of the Division of
Anti-inflammatory, Analgesic and Ophthalmic Drug Products in the FDA’s
Center for Drug Evaluation and Research (CDER), and Dr. Lee-Jen Wei,
Professor of Biostatistics at the Harvard T.H. Chan School of Public
Health.
Pacira and the individual physician plaintiffs are represented in this
lawsuit by Ropes & Gray LLP. Pacira is also represented by Latham &
Watkins LLP and Lowenstein Sandler LLP.
About Pacira
Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) is a specialty
pharmaceutical company focused on the clinical and commercial
development of new products that meet the needs of acute care
practitioners and their patients. The company’s flagship product,
EXPAREL® (bupivacaine liposome injectable suspension), indicated for
single-dose infiltration into the surgical site to produce postsurgical
analgesia, was commercially launched in the United States in April 2012.
EXPAREL and two other products have successfully utilized DepoFoam®, a
unique and proprietary product delivery technology that encapsulates
drugs without altering their molecular structure, and releases them over
a desired period of time. Additional information about Pacira is
available at www.pacira.com.
About EXPAREL®
EXPAREL (bupivacaine liposome injectable suspension) is currently
indicated for single-dose infiltration into the surgical site to produce
postsurgical analgesia. The product combines bupivacaine with DepoFoam®,
a proven product delivery technology that delivers medication over a
desired time period. EXPAREL represents the first and only
multivesicular liposome local anesthetic that can be utilized in the
peri- or postsurgical setting. By utilizing the DepoFoam platform, a
single dose of EXPAREL delivers bupivacaine over time, providing
significant reductions in cumulative pain score with up to a 45 percent
decrease in opioid consumption; the clinical benefit of the opioid
reduction was not demonstrated. Additional information is available at www.EXPAREL.com.
Important Safety Information
EXPAREL is contraindicated in obstetrical paracervical block anesthesia.
EXPAREL has not been studied for use in patients younger than 18 years
of age. Non-bupivacaine-based local anesthetics, including lidocaine,
may cause an immediate release of bupivacaine from EXPAREL if
administered together locally. The administration of EXPAREL may follow
the administration of lidocaine after a delay of 20 minutes or more.
Other formulations of bupivacaine should not be administered within 96
hours following administration of EXPAREL. Monitoring of cardiovascular
and neurological status, as well as vital signs should be performed
during and after injection of EXPAREL as with other local anesthetic
products. Because amide-type local anesthetics, such as bupivacaine, are
metabolized by the liver, EXPAREL should be used cautiously in patients
with hepatic disease. Patients with severe hepatic disease, because of
their inability to metabolize local anesthetics normally, are at a
greater risk of developing toxic plasma concentrations. In clinical
trials, the most common adverse reactions (incidence greater-than or
equal to 10%) following EXPAREL administration were nausea,
constipation, and vomiting.
Please see the full Prescribing Information for more details available
at http://www.exparel.com/pdf/EXPAREL_Prescribing_Information.pdf.
Forward Looking Statements
Any statements in this press release about our future expectations,
plans, outlook and prospects, and other statements containing the words
“believes,” “anticipates,” “plans,” “estimates,” “expects,” and similar
expressions, constitute forward-looking statements within the meaning of
The Private Securities Litigation Reform Act of 1995. Actual results may
differ materially from those indicated by such forward-looking
statements as a result of various important factors, including risks
relating to: the success of our sales and manufacturing efforts in
support of the commercialization of EXPAREL; the rate and degree of
market acceptance of EXPAREL; the size and growth of the potential
markets for EXPAREL and our ability to serve those markets; our plans to
expand the use of EXPAREL to additional indications and opportunities,
including nerve block, oral surgery and chronic pain, as well as
pediatrics, and the timing and success of any related clinical trials;
the related timing and success of a United States Food and Drug
Administration supplemental New Drug Application; the adverse effects
and impacts of FDA warning letters; the outcome of the U.S. Department
of Justice inquiry; our plans to evaluate, develop and pursue additional
DepoFoam-based product candidates; clinical studies in support of an
existing or potential DepoFoam-based product; our plans to continue to
manufacture and provide support services for our commercial partners who
have licensed DepoCyt(e); our commercialization and marketing
capabilities; our and Patheon UK Limited’s ability to successfully and
timely construct dedicated EXPAREL manufacturing suites; and other
factors discussed in the “Risk Factors” of our most recent Annual Report
on Form 10-K for the fiscal year ended December 31, 2014 and in other
filings that we periodically make with the SEC. In addition, the
forward-looking statements included in this press release represent our
views as of the date of this press release. Important factors could
cause our actual results to differ materially from those indicated or
implied by forward-looking statements, and as such we anticipate that
subsequent events and developments will cause our views to change.
However, while we may elect to update these forward-looking statements
at some point in the future, we specifically disclaim any obligation to
do so. These forward-looking statements should not be relied upon as
representing our views as of any date subsequent to the date of this
press release.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150908006707/en/
Source: Pacira Pharmaceuticals, Inc.
Company Contact:
Pacira Pharmaceuticals, Inc.
Jessica
Cho, 973-254-3574
or
Media Contact:
Pure
Communications, Inc.
Dan Budwick, 973-271-6085
