Off-Label Promotion Leads to Criminal Plea,
Consent Decree of Permanent Injunction,
Disgorgement of Proﬁt
United States v. Eli Lil y and Company
The Food and Drug Administration (FDA) has just concluded a signiﬁcant enforcement action involving al eged off-label promotion of a prescription drug.
On December 21, 2005, the Department of Justice and Eli Lil y and Company (Lil y) announced agreements to resolve an investigation into the marketing and
promotion of Evista® (raloxifene hydrochloride).1 Lil y agreed to a criminal ﬁne of
$6 mil ion, a civil disgorgement of $24 mil ion, and forfeiture of another $6 mil ion
to the government, together with a consent decree of permanent injunction. The
government al eged that Lil y had promoted Evista, a drug approved only for the
prevention and treatment of osteoporosis, for other uses, including the prevention
and reduction in risk of breast cancer and the reduction of risk of cardiovascular
disease.2 The actions taken, and the government’s legal rationale, offer several
important lessons for pharmaceutical and medical device companies.
FDA CAN ARGUABLY AVOID FIRST AMENDMENT ISSUES
WHILE ACTING AGAINST OFF-LABEL PROMOTION BY USING
TRADITIONAL LEGAL THEORIES REGARDING “INTENDED USE”
Lil y was charged with intending that Evista be used for indications that were
not approved and for which there were no adequate directions for use in the
labeling. The government did not al ege that any of the materials disseminated
or supported by Lil y were false or misleading.
Thus, the prosecution’s rationale
sought to avoid First Amendment issues: instead of arguing that Lil y’s speech was
violative by itself, the government focused on the consequences of the speech
This summary is intended to be a general
, the creation of new intended uses for Evista). In this regard, FDA’s approach
is analogous to other areas where speech can have legal consequences despite
constitute legal advice. You should consult with competent counsel to determine
First Amendment protections (e.g.
, damages for libel, breach of conﬁdentiality
applicable legal requirements in a speciﬁc
agreements; criminal sanctions for hate crimes).
FDA’s position in the WLF
al eged activities to establish that the
FDA CAN SEEK
“DISGORGEMENT” FOR ALL
PROFITS DERIVED FROM
the “intended use” in order not to be
court orders for restitution to consumers
al egedly il egal importation of drugs.8
Brieﬁngs for securities analysts on
“safe harbors” that would ensure that
company of so-cal ed “il -gotten gains”
or “unjust enrichment” in the context
of “intended use.” On this basis, the
detailed explanation of the basis for the
Integrity Agreements (“CIA”) between
FDA CAN REQUIRE A
PROGRAM, SIMILAR TO,
BUT WITH IMPORTANT
DISTINCTIONS FROM, OFFICE
OF INSPECTOR GENERAL
the rules against fraud and abuse in the Medicare and Medicaid programs,
arguably to strip al proﬁts derived from
regarding exclusion. Presumably, FDA could refer a breach to the OIG
C o m p l i a n c e O f f i c e r a n d
Arnold & Porter LLP has one of the
nation’s leading pharmaceutical and
medical device regulatory practices,
including expertise on marketing and
promotion in the complex environment
criminal information and civil complaint,
created by FDA law; laws against fraud
which (together with the plea agreement,
and abuse; the False Claims Act; and
state laws and regulations. If you would
like more information, please feel free
risk of breast cancer in 1999. Zeneca
Inc. and Barr Laboratories, Inc.
v. Eli Lilly
, 1999 WL 509471 (S.D.N.Y.
Washington Legal Found.
v. Universal Mgmt. Servs.
, Inc., 191
F.3d 750 (6th Cir. 1999); U.S.
v. Lane Labs-
, 427 F.3d 219 (3d Cir. 2005).
v. Rx Depot, Inc. et al.
10 Plea Agreement, para. 4(h).
(especially 9-16 and 29).
12 See, for example, CIA between OIG and
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