JANUARY 2006 Off-Label Promotion Leads to Criminal Plea, Consent Decree of Permanent Injunction, Washington, DC 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
(i.e., 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 case.
al eged activities to establish that the
FDA CAN SEEK “DISGORGEMENT” FOR ALL PROFITS DERIVED FROM “OFF-LABEL” MARKETING.
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 RIGOROUS LONG-TERM CORPORATE COMPLIANCE PROGRAM, SIMILAR TO, BUT WITH IMPORTANT DISTINCTIONS FROM, OFFICE OF INSPECTOR GENERAL CORPORATE INTEGRITY AGREEMENTS.
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
ENDNOTES 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 Dara Corrigan Inc. and Barr Laboratories, Inc. v. Eli Lilly and Company, 1999 WL 509471 (S.D.N.Y.
Daniel Kracov Arthur Levine Washington Legal Found. v. Henney, 202
U.S. v. Universal Mgmt. Servs., Inc., 191
F.3d 750 (6th Cir. 1999); U.S. v. Lane Labs-USA, Inc., 427 F.3d 219 (3d Cir. 2005). U.S. v. Rx Depot, Inc. et al., appeal
10 Plea Agreement, para. 4(h). 11 Id. (especially 9-16 and 29). 12 See, for example, CIA between OIG and
^kqfqorpq=C=`ljmbqfqflkNO ABUSE OF DOMINANT POSITION WITHOUT A LINK BETWEEN THE PREDATORY PRACTICE AND THE DOMINATED MARKET Sarah Temple-Boyer September 2009 In a landmark decision dated March 17, 2009 , the Cour de cassation (French Supreme Court) upheld the position adopted by the Paris Court of Appeals in a judgment dated April 8, 2008 that reversed a ruling of the Conseil de la c
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