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Rxcompliancereport.com

SUPPLEMENT
Lilly’s consumer protection settlement regarding
Zyprexa: Compliance provisions
Here are the compliance requirements included in Eli Lilly’s $62 million consumer protection settlement
with 32 states announced October 7, 2008:

1. Promotional Activities
symptoms and the relevant diagnostic criteria are available in the Diagnostic and Statistical A. Lily shall not make any written or oral claim that is false, misleading or deceptive regarding II. Dissemination of Medial Information
B. For six years from the Effective Date of this Judgment, Lilly shall not Promote Zyprexa for A. General Terms
1. The content of Lilly’s communications C. For six years from the Effective Date of this concerning Off-Label uses of Zyprexa shall Judgment, Lilly shall not present patient profiles/ not be false, misleading or deceptive.
FDA-approved indication(s) when promoting B. Medical Letters and Medical References
1. The following subsections shall be effective for six years from the Effective Date of this indication(s) being Promoted is/are stated clearly and conspicuously in the same spread (i.e. on the same page or on the facing page) in 2. Lilly Medical shall have ultimate responsibility for developing and approving the medical content for all Medical Letters and Medical References regarding Zyprexa, including any a. With respect to Promotional Slide Kits: that may describe Off-Label information. Additional approvals may be provided by Lilly Regulatory and Lilly Legal. Lilly shall not indication(s) on the same slide in which a. Clinically Relevant Information is included in these materials to provide scientific Section I.C.1.a.(i) on the same slide as each b. Data in these materials are presented in an subsequent reference to selected symptoms (e.g., “See complete list of FDA-approved c. These materials are distinguishable from sales aids and other Promotional Materials.
(iii) Lilly shall require any presenter of Lilly’s Promotional Slide Kits to present the 3. Lilly Sales and Lilly Marketing personnel shall statement required in Section I.C.1.a (i), as not develop the medical content of Medical Zyprexa. This provision does not prohibit 2. Promotional Materials have a reference Lilly Sales or Lilly Marketing personnel from indicating that the full constellation of suggesting topics for Medical Letters or Rx ComplianCe RepoRt 1
4. Lilly Sales representatives shall not distribute orally to an Unsolicited Request for Off-Label any Medical Letter describing any Off-Label only by informing the HCP of the presence or misleading representation regarding Zyprexa absence of published studies concerning the Off-Label topic or acknowledge whether the topic is an area of research, and by offering to request on behalf of the HCP that a Medical C. Responses to Unsolicited Requests for
Letter or other information set forth above in Off-Label Information
II.C.4 be sent to the HCP in follow up. Lilly Non-Medical personnel shall not characterize, 1. The following subsections shall be effective for describe, identify, name, or offer any opinions six years from the Effective date of this 2. In responding to an Unsolicited Request for D. Reprints
Off-Label information regarding Zyprexa, including any request for a specific article 1. The following subsections shall be effective for related to Off-label uses, Lilly shall advise the six years from the Effective Date of this Off-Label use and inform the requester of the drug’s FDA-approved indication(s) and or/ 2. Reprints Containing Off-Label Information a. Lilly Medical shall be responsible for the 3. If Lilly elects to respond to an Unsolicited Request for Off-Label information form HCP Off-Label Information regarding Zyprexa.
regarding Zyprexa, Lilly Medical personnel shall provide specific, accurate,objective and b. Reprints Containing Off-Label Information scientifically balanced responses. Any such response shall not Promote Zyprexa for an prescribing information for the product and 4. Any written response to an Unsolicited contain a disclosure in a prominent location, Request for Off-Label information regarding which would include the first page or as a cover page where practicable, indicating a. an existing Medical Letter prepared in (ii) shall not be referred to or used in a b. a Medical Letter or other document such as slides prepared in response to the request in c. Reprints Containing Off-Label Information disseminated by Lilly Medical personnel to reasonable literature search using terms not disseminate these materials to HCPs, absent to the exception described below in 5. Lilly Non-Medical personnel may not respond in writing to an Unsolicited Request for Off-Label information regarding Zyprexa.
circumstance in which there is a clinical 6. Lilly Non-Medical personnel may respond Rx ComplianCe RepoRt 2
personnel disseminate a Reprint Containing Off-Label Information directly to HCPs, the E. Health Care Economic Information
prohibition described in Section II.D.2.c above for the Reprint Containing Off-Label 1. Nothing in this Judgment shall preclude Eli Lilly from providing Health Care Economic Information to a formulary committee or other (ii) If the Clinical Necessity Exception is similar entity or its members on the course of invoked, Lilly will notify each Signatory the committee or entity carrying pursuant to Attorney General of its intent to invoke the the standards of FDAMA Section 114 if the Clinical Necessity Exception at least 30 information directly relates to an approved business days prior to disseminating through indication for Zyprexa and if it is based on Lilly Sales representatives of any Reprint competent and reliable scientific evidence.
III. Continuing Medical Education (CME) and
A. The following subsections shall be effective for six years from the Effective Date of this Judgment.
Necessity Exception, then the State will B. Lilly shall disclose information about grants, provide Lilly with written notice within consistent with the current disclosures of the Lilly opportunity to discuss its desired use of Grant Office Registry at Zyprexa consistent with the current disclosures of the Lilly Grant Office Registry at www.lillygrantoffice.com (hereinafter, “LGO website”) or as required by applicable law.
(b) If the State and Lilly do not come to 1. Lilly shall maintain this information on the a resolution, then the State may initiate LGO website once posted for at least two legal action to prevent the dissemination years and shall maintain the information in a readily accessible format for review by States upon written request for a period of five years.
C. The Lilly Grant Office shall manage all requests (c) If the State initiates legal action to for funding related to CME regarding Zyprexa. prevent the dissemination of the Reprint Approval decisions shall be made by Lilly Grant Office alone, and shall be kept separate from the Lilly Non-Medical personnel, Lilly shall D. Lilly shall not use grants to Promote Zyprexa. Off-Label Information in that State until This provision includes, but is not limited to, the 3. Nothing in this Judgment shall preclude Lilly 1. Lilly Sales and Lilly Marketing personnel shall from disseminating reprints which have an not initiate, coordinate or implement grant incidental reference to Off-Label information. applications on behalf of any customer or If reprints have an incidental reference to Off-Label information, such reprints shall contain the disclosure required by Section Rx ComplianCe RepoRt 3
2. Lilly Sales and Lilly Marketing personnel shall B. This Section shall apply to the U.S. based not be involved in selecting grantees or Consultants and Promotional Speakers to the 3. Lilly Sales and Lilly Marketing personnel shall C. Lilly shall provide to each Signatory Attorney not measure or attempt to track in any way the General, in an electronic spreadsheet format, a impact of grants or speaking fees on the participating HCP’s subsequent prescribing Consultants who were paid by Lilly any taxable income in excess of $100 for Promotional speaking and /or Consulting performed for Lilly E. Lilly shall not condition funding of a CME in the U.S., a list of all titles of Promotional program grant request regarding Zyprexa upon presentations made, and the following additional the requestor’s selection or rejection of particular information with respect to each individual F. Lilly shall not suggest, control, or attempt to 1. total compensation from Lilly for any influence selection of the specific topic, title, content, speakers or audience for CME’s regarding Zyprexa, consistent with ACCME 2. total number of Promotional speaking events G. Lilly Sales and Lilly Marketing personnel shall 3. the state the Promotional Speaker/Consultant not approve grant requests regarding Zyprexa, had provided to Lilly for contact purposes.
nor attempt to influence the Lilly Grant Office to reward any customers or HCP’s with grants for 4. the state(s) in which the Promotional Speaker their prescribing habits, practices or patterns.
H. Lilly shall contractually require the CME provider 5. any other compensation from Lilly as set forth to disclose to CME program attendees Lilly’s in IRS Form 1099. On or before July 1, 2009, financial support of the CME program and any Lilly shall provide the data requested in Nos. financial relationship with faculty and speakers at 1-4 for the period January 1, 2009-March 31, such CME. As part of the disclosure of a financial 2009. On or before October 1, 2009 Lilly shall relationship with faculty and speakers, Lilly shall provide the data requested in Nos 1-4 for the contractually require the CME program to period April 1, 2009-June 30, 2009. On or identify the URL of a Lilly website, and reference before January 1, 2010, Lilly shall provide the that website as the source for further information date requested in Nos 1-4 for the period July concerning grant funding regarding Zyprexa.
April 1, 2010 and on or before April 1 each I. After the initial delivery of the CME program, Lilly subsequent year, Lilly shall provide the data shall not fund the same program, nor shall it requested in Nos 1-5 for the full preceding provide additional funding for re-distribution of the same program, if it knows the program’s speakers are Promoting Zyprexa for Off-Label D. Lilly shall disclose to the Promotional Speaker or Consultant that the information in Section IV.C. IV. Payments to Consultants and Speakers
A. The following subsections shall be effective for six years from the Effective Date of this Judgment.
Rx ComplianCe RepoRt 4
V. Product Samples
accessible website of all Lilly-sponsored Phase II, III, and IV clinical trials that were A. The following subsections shall be effective for six years from the Effective Date of this Judgment.
B. When presenting information about a clinical B. Lilly Sales representatives may only sample study regarding Zyprexa in all Promotional Zyprexa to HCP whose clinical practice is Materials, Lilly shall not do any of the following consistent with the product’s current Labeling. Currently, Lilly samples Zyprexa to the following practices: emergency medicine, family practice, general practice, internal medicine, and 1. present favorable information or conclusions from a study that is inadequate in design, scope, or conduct to furnish significant support C. If a HCP whose clinical practice is inconsistent with the product’s Labeling requests samples, Lilly personnel shall refer the practitioner to 2. use the concept of statistical significance to 1-800-LillyRx where the practitioner can speak directly with a Lilly representative who will demonstrated to have clinical significance or provide answers to their questions about Zyprexa validity, or fails to reveal the range of variations around the quoted average results; appropriate (i.e., if the physician requests the 3. use statistical analyses and techniques on a retrospective basis to discover and cite findings VI. Clinical Research
not soundly supported by the study, or to suggest scientific validity and rigor for data A. Lilly shall report research regarding Zyprexa in an from studies the design or protocol of which accurate, objective and balanced manner as 1. To the extent permitted by the National 4. present the information in a way that implies Library of Medicine and as required by the that the study represents larger or more general experience with the drug than it 110-85), Lilly shall register clinical trials and submit results to the registry and results data bank regarding Zyprexa as required by FDA 5. use statistics on numbers of patients, or counts of favorable results or side effects, derived regulations that may be promulgated pursuant from pooling data from various insignificant or to the act. With the respect to Zyprexa, Lilly dissimilar studies in a way that suggests either will register on a publicly accessible website that such statistics are valid if they are not they the initiation of all Lilly-sponsored Phase II, are derived from a large or significant studies III, and IV clinical trials beginning after July 1, supporting favorable conclusions when such is 2005 and will post results on a publicly Rx ComplianCe RepoRt 5

Source: http://rxcompliancereport.com/issues/2008/LillySettlement.pdf

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