The Zyprexa and Bextra Settlements How State Attorneys General Are Reshaping Pharmaceutical Marketing and Compliance through Fraud Investigations and Settlements The Zyprexa and Bextra Settlements Meredith Manning December 17, 2008 © 2008 Hogan & Hartson LLP. All rights reserved.

Observations The State AGs are filling the gaps left by FDA in key areas of “medical communication” Medical Information Responding to Unsolicited Requests Dissemination of Reprints Samples Companies will need to assure not only that they observe FDA’s actions going forward but that they calibrate policies and procedures to States’ expectations This will have long-term implications for company policies unless FDA acts to “occupy the field” © 2008 Hogan & Hartson LLP. All rights reserved.

Observations Each of the settlements to date (Zyprexa, Vioxx, and Bextra) have been under state consumer protection laws And, each essentially equates the state standards with FDA standards But, at least one state allows its consumer protection statute to be enforced privately Of course, the FDCA may not be enforced privately So, these settlements raise major questions about whether private claims for violations of the FDCA will be brought against pharma companies under state consumer protection laws, particularly California’s § 17200 © 2008 Hogan & Hartson LLP. All rights reserved.

Lilly Illustrates the Gap Filling Medical Information Legal and Regulatory must review medical response letters Materials must be “distinguishable” from sales aids Responses cannot be misleading Responses to Unsolicited Requests Medical personnel shall provide “accurate, objective, and scientifically balanced responses” Written responses shall include existing Medical Letters or slides prepared as “standard” responses or a report of a literature search Non-Medical personnel may not respond in writing Oral responses are limited to telling the HCP about studies that might exist or acknowledging that the topic may be the subject of research and offering a medical response letter © 2008 Hogan & Hartson LLP. All rights reserved.

Lilly Illustrates the Gap Filling Reprints Medical is responsible for selecting off-label reprints and disseminating them This is more restrictive than the WLF standard Allows dissemination of reprints that include “incidental” references to off- label information This is similar to the FDA 1996 guidance allowing dissemination of registrational studies (that was ultimately withdrawn during the WLF litigation) Samples May only be distributed to physicians with “practices consistent with the product’s current labeling” If an inconsistently-practicing doctor requests a sample from a call center, Lilly must decide whether the proposed use of the sample is “appropriate” before making it available © 2008 Hogan & Hartson LLP. All rights reserved.

Some Issues Remain Some provisions will be difficult to interpret and therefore may not serve as good guidance for other companies e.g. promotional materials may not present conclusions from a study that is “inadequate in design, scope, or conduct to furnish significant support” for the conclusions (Lilly) Pfizer sponsored trials must use “legally effective informed consent” is the use of “trial” as opposed to “study” significant? When presenting information from “studies”, Pfizer cannot imply more general experience than the study supports or pool data to suggest validity © 2008 Hogan & Hartson LLP. All rights reserved.

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