Through the Looking Glass - Exploring Transparency, False Claims Act, and Promotional Claims

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Life Science Compliance

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U.S. EDITION Volume 2.2 | February 2016

prohibition on such activities arises from the statute’s bans on introducing a new drug into interstate commerce and on misbranding. At the risk of oversimplification, a prescription drug is misbranded if a manufacturer’s promotional claims manifest an intent that the drug be employed in an unapproved use; in such situations, the drug’s label necessarily lacks the “adequate information for its use” as the regulation requires.2 The FDA, however, distinguishes between “promotion,” which is prohibited, and the dissemination of information concerning the drug, which is sometimes permitted.3 For example, a manufacturer may disseminate information related to an off-label use by submitting original research to peer-reviewed publications, or by distributing peer-reviewed medical journal articles directly to prescribers.

Through the Looking Glass - Exploring Transparency, False Claims Act, and Promotional Claims Charles Sullivan, Professor of Law, Seton Hall University School of Law This article discusses the new white paper issued by Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy, analyzes the role of federal and state agencies, and their relationship with private “relators,” in direct and indirect enforcement of the Food and Drug Administration’s (FDA) off-label promotion rules.

A recent white paper issued by Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy, analyzes the role of federal and state agencies, and their relationship with private “relators,” in the direct and indirect enforcement of the Food and Drug Administration’s (FDA) off-label promotion rules.1 The white paper describes from beginning to end how a qui tam case proceeds, warns that pharmaco-economic communication is the next frontier for enforcement, and makes suggestions for an enforcement regime more efficient and effective in achieving public health goals.

In addition to setting the ground rules for conduct in this area, the FDA engages in what might be called direct enforcement. Misbranding can be either a felony or a misdemeanor, depending on the manufacturer’s intent to defraud or mislead. Direct enforcement, then, includes the FDA seeking to initiate criminal prosecution, although the agency also has other civil remedies it may employ. But the significance of such direct enforcement by FDA pales when compared to enforcement through the False Claims Act. In recent years, billion dollar settlements against pharmaceutical companies accused of promoting their products for unapproved “off-label” uses have been commonplace. For example, in 2009, Eli Lilly settled with the government for $1.415 billion4 and Pfizer settled for $2.3 billion.5

The FDA is, of course, the source of what is called the ban on off-label promotion and has the power to seek to enforce its rules. While the words “off-label promotion” do not appear in the Food, Drug, and Cosmetic Act or in its implementing regulations, a

1 healthlaw@shu.edu | www.shu.edu


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