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Off-Label Promotion and Product Liability Considerations
The Food and Drug Administration ('FDA') prohibits the pharmaceutical industry from promoting products for off-label uses, unless certain prescribed statutory and regulatory requirements are met. A company may choose, although ill advised, to ignore this regulatory prohibition and admonition, but it must consider what happens when unfavorable events occur.
It is well documented that government bodies are scrutinizing companies' promotional efforts, particularly marketing of products for unapproved uses, commonly referred to as 'off-label promotion.' These government bodies include: Congress; the Food and Drug Administration; the U.S. Department of Health and Human Services' Office of Inspector General; the Justice Department; and state attorneys general. Of course, it is important for any company to consider the regulatory implications of disseminating off-label information. However, it is shortsighted for companies not to consider potential product liability implications of off-label promotion.
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