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.
Off-Label Promotion and Product Liability Considerations
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.' 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.
By
Alan G. Minsk And David L. HoffmanThis premium content is locked for LawJournalNewsletters subscribers only
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