In a surprising turn of events, Pacira Pharmaceuticals, Inc. and the Food and Drug Administration (FDA) announced that they have settled their dispute regarding the off-label promotion of Exparel, one of Pacira’s anesthetic drugs. This settlement represents the latest marker of the FDA’s diminishing power to regulate off-label promotion.
BACKGROUND -
Off-label promotion is the promotion of a drug for indications not approved by the FDA, which the FDA contends is a violation of the Federal Food, Drug, and Cosmetic Act (FDCA). The FDCA prohibits the introduction into interstate commerce of any drug that is misbranded. Under the FDCA, a drug may be misbranded for a number of reasons, including false or misleading labeling or labeling that fails to include adequate directions for use.
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