Off-Label Promotion vs Off-Label Use The concept of what constitutes off-label promotion is intrinsic to understanding the new policy dynamics. Under regulations issued by FDA following enactment of the 1962 Drug Amendments, companies may not promote medical products for uses not approved by FDA or not supported by substantial evidence or substantial clinical experience. At the same time, healthcare professionals may and very frequently do prescribe and use products off-label, creating what some have called the "off-label paradox," a situation whereby doctors may actually prescribe prescription drugs and products for uses that manufacturers are forbidden to freely discuss with them, although a company may respond to a specific request about off-label uses through its medical affairs department. Settlements have defined off-label promotion as efforts by drug or device companies to encourage the use of their products for purposes not in the FDA-approved labeling, even when such uses are generally accepted as standard care by the medical community and even when such uses have been approved subsequently by FDA. Included in the case-by-case allegations are overt off-label promotional activities by company sales representatives, as well as more subtle activities such as the use of third- party, consultant physicians to discuss off-label uses. The Anatomy of an Enforcement Action Typically, a case begins with a complaint filed with the Department of Justice. The US Attorneys' offices that have handled the most cases are those in Philadelphia and Boston. The cases are almost always whistleblower cases, brought by a present or former employee. If the government decides to pursue the case, it then conducts an investigation. At some point it will
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