Is this a violation?

It may be difficult to assess whether that specific practice is unlawful because this type of analysis is typically quite fact specific. Broadly speaking, pharmaceutical companies may not promote their drugs for uses, doses, or populations not specifically approved by the FDA as safe and effective. This could include, for example, if a drug is approved for use in treating severe psychiatric disorders, and the drug company’s sales representatives promote it for widespread use in calming elderly patients in nursing homes. Our law firm has compiled a list of successful enforcement actions involving off-label allegations that may be of interest to you: https://constantinecannon.com/tag/off-label/.

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