A product’s regulatory history and competitive landscape may factor into the US Food and Drug Administration’s evaluation of whether drug promotions are consistent with labeling, but false and misleading efficacy problems remain a focus.
Drug Promotion: Sponsors Are Running Afoul Of US FDA’s CFL Guidance
Recent Office of Prescription Drug Promotion enforcement letters provide several learnings, including the need to be aware of a product’s regulatory history and competitive landscape when developing promotions that are consistent with FDA-labeling, experts said.
