This webinar will be broadcast in Eastern Time (ET)

The promotion of drugs for use beyond the approved label is not clearly defined by FDA guidances and regulations. As a result, pharmaceutical companies have turned to the higher courts for help interpreting the current legislation. The outcomes of the judicial decisions may have future implications on the way the pharmaceutical industry and health authorities cooperate in the dissemination of drug information to consumers and healthcare professionals. During this webinar, expert panelists from regulatory affairs, legal, and medical affairs will address questions such as, “What drug information can be shared with consumers?" and “How will FDA react to judicial rulings?”

Most recently, the District Court of Southern New York ruled in favor of First Amendment protection for a pharmaceutical manufacturer’s off-label promotion of an otherwise approved drug. In this ruling entitled Amarin Pharma vs. FDA, Amarin claimed that the FDA’s threat of a misbranding action kept it from engaging in constitutionally protected truthful speech. Amarin sought preliminary relief to ensure its ability to engage in truthful and non-misleading speech free from the threat of a misbranding action.

The Amarin case is not the only First Amendment challenge brought to the courts by the pharmaceutical industry. This webinar will provide a broad overview of such cases from each panelist’s perspective. Panelists will discuss the implications of the judiciary decisions on drug promotion and dissemination of off-label drug information, as well as share potential strategies to navigate FDA’s guidance in this area.