Medical and Scientific Communications 2013 Annual Forum

In a regulated industry such as ours, regulatory guidance documents from the Food and Drug Administration (FDA), corporate integrity agreements (CIAs) and the Office of Inspector General (OIG), and legal decisions affecting the pharmaceutical industry may substantially impact how we work in medical and scientific communications. How has the 2011 FDA draft guidance entitled “Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Device” impacted industry interactions with consumers and health care providers? Has the guidance restricted, enhanced, or built upon current practices across Medical Communications Departments? How have recent CIA and State AG settlements impacted medical and scientific communications? What is the importance of recent judicial opinions on FDA regulation of off-label communications, especially U.S. v. Caronia? What is the potential impact on medical and scientific communications?