What Differentiates Company-Led Education from IME/CME: Perspectives from Industry and Education Providers (Level 3)

Session Description: Pharmaceutical manufacturers use commercial or corporate speech in their overall efforts to sell and market their products. The Food, Drug, and Cosmetics Act gave the FDA the authority to decide whether a drug may be offered for sale and how it's marketed. The medical education provided by pharmaceutical manufacturers is highly regulated by the FDA, specifically the Office of Prescription Drug Promotion (OPDP). Under FDA rules, any company's promotional materials should be truthful, balanced, non-misleading, and supported by substantial evidence. In addition, it has been illegal for drug manufacturers to directly promote or advertise a drug for any indication that the FDA has not approved. Pharmaceutical companies often pay agencies and medical education companies to create promotional assets with the intention of educating healthcare providers on the intended use of their products. The type of assets that are produced are considered promotional or company-led, or directed because there is influence over the content and therefore is regulated by the FDA.
In recent years, Medical Affairs has begun to be responsible for company-led or directed educational efforts focusing on scientific exchange, disease awareness, and differentiating clinical trial data. It is important to know how company-led or directed education differentiates from IME/CME in order to be compliant to regulations and guidances. During this session, through utilizing cases, panelists will discuss and demonstrate the important elements of company-led education and how it differentiates from IME/CME.