Real-World Evidence: What Can You Say to Payers and Patient Advocates?

Medical Affairs professionals want to share Real-World Evidence (RWE) about drug products with payers, patient advocates and others, but communications about drug products are highly regulated. Federal laws, including FDAMA Section 114, FDA guidance materials and FDA enforcement actions all provide insight into the types of communications FDA will and will not accept. This presentation will provide insights into the types of communications that FDA has indicated are or are not permissible, and the uncertainties that still remain.