The Prescription Drug Marketing Act (PDMA) requirements are in full effect, and pharmaceutical manufacturers must ensure they have policies and procedures in place to manage compliance requirements. The PDMA contains stringent regulations to ensure the proper use and distribution of pharmaceutical samples, and to combat drug diversion. PDMA provisions require pharmaceutical companies to implement controls to track all samples, from the time they leave the manufacturing facility to the time they are placed in the physician's hands.
PwC has proven methodologies that will enable your company to comply with these new regulatory requirements. We will perform an initial assessment to gain an understanding of your existing sample-management control processes and determine areas that require modified controls. We work with you to develop new processes around a variety of functions.