The firm has extensive experience in the highly regulated field of pharmaceutical compliance. We have handled numerous matters involving the FDA’s Office of Prescription Drug Promotion (“OPDP”) (formerly known as the Division of Drug Marketing, Advertising and Communication (DDMAC)), including responding to “Bad Ad” Letters issues by the OPDP. Our broad knowledge of the pharmaceutical industry, combined with our extensive expertise in conducting internal investigations, makes us uniquely qualified to coordinate a comprehensive and effective response to any governmental inquiry.
We have also worked to develop prophylactic measures designed to ensure compliance by our clients with the myriad Federal and State regulations which are applicable to the pharmaceutical industry. Our goal is to prevent compliance issues before they occur, thereby saving out clients the substantial expenses and potential liability which would otherwise arise from future compliance issues.
We have worked with our clients to implement company appropriate compliance programs and to monitor activities within the company to ensure ongoing compliance with those programs. These efforts have also allowed our clients to establish rigorous internal disciplinary standards which have created uniform guidelines and consistent penalties which enhance the company’s ability to achieve buy-in and cooperation from its employees, from management to the sales force.