Biography

Michael A. Misocky, R.Ph., J.D., CHC has 15 years of experience in the healthcare industry. Mr. Misocky is a registered pharmacist, a licensed attorney, and is nationally certified in healthcare compliance. Mr. Misocky’s regulatory compliance experience also includes working as a Regulatory Review Officer for the Division of Drug Marketing, Advertising, and Communications (DDMAC) at the FDA.

He is currently the President of the Misocky Consulting Group, LLC where he provides expert consultative advice to pharmaceutical and biotechnology clients with regard to their regulatory compliance needs including, but not limited to, the following key areas:

-         DDMAC Promotional Reviews

-         Responding to External Violation or Advisory letters

-         Promotional and Educational Material Audits

-         Continuing Medical Education Grant Reviews

-         Advisory Board and Speaker Engagement Reviews   

-         Corporate Compliance Program (CCP) assistance with a special focus on development of a CCP infrastructure including drafting policies and procedures, developing training and education programs, assisting with the development of monitoring practices, performing risk assessments, and compliance with various State Compliance Laws

Mr. Misocky previously worked as Assistant Vice President and Deputy Compliance Officer at ImClone Systems Incorporated from 2004-2007 where he was responsible for building and overseeing all commercial, clinical and regulatory compliance activities as well as performing regulatory reviews to ensure DDMAC Compliance. Prior to joining ImClone, Mr. Misocky spent the previous 5 years in management positions at both Abbott Labs and Bristol-Myers Squibb where he oversaw regulatory compliance activities (including DDMAC promotional reviews) for various franchises within these organizations.

Mr. Misocky is on the Editorial Board for the FDA Advertising and Promotion Manual and regularly speaks and writes about regulatory compliance issues affecting the pharmaceutical industry. He received his B.S. in pharmacy from the University of Toledo and his J.D., cum laude, from the University of Akron, where he served as Editor of the Law Review and as President of the Health Law Society. Mr. Misocky is admitted to the Bar in the State of Ohio.

You may contact Mr. Misocky directly at michael@misocky.com for a full CV, potential speaking engagements, or expert testimony /analysis.