The FDA’s 2011 reorganization, renaming and elevation of the Division of Drug Marketing, Advertising and Communications (DDMAC) into the Office of Prescription Drug Promotion (OPDP), indicated that the agency was bringing new tools and a more energized force to fight drug promotion violations. While pharmaceutical companies haven’t seen so much as a major change in enforcement, they have been the focus of better efforts to communicate what’s expected of them to stay within the FDA’s good graces regarding drug promotions. Plus, many more guidances and regulations have been promised by the agency. This issue of The Food & Drug Letter looks at actions during the past year since the change, spotlights the most important aspects of good drug promotion practices and profiles a few companies recently cited with violations.
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