On October 25, 2013, the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) updated its “Bad Ad Program” website to add an accredited CME module and case studies, designed to “educate healthcare professionals and students about the role they can play in helping the FDA ensure that prescription drug advertising and promotion is truthful and not misleading.”  The one-hour online module is designed to enable participants to: “(1) Identify the role that FDA, OPDP and HCPs play in regulating prescription drug promotion and advertising; (2) Describe the most common regulatory issues raised by prescription drug promotion; and (3) Recognize false or misleading prescription drug promotion.” 

Under the topic “Common Prescription Drug Promotion Issues”, the online CME course highlights (in order): (1) Omission of Risk (the video discussion focuses largely on black box warnings); (2) Minimization of Safety Information  (the video discussion focuses on prominence and readability); (3) Overstating Effectiveness (including overstating or exaggerating the effectiveness of a drug; making claims regarding the efficacy of the drug that are not supported by substantial evidence or substantial clinical experience; or misrepresenting data from clinical studies); (4) Promoting Uses not Addressed in Approved Labeling; and (5) Misleading Drug Comparisons (such as representing a drug is safer or more effective than another without substantial evidence/substantial clinical experience).

The CME module also links to a number of resources including a list of OPDP Warning and Untitled letters that were issued as a result of complaints to the Bad Ad Program (nine letters as of September 30, 2013), and a summary of Common Drug Promotion Issues.  While the CME training is geared toward healthcare professionals (and has a focus on reporting of violative materials to the FDA), manufacturer regulatory personnel (as well as other individuals involved in promotional and advertising material production and review) may benefit from reviewing the program and case studies as another means to inform themselves as to areas of particular FDA enforcement risk.

Posted by Kathleen Peterson

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