On May 11, 2010, the Division of Drug Marketing, Advertising, and Communications (DDMAC), now the Office of Prescription Drug Promotion (OPDP), announced the launch of the Bad Ad Program “to help health care professionals recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency.” The Bad Ad Program asks health care professionals to “recognize and report” to the Food and Drug Administration (FDA) any activities or messages that may be false or misleading.
To date, OPDP has issued nine letters, four of which have been Warning Letters, in response to complaints submitted to the Bad Ad program. These letters peaked in 2011 with five letters, declined to three letters in 2012, and in 2013 Bad Ad Program letters were non-existent. Have healthcare providers stopped reporting misleading activities to the FDA, or is there another explanation for the decline?
Although there were no letters issued in 2013, on November 14, 2013, as part of the program, the FDA announced an e-learning CME/CE course to help HCPs and HCP students learn how to identify prescription drug promotion that may be misleading or raise other regulatory issues and report it to the FDA. The target audience for the course includes current and future physicians, physician assistants, nurses, nurse practitioners, and pharmacists. According to OPDP's announcement, "[t]he goal of this activity is 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 course includes modules on the Bad Ad Program, FDA Oversight of Prescription Drug Promotion and Marketing, Common Drug Promotion Issues, Principals of Persuasion and Reporting Potential Drug Promotion Issues. Upon completion of the course, participants will be able to identify the role that the FDA, OPDP and HCPs play in regulating prescription drug promotion and advertising, recognize false or misleading prescription drug promotion and describe the most common regulatory issues raised by prescription drug promotion. In addition, OPDP developed several case studies based on recent enforcement letters designed for HCP school curriculums to raise awareness about misleading prescription drug promotion.
Please click here for more information on OPDP's Bad Ad Program.