FDA Advertising Enforcement Highlighted By HHS Amid Drop In Citations
HHS blog post details activity of US FDA's Office of Prescription Drug Promotion during a year in which the office has only issued one enforcement letter, continuing a downward trend.
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Office of Prescription Drug Promotion is focused on most egregious issues where human safety is at stake; CDER's Woodcock also says that First Amendment issues are affecting enforcement.
OPDP's first enforcement letter of 2018 is notable because it comes much earlier than 2017's first, cites an opioid, and signals that the US FDA is monitoring medical meetings.
Last year's record low five letters came as FDA launched flurry of studies on DTC, professional ads; 'Bad Ad' complaints totaled more than 100.