US FDA’s ‘Bad Ad’ Program Snares Paragard Contraceptive TV Video Promo
CooperSurgical is hit with second letter for misleading promotion of its copper-containing intrauterine contraceptive. Video lacked any safety information, agency says in request for corrective communication.
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Office of Prescription Drug Promotion issued six enforcement letters and launched three research projects in 2021. There were more internal changes as the office switched to electronic submissions of promotional materials and went through year-end reorganization.
US FDA's staff have sometimes worked late into the night to help sponsors meet deadlines and avoid errors in responding to a notice of violation. As is often the case, early communication helps avoid problems.
Agency cites video promoting Biohaven’s Nurtec ODT, which first aired on ABC’s TV show The View, for misleading comparative claims, inadequate display of risk information, and failure to submit promo for review.