Ascend’s EstroGel Promotion Misrepresents Efficacy Compared To Other Products, US FDA Says
Professional sell sheet falsely suggests estradiol gel contains lowest effective dose of estrogen compared to other estrogen products, OPDP says in fourth “untitled” letter of 2018.
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‘Untitled’ letter is FDA's third in the past eighteen months to target promotions for women’s health products. In the case of advertisement for CooperSurgical's copper-containing intrauterine device, which is regulated as a drug, the agency took issue with distracting visuals and reliance on superimposed text.
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.
Third enforcement letter of the year cites meeting exhibit and webpage that suggest crenolanib is safe and effective for an unapproved use.