Former US FDA Chief Counsels Offer Advice For Navigating Thorny First Amendment Conundrum
Daniel Troy suggests FDA increase its investment in science of consumer understanding, while Richard Cooper recommends bully pulpit approach to get attention of industry; panel of former chief counsels stresses that agency cannot continue to ignore First Amendment issues.
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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.
Upcoming research projects will look at presentation of FDA approval status, timing of disease awareness ads, and healthcare professional views.
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.