Advertising Enforcement: US FDA Content To Let Competitors 'Duke It Out,' Woodcock Says
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.
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Novartis’ Kisqali Consumer Promos Inappropriately Convey Superiority, NAD Finds In Unusual Ruling
However, similar claim in materials directed at health care providers need not be discontinued, National Advertising Division says in challenge brought by Lilly; NAD decisions in Rx promotion disputes are rare, but voluntary resolution process could become more appealing to pharma firms.
Comparative Claims In Product Promotions: FDA Isn’t Entirely Leaving It To Firms To ‘Duke It Out’
Four years after Woodcock’s famous comments, OPDP notes it is evaluating comparative claims as indicated in a recent untitled letter. DOJ is also looking at comparative claims. New FDA guidances are in the works, but it remains unknown when they will issue.
FDA Creates Division To Support First Amendment Policy Development, Oversee Advertising Research
Multiple unfavorable court decisions have forced the agency to adjust its advertising enforcement strategies.