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.
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ViiV Wants FDA, Not NAD, To Handle Dispute Over Its Dovato HIV Drug Ads
National Advertising Division refers Gilead’s challenge of ViiV’s advertisements to the FDA and FTC after ViiV declines to participate in its review. Gilead says the ads claim Dovato is superior to its HIV drug Biktarvy, while ViiV suggests a review would amount to second-guessing the FDA.
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.
US FDA Mulls Granting Regulated Industry Flexibility To Respond To Misinformation
The rapid pace with which inaccurate information can spread on social media may necessitate loosening some of FDA’s regulations on sponsors to let them respond, Commissioner Robert Califf said at the J.P. Morgan Healthcare Conference. Califf also worried about how legitimate debate can undermine public confidence in FDA.