Bausch’s Duobrii Promos Censured For Excluding Risk Info, Making Misleading Superiority Claims
Bausch gets an untitled letter from the US FDA criticizing a video and webpage promoting its psoriasis lotion. The agency also objects to superiority efficacy claims based on post hoc analyses of a single phase II trial after expressing similar concerns to the company two years ago.
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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.
Althera’s misleading claims about its cholesterol drug Roszet is based on a ‘scientifically unsound analysis,’ OPDP tells company. FDA says studies cited in the pamphlet for doctors do not support claims regarding the magnitude of treatment effect.
OPDP warning letter objects to video interview in which CytoDyn's then CEO touts use of the investigational drug for COVID-19. The exec says he is ‘making up numbers’ but if the pattern continues there will be ‘the most fantastic results’ anybody could ever imagine.