OPDP sends Warning Letter to Acorda
OPDP hit Acorda Therapeutics with a warning letter dated July 25 for an Ampyra print ad. The agency's ad lookout said the company's print ad in a February issue of the Des Moines Sunday Register failed to include risk information, rendering it false or misleading.
The ad was an invitation to a multiple sclerosis presentation, and featured the company logo and drug name as well as some drug benefit statements. It also included the statement, “This presentation is not medical advice or an attempt to provide medical advice” and says readers should talk to a healthcare provider to discuss the treatment.
OPDP says the provider language doesn't cut it, because “this does not mitigate the misleading omission of risk information from the print ad.”The July note was not limited to the February transgression, and doubled as an expression of frustration, saying Acorda's misleading ad is “particularly troubling considering OPDP expressed concerns regarding violative promotional activities as recently as June 21, 2012.” A 2012 Acorda Amypra video triggered an untitled letter that said the drug's efficacy was overstated and risk information minimized.