Mannkind is in hot water for its Afrezza Facebook page. The FDA’s Office of Prescription Drug Promotion chastised the pharma for failing to mention the inhaled insulin’s risks, citing claims that included Afrezza “will help your body work its best and protect you from health complications” with “no drama.”
In a warning letter (PDF), OPDP said the Facebook material “suggests that there are no risks associated with the use of the drug” when that may not be the case.
The complaint initially came through the OPDP Bad Ad program, in which concerned parties can report problematic advertising to the drug policing division.
OPDP demanded that Mannkind pull any offending materials and report its actions to the agency by Oct. 19. The page OPDP criticized does not appear to be on Facebook anymore.
It is the OPDP’s fifth citation of the year, but its first warning letter, generally considered a tougher measure than an untitled letter.
Mannkind has struggled to get widespread adoption of Afrezza, the only inhaled insulin on the market. It has launched awareness and branded campaigns to help drum up business, but sales are still modest with full year revenue projected at about $17 million, according to analysts, below guidance of $22 million to $25 million.
MannKind recently struck a $45 million development deal with United Therapeutics to create a dry powder version of treprostinil, adding a needed cash infusion with the potential for royalties and more down the line.