OPDP letter dings Kadmon for previous violation
The Office of Prescription Drug Promotion is not happy with Kadmon Pharmaceuticals. The Health and Human Services agency, which is responsible for ensuring a drugmaker's marketing materials do not overstep approved claims, sent a warning letter to Kadmon over a letter that accompanies the Ribasphere RibaPak.
In short: the agency said the marketing materials indicate patients outside the approved indication could benefit, make "unsubstantiated efficacy claims,” and omit risk information.
The agency also hinted at a degree of frustration with the Warrendale, PA, drug manufacturer, writing that “false or misleading presentations by Kadmon are particularly troubling considering OPDP expressed concerns regarding similar violative promotional activities in March 2011,” referring to a notice sent about Infergen. The 2011 incident mirrors that of 2013: the agency said the Infergen material “broadened and omitted material facts...overstated efficacy.”
Kadmon is not the first company to push its messaging beyond bounds: Acorda was written up for a similar pattern in August over a print ad for its MS drug Ampyra, but OPDP's November letter to Kadmon said the unit is concerned the company "is continuing to promote its prescription products in a violative manner.”