The Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) recently reviewed Bracco Diagnostics’ website, www.impactcin.com (IMPACT website), for its drug product, Isovue.
As part of its monitoring and surveillance programme, DDMAC found that the website “contains false and unsubstantiated claims related to Isovue, and omits and minimises the risks associated with the drug product”.
It has been observed that there are numerous false claims and presentations on several webpages within the IMPACT website and in the video that describe the design of the IMPACT study.
According to DDMAC, these claims and presentations falsely indicate that the IMPACT study was a prospective study that compared the primary endpoint of incidence of CIN between Isovue (iopamidol370) and Visipaque (iodixanol-320). It added that contrary to these claims, the IMPACT study was not such a study, but rather was a post-hoc combination of two already-completed trials, INVICTA and VIRPACT, that were designed to study image quality as a primary endpoint and that listed CIN risk as a secondary endpoint.
“We are concerned about your false characterisation of the IMPACT study design, as well as the misleading implication in your promotional materials that IMPACT, due to its touted design characteristics, provides “the truth” regarding the comparative incidence of CIN associated with Isovue versus Visipaque,” stated DDMAC.
DDMAC has directed Bracco to cease the dissemination of violative promotional materials for Isovue.
