STAT+: FDA scolds drugmaker over promotion that touts ‘misleading’ comparison with generics
For what appears to be the first time, the FDA scolded a company for a promotional display that falsely claimed its brand-name medicine was more effective than generic versions.
The U.S. Food and Drug Administration scolded a company for a promotional display that falsely claimed its brand-name medicine was more effective than generic versions, which is apparently the first time the agency office responsible for monitoring advertising has cited such an issue.
In a Feb. 3 letter posted on the FDA website this week, the Office of Prescription Drug Promotion wrote that Edenbridge Pharmaceuticals displayed a panel about its Hemady treatment for multiple myeloma in a conference exhibit booth. However, not only was there a lack of important risk information, but the promotional panel also maintained there was greater patient adherence to its drug compared with generics.
The agency pointed out that the study cited by the company did not support this conclusion because of problems with the study design and methodology. For instance, it was not clear whether the patients given a generic version were newly diagnosed or had relapsed multiple myeloma, which are distinct patient groups that require different treatment regimens.
