Another set of FDA letters is warning drugmakers off misleading promotions: This time, it's Roche, Sanofi-Aventis and Adolor that get the agency scolding for a multimedia array of promotions.
The biggest drug on the list is the cancer drug Herceptin. The FDA takes issue with a consumer video from Roche unit Genentech. That production "minimizes the serious risks associated with the use of Herceptin" and misleads viewers about the drug's benefits, the letter states. But Roche also was chastised for sales materials for HIV drug Invirase; the FDA said those materials made misleading claims, too. Roche says it took the video down from the Herceptin website and stopped using the Invirase promos.
Meanwhile, Adolor was criticized for a live promo: At a pharmacists' meeting last December, the FDA says, an Adolor sales rep minimized the risks and overstated the effectiveness of the bowel drug Entereg. And Sanofi drew fire for promotions that "made unsupported claims" about its prostate cancer med Eligard.
These letters about marketing infractions have become a regular thing. It seems as if we're getting a batch almost every week. Yet another change we've noticed with the Obama administration's FDA.
- read the Reuters story