In the ongoing saga of trial-and-error online marketing, the FDA has cited Johnson & Johnson for a web video promoting its chronic pain drug Ultram ER. According to the agency, the video exaggerates the drug's effectiveness--so FDA is asking J&J to stop using the video and to offer "corrective" promotional materials about the drug.
J&J already yanked the video off the Internet. "We are reviewing the [FDA] letter internally and we will respond to the FDA," a company spokesman told the Wall Street Journal. "The video in question ... is no longer available to the public."
In the seven-minute video, a doctor and patient--which happens to be Olympic gold medalist Nikki Stone--talk about the benefits of Ultram ER for six minutes. The final 60 seconds presented risk information in "a telescript format, with rapidly scrolling text in a small type font, and with no accompanying audio," the FDA's letter said.
The agency also points out that the risk info didn't include some of Ultram ER's potential side effects. And the testimonial portion overstated the drug's effectiveness, the letter said, implying that it can alleviate depression and improve sleep quality. "FDA is not aware of any evidence to support such effects," the letter states.