The FDA hit Johnson & Johnson with a warning letter over a webcast promoting pain med Ultram ER, saying it overstated efficacy and underplayed or omitted risks.
J&J promptly pulled the video, titled “Making Sure Your Relationships Aren’t Pained When You’re In Chronic Pain,” from painawareness.org, a site hosted by Montclair, NJ-based medical communications company Aventine HealthSciences.
According to the Division of Drug Marketing, Advertising and Communications letter, dated May 12, the video runs seven minutes, the first six of which are taken up by testimonials from a professor of family medicine and an Olympic Gold Medalist offering no risk information. In the video’s final minute, risk information appears “in a telescript format, with rapidly scrolling text in small type font, and with no accompanying audio presentation.” Even there, the agency said, important contraindications are left out.
Furthermore, statements regarding the benefits of the drug in the testimonial portion “greatly misrepresent what is known about the efficacy of Ultram ER,” the agency said.
J&J had submitted the video for DDMAC review on behalf of its Ortho-McNeil-Janssen unit, which makes the drug.
