Looks like FDA might be paying closer attention to YouTube.
Last week, Shire was part of a blitz of warning letters sent to ADHD drug manufacturers, citing omission or lack of risk information. Johnson & Johnson, Novartis, Mallinckrodt, and Lilly were also included—but Shire’s situation is different.
The letter to Shire noted an overstatement of efficacy in a video testimonial provided by celebrity spokesperson Ty Pennington for Adderall XR. The letter literally highlights every instance of claims that cannot be substantiated by clinical evidence.
“The video cites no references in support of these claims, and we are not aware of substantial evidence to support them,” the letter to Angus Russell, CEO of Shire, states. “In fact, the effect of Adderall XR on patients’ total scores on the ADHD-RS-IV in clinical trials versus placebo, while statistically significant, does not demonstrate an effect that in any way supports the ‘amazing transformation’ claim, nor do the symptoms measured in this rating scale include the outcomes claimed in this testimonial.”
FDA claims that Shire posted the video on YouTube, and must cease distribution of the video immediately. Pharm Exec called Matt Cabrey, Shire’s director of communications, who confirmed that it was indeed Shire (or an agency working with the company) that uploaded the short flick to the popular video-sharing site on May 2007.
“What’s important to note is that Shire received a letter of inquiry from FDA on this same topic on May 10, 2007,” Cabrey said. “At that time, Shire removed the video and wrote a complete response to FDA on June 1, 2007. We were not expecting a warning letter because we thought the issue was resolved.”
Cabrey said that the posting was made in error. The video was intended to be included on a Shire Web site with risk information listed below the testimonial.
In this particular case, Pennington was a paid spokesperson for the brand, but the situation brings up the question of whether pharma companies are responsible for consumers who repost pharma ads, spoof ads, or their own testimonials about experiences with a drug.
“There is a reason why FDA has not issued explicit regulations regarding the use of new media, and that’s because the same rules should apply regardless of the media,” Ignite Health President Fabio Gratton said. “The fact that FDA is looking at this channel as seriously as they’re looking at television is a validation for a lot of companies that don't look at e-media as a fringe media.”
The worry is that if FDA issues a warning letter about a social media ad, some pharma companies could react negatively toward the channel as a whole. “I can see myself walking into a regulatory meeting with a YouTube strategy, and somebody says that they think the FDA frowns upon it,” Gratton told Pharm Exec on Tuesday. “We don’t want to encourage a fear factor around YouTube.”
Shire said that the warning will not hinder its new media strategies, and will continue looking at alternative areas to market its products.
“We now have an e-marketing initiative that four years ago didn’t exist,” Cabrey said. “E-marketing is a big part of our approach to reaching out to specific stakeholders or audiences, whether they are consumers, physicians, parents of patients. There is going to be some robust activity around how can we best reach patients through this medium with appropriate messaging.”