A lot of us (myself included) think of the Internet as a wild frontier where anything’s possible. It’s a place with no rules where journalists and researchers can publish considered opinions and bloggers can say outrageous things (myself excluded, of course). The Internet is a place where you have to use your own judgment because no one is monitoring the truth or accuracy of people’s claims.
Or so we thought.
Shire (Basingstoke, Hampshire, UK) found out the hard way that a sheriff is patrolling the wild frontier. The company posted a video testimonial on YouTube, featuring spiky-haired celebrity designer Ty Pennington, to promote its “Adderall XR” capsules as a treatment for attention deficit hyperactivity disorder. The US Food and Drug Administration sent Shire a Warning Letter, charging that the video overstated Adderall XR’s efficacy. The agency took issue with Pennington’s implication that the drug will “transform” a patient’s life and help him or her “fit in” and not feel “alienated.” FDA also said the video omitted important information about Adderall XR’s contraindications and common adverse events. The video should have been submitted to the agency for approval, according to the letter.
The Internet is an open form with wonderful possibilities for exchanging information and ideas. The exchange should be free, but promotional materials such as Shire’s video should be subject to conventional regulation. FDA is sometimes portrayed as a lax regulator that is technologically behind. That the agency was aware of Shire’s video and asserted its jurisdiction over it is an encouraging sign.