Earlier this week a pharma/device industry watchdog called The Prescription Project filed a petition with the FDA claiming that three medtech companies were illegally advertising their products on YouTube because their videos lacked the mandated disclosures (e.g. warnings, precautions, potential side effects and contraindications) required in DTC ads. The group pointed to videos from:
- Abbott for its XIENCE™ V drug-eluting stent
- Medtronic for its Prestige® Cervical Disk
- Stryker for its Cormet™ Hip Resurfacing technology
More importantly, to me at least, the group challenged the FDA to "issue a Guidance on Consumer-Directed Broadcast Advertising of Prescription Drugs and Restricted Devices on the Internet to clarify how federal law and FDA regulations apply to online drug and device promotions."
A big impediment for pharma marketers hoping to use the Web and social media for product education has been the lack of clear guidance from FDA. It is easy to make mistakes when you don't know what the rules of the game are. So I'm glad that the Prescription Project has formally asked.