Digitas Health has announced the release of Effective Review and Approval of Digital Promotional Tactics, written by Dale Cooke, who is its VP/group director, regulatory review with Digitas Health. The Food and Drug Law Institute published the comprehensive primer.
In addition to an approachable and optimistic view of FDA’s most recent guidance on social media use, the primer provides guiding principles for how pharmaceutical marketers can embrace digital, while ensuring compliance.
“People need to understand how to effectively review promotional tactics,” Cooke told Med Ad News. “I have heard people at top companies proudly announce that they are responsible for developing company guidelines for using social media despite the fact that they don't have a Facebook account. Imagine someone trying to review a television commercial without having ever seen a television. They wouldn't know the importance of asking about things such as how fast the voiceover is delivered or whether the music will overwhelm the audio. But those are extremely important factors that determine whether the resulting promotional material is compliant. Exactly the same is true of all media. Reviewers need to understand, and preferably use those media to appreciate all of the factors that contribute to whether a message is compliant.”