If you own “it,” finance “it” or influence “it” you are responsible for “it.” In essence that’s what the FDA recently said in their draft guidance on “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.”
Finally, the FDA has provided the long overdue requirements for pharmaceutical manufacturers to use in conjunction with product communications in blogs, microblogs, social networking sites, online communities and live podcasts.
The guidance assigns FDA regulatory approval to messaging that a manufacturer owns, finances or influences. On the other hand, user generated content that is posted by an HCP, patient or other non-affiliated individual is not the responsibility of the pharma company. Whew! That’s a load off most brand marketing team’s minds.
The typical FDA regulatory approval process for a post marketing website launch remains unchanged even if the site contains an online forum. After a product’s launch, real time interactions don’t have to be pre-approved; however, they are subject to a new monthly reporting requirement that is outlined in the recommendations.
Here are a couple of the more useful points of direction that the FDA provided:
1. “Under certain circumstances, a firm is responsible for promotion on third-party sites.”
If a brand is promoted on a third-party site that content has to be submitted to the FDA for review and approval.
2. “A firm is responsible for the content generated by an employee or agent who is acting on behalf of the firm to promote the firm’s product.”
Pharmaceutical manufacturers continue to be responsible for the messages delivered by employees or other individuals who communicate on behalf the company. Also, the FDA recommends a manufacturer disclose or provide transparency regarding content posted, blogged, etc. by its employees or others acting on behalf of the company.
These 7 pages of guidelines address a myriad of issues in a practical, common sense manner that will aid all pharmaceutical marketers in engaging patient populations and HCPs through the most effective communication channels.
Click here for the FDA’s complete Interactive Promotional Media document.