On Monday, the FDA released a draft of their much-anticipated guidelines for social media (“interactive promotional media”) for Human and Animal Drugs and Biologics. While this guidance does not include a comprehensive approach to best practices for digital asset or detail how the FDA will regulate drug promotion via social and digital media, it does outline how pharma companies should submit forms to the FDA in order to fulfill requirements for post-marketing submissions.
While the guidelines are not a playbook, they do acknowledge that “interactive promotional media” poses some unique attributes and challenges, the guidelines will allow pharma companies to have the opportunity to promote products and disease awareness, engage with patients, and distinguish themselves as leaders digitally.
Outlined below, is a topline summary of the FDA draft guidance release.
Key highlights of FDA’s Guidance for Industry Fulfilling Regulatory Requirements for Post-marketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics
1. The FDA acknowledges that a drug firm is responsible for product promotional communications on sites that are “owned, controlled, created, influenced, or operated by, or on behalf of, the firm. Such product promotional communications may include firm-sponsored microblogs (e.g. Twitter), social networking sites (e.g., Facebook), firm blogs, and other sites that are under the control or influence of the firm. A firm is responsible for promotion on a third-party site if the firm has any control or influence on the third-party site, even if that influence is limited in scope. For example, if a firm collaborates, or has editorial, preview, or review privilege, then it is responsible for its promotion on the site and, as such, that site is subject to submission to FDA to meet post-marketing submission requirements. However, if a firm provides only financial support (e.g. through an unrestricted educational grant) and has no other control or influence on that site, then the firm is not responsible for information on a third-party site, and has no obligation to submit the content to FDA.
Key implication(s): Pharma companies can be held responsible if they advertise or sponsor the content on 3rd party sites and the site makes exaggerated product claims. If an employee uses social media to talk about a product (Twitter, Facebook, LinkedIn, etc.) that employee could be considered an agent of a company and subject to FDA guidelines and enforcement thereof.
2. ”FDA intends to exercise its enforcement discretion under certain circumstances due to the high volume of information that may be posted within short periods of time using interactive promotional media that allow for real-time communications.”
Key implication: This suggests that pre-scripted approvals for posts on user-generated content sites (owned) is preferred – this includes tweets, blog posts, etc. HOWEVER, the FDA also acknowledges that some of these occurrences can happen in real-time.
3. ”Once every month, the firm should submit a Form FDA 2253 or Form FDA 2301 for the non-restricted sites for which the firm is responsible or in which it remains an active participant and that include interactive or real-time communications. Multiple sites and the corresponding documents can be submitted with a single Form FDA 2253 or Form FDA 2301. Firms should include a separate document for each site which includes the site name, URL, and date range, as well as a cross-reference to the date of the most recent submission of the site.”
Key implication: For agencies placing ads on 3rd party sites, the contact should be limited to placement of ads/content and that approval should be around the placement only, not the context/placement.
While the FDA’s guidance does not dictate regulations in locally, Edelman will continue to watch this space and continue to adapt our digital strategies to adhere to the evolving guidelines of pharma’s regulation bodies. If you have any questions or wish to discuss how we anticipate these guidelines may affect digital implementation regionally or in Australia, please do not hesitate to contact Edelman Healthcare Team.
Betsy Oyler - Betsy.Oyler@edelman.com