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Navigating Promotional Content Review:

FDA Warnings, Stakeholder Needs, and Social Media at Allergan

Navigating Promotional Content Review:

FDA Warnings, Stakeholder Needs, and Social Media at Allergan

 

Medical information remains highly regulated in 2017. With the new administration taking shape, many companies are wondering how to better involve stakeholders and reach audiences while ensuring that their information is complaint. The promotional review process is multi-faceted and incorporates many different techniques and stakeholder needs.

To learn more about developing a comprehensive review process, we turned to Janet Gottlieb, PhD, Director of Medical Communications at Allergan. Gottlieb explained that though the process of promotional review is not changing, developing a comprehensive system requires the right tools, the right communication, and the right balance.

Balancing Stakeholder Needs

Promotional content revolves around stakeholder perspectives and needs. Addressing these while ensuring information compliance is key to successful information distribution. To make sure that these needs are addressed, Gottlieb recommends keeping an open mind. She explains, “When reviewing promotional content, it is important to keep a ‘solutions-oriented’ perspective in mind.  Instead of simply saying ‘no’ and shutting down any discussion on content and material, we encourage our reviewers to offer alternatives as well as being open to other possibilities to address needs in a compliant manner.”

Productive teams must work together when reviewing content, to ensure that many perspectives are included, “Communication is key to move any issues forward in a productive manner, which provides the opportunity for stakeholders to be in a collaborative position.”

Encouraging Executive Involvement

Collaborating and communicating enables medical information professionals to create well-balanced content. Getting executive decision makers involved in the content creation and review processes may further this balance and help make the team more efficient in their roles.

Gottlieb recommends keeping executive decision makers in the loop, “It is important to keep your executives in the loop, especially with key decisions.  As with any important collaboration, communication is vital to keeping executives up to speed on current events that might be applicable to their environment. Proactively engaging stakeholders on how and why decisions are made is also effective and leads to greater efficiencies moving forward.”

 

Medical Information in Social Media

With the explosion of social media, companies are now able to release more content to a wider audience. While guidelines have outlined how medical information professionals should conduct this information distribution, content review should rely on a diverse amount of resources which may include compliance warnings.

Gottlieb explains, “While social media has provided another opportunity to communicate product information, the review process has not changed if the content is considered promotional in nature.  FDA’s Social Media Guidance provides the framework for ensuring this content is compliant.  Additionally, warning and untitled letters in response to volatile social media content also provide guidance in the promotional review process.”

FDA Warning and Untitled Letters

Using warning and untitled letters in each stage of the content review process means that companies can anticipate the expectations of the Office of Prescription Drug Promotion. This may ensure that content is compliant even in a changing landscape, “FDA untitled and warning letters are excellent tools to understand OPDP’s perspective on promotional materials as well as an educational resource to guide and communicate decisions made during the review process.  Many times, when it is unclear whether specific content should be included in promotional materials, these communications assist in ensuring materials are consistent with OPDP’s position.”

Utilizing different tools to review content enables Gottlieb’s team to create, review, and promote informational and compliant content. To hear more from Janet Gottlieb, or to learn more about best medical communication practices in 2017 and beyond, register for the Customer Centric Medical Information Conference, July 24-25 in Boston, MA.