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FDA Guidance: Submission and Review Implications

Given the prevalence of social media in today’s society, it was inevitable that the FDA would release guidance for social media (even if they did need encouragement from congress).[1] Due to the complex nature required for each submission, following new FDA guidance may turn out not to be the most productive use of time for marketing companies or their agency counterparts. Given the multiple layers of internal review that a project must go through at the marketing company review level (prior to FDA 2253 submission), efficiencies will be required in order to optimize submissions under the new requirements. The system outlined below describes how to maximize the effectiveness of a marketing company’s internal Medical Legal and Regulatory (MLR) team.

Summary of FDA 2253 submission requirements for Interactive Promotional Media:

  • Marketing company is responsible for product promotional communications on sites that are “owned, controlled, created, influenced, or operated by, or on behalf, of the company.”
  • Each submission is required to be accompanied by a completed Form FDA 2253 that is both “archivable” and “easily digestible” in manner.
  • No matter the scope of “control” or “influence” that a company may have on a third-party website, they are responsible for submissions to FDA to meet intended requirements.
  • The FDA suggest that a company submit an updated listing of all nonrestricted sites for which it is responsible on a monthly basis. Screenshots and other visual representations of the interactive or real-time communication are not required with monthly updates (this step happens at time of initial submission).
  • If a company follows the terms of submission within the FDA guidance and properly submits above mentioned content, “enforcement discretion” is intended to be used by the FDA. This means the FDA will not get involved unless safety concerns are identified in the material.[2]

Rules and recommendations for the ideal submission through a marketing company’s MLR review team:

Submitting content monthly to the FDA will require cooperation from all parties involved in the submission process. Without timely FDA submissions, marketing companies run the risk of wasting valuable marketing dollars on an ill-fated attempt to promote their product through interactive promotional media. To achieve timely and cost-efficient project pushes into the market, everyone will need to be on the same page.

If a marketing company’s MLR reviewers are to regulate the new FDA 2253 submission requirements prior to submission, it’s imperative that the review team clearly define and interpret terms within FDA guidance (e.g., influence, control). There must be a consensus within the company. Different interpretations of the FDA guidance within the same company will create inconsistent and unpredictable direction for the agency responsible for submission. In turn, clear and concise direction by the MLR team will eliminate the need for multiple internal submissions, thus saving the marketing company time and money.

With all “archivable” content required to be placed into a digestive format (as end users would see), companies may need to invest in propriety technology in order to achieve desired FDA review parameters. Current options to utilize existing programs do exist, such as ArchiveSocial, which claims to “manage public records of social media.”[3] We have yet to see if pharmaceutical marketing companies will adopt an existing platform, or develop proprietary technology to appease FDA submission regulations. Either way, the cost to do business just became more expensive.

Because the FDA will utilize “enforcement discretion” upon reviewing submissions, it is incumbent upon the MLR review team to determine what material may be deemed a “safety concern,” thus warranting further review by the FDA. With these review criteria in mind, the MLR reviewers are sure to examine documentation with added scrutiny. Concerns around timing and costs will ensue for each time the MLR review team pushes back on content it may see as a potential safety concern.

Marketing companies should consult various specialists in the field, including those that are most knowledgeable in “Interactive Promotional Media” FDA submissions to determine a plan that best works for their business.



[1] SEC.1121. GUIDANCE DOCUMENT REGARDING PRODUCT PROMOTION USING THE INTERNET

[2] FDA.gov, PDF, 3-Enforcement-Discretion-Hooberman

[3] www.ArchiveSocial.com

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