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Jan 21, 2014

FDA Releases Draft Guidance on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Drugs and Biologics

Published

Jan 21, 2014

On Jan. 14, FDA issued draft guidance for industry called “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.”

The Agency’s release is in response to stakeholder requests for specific guidance on FDA’s current views on how manufacturers, packers and distributors of prescription drugs and biologics can fulfill regulatory requirements for postmarketing submissions of interactive promotional media for their FDA-approved products.

This guidance provides FDA’s recommendations to drug firms regarding how to fulfill the regulatory requirements for postmarketing submissions of interactive promotional media for FDA-approved products.  FDA defines “interactive promotional media” as tools and technologies that firms use to promote their drugs and biologics, which often allow for real-time communications and interactions (e.g., blogs, social media, live podcasts, etc.).  Notably, the guidance outlines what considerations FDA takes into account while determining whether product communications using interactive technologies are subject to substantive influence by firms that market the product:

  • A firm is responsible for product promotional communications on sites that are owned, controlled, created, influenced, or operated by, or on behalf of, the firm.
  • Under certain circumstances, a firm is responsible for promotion on third-party sites, if the firm has any control or influence on the third-party site, even if that influence is limited in scope.
  • 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.
  • Comments on the draft guidance, available here, are due April 14.  The FDA docket for comments is available here.  After the comment period ends on April 14, FDA will review submitted comments and issue a final guidance.
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