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Promotional Communication: Keeping Up with FDA’s Off-Label Use Policy

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Promotional Communication
Keeping Up with FDA’s Off-Label Use Policy

After recent court rulings that promotional communications is protected speech under the First Amendment — as long as it is truthful and not misleading — the FDA has worked to clarify its policy. The immediate result of public meetings and soliciting comments from stakeholders is two draft guidances published last January:
  • Medical Product Communications That Are Consistent With the FDA-Required Labeling
  • Communications With Payers, Formulary Committees, and Similar Entities

And these are just a start. Promotional Communication: Keeping Up with FDA’s Off-Label Use Policy explores the draft guidances and other FDA activity on the subject of promotional communication — explaining what companies must do to stay on the right side of the agency’s new policies and how to take advantage of the opportunities they present. The report covers:

  • How the FDA has evolved the definition of “intended use”

  • Content and industry reaction to the FDA’s recent memorandum on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products”

  • Differences between on-label use, off-label use and out-of-label use

  • How to mitigate the risk of inconsistent communications

  • New safe harbors for communication with payers

  • How the 21st Century Cures Act expanded the interpretation of Healthcare Economic Information.

Included in the report are copies of the draft guidances and the FDA memorandum on manufacturer communications.

Promotional Communication provides you with a clear understanding of what promotional speech about off-label uses the FDA will allow.

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Who Will Benefit

  • Legal
  • Compliance
  • Regulatory
  • Marketing/Commercial
  • Medical Affairs
  • Clinical Affairs/R&D

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