Off-Label Communication Policy ‘Speech-Enabling,’ FDA Legal Memo States

 
• By Michael McCaughan

The US FDA says in a legal memo that its new guidance on scientific information on unapproved uses (SIUU) is “speech-enabling” and argues that challenges should be interpreted as attempts to roll back the approval process.

Dolls on laptop keyboard in front of screen reading "Freedom of Speech."
(Muhd Imran Ismael/Shutterstock)
Key Takeaways
  • Recently finalized FDA guidance on communicating scientific information on unapproved uses included a memo arguing the policy allows rather than restricts speech.
  • The language suggests the agency already has prepared the legal briefs for the inevitable court challenges of the policy.
  • Among the many policy alternatives considered, the FDA said the BIO/PhRMA principles were not specific enough.

The US Food and Drug Administration argues that its recently finalized guidance on off-label communication by medical product sponsors does not run afoul of

The agency issued the final guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” on 6 January. The “SIUU” guidance is the

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