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Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products – Questions and Answers
src : https://www.fda.gov/media/184871/download?utm_source=substack&utm_medium=email
This Q&A guide provides guidelines on how companies can communicate scientific information to healthcare professionals regarding unapproved uses of their approved medical products.
However, even if the recommendations in this guide are followed, such communication is
not sufficient to substantiate this new claim. The FDA also does not want these
communication elements be submitted to it.
The guide concerns: medical devices, drugs, and products for veterinary use.
It recalls several definitions, including:
The FDA recognizes that healthcare professionals consider off-label uses of medical products to meet specific patient needs. At the same time, firms often wish to share relevant scientific information about these off-label uses.
The FDA therefore recognizes their importance, but only if they are accurate, not misleading, and based on sound scientific evidence. Specifically, these communications must adhere to the following principles:
• Accurate and non-misleading: Information must be factual, balanced, and not
misleading.
• Scientific information: Communications must be based on relevant scientific data and
analyses.
• Transparency: It must be clearly stated that the uses discussed are not approved or
authorized by the FDA.
• Appropriate Context: Information must be presented in a manner that does not
encourage unapproved use without appropriate medical justification.
Thus, the FDA is inclined to accept that a company communicates scientific health
information about unapproved uses to professionals without it being considered a violation.
