US FDA Considering New Requirements for Off-Label Use Data
US regulators have published updated draft guidance addressing distribution of scientific and marketing materials related to unapproved uses of medical devices, drugs and other products under Food and Drug Administration oversight. The agency is accepting public comments on the guidance through April 2014.
Revising guidelines originally issued in 2009, the FDA has now developed recommended best practices for manufacturers providing information to medical or scientific publications that discuss unapproved uses for devices already registered for sale in the US. The guidance includes recommendations for three broad types of information:
- Scientific or medical journals
- Scientific or medical reference texts
- Clinical Practice Guidelines
Device manufacturers intending to distribute information on unapproved uses of their products should take steps such as peer review, separation of scientific information from promotional or marketing materials, disclosure of any financial ties authors or publishers of materials may have to featured devices or manufacturers, and systematic reviews of existing clinical or scientific evidence.
The FDA’s call for comments on these recommendations should be welcomed by industry participants given how thorny the issue of discussing uses of medical devices not covered by their Premarket Approval (PMA) registrations can be.