Off-Label Promotions Approved by FDA but with limits

There has been a lot of discussion about the new FDA guidance document draft “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.” The question we hear most is about usage of the document.

First, it is a draft document and not in its final form. The FDA has the right to change the document, so keep an eye on the revision you reference. Because the document is in draft form you also cannot count on its support as a reference document if problems ever come up.

Second, any medical device that has an indication not approved or cleared by the FDA is considered adulterated and misbranded and therefore in violation of the law. That being said, the FDA also understands that off-label uses of medical devices may advance public health and even become a recognized standard of care. The FDA guidance document specifically addresses these off-label uses through manufacturer reprint of journal articles.

Key points to remember:

  1. The article must be in a peer-reviewed journal.
  2. The manufacturer may not modify the article or reprint selected sections. This includes highlighting or calling attention to specific sections/information.
  3. The article cannot be funded or connected financially to the manufacturer.
  4. The full article must be supplied. Abstracts are not enough. The bibliography must be included.
  5. Disseminate the article only with the approved labeling attached.
  6. The article cannot be distributed with any promotional material. The article cannot be discussed during sales visits or at promotional trade shows.
  7. The following statement should be attached to the article (excerpt directly from FDA guidance):
    1. that the uses described in the information have not been approved or cleared by FDA;
    2. the manufacturer’s interest in the device that is the subject of the journal reprint or reference text;
    3. all significant risks or safety concerns known to the manufacturer concerning the unapproved use that are not discussed in the journal article or reference text.

While the guidance is still in draft form, it provides insight into the FDAs opinion. Off-label promotions are acceptable and even provide a public service. As with anything from the FDA, there are limitations. If you have any concerns about your product labeling or off-label promotions Regulatory Specialists is always here to help.

The full guidance can be reviewed here :

http://www.fda.gov/RegulatoryInformation/Guidances/ucm125126.htm
Or downloaded as a pdf here:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM387652.pdf