Answer as of January 19, 2009 because it is time-sensitive. The U.S. FDA document is a "Guidance" out for comment and it is not law, so caution in interpreting it is needed. Also, it is very complex and you can see the whole thing at http://www.fda.gov/oc/op/goodreprint.html. There are lots of caveats and requirements to meet. Read the disclaimers carefully. This guidance replaces the FDAMA 401 provision that expired in 2006 (since 2000). The FDA has been wrestling this issue since then. Keep in mind the US government has changed to a Democrat driven government in both the presidency and the House, and Health Care reform is now the number two issue behind the economic situation. There are a number of hawks that are interested in reining in pharmaceutical industry marketing practices and several have spoken against this guidance. A new FDA Commissioner will be selected soon by the new House and we will see what will be the new direction. Keep in mind Eli Lilly just got hit with a 1.4 billion dollar settlement for alleged criminal action regarding off-label promotion during the period 1999 to 2003. There are a number of other recent off-label cases that the Department of Justice and Office of the Inspector General (not the FDA) have acted on. I have recently asked Health Canada about any action in Canada to move in this direction and the answer is "no". Remember that advertising laws in Canada are not the same as laws in the USA.
