FDA is establishing a few fundamental criteria that will help ensure that scientific exchange doesn't end up being promotional. The first criterion is independence. It requires that the sponsor of an activity, the drug firm, have neither express nor implied control over the scientific content of the program. Second is objectivity, which should ensure that the treatment of a drug or class of drug is not promotional. It suggests that sponsors should fund educational activities through organizations known for their objectivity.
Balance is the third quality.
It requires the activity to include a range of views about the drug, class of drug, or disease under discussion. Let me move on to yet another example of the need to provide complete and accurate information about a product under our purview. Last week, the FDA initiated a seizure action against one brand of breast implant. The U.S. attorney in Minneapolis filed a seizure action against these breast implants on behalf of the FDA because the manufacturer was marketing an unapproved breast implant, and because of unsubstantiated claims about that product. Unsubstantiated claims such as this one are simply inappropriate.