In light of the court’s recent decision regarding off-label promotion and First Amendment rights, some have suggested that off-label promotion need only comply with the FTC standard for advertising being “truthful and not misleading.” If that is the case, then what exactly is “truthful and not misleading?” Does it mean that an indication should be able to be promoted based on a published study (or studies) even if the underlying data and analyses have not been scrutinized by an impartial third party to assure that published results accurately reflect the data that were collected? Does it mean that an indication may be promoted even if inadequate safety data have been collected for the specific patient population targeted by the new indication? Is it sufficient to “accurately” note that a study has identified a positive effect and state that “the indication has not been reviewed by the FDA” when there is a pervasive lack of understanding by the target audience (practitioners) of what the FDA does when it reviews a drug application? Obtaining positive data in a clinical study is just the first step in obtaining a drug approval. An immense level of scrutiny is applied to the submitted data and safety aspects of the proposed indication once a drug application is accepted by the FDA for review. Can the promotion of an indication without these safeguards truly be considered to be “not misleading?”
Posted by Carrie Rabe, Senior Consultant. For more information, please contact Carrie at firstname.lastname@example.org.