Exceptions for Off Label Speech:
As it presently exists, life science companies can engage in off-label discussions provided that the conversation occurs in one of 4 safe harbors.
The courts have repeatedly limited the FDA’s ability to control “truthful and non misleading” information put out by life science companies. This is rather difficult to do, and hence the FDA is careful not to prosecute as long as it meets this standard. However, to avoid problems, companies have assigned the medical affairs function to discuss off-label uses of a product. Individuals working in the medical affairs function must typically be staffed by individuals with a strong scientific background and are not held responsible for sales, since it might be deemed to be “commercial speech”.
Subject to certain guidances, continuing medical education providers may be funded in whole or in part by unrestricted grants by life science companies. During meetings funded through these unrestricted grants, individuals can communicate off-label information to clinicians provided that, amongst other criteria to be met, the content of the conversation is not controlled by life science companies.
This was further explained by a guidance from the FDA. The FDA pointed out that companies may share share off label information in response to an unsolicited request provided that the information was shared by the medical affairs departments and was not being done with the purpose of promoting sales.
Journal Articles and scientific/medical reference publications
In the same vein as described above – the FDA has put out guidances describing articles and documents that may have content that is deemed to be off-label, but may nevertheless be shared. This sharing can only occur in the context of specific disclosures and within specific contexts.
The FDA has repeatedly lost cases in the 2nd Circuit as recently as a week ago – on the promotion of FDA regulated products of off-label indications. Courts have repeatedly determined that as long as the information shared is “truthful and not misleading”, the FDA may not prevent such conversations. It is, however, apparent that such spreading of off-label information will be subject to FDA requirements. It is important that companies appreciate FDA expectations before making promotional off-label claims.
Impact on Brand Teams
If a company decides to promote a product off label, they will require the assistance of the Brand Team. The team will need to clarify – with specificity, the specific claims that they would like to make, and then work with the Medical Affairs and legal/compliance departments to ensure that the statements are “truthful and not misleading”.