The holy grail of pharmaceutical advertising is legally compliant off-label advertising. However, like every grail search many have perished in the search of the promised land.  Non compliant off-label promotion has, however, been problematic and has even resulted in multi-billion dollar fines over the last few years. However, recent court cases have opened up opportunities for compliant off-label communications.

Exceptions for Off Label Speech:

Companies are often trying to address the needs of prescribers. These needs often show up as off-label questions.  As it presently exists, life science companies can engage in off-label discussions provided that the conversation occurs in one of 4 safe harbors that have traditionally been non-promotional.

Non Promotional

Scientific discussion

The courts have repeatedly ruled that scientific discussion is subject to governmental controls provided that it meets the “strict scrutiny” standard. This is rather difficult to do, and hence the FDA is careful not to prosecute as long as it meets this standard. This is also the basis of medical affairs being typically staffed by individuals with a strong scientific background and not being responsible for sales, since staffing it by sales people without a scientific background it might be deemed to be “commercial speech and not protected by the court rulings

Continuing Medical Education (CME)

Subject to certain guidance, 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 the content of the conversation is not controlled by life science companies and is not promotional in nature.

Unsolicited Requests

This was further explained by a guidance from the FDA. The FDA pointed out that companies may 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

As seen in other non-promotional discussions, I– the FDA has put out guidances describing articles and documents that may have content that is deemed to be off-label, but may still be shared. This sharing can only occur in the context of specific disclosures and within specific contexts such as unedited textbooks or chapters etc.

Non promotional off-label conversations have been the cornerstone of communications that addressed the needs of prescribers and other healthcare providers. However, the needs of clinicians are routinely off-label. Restricting these necessary conversations to only a small part of the clinician facing teams does a disservice to clinicians and patients alike. A recent set of court rulings may change this.


The FDA has repeatedly lost cases in the 2nd Circuit 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 apparent that such spreading of off-label information will be subject to FDA requirements. It is important that companies consider FDA expectations before making promotional off-label claims. In the absence of specific guidance from the FDA, it is likely that this will at least include some expectations of fair balance.


Off-Label promotions can have dramatic ramifications. It is critical that companies and the various stake holders understand the implications of off-label advertising.

Impact on Legal

If a company decides to promote a product off label, they will require the assistance of the legal and compliance department(s). There are a variety of possible steps the legal and compliance department may take. One of the more conservative steps includes reaching out to the FDA to evaluate the potential promotional pieces.

Impact on Medical Affairs

If a company decides to promote a product off label, they will require the assistance of the Medical Affairs department. Medical Affairs departments evaluating off-label promotional claims will likely need to not only review the claims to ensure that they are “truthful and not misleading” but also ensure that fair balance requirements may also need to be met.

Impact on Promotions

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”.

Off-label communications can impact multiple sections of a life science company. It is critical that this impact be appropriately managed. Subscribe to the Firm’s blog to keep abreast of promotional compliance needs and their impact.

Disclaimer: The opinions stated in this blog are the sole and present opinions of the blogger and do not necessarily represent the opinions of the Kulkarni Law Firm, PC and/or its attorneys. Such opinion(s) may change over time. Such opinion(s) should not necessarily be attributed to the institution for which these individuals may work or otherwise represent in any capacity. These blogs do not constitute legal advice and should not be construed as such.