In the current heightened enforcement environment, life science companies continue to struggle to develop internal policies and practices regarding permissible off-label communications. CIAs issued to companies like Boston Scientific, Johnson & Johnson, Novartis, and Pfizer, all of which have entered into settlements to resolve allegations off-label promotion ranging from $22 million to $2.3 billion, respectively, serve as warnings to other life science companies as they attempt to decipher where exactly the seemingly indistinguishable line between permitted and prohibited off-label communications is located.
This month, seven pharmaceutical companies (Allergan, Inc.; Eli Lilly and Company; Johnson & Johnson; Novartis Pharmaceuticals Corporation; Novo Nordisk, Inc.; Pfizer, Inc.; and sanofi-avanetis U.S. LLC) took matters into their own hands to formally address the off-label conundrum by submitting a joint Citizen Petition asking the Commissioner of Food and Drugs to clarify FDA regulations and policies regarding off-label communication. Specifically, the petition seeks clarification and, in some instances, formal rulemaking with regard to FDA’s policies regarding the following types of off-label communications: manufacturer responses to unsolicited requests; manufacturers ability to engage in “scientific exchange”; interactions with formulary committees, payors, and similar entities; and dissemination of third-party clinical practice guidelines. Historically, FDA has provided some guidance with regard to these off-label communications and, in some cases, acknowledged the permissibility of such communications. Yet, according to the petition, such guidance has been informal or lacking in specifics. Jointly, these seven pharmaceutical companies seek FDA’s assistance in promulgating specific guidance and regulations regarding the scope of permissible off-label communications within these four identified manufacturer-communications.
Given the lack of clarity, companies currently have two choices, under-communicate or risk over-communicating off-label uses. Limiting communication that may be appropriate communication has a potentially harmful impact patient care and may also place the company at a competitive disadvantage. Over-communication, however, carries substantial risk of criminal and civil sanctions. Neither option provides an optimal solution.
If FDA responds to the petition with formal rule-making clarifying the scope of permissible off-label communication, should we expect to see FDA clarify, even enhance, what appears to be existing policies of permitting limited off-label communication? Or, will FDA move the line of what was previously informally considered permissible off-label communication to be more limiting? How would such rules impact communications by medical device companies when there are somewhat different considerations related to the “off-label” issue?