Draft FDA Guidance on Reprints Provides Welcomed Clarity
Whether responding to an unsolicited request for information or distributing a journal reprint, pharma and medical companies must carefully consider their approach to discussing or responding to off-label discussions of their brands. A recent court decision in New York signaled that an individual pharma rep’s right to free speech trumps the prohibition against off-label discussions. Yet, as the FDA continues to update their official guidance documents to provide more clarity, the questions each company must ask are:
- Do these guidelines give us permission to have these off-label discussions?
- Or will they lead brands into risky territory?
In 2009, the FDA provided initial guidance for drug and device manufacturers who wanted to disseminate information on unapproved uses to healthcare providers (HCPs) and other certain entities. This guidance was created in response to 1997 regulations in the Food and Drug Administration Modernization Act (FDAMA) which provided a safe harbor for manufacturers who chose to disseminate information on unapproved uses. The FDA included off-label conversations in its 2011 guidance. These updates provided guardrails for companies that were debating how to respond to queries, both online and offline, in public or non-public venues. For example, one of the most pertinent statements in the 2011 guidance was the recommendation that sales and marketing personnel have no input on the content of responses to unsolicited questions or requests for off-label information.
Last month, the FDA issued a new draft guidance which provides even greater clarity on good reprint practices. This draft seeks to amend the 2009 version, which was deemed too vague. Specifically, the new guidance provides detailed recommendations for three separate types of publications:
- Scientific or medical journal articles
- Scientific or medical reference texts
- Clinical practice guidelines
Understandably, many clients feel apprehensive as they venture into new promotional channels, such as social media, electronic medical records, and digital tactics. It is up to us, their partners on the agency team, to stay informed on emerging opinions from FDA regulators. As marketers, we must remember that our focus — and our messaging — must always be on our core indications and approved uses. Off-label education and responses belong to our medically empowered partners.
And let’s not forget that our HCP customers have challenges of their own. In addition to financial pressures and the uncertainty surrounding the Affordable Care Act, they face significantly restrictive ICD-10 coding changes and demands for improved patient outcomes. Our initial inclination may be to provide more details about our brands via regular sales and marketing channels than might be prudent. We have to weigh the benefits over the risks of our responses against their need to know and ensure that the appropriate medical and scientific channels exist to satisfy their informational needs.
Ultimately, our goals in the new pharma landscape are: (1) to support HCPs so they can meet their practice goals and improve outcomes; (2) to enable patients get the most appropriate and beneficial treatments; and (3) to help payers provide the broadest coverage possible to the most patients. I believe that the FDA shares these goals. As they endeavor to provide ever more finite guidelines, it makes sense that we endeavor to follow them.