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| 2 minutes read

FDA's New Off-Label Reprint Guidance – "Standing Alone" Enforcement Doctrine Rears Its Head Again

In October 2023, the Food and Drug Administration (FDA) published its latest iteration of a draft Guidance on dissemination of information from medical publication “reprints” concerning unapproved (“off-label”) uses of approved or cleared drugs and devices. With this, FDA is once again seemingly revisiting a set of decades-old issues that has generated highly-contentious litigation setbacks for the FDA (notably the Washington Legal Foundation lawsuits), and which the agency has repeatedly struggled to address (first in a 1995 FDA Guidance, in a 2009 Guidance, and in a 2014 Guidance). The new Guidance purports to merely be a “procedural revision,” limited to “a revised title, a question-and-answer format, and certain changes in scope,” but there are many new minutiae that hide the elephant in the room—namely a potentially significant change in the agency's enforcement policy regarding dissemination of off-label information. Thus, the key question is whether the new Guidance signifies a policy pivot by FDA that may foreshadow new enforcement activity. A close reading of the new Guidance suggests that this is a strong possibility. 

The heart of the new Guidance, as with the 2014 version of the Guidance and with other related Guidances, is a statement of FDA's “enforcement policy” governing when and how FDA may deem a company's communication of certain off-label information “to be evidence of a firm's intent that the medical product be used for an unapproved use,” and thus, subject to enforcement action as a violation of the Federal Food, Drug and Cosmetic Act. In the new Guidance, FDA states that “[i]f a firm shares an [off-label] communication with HCPs [health care providers] in a manner that is consistent with the recommendations in this guidance, FDA does not intend to use such communication standing alone as evidence of a new intended use.” (emphasis added). However, the prior 2014 enforcement policy statement did not include the limiting phrase “standing alone,” suggesting that FDA is indeed laying down a marker that off-label reprint dissemination may well be used by FDA in support of future enforcement actions.

The “standing alone” caveat, while new to this version of this Guidance, has its own recent and controversial history, in a 2015-2021 FDA rulemaking in which FDA implemented changes to its regulatory definition of “intended use”—the key criteria upon which many FDA enforcement actions are grounded. In that rulemaking, FDA inserted a similar caveat to the regulatory definition of “intended use” to assert that a manufacturer's knowledge of unapproved uses of its product by others would not be used “solely” (i.e., “standing alone”) as evidence of the manufacturer's unlawful intended use of its product. FDA argued at the time that this approach simply reflected the agency's longstanding interpretation, but many have objected to the idea that their mere knowledge of off-label uses could still be used against them in court so long as it was used in conjunction with other evidence. Similar concerns are likely to arise in response to the new off-label reprint Guidance. And while FDA has yet to fully deploy this enforcement weapon, the new Guidance can be seen as a further step in an incremental FDA march towards a seemingly more-aggressive posture against off-label communications that should be watched with caution by regulated companies.


life sciences, fda regulatory & compliance