Continuing the Discourse: FDA’s Public Hearing on Off-Label Communications
By: Avia M. Dunn and Elizabeth L. Berry (Skadden, Arps, Slate, Meagher & Flom LLP)
Editing By: Cynthia L. Meyer (Kleinfeld Kaplan & Becker LLP)
On November 9 and 10, 2016, the U.S. Food and Drug Administration (FDA) held a public hearing on drug and device manufacturers’ ability to communicate information about unapproved uses of medical products that have at least one approved or cleared indication, or “off-label communications.”[i] The two-day forum provided stakeholders with an opportunity to weigh in on policy issues FDA should consider as the agency re-examines its regulation of such communications in light of recent changes in the legal landscape. This article provides an overview of key issues discussed during the hearing and outlines several key takeaways and points for further consideration.
FDA currently permits manufacturers to engage in off-label communications in certain specific circumstances—including responses to unsolicited requests, sponsorship of continuing medical education events at which off-label uses are discussed, dissemination of peer-reviewed journal articles, medical texts, and clinical practice guidelines containing off-label information and, for drugs, health care economic data. However, the scope of FDA’s authority to restrict off-label communications has been successfully challenged in a series of recent court decisions that suggest companies may distribute truthful, non-misleading information about off-label uses of their products without violating the FDCA.[ii] Congress has also weighed in on the discussion; the Committee on Energy and Commerce issued draft statutory language that highlights the public health interest of sharing new data generated by real-world evidence after product approval.[iii]
Notwithstanding the significant First Amendment questions raised by courts regarding FDA’s current approach to off-label communications, an equally important—but often overlooked—consideration in the off-label discourse is whether the medical community is fully aware of the potential risks associated with off-label use and how this may impact the public health.
It is against this challenging backdrop that FDA called the two-day hearing, seeking stakeholder input to help ensure that agency regulation of off-label communications “best protects and promotes the public health in view of ongoing developments in science and technology, medicine, health care delivery, and constitutional law.”[iv]