In an important update, the US Food and Drug Administration (FDA) has issued a Revised Draft Guidance addressing communications by drug and device manufacturers about “off-label” uses of approved products. This updated guidance supersedes the FDA’s previous 2014 Draft Guidance on “Distributing Scientific and Medical Publications on Unapproved New Uses.” It reflects recent shifts in FDA thinking on the subject, demonstrating expanded scope yet pointing out certain limitations that remain in off-label communication.
The term ‘off-label’ refers to the use of approved medications or medical devices in ways that have not received specific approval by the FDA. While such usage falls squarely within the practice of medicine, it has long drawn FDA scrutiny due to potential patient safety concerns and the implications for the marketing practices of pharmaceutical and device manufacturers.
The Revised Draft Guidance offers pharmaceutical and device manufacturers a revised set of directions on how they can communicate about off-label uses of their products. The new document substantially builds upon the limitations set out by the FDA’s previous 2014 Draft Guidance. However, the Revised Guidance still delineates certain restrictions and continues to reiterate the necessity of securing FDA approval prior to marketing new uses for approved drugs and devices.
With this latest release, businesses and legal professionals working in the pharmaceutical and medical device industries will need to quickly comprehend and adapt to the altered regulatory landscape. It is integral to understand that while the Revised Draft Guidance provides a greater degree of flexibility in communications, the fundamental requirement for FDA approval before marketing a new use remains steadfast.
To learn more about the Revised Draft Guidance in detail and possible implications, refer to the full review on JD Supra provided by Dechert LLP, an international law firm.