The Food and Drug Administration (FDA) released a new draft guidance on Monday, October 24, directed toward communications from firms to health care providers about scientific information on unapproved uses of approved/cleared medical products. This move marks a significant update, as this draft guidance replaces the previous FDA’s 2014 draft guidance entitled “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices”.
This update reminds us of the need for firms in the medical industry to be vigilant about their communication practices concerning off-label uses of their products. The FDA has historically taken a strict stance against promoting off-label uses of medical products due to the potential risks to patient safety.
An interesting feature in this new draft guidance is that no recommendations have been made yet in relation to distributing scientific and medical publications referencing unapproved new uses. The industry is expected to keep an eye on this in the following comment period. Industry stakeholders and members of the public are encouraged to submit their comments on the draft guidance by December 26.
Firms navigating through these fresh guidelines could benefit from seeking professional legal counsel to ensure their practices align with this new draft guidance. JD Supra provides more context and guidance on this matter.