The United States Food and Drug Administration (FDA) has extended the comment period for comments on the revised draft guidance for industry entitled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.” Interested parties can submit electronic or written comments until January 5, 2024. A previous article that details the draft guidance in greater detail can be found here.
The draft guidance outlines the FDA’s current thinking on common questions surrounding communications by firms to health care providers of scientific information on unapproved use(s) (SIUU) of approved/cleared medical products. More specifically, the guidance covers information for firms sharing certain communications with health care providers, including published scientific or medical journal articles (reprints); published clinical reference resources (i.e., clinical practice guidelines, scientific or medical reference texts, and materials from independent clinical practice resources); and firm-generated presentations of scientific information from an accompanying published reprint.
Throughout the guidance, the FDA tries to strike a balance between the interests of health care providers in information about unapproved uses of approved medical products to inform their clinical practice decisions and other government interests, such as protecting patients from medical product uses that have not been shown to be safe and effective.
The guidance notes that if a firm’s communications comply with the requirements found in the draft guidance, the FDA does not intend to use such communications alone as evidence of a new intended use. However, the draft guidance does not clarify whether FDA considers this to be an exercise of enforcement discretion or a legal interpretation that compliant SIUU communications are not regulated promotional speech.
For additional information and background, see our previous article on the draft guidance here.
As noted above, while you can comment on any guidance at any time, to ensure that the FDA considers your comments in creating the final guidance document, comments should be submitted prior to January 5, 2024.