Yesterday, FDA published a new Draft Guidance, "Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers" (SIUU Guidance or Draft Guidance). Previous iterations of this guidance from 2009 and 2014 (blogged on here and here) were known as Good Reprint Practices (GRP). These guidances focused on the types of scientific publications (journal articles, reference texts, and in 2014, clinical practice guidelines) and necessary accompanying information that firms could proactively provide in a manner that would not, on its own, constitute evidence of a new intended use. The SIUU Guidance, which supersedes the 2014 Draft GRP Guidance, is not substantially different in that regard and contains similar information as to the types of disclosures previously recommended. However, there's a clear shift in FDA's approach that is noticeable from the title of the Draft Guidance, alone.
The SIUU Guidance introduces two new concepts that are of note to industry regarding information it may choose to disseminate under this "safe harbor:" 1) application to firm-generated presentations of scientific information; and 2) material that meets a new evidentiary standard – scientifically sound and clinically relevant.
Creation of a "Safe Harbor" for Firm-Generated Presentations of Scientific Information
FDA acknowledges that firms may develop presentations of scientific information from an accompanying reprint. Firm-generated communications must meet the general recommendations in the Draft Guidance and "should be truthful, non-misleading, factual and unbiased and provide all information necessary for HCPs to interpret the strengths and weaknesses and validity and utility of the presented information . . ." The presentation should be accompanied by the reprint and the reprint, itself, must meet the criteria articulated in the SIUU Guidance for reprints. FDA recommends that firm-generated portions of an SIUU communication should use "plain language," as despite having specialized training, "research indicates that HCPs may nonetheless have difficulty understanding some types of scientific information, including clinical trial data, and the design and methodological limitations of studies."
Creation of a New Evidentiary Standard
FDA's new standard, scientifically sound and clinically relevant, is a departure from its decades-long approach under GRP that articles about unapproved uses of approved products must describe adequate and well-controlled clinical investigations. Throughout the SIUU Guidance, FDA refers to studies and analyses, suggesting that publications may cover more than a description of an adequate and well-controlled clinical trial. FDA notes that real-world data and associated real-world evidence may be scientifically sound and clinically relevant depending on the circumstances.
Other Topics of Note
In addition to the two concepts above, FDA also discusses the use of dedicated vehicles, channels, and venues to distinguish SIUU communications from promotional communications to reduce the risk of HCPs confusing approved and unapproved use information. FDA also addresses social media platforms, providing advice for firms seeking to communicate on platforms that may impose character-space limitations that would hinder a firm from including all recommended disclosures (hint: keep the communication unbranded, linking out to a fully formed SIUU communication).
FDA repeatedly references that in creating the SIUU Guidance, it has sought to balance HCP interests in scientific information with mitigating the potential that government interests in motivating firms to comply with premarket requirements will be undermined. While the information in the SIUU Guidance is a welcome departure from FDA's more restrictive approaches under GRP, it may not go far enough. For example, FDA's references to firm-generated communications appear inextricably linked to an underlying reprint publication, which seems arbitrary, as firms can generate truthful and non-misleading information about studies and analyses that have not been published. The SIUU Guidance may leave industry with the feeling that it still hasn't found what it is looking for in terms of FDA's attempts to strike the right balance.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
