On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers ("SIUU Final Guidance"). The SIUU Final Guidance updates an October 2023 draft guidance of the same name, which we described in a prior Alert and podcast. In the SIUU Final Guidance, FDA describes recommendations for medical product manufacturers intending to disseminate or discuss scientific information contained in reprints, clinical practice guidelines, reference texts, or digital clinical practice resources about unapproved uses of approved or cleared medical products. The SIUU Final Guidance includes incremental clarifications regarding the contours of FDA's enforcement policy and addresses some important issues that industry raised regarding the draft.
In conjunction with issuing the SIUU Final Guidance, FDA also released an addendum to its January 2017 memorandum, Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products ("Addendum"), which we also discussed in a prior Alert. The Addendum represents FDA's latest defense of its legal framework governing manufacturer communications. It doubles down on FDA's prior positions, citing heavily to the December 2023 First Circuit decision in United States v. Facteau,1 which was largely favorable to FDA and which we discussed in a prior Alert and podcast.
While the SIUU Final Guidance provides companies with some flexibility to communicate off-label scientific information under certain circumstances, it remains premised on FDA's expansive view of its authority to regulate manufacturer communications. FDA's publication of the SIUU Final Guidance and Addendum less than two weeks before a change in presidential administration likely reflects the outgoing administration's desire to memorialize its views post-Facteau and to impact the agency's regulatory approach going forward, whether to lay the foundation for renewed government enforcement efforts relating to off-label communications, or to defend against industry challenges relating to FDA's regulatory regime. However, the precise impact of the SIUU Final Guidance and Addendum remains to be seen as the new Trump administration takes office.
This Alert summarizes key changes in the SIUU Final Guidance as compared to the 2023 draft, explains the significant updates to FDA's First Amendment positions articulated in the Addendum, and describes important implications for industry.
The SIUU Final Guidance
The SIUU Final Guidance describes FDA's recommendations for dissemination and discussion of off-label scientific information about approved products. Consistent with the 2023 draft guidance, FDA continues to recognize that firms can disseminate certain forms of scientific information related to unapproved uses, subject to the key tenets that the communication should be truthful and non-misleading and present all information necessary for health care professionals ("HCPs") to understand and evaluate the strengths and weaknesses, validity, and clinical utility of the information. As in the draft guidance, FDA describes the SIUU Final Guidance as an "enforcement policy" and asserts that it does not intend to use communications consistent with the SIUU Final Guidance "standing alone" as evidence of a new intended use (i.e., an off-label use).
While the basic framework and many of the recommendations in the SIUU Final Guidance are unchanged from the draft, there are several important changes:
Removal of "Clinically Relevant" Standard. FDA has modified the substantiation standard for SIUU communications. Whereas the 2023 draft guidance recommended that source publications for SIUU communications be both "clinically relevant" and "scientifically sound," the substantiation standard in the SIUU Final Guidance no longer refers to clinical relevance. Under the 2023 draft guidance, FDA described clinically relevant information as "pertinent to HCPs engaged in making clinical practice decisions for the care of an individual patient," noting that "preliminary scientific data" and other data that may be generated in the "early stages of medical...
