SIUU-SIUU-Sudio: FDA Finalizes Guidance on SIUU and Distribution of Off Label Information

Who among us, upon reading FDA’s draft guidance on the distribution of off label information and their coining of the acronym SIUU (standing for Scientific Information on Unapproved Uses) did not automatically think of Phil Collins’ classic song Sussudio?  (Other than anyone under 50, that is.  In any event, you whippersnappers should look up the album No Jacket Required – it’s a classic.)

In any event, in the waning days of the Biden Administration, the FDA finalized this gem.  And in all seriousness, the finalization of this guidance is somewhat historic given that industry has been relying on various versions of draft “Good Reprint Practices” guidance since 2009.   This final guidance (16 years in the making!) is very similar to the draft guidance with a few notable exceptions:

• FDA expanded the list of source publications that can be used as the basis of firm generated presentations to include all the source publications that are permitted as SIUU (answering the call of all who read the draft guidance and wondered why reprints were given more weight than medical texts).
• FDA deleted the requirement that SIUU be “clinically relevant” and left only the requirement that the information be “scientifically sound” (thank you FDA – on behalf of industry, we are still getting used to the SASS standard from the CFL guidance and yet another evidentiary standard imposed on product communications was a bit much).
• FDA acknowledged that “scientifically sound” studies can include early stage studies and other studies that were not accepted under the draft guidance (can we get a “hallelujah?”).

Other than these changes, reorganizing the guidance, and including a definitional section, the final version is quite similar to the draft.  One other notable change is that the final guidance discusses the in person distribution of SIUU which was absent from the draft.  The guidance states:

FDA recommends that firms ensure that the personnel who are engaged in sharing SIUU communications have specialized training in providing truthful, non-misleading scientific information about unapproved uses of the firms’ approved medical products.  A firm’s personnel who are sharing SIUU communications should also be trained to handle potential questions that may arise about the information they are sharing or know how to direct the questions to personnel who are best qualified to respond (e.g., medical or scientific/technical representative or department).  (Guidance at 19, n.49)

This is notable as it suggests that the personnel engaged in sharing SIUU apparently do NOT have to be within the medical affairs department.  This vague set of instructions may cause companies to ask what precisely the limits are for in  person sharing of SIUU.  We know with certainty, however, that promotional communications and scientific communications must lead “separate lives” so to speak.

While not a remarkable change from the draft guidance, we welcome the loosening of some of the restrictions as noted above.  Even if it is against all odds we welcome anything that more closely aligns FDA’s regulatory positions with the First Amendment.