LSHC Horizons Brochure 2024 - Flipbook - Page 99
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | United States
99
Unpacking FDA’s new draft guidance on scientific information on
unapproved uses of approved products
In late 2023, FDA issued draft guidance on
drug manufacturer communications to health
care providers (HCPs) regarding scientific
information on unapproved uses of approved/
cleared medical products (SIUU). Although
positioned as a revision to an existing guidance
from 2014 on permissible dissemination
of certain publications about unapproved
uses (commonly referred to as the “reprints
guidance”), this new guidance threw industry
for a loop as it seems to reinterpret the
“rules of the road” for drug manufacturer
communications to HCPs after nearly a decade
of very little change in the agency’s approach
to HCP communications. However, agency
officials have publicly described the changes as
important, but “narrow” in scope, and limited
to specific categories of information.
Unlike the old reprints guidance, the new
guidance permits drug manufacturers to
disseminate “firm-generated presentations”
of SIUU, in addition to traditional materials
covered by the reprints guidance (e.g., scientific
publications, reference texts, clinical practice
guidelines). The shift seems to reflect the
agency’s endorsement or tacit acknowledgement
of increasingly common industry activities,
including availability of SIUU information on
company-sponsored websites.
Heidi Forster Gertner
Partner
Washington, D.C.
The new guidance also introduces a new
standard for evaluating information being
presented: the information and analyses should
be “scientifically sound” and provide “clinically
relevant” information. Like other evidentiary
standards set forth by FDA related to medical
product advertising and promotion (e.g.,
“competent and reliable scientific evidence”
and “scientifically appropriate and statistically
sound”), this latest standard is defined broadly
and presents both challenges and leeway
in interpretation.
Ultimately, the draft guidance raises as many
questions as it purports to answer. For example,
FDA recommends that SIUU communications
should not use “persuasive marketing
techniques” in firm-generated presentations,
but does not fully explain the scope of such
techniques. The draft guidance is also agnostic
as to who may engage in SIUU communications,
leaving open to interpretation whether
Commercial and/or Medical functions may
be involved in such discussions.
The SIUU draft guidance adds to a constellation
of guidance documents related to appropriate
communications to HCPs and payors. Whether
it also portends increased enforcement activity
by the Office of Prescription Drug Products
or other agencies remains to be seen. We will
monitor for developments in this area as we
continue to counsel clients on effective and
compliant communications to HCPs, patients,
and payors.
Komal Karnik Nigam
Counsel
Washington, D.C.
Sally Gu
Senior Associate
Washington, D.C.
