LS&HC Horizons 2023 - Flipbook - Page 21
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | Digital Health and AI
21
Current regulatory landscape of digital health technologies
for pharmaceuticals
Digital health technologies are transforming
drug development, spurring technological
advancement in various stages of the
pharmaceutical life cycle. Some of the most
unique developments are occurring in the
combination product space. For example,
FDA has previously approved products that
integrate ingestible event marker sensors;
wearable sensors that transmit data to a
smartphone, smartphone application, or
a web-based portal for prescribers; as well
as products with electronic modules that
can record and store information.
Digital health technologies can have significant
advantages for drug development, including
remote monitoring of patients (thereby
automating processes which typically require
patient initiative), increasing effectiveness
of drugs, reducing manufacturing costs,
and increasing follow-up participation for
clinical trials.
Jason F. Conaty
Counsel, Washington, D.C.
Ashley Grey
Law Clerk, Washington, D.C.
While the regulatory paradigm for
digital health technologies is evolving, it
remains unclear how FDA will regulate the
incorporation of digital health technologies
in drug, biologic or combination products.
In the past year, FDA issued and/or finalized
several guidance documents describing
its approach for regulating digital health
technologies. These guidance documents are
specifically tailored to products regulated as
medical devices. There is a gap with respect
to digital technologies that are integrated into
New Drug Application (NDA)- and Biologics
License Application (BLA)-regulated products.
We are continuously studying the evolution
of this paradigm to provide insight on FDA’s
approach to digital health pharmaceutical
products. As more drug and device
manufacturers create these innovations in the
face of limited regulatory guidance, there is
both uncertainty and opportunity. Sponsors
should engage proactively with the agency,
especially when the constituent products and
technologies are completely new, and where
there is opportunity to lean in and influence
this emerging regulatory framework.
Yetunde Fadahunsi
Senior Associate, Washington, D.C.
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