2021 LS&HC Horizons - Flipbook - Page 70
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Hogan Lovells
Combination products
Combination products are multicomponent
therapeutic systems with feet planted in separate
regulatory worlds. Development pipelines
are expanding to accommodate increasingly
complex, integrated systems. We have been
side-by-side with our pioneer clients on charting
pathways for novel drug eluting implants,
prefilled injectors, complex inhalation systems,
and newer drug-biologic therapies.
Classification and jurisdiction based on
primary mode of action is often murky. There
is an absence of clarity and consistency in
determining which products may be reviewed
under a single New Drug Application (NDA) or
Biologics License Application (BLA), and which
types of products may require a device 510(k) or
Premarket Approval (PMA). The divide between
CDER and CDRH on clinical trial design,
endpoints, and outcomes among closely related
combination products – where some are directed
to CDER and some to CDRH – creates even more
uncertainty.
Meanwhile, FDA has widened its lens for what
constitutes a combination product, and in some
cases has indicated that components previously
regulated as containers may be considered
device constituents of a combination product.
This has been jarring for companies with GMP
compliance cultures who may be less fluent in
device quality standards.
The patent and exclusivity landscape for
combination products has also changed
markedly in the last few years. For drug-device
combination products with a device primary
mode of action, the 21st Century Cures Act now
applied Hatch-Waxman requirements to the
premarket review process. Patent certification
and drug exclusivity provisions, including
orphan drug exclusivity, can be read onto the
device clearance and approval process. On the
drug side, one immediate issue is whether FDA
will take steps to limit listing of “device-only”
patents in the Orange Book. The newly enacted
“Orange Book Transparency Act of 2020” gives
legislative backing to the process FDA began in
June 2020 seeking feedback on current patent
listing practices.
Finally, 2020 saw the FDA abandon a proposed
regulatory approach for medical devices
referencing drugs that would have allowed
devices to be authorized for new uses with
already approved drugs without the participation
of the drug sponsor. The question of mutually
conforming labeling is a thorn for device
sponsors who are seeking the use of approved
drugs, and a solution to the “cross-labeling”
problem remains elusive.
David Fox
Partner, Washington, D.C.
david.fox@hoganlovells.com
Heidi Gertner
Partner, Washington, D.C.
heidi.gertner@hoganlovells.com
Jason Conaty
Counsel, Washington, D.C.
jason.conaty@hoganlovells.com
