LS&HC Horizons 2022 - Flipbook - Page 70
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
70
United States
Reclassification of certain drugs as devices and combination products after Genus v. FDA
Sponsors are facing uncertainty regarding some products’
regulatory classification after the April 2021 decision Genus Medical
Technologies LLC v. FDA. In Genus, the DC Circuit held that FDA
does not have discretion to classify as a “drug” products that meet the
statutory definitions of both “drug” and “device.”
The case arose out of a dispute over Genus’s diagnostic contrast
agents, which FDA classified as drugs, notwithstanding FDA’s
acknowledgment that the products also satisfied the overlapping
statutory definition for devices. The court determined that, excepting
combination products, drugs (that do not also meet the “device”
definition) must be regulated as drugs, and devices as devices.
Genus is now critical to determining the regulatory status of certain
single-entity products and products that appear to combine in one
product a drug with a device, such as pre-filled syringes. Based on
the statutory definitions of “drug” and “device,” the analysis turns on
whether an “article” achieves “its primary intended purposes through
chemical action within or on the body,” such that it is excluded
from being regulated as a device. Deep analysis of FDA’s statements
in this regard will be required to determine regulatory status. We
are assisting clients with analyzing the likelihood and impact of
reclassification and optimal outcomes for regulation moving forward.
In an August 2021 Federal Register notice, FDA announced that it
would comply with Genus and establish a process to determine which
drug products should transition to device status. Notwithstanding
its offer to establish a transition process, sponsors of certain drug
products are already receiving deficiency notices, complete response
letters, and information requests indicating that products are being
transitioned to “device” or “combination product” status.
David M. Fox
Partner, Washington, D.C.
Meredith Manning
Partner, Washington, D.C., Denver
Komal Nigam
Senior Associate, Washington, D.C.
Band One for Life Sciences:
Regulatory/Compliance by
Chambers USA, 2021
