LSHC Horizons Brochure 2024 - Flipbook - Page 89
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | United States
89
A regulatory paradigm shift for OTC drugs under the ACNU rule
Over-the-counter (OTC) products have
historically been intended primarily for acute,
self-limiting conditions. Over the past decade,
however, FDA has been considering ways to
expand access to OTC medications for chronic
conditions, such as diabetes, hypertension,
and high cholesterol. This year may mark a
momentous shift in the agency’s formerly
dichotomous OTC/prescription (Rx) drug
regulatory paradigm. FDA’s submission to the
Fall 2023 Unified Regulatory Agenda indicates
that the agency has assigned a high priority
to finalizing its 2022 proposed rule entitled
Nonprescription Drug Product With an
Additional Condition for Nonprescription
Use (ACNU).
The 2022 proposed rule aims to expand
consumer access to a wider range of OTC drugs
by making it easier for sponsors to “switch”
products from Rx-only to OTC. Specifically, the
proposed rule would allow more drugs to be
marketed OTC even when the labeling, by itself,
is insufficient for independent self-selection
and/or actual use, by requiring applicants to
implement an ACNU that would allow for safe
use without the supervision of a health care
practitioner. The proposed rule would also, in
some cases, permit the simultaneous marketing
of Rx and OTC products with the same active
ingredient, dosage form, strength, route of
administration, and indication, in part, to
ensure access for patients who may be unable
to use self-selection platforms.
Heidi Forster Gertner
Partner
Washington, D.C.
FDA embraces the use of modern technologies
for an ACNU, including digital self-selection
channels such as a questionnaire on a mobile
app or via an automated telephone system
intended to help consumers determine if
they should use the drug. Although FDA will
not require generics to have the exact same
ACNU system, the use of patented digital
technologies as an ACNU for OTC drugs
may challenge a generic drug’s ability to
demonstrate “sameness”. ANDA applicants
would be required to demonstrate that the
operationalization of the ACNU is the same
as the reference listed drug (RLD) (e.g., both
use mobile apps) or show that a different
operationalization of the ACNU achieves the
same purpose as the ACNU for its RLD and
such differences are otherwise acceptable.
Whether FDA will make any substantive
changes to address concerns raised in
comments on the proposed rule is yet to be
seen. Three important issues identified in
comments include:
1. the requirement that sponsors “fail first” by
providing data from failed self-selection and
label comprehension studies rather than
allowing sponsors to incorporate an ACNU
into their original switch programs;
2. the patentability of ACNU systems; and
3. the exclusion of the majority of OTC drugs
– OTC monograph drugs – with limited
justification.
David Horowitz
Partner
Washington, D.C.
Katie E. Kramer
Associate
Washington, D.C.
