Download FDA Finalizes Rule That Could Expand

Food and Drug Regulation
MARCH 2002
FDA Finalizes Rule That Could Expand
OTC Drug Marketplace
The United States (U.S.) Food and Drug
Administration (“FDA”) recently issued a final
regulation that expands the criteria and procedures
for over-the-counter (“OTC”) conditions to be
included in the U.S. OTC drug monograph system.
67 Fed. Reg. 3060, 3074 (Jan. 23, 2002) (to be
codified at 21 C.F.R. Part 330). This regulation may
represent a significantly less expensive means than
the traditional new drug approval (“NDA”) process
for dietary supplement and cosmetic manufacturers
to make therapeutic claims, as well as a potential
avenue for expanded claims for the OTC drug
industry.
Under the new regulation, which became effective
February 22, 2002, FDA will now consider foreign
marketing experience in assessing the inclusion of an
OTC condition in the OTC drug monograph system.
An “OTC condition” is defined as an active
ingredient or botanical drug substance (including
combinations of active ingredients or botanical drug
substances), dosage form, dosage strength, or route
of administration marketed for a specific OTC use.
To be eligible for consideration under this regulation,
the OTC condition must have been marketed for
OTC purchase outside the U.S. (irrespective of
whether as a drug, cosmetic, or dietary supplement)
for a “material time” and to a “material extent.”
The expansion of the OTC drug provisions to include
foreign marketing data represents a fundamental
change for the agency. Historically, FDA has
interpreted the “use” provision in the Federal Food,
Drug, and Cosmetic (“FDC”) Act’s “new drug”
definition to mean use in the U.S. only.
evaluate the condition for general recognition of
safety and effectiveness (GRAS/E). A minimum of
five continuous years of marketing experience in one
country is required and, as part of the subsequent
safety and effectiveness review, an official or
proposed USP-NF drug monograph must be
submitted. Consistent with FDA’s current OTC drug
policy, FDA will allow interim marketing of new
OTC conditions under certain circumstances.
The material time/extent regulation offers a
promising alternative to the NDA process for several
distinct categories of conditions: (1) ingredients
historically marketed in Europe as cosmetics—such
as sunscreens, antiperspirants, anti-dandruff
shampoos, and skin protectants, to name a few;
(2) botanical ingredients that have historical
marketing data to support therapeutic claims
consistent with existing OTC drug monographs; and
(3) certain combination OTC drug/dietary
supplement products. It also offers the OTC drug
industry a means for expanding several existing OTC
monograph conditions. While not for everyone,
manufacturers may want to consider this option,
alone or as part of an industry coalition, when the
OTC drug system offers expanded labeling
opportunities and significant foreign use data exists.
If you are interested in learning more about FDA’s
material time/extent regulation, the petition/
submission requirements for the issuance of a
USP-NF drug monograph, or have questions about
TEA submissions, please contact Suzan Onel at
[email protected] or (202) 778–9134.
The material time/extent regulation establishes a twostep process by which FDA first reviews a “time and
extent application” or “TEA” and, after the condition
is found eligible based on the TEA, FDA would
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should not be used or relied upon in regard to any particular facts or circumstances without first consulting with a lawyer.
© 2002 KIRKPATRICK & LOCKHART LLP.
ALL RIGHTS RESERVED.