meaningfultopatients,eventhoughtheymayappear
minor to the pharmacologist, who is not actually
using the drug him/herself. For example, in the
case of an antinausea drug, a difference in onset of
actionof10–15mincanbeveryimportantifyouare
the one who is nauseated, and yet completely insig-
nificant tothe medical reviewer ofthe originalNDA
attheregulatoryauthority.Theothersideofthecoin
isthatdifferencesthatarenotmeaningfultopatients
will not generate sales: do not let the scientists
run this part of the company! And do not allow
expectations grow out of hand; chasing after advan-
tages that never existed in the first place leads to
designing studies for bizarre purposes with a very
high failure rate.
New claims
Once a probable new claim has been identified and
the chances of its being scientifically valid have
been assessed, two good-quality studies are usually
necessary to support them (rarely, a single study
may be enough).
A different regulatorymilieucompared with
prescription-only medicines drives what is
needed to support a new claim for an OTC pro-
duct. Typically, after a brief initial period, over-
sight of the OTC product passes to the
government authorities that deal with consumer
products and trading in general, rather than the
EMEA or FDA (for example, in the United
States, this is the Federal Trade Commission).
In practice, advertising of OTC products must
conform to the standards that might equally
apply to, say, washing powder, fashion clothing,
‘herbal remedies’ or shoes. The OTC pharma-
ceutical industry also tends to be self-enforcing;
companies maintain eagle eyes on each other’s
advertising as part of the literature surveillance
program described above, and often their compe-
titors when unsupportable claims are suspected.
The possession of scientifically sound studies is
of great value in preventing, prosecuting and
defending such lawsuits.
Thus the medical director for OTC products often
find himself or herself under oath, and there is less
trepidation when you have carefully prepared a
satisfactory scientific basis for the advertising
claims that you have approved.14.7 Summary
An OTC product has two components: the galleni-
cal itself and its labeling. New OTC products
are developed either by compliance with regula-
tors’ pre-approved monographs or by regulatory
approval of Rx-to-OTC switches using the New
Drug Application/Marketing Authorization Appli-
cation procedures. The former is often without
direct governmental oversight and places a greater
responsibility solely on the Sponsor than the latter.
Obstacles to Rx-to-OTC switches may or may not
be related to product safety and efficacy, and the
information needed to support such applications
depends greatly on whether there will be any pro-
posed change in indication or dose size, demon-
strating a contribution to the public health, and
finding a relevant precedent make success more
likely. The clinical data in support of a new OTC
product should be obtained under conditions that
are as close to the proposed ordinary use of the
product as possible; in particular, investigator–
patient interaction runs counter to obtaining real-
world information about usefulness of labeling,
capability for self-diagnosis, likelihood of product
selection in the retail environment and product
effectiveness. Timing Rx-to-OTC switch applica-
tions well is key, and realistic anticipation of pre-
scription product patent expiration usually offers
one such opportunity. The volume of sales of OTC
products in spite of the generally lower unit price
can, on occasion, mitigate the loss of, or even
exceed revenues formerly realized by, the corre-
sponding proprietary prescription-only drug.14.7 SUMMARY 189