concerned with detailed issues of formulation and
manufacturing.
Because staff are fewer and the hierarchy sim-
pler, the OTC clinician has much more general
authority, with broad responsibility for in-line,
new and forthcoming products. On the prescription
side, this would not be true of any job short of the
Vice President of Clinical Research.
Another difference concerns marketing. Typi-
cally in the prescription area, interaction with the
marketing department is infrequent, although
sometimes intense. In the OTC area, it is constant.
The clinician educates the marketing department
on medical issues surrounding a particular drug
and on the opportunities and limitations that
these present. In particular, the clinician must
understand the needs of the brand managers and
be able to offer guidance. For instance, when diffi-
culties occur in the implementation of marketing
plans, the clinician must be able to assist in devel-
oping alternative strategies. An OTC business is
subject to intense market pressures. The clinician
must help the marketers deal with them effectively
by frequently playing the roles of educator and
creative thinker, as well as medical expert.
One of the most surprising aspects of the clin-
ician’s role in OTC medication development is the
very high degree of creativity that is required. With
prescription medication, one must work with what-
ever compounds have been previously developed
by chemistry and toxicology. These are brought to
the clinician for clinical testing. There is seldom
any input by the clinician into drugs he/she will be
required to work on. Sometimes the project on
which the clinician will be spending years of his/
her life is of considerable medical interest, in other
cases it is not. No matter what the case, the clin-
ician will be able to exercise only minimal control
over what compounds he/she is working on at any
given time. Although it is possible for the clinical
development of a new chemical entity to be poorly
handled, it is not possible for the clinical researcher
to add any characteristic that the particular chemi-
cal entity did not possess when it was synthesized.
In contrast to this, in the OTC area, the clinician
is actually in a position to greatly influence the
choice of compounds on which he/she and the
company will do research. He/she can even
creatively discover new indications suitable for
OTC therapy. The OTC clinician typically enjoys
major input into all decisions involved in the com-
pany’s commitment to particular compounds and
formulations. This is true for OTC switch and for
new formulations of older products. The formula-
tors in an OTC operation seek extensive input from
their medical colleagues, and the corporation looks
to the clinician for more than just straightforward
opinions. Creativity is required and he/she has an
opportunity to devise concepts that are actually
developed by the company.
Because the development cycle of OTC drugs is
much shorter than that of prescription compounds,
the clinician is often able to see an idea of his/her
own brought to fruition in the form of an actual
product. Typically, it requires only three years or
less for the development of an OTC drug, as
opposed to 7–10 years for a new chemical entity.
The skillful use of medical knowledge and its
creative application to new products can make all
the difference in the medical and business success
of an OTC company.
The extent to which the OTC clinician is a key
decision maker is especially clear in dealing with
the release to market of new formulations of drugs
that have monograph status. Here the Sponsor
makes direct judgments on the safety and market-
ability of products without the intervention of a
regulatory agency. The US FDA has provided for
the direct marketing of awidevariety of OTC drugs
which it has pre-approved in the so-called ‘mono-
graph’ system. The underlying concept of this sys-
tem is that there are many drugs that have long been
on the OTC market and for which abundant infor-
mation already exists. Therefore, it would be
redundant and wasteful for a new NDA to be sub-
mitted each time a new formulation of one of these
compounds is to be brought to market. The FDA
has provided a series of numerous monographs,
each one of which deals with a particular narrow
therapeutic area, ranging from acne and anti-
helminthics to hormones and weight control. The
therapeutic area is discussed in some detail and
specific requirements for well-established drugs in
that area are set forth. As long as a new formulation
remains within the exact requirements set forth in
the monograph for type of drug, dosage, indication14.3 THE UNIQUE CHARACTERISTICS OF THE OTC FIELD FROM THE SPONSOR’S VIEWPOINT 183