When starting with a prescription-only medi-
cine, it is extremely important to begin interac-
tions with the regulatory agencies as soon as
possible, if only to establish whether or not there
are concerns that the company has not anticipated.
Obstructions to an Rx-to-OTC switch might not be
related to safety or efficacy, and can involve some
other peripheral but still highly important consid-
erations. Examples of such problems are indica-
tions which the FDA does not regard as self-
diagnosable, spread of antibiotic resistance or
inability to keep the OTC product out of the
hands of children. It should be remembered that
Regulators’ principal concern in considering an
Rx-to-OTC switch is from a public health perspec-
tive. This is in contrast to the usual viewpoint of
the pharmaceutical companies, which tends to be
focused on the treatment of the individual patient.
There is nothing that will facilitate the Rx-to-OTC
switch of a drug more powerfully than convincing
Regulators that this will contribute toward the
health of the public.
Other issues that may concern Regulators are
when a precedent is being set. It is possible that the
precedent set by one particular Rx-to-OTC switch
could be damaging in terms of their overall policy,
even when they have relatively little concern about
the switch itself; this may be the reason for hesi-
tancy shown in approving ‘Plan B’, a proposed
OTC product for emergency contraception by the
US FDA. Careful negotiation is called for. The
corollary is that if your proposed Rx-to-OTC
switch can be shown to follow some sort of pre-
cedent, then your road with the regulators will be
smoother.
Another broad-scale public health concern
which may worry the FDA is the implied message
given to the consumer by the OTC availability of a
particular compound. This concern is illustrated by
the situation with soluble fiber cholesterol-lower-
ing agents of the psyllium-type. These agents have
been shown to lower cholesterol but only to a very
small degree. It was felt by the FDA that, if they
become established with claims of cholesterol
reduction, the population may be misled into feel-
ing that they have made a major beneficial inter-
vention in their lipid profile, when, in fact, they
have not. The message communicated to the
consumer by making these compounds available
constitutes a barrier to this Rx-to-OTC switch.
Thetimingof the Rx-to-OTC switch can be a
major contribution to its success. The timing is
influenced by both regulatory and commercial con-
siderations. The completeness of the available
database is critical, and the time this takes can
dictate the timing of a switch. Often, however, it
is a commercial factor which is the key to deciding
when an Rx-to-OTC switch should take place.
Before the end of patent expiration is one obvious
opportunity for major benefits to a company to
obtain OTC status, and offset the foreseen precipi-
tous decline unit price of the prescription product,
and reduction the Sponsor’s share of that segment
of the Rx market. Typically, once a drug has
become an OTC product, it is sold at a lower unit
price with smaller profit margins, but the total
volume increases several-fold. On occasion, the
rapid growth of an OTC market can be even larger
than the original prescription sales.
Unfortunately, in many cases, an Rx-to-OTC
switch at the time of patent expiration does not
occur and there is a long hiatus before OTC status
is secured; this is the consequence of failing to
seriously examine the need for an OTC switch
early enough. Unlike for monograph products,
two years are quite insufficient for the necessary
studies and regulatory applications in time for an
Rx-to-OTC switch. Thus, realistic expectations of
loss of patent coverage must be made to create the
greatest opportunity. Organizations often exhibit an
ebullience, exhibited in one form as the require-
ment of its staff to believe and promulgate that their
weakest method of use patent will prevail against a
generic challenge. This weak patent is inevitably
the latest. Long-range revenue projections are cre-
ated and published accordingly, and woe betide
anyone suggesting planning for an Rx-to-OTC
switch as a contingency.
Awareness of the OTC potential of the compa-
ny’s portfolio of drugs, and the time it will take to
implement, should be constant.
There are two fundamentally different types of
Rx-to-OTC switches from the standpoint of the
scope of the research program required. Switch
programs can vary from large NDA programs, as
extensive and expensive as anything found in the186 CH14 THE UNIQUE ROLE OF OVER-THE-COUNTER MEDICINE