The current European draft legislation, as supported
by the pharmaceutical industry, will forbid competitors from marketing
generics of a switched drug for a number of years. The pretext cited
is that companies' new clinical data need to be protected from exploitation
by competitors. This is specious, however, as OTC switch trials are
neither obligatory nor necessary.
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The
term "OTC switch" (OTC = over the counter) refers to the
decision by a drug company to make a prescription-only drug available
for self-medication. The company also switches its promotional efforts
from prescribers to pharmacists and the public, through media campaigns.
The
prescription drug is often maintained on the market, while the OTC
version is sold under a different name and at a higher (uncontrolled)
price. In France, for example, loperamide is sold under the names
Imodium° (for prescription) and Imossel° (for self-medication),
and the same antacid combination is sold under the names Xolaam°
(for prescription) and Maalox° (for self-medication).
The
"OTC switch" is a trick commonly used to relaunch a drug
whose sales are waning or will shortly face competition from new
drugs or generics.
The
"OTC switch" is fairly simple. The company simply has
to obtain exemption from regulations governing prescription-only
drugs. This exemption, granted by the national minister of health,
specifies, for safety reasons, the maximal dose per intake and the
maximal quantity per box for safe self-medication. The exemption
may be restricted to a particular route of administration, for example
local or oral but not parenteral use.
As
a rule, the switched drug is granted marketing authorisation on
the basis of a simple bibliographic dossier. No new clinical evaluation
is required for well-known substances that have been used for many
years in the same indication. The expected benefits and risks have
already been assessed, and extensive follow-up data are generally
available. Further evaluation is rarely necessary or requested.
Companies
sometimes sponsor a small clinical trial of the drug at the exempted
dose. When done by an opinion leader in the relevant indication,
the data can be used to support the OTC launch campaign.
The
current European draft legislation, as supported by the pharmaceutical
industry, will forbid competitors from marketing generics of a switched
drug for a number of years (up to 3 years according to some proposals
of amendments). The pretext cited is that companies' new clinical
data need to be protected from exploitation by competitors. This
is specious, however, as OTC switch trials are neither obligatory
nor necessary.
Prices
of OTC drugs are fixed freely by the companies. Theoretically, this
should be counterbalanced by free market competition. Supplementary
data protection would stifle this competition.
Medicines
agencies' requirements for OTC switches should be uniformly minimal
across the European Union. It is up to medicines agencies to protect
consumers, and up to drug companies to ensure their products are
profitable, on a level playing field.
©Medicines in Europe Forum 15 October
2003
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