OTC medicines

[Guest guest]

This piece has been copied from :How the drug industry distorts

medicine and politics.

America's Other Drug Problem

By Arnold S. Relman and Marcia AngellFrom: The new republic :

december 16, 2002 : 37

as fair use.

NetRUMians please do read what is happening elsewhere in the world

also.

Dr Vijay Thawani

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Three stories are illustrative of the many ingenious, often

questionable tactics that are used to extend exclusivity. The first

concerns the blockbuster Claritin—an antihistamine

said to cause less drowsiness than cheaper over-the-counter drugs

such as Benadryl. (Claritin costs $80 to $100 for one month's

supply, compared with about one-tenth that for Benadryl.)

It was patented by Schering-Plough in 1981, but not approved by the

FDA until 1993 (after much scientific controversy about whether it

was really effective at the low doses necessary to prevent

drowsiness). Last year Claritin had sales of about $2.7 billion and

brought in about one-third of Schering-Plough's revenues. The 17-

year patent should have expired in 1998, but, according to a

story last year in The New York Times Magazine by Hall,

Hatch- Waxman added two years, and GATT added 22 months, and

pediatric testing added another six months. These three extensions

added four and a half years to the drug's exclusivity—worth billions

of dollars. Starting in 1998, Schering- Plough sued eight generic

drug companies for infringement of one or more

of its four patents listed in the Orange

Book. Hall reported the company's

legal costs to be about $5 million per

case—still a pittance compared with

the stakes.

Back in 1987, Schering-Plough, with

great foresight, patented the active

metabolite of Claritin—that is, the

molecule into which the body converts

Claritin, which accounts entirely for the

action of the drug. In December last

year, it received FDA approval to market

the Claritin metabolite under the name

Clarinex, and began a massive promotional

campaign to switch Claritin users to

the new drug before Claritin was scheduled

to lose its exclusivity in December

2002. To that end, it also priced Clarinex

slightly below Claritin. Clarinex was

approved for the treatment of year-round

indoor allergies as well as seasonal outdoor

allergies. That means Schering-

Plough can market it as an improvement,

even though it is simply what Claritin

turns into after it is swallowed.

This year Schering-Plough petitioned

the FDA to change Claritin from a prescription

drug to an over-the-counter

product. By law, the same drug at the same

dose cannot be sold both ways, so the move

will stop generic companies from competing

in the prescription market when

the patent expires. Last month the switch

was approved. Claritin will probably be on

drugstore shelves by the end of this year

and Clarinex will be the only prescribed

Schering-Plough allergy drug. We can see

from the Claritin story that drug companies

leave nothing to chance. They work

simultaneously on every angle that might

extend the exclusive marketing life of

their blockbusters.