FDA APPROVES GENERIC VERSIONS OF OXYCONTIN

WASHINGTON -- The Food and Drug Administration approved the first
generic versions of the controversial painkiller Oxycontin late
Tuesday, a move that promises to significantly lower the drug's cost.

Oxycontin is a long-lasting version of oxycodone, a narcotic
considered important therapy for many patients suffering long-term,
severe pain from cancer or other illnesses. When swallowed whole, the
tablet provides 12 hours of pain relief.

But if chewed, snorted or injected, Oxycontin produces a quick and
potentially lethal high. It has been linked to more than 100 deaths
and bears the FDA's strongest warning label, which says the drug is as
potentially addictive as morphine.

While abuse of Oxycontin is a serious law-enforcement problem, its
cost -- hundreds of dollars a month -- has had patients who depend on
its pain relief anxiously awaiting generic competition.

As part of FDA's approval, manufacturers Teva Pharmaceuticals and Endo
Pharmaceuticals may sell generic versions of extended-release
oxycodone -- as long as they include abuse warnings and other steps
designed to minimize illegal use that are similar to the
risk-management program run by Oxycontin maker Purdue Pharma.

It's not clear how soon the generic versions could begin selling, as
Purdue Pharma has filed patent lawsuits.

Purdue Pharma also had petitioned the FDA to block generic approval
unless its competitors used an identical risk-management program, but
the FDA on Tuesday decided that the generic companies' plans were
similar enough.

Teva and Endo haven't said how much they will charge, although generic
competition can eventually cause drug prices to drop by a third or
even half.

Generic competition promises to add to the controversy over Oxycontin
because lower prices for legitimate patients can mean lower prices for
drug abusers, too.

But the FDA is bound by law to approve generic competition of
effective drugs. Agency officials said in a statement they were
seeking to balance effective pain management for more than 10 million
Americans who suffer chronic pain with a minimized potential for abuse.

Earlier this month, the Bush administration announced new steps to
help curb abuse of Oxycontin and other prescription painkillers,
including steps to help states track patient use, spot doctor shopping
and shut down "pill mills" that illegally sell controlled substances
over the Internet.