FDA PANEL: OXYCONTIN'S APPROVAL SHOULDN'T BE LIMITED

WASHINGTON -- The approved uses of powerful prescription painkiller OxyContin
shouldn't be further restricted to prevent illegal use of the drug , a federal
panel said Tuesday.

A group of pain and drug abuse experts agreed with the drug's maker Purdue
Pharma L.P. and the Food and Drug Administration that the drug's approval for
moderate to severe pain should remain as is. This recommendation contrasts
moves urged by the Drug Enforcement Administration and two Congressman at
Tuesday's meeting.

Panelists said people with moderate pain, other than those with advanced AIDS
and malignancies, should try other options first. However, the physician
experts said OxyContin's current label adequately describes the drug's intended
use.

The DEA urged rescinding the drug's approval for moderate pain and allowing
only pain specialists, not general practitioners, to prescribe the drug just
for severe pain.

OxyContin, a drug known on some streets as "hillbilly heroin" or simply "Oxy"
is the subject of a two-day federal panel meeting, which started Tuesday, to
discuss ways to stop the drug's illicit use. OxyContin, which had $1.4 billion
in sales last year, already carries a warning, set off by a black box and falls
in the class of the most restricted legal drugs.

Purdue said OxyContin, which has been sold in the U.S. since 1996 is approved
for patients who need around-the-clock, long-term treatment with an opioid for
moderate to severe pain.

During the meeting, which was called by the FDA, Rep. Harold Rogers, a
Republican from Kentucky, added some spice to a long list of presenters with a
dramatic oratory style and Southern accent not often seen in long scientific
drug reviews.

Rogers said OxyContin abuse has devastated several small mountain towns in
Kentucky and needs to be restricted.

"This is tearing apart families and ruining lives," Rogers said.

When asked to tell the panel if he had any stake in Purdue or any competitor,
Rogers answered: "I have no financial interest, the only interest I have is a
lot of young people who are dying because of addiction to OxyContin."

Virginia Republican Rep. Frank Wolf accused the FDA of being slow to respond to
OxyContin abuse.

The FDA has long said the agency is responsible for regulating drug makers to
make sure approved medicines are safe and effective, promoted correctly and
produced in a quality manner. While the FDA's position has been that it is
DEA's job is stopping illegal drug use.

At the meeting the DEA threw the ball in FDA's court and urged the FDA to limit
OxyContin's approval to severe pain and certain diseases.

The "DEA hasn't been able to address all of the criminal use," said Terrance
Woodworth, deputy director of the DEA's office of control.

People who illegally use the drug , often feign pain to get doctors to write
prescriptions or steal from hospitals or pharmacies.

"More than 90% of the diversion occurs at the doctor and pharmacy level,"
Woodworth told the panel of pain and drug abuse experts.

Purdue's Dr. J. David Haddox, a pain specialist and the company's vice
president of health policy, said law-abiding pain sufferers shouldn't be
punished because of criminals who choose to steal or misuse OxyContin.

Haddox estimates that there are fewer than 4,000 pain specialists in the U.S.
and they mostly practice in large cities or work in well-known academic
centers. If the drug can only be prescribed by doctors who concentrate on
treating pain, patients in rural areas will have their options limited, he
said.

"We can't allow people who choose to abuse to dictate healthcare policy for
rest of society," Haddox said in an interview.

The company has several programs in place to curb the illegal use of OxyContin,
including educating health workers about spotting addiction and abuse. Purdue
has delivered 10 million tamper-resistant prescription sheets to 14,500 doctors
in 34 states to help prevent altering of legitimate prescriptions.

Purdue will testify Wednesday and tell the panel the results of its surveys of
OxyContin abuse. The company will also outline its plan for preventing misuse
of its experimental product Palladone.