-->FDA Panel Says OxyContin's Approval Shouldn't Be Limited
Tuesday September 9, 8:11 pm ET
By Otesa Middleton

WASHINGTON -- The approved uses of powerful prescription painkiller OxyContin shouldn't be further restricted to prevent illegal use of the drug, said a federal panel.
A group of pain and drug abuse experts agreed with the drug's maker, Purdue Pharma (News - Websites) LP, and the Food and Drug Administration (News - Websites) that OxyContin's approval for moderate to severe pain should remain as is. That 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 (R., Ky.) 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.

He said OxyContin abuse has devastated several small mountain towns in Kentucky and needs to be restricted."This is tearing apart families and ruining lives," he added.

When asked to tell the panel if he had any stake in Purdue or any competitor, Rep. 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."

Rep. Frank Wolf (R., Va.) accused the FDA of being slow to respond to OxyContin abuse.

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

Tuesday, 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," Mr. Woodworth told the panel of pain and drug-abuse experts.

Dr. J. David Haddox, a pain specialist and Purdue'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.

He estimated 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, Dr. Haddox said patients in rural areas will have their options limited.

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

Purdue has several programs in place to curb the illegal use of OxyContin, including educating health workers about spotting addiction and abuse. The company 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.