Generic Version Stirs New Concerns

The first generic versions of the potent painkiller OxyContin have been approved for the market. That is likely to help save money for patients who have long-term pain, but the step also is causing concern it may spur more illegal drug abuse.

OxyContin is a long-lasting version of oxycodone, a narcotic considered important therapy for many patients suffering chronic, moderate to severe pain from illnesses such as cancer.

The tablet, when swallowed whole, provides 12 hours of pain relief. But the drug can produce a quick and potentially lethal high if it is chewed, snorted or injected. It has been linked to more than 100 deaths and bears the government's strongest warning label, which says the drug may be as addictive as morphine.

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

Late Tuesday, the Food and Drug Administration said Teva Pharmaceuticals and Endo Pharmaceuticals could sell generic versions of extended-release oxycodone.

As a condition, the companies must include abuse warnings, doctor education and other steps aimed at minimizing illegal use that are similar to the risk-management program run by OxyContin maker, Purdue Pharma. It is not clear when the generic versions will go on the shelves.

A federal judge recently ruled that some OxyContin patents are unenforceable, clearing the way for generic competition. Purdue Pharma has filed legal notice that it will appeal.

"This development does not diminish our confidence that the court of appeals will overturn the lower court's decision,'' Purdue Pharma spokesman Robin Hogen said Wednesday.

Teva and Endo have not said how much they will charge, but generic competition can eventually cause drug prices to drop by a third or even half. OxyContin generated about $1.9 billion in sales last year.

Lower-priced generics may lead to more drug abuse, Rep. Frank Wolf said Wednesday at a House Appropriations subcommittee hearing with the Drug Enforcement Administration.

"I just don't think the administration has done a good job on this,'' said Wolf, R-Va. "Can they do everything? No. But they ought to do something. People are dying every day.''

The agency's administrator, Karen Tandy, said the DEA is aggressively targeting abuse.

A second lawmaker praised the FDA's requirement that generic makers take risk-management steps. But Rep. Harold Rogers, R-Ky., said that "in order to reduce abuse of these drugs, I remain convinced that the FDA should require that Oxycontin or any generic substitute be prescribed for severe pain only.''

Generic competition usually does not increase overall use of a medication very much, said Tom Riley of the White House's Office of National Drug Control Policy. He said many of the prescription painkillers that are abused come from stolen supplies.

"Areas where abuse is more flagrant are operating under a different price mechanism anyway,'' Riley said. "The price is what the criminals want to charge.''

The FDA is bound by law to approve generic competition for 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.