The federal agency that approved the drug OxyContin for moderate to severe pain is caught between defending a controversial product it approved and disciplining the company that makes the powerful painkiller.
Some critics are asking the Food and Drug Administration to require tighter restrictions on prescribing of the narcotic, made by Purdue Pharma of Stamford, Conn.
“The FDA has a responsibility to do much more to look at why OxyContin is being abused, how it is prescribed, what levels of pain require a drug such as OxyContin and what steps must be taken to halt the abuse of these drugs so that we can stop people from dying,” said Rep. Frank Wolf, R-Va., chairman of an appropriations subcommittee that asked congressional auditors to investigate Purdue’s marketing practices.
The report was due Oct. 27 but was delayed; a later deadline of Nov. 17 has also passed.
In approving the drug in 1995, the FDA followed its routine policy for a new medication. After reviewing clinical tests conducted by Purdue Pharma, the agency decided that OxyContin’s benefits outweighed its known risks as a Schedule II narcotic with high potential for abuse.
However, once OxyContin was released, the FDA’s role changed.
One of the agency’s jobs is to oversee how a company markets its drug, and it has the authority to reject ads and promotions. While the FDA can restrict how drugs are sold and can pull them off the market, it has limited control over doctors, pharmacists or patients.
And that has prompted calls for the FDA to get tougher with Purdue. Wolf, Rep. Hal Rogers, R-Ky., and a top officer with the Drug Enforcement Administration want the FDA to limit the prescribing of OxyContin.
The issue has created tension between the DEA and the FDA.
Laura Nagel, diversion chief for the DEA, said she has tried to work with her FDA counterparts.
“But they keep trying to tell me I’m outside my box,” said Nagel, whose office is responsible for enforcing laws pertaining to legally manufactured drugs. “So we have a little control issue working there.”
FDA officials did not respond to requests for an interview.
Nagel’s observation spotlights the disconnect between the DEA and the FDA about how to protect the public from a new generation of powerful painkillers. DEA reports nationwide show prescription drugs are abused almost twice as often as illegal drugs such as heroin and cocaine. A DEA study stated almost 1 million people said they used OxyContin for nonmedical reasons.
Last month, DEA and FDA officials went head to head over proposals to restrict sales of OxyContin and a new Purdue drug called Palladone that scientists say is 10 times more potent than morphine.
Nagel and the two congressmen want the FDA to limit sales of OxyContin to severe pain only. But so far, the FDA has stuck with its 1995 decision to approve OxyContin for moderate to severe pain. As for Palladone, a time-release form of Dilaudid, an FDA advisory panel supported Purdue’s plan to introduce the drug in a phased launch that would include monitoring of doctors’ prescribing practices and reports of abuse or addiction.
The FDA is requiring Purdue to use a strongly worded warning with Palladone: “Use in non-opioid tolerant patients may lead to fatal respiratory depression.”
The agency has not set a date for Palladone’s release.
Nagel said her agency is working on a plan that would require doctors seeking a DEA narcotics license to take classes on pain and addiction.
The FDA has sent three warning letters to Purdue, including one that criticized the company for using contaminated alcohol in its production of OxyContin, leading to the recall of 388 lots of the tablets.
The other two letters dealt with FDA complaints about Purdue’s advertising in medical journals. The FDA complained that one ad was misleading and the other promoted OxyContin “for uses beyond which have been proven safe and effective.”
Purdue pulled the ads.
At other times, the FDA has sided with Purdue. The FDA did not act on a DEA report that claimed OxyContin likely was involved in half of 950 deaths studied in a 2002 nationwide autopsy review.
The DEA’s Nagel has found allies in lawmakers Rogers and Wolf.
The three agree that OxyContin can be useful for severe pain that cancer patients and others with similar conditions suffer. But they are keenly aware of the devastation the drug has carved through Appalachia, where OxyContin became known as “hillbilly heroin.”
“This drug is tearing apart families; it is ruining lives; it is stretching the resources of law-enforcement and social service agencies to the absolute limit,” Rogers told the FDA advisory panel last month.
Wolf criticized the FDA as being slow to respond to OxyContin problems. He noted how quickly the FDA acted when it warned the public about the stimulant ephedra after reports showed two deaths, four heart attacks and nine strokes.
“Where is the same urgency with OxyContin?” Wolf asked.
In Florida from 2001 to 2002: 573 deaths linked to oxycodone
Oxycodone is the active ingredient in OxyContin. By comparison, 521 people died of heroin overdoses in the same time period.
Most likely to die: A white male, age 30 to 60, with back pain
Of those who died, 52 percent were white males ages 30 to 60.
The makers of OxyContin refer to people who die while taking the medication as drug abusers. The company’s drug-abuse prevention programs have been aimed almost entirely at teenagers.
Medication linked to the most deaths: OxyContin
In cases in which oxycodone deaths can be traced to a specific medication, 83 percent were linked to OxyContin, produced by Purdue Pharma.