An FDA advisory panel voted to increase controls on painkillers containing hydrocodone, such as this generic version of Vicodin.
A key federal panel Friday recommended placing new restrictions on Vicodin and similar prescription painkillers.
At the conclusion of an emotional two-day hearing, the Food and Drug Administration advisory committee voted 19-10 to recommend the agency change how drugs that contain the opioid hydrocodone are classified as controlled substances.
If the agency goes along with the panel's recommendation, which is typical but not required, the drugs would be more stringently regulated, moving to so-called Schedule II from Schedule III.
The change would impose a variety of new restrictions on the drugs. For example, doctors could only write prescriptions for 30-day supplies and could no longer call in new prescriptions without patients coming back to the office. In addition, nurse practitioners and physician assistants in some states would no longer be able to prescribe them.
The vote was praised by those seeking new restrictions. "I believe that this change will mark a turning point in the epidemic," said Dr. Andrew Kolodny of the Maimonides Medical Center in Brooklyn, N.Y. "It will lead to less people becoming addicted, which is the most important thing that needs to happen to bring this crisis under control."
But pain specialists expressed concern about the effect of new restrictions on patients struggling with debilitating pain. "If the FDA agrees with the advisory committee, the decision will have far-reaching impact on access and cost to pain care," said Dr. Lynn Webster, president-elect of the American Academy of Pain Medicine. "I hope people in pain won't suffer as a result."
Top officials at the FDA will now consider the vote in making a recommendation to the Department of Health and Human Services, and the agency isn't saying when that might happen. In 2008, the FDA rejected a similar request.
"We will pay close attention to everything we've heard as we proceed," the FDA's Douglas Throckmorton told the panel at the conclusion of the hearing.
Drugs containing hydrocodone are at the center of an emotional debate that pits the needs of pain patients against efforts to fight widespread abuse of these and other opioid painkillers.
More than 136 million prescriptions for these products are dispensed every year, making them the most widely used prescription drugs. Vicodin is probably the best-known hydrocodone medicine, but there are many others, sold under brand names such as Lortab and Norco.
The request for the change came from the Drug Enforcement Agency, which, along with others, argues these drugs are just as addicting and abused as frequently as other powerful opioids such as Oxycontin and Percocet, which are Schedule II drugs.
While powerful painkillers, opioids are highly addictive and are abused by millions. The number of Americans overdosing from these drugs has been increasing rapidly in recent years, and more than 15,000 now die every year, according to the Centers for Disease Control and Prevention.
But about 100 million Americans suffer from chronic pain, and many of them and their doctors fear the change would make it difficult, if not impossible, for these patients to get drugs they need.
The concern is that many people, such as the elderly and those living in rural areas, won't be able to make the extra trips to the doctor to get new prescriptions, or afford additional visits. Doctors worried about getting into trouble with the DEA may also stop prescribing the drugs, and insurance companies may stop paying for them.
In addition to testimony from DEA and FDA officials and from pain and addiction specialists, the committee heard from several parents whose children died from overdoses after becoming addicted to hydrocodone products. Many of them broke down in tears or expressed anger at the widespread availability of the drugs.
"They are highly addicting. My son is proof," said Cheryl Placek of Niagra Falls, N.Y., who sobbed as she described how her 28-year-old son Daniel committed suicide after becoming addicted to hydrocodone he received for back pain.
"All he did is follow his doctor's instructions," she said. "In the end, the drug took his life. We look for medicine to get us better, not kill. The addiction to hydrocodone stole my son's life and destroyed his family."
The committee also heard from several patients suffering from chronic, debilitating pain. They pleaded with the committee not to impose new restrictions.
Shani Weber of Mount Airy, Md., said she depends on the drugs for managing pain from Ehlers-Danlos syndrome, which among other things causes her joints to suddenly dislocate, triggering intense pain. She described one incident that occurred last week.
"I awoke with a pain level so high I was struggling to breathe," Weber said. It was all I could do to not fall into a fetal position screaming.... I was extremely thankful for access to hydrocodone."
In addition to the DEA request, some doctors and addiction specialists want the FDA to change the labels on all opioids, including drugs such as Oxycontin and Percocet. They want the labels to say they should only be prescribed for severe pain, at much lower doses and for no more than 90 days.
The goal is to get drug companies to stop marketing these drugs as aggressively and get doctors to be much more cautious about prescribing them. The FDA's has scheduled another hearing on that request next month.
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Transcript
ROBERT SIEGEL, HOST:
From NPR News, this is ALL THINGS CONSIDERED. I'm Robert Siegel.
MELISSA BLOCK, HOST:
And I'm Melissa Block. A Food and Drug Administration panel has endorsed new restrictions on Vicodin and similar prescription painkillers. This is a recommendation, not yet policy. Supporters say the new restrictions are needed to fight rising abuse of these drugs. Addiction to painkillers is widespread, and there are thousands of overdose deaths every year.
But there are those who oppose limiting access to these drugs; among them, some doctors and their patients who suffer from debilitating pain. NPR's Rob Stein joins us now to explain the debate and today's vote. And Rob, the DEA and others call prescription painkiller abuse an epidemic in this country. How big a problem is it and who, exactly, is abusing these drugs?
ROB STEIN, BYLINE: It's really two different kinds of patients. One of them are patients who get prescribed these drugs for legitimate medical reasons. They have an operation, or they have back pain, and they end up getting addicted; these drugs can be highly addictive. And the second group are people who are just kind of looking to get high - you know, teenagers who are rummaging through their parents' medicine cabinets - and they start taking these drugs, and they get addicted.
And everybody agrees that it's a really big problem that's getting a lot worse. There are millions of people who are estimated to abuse these drugs, and millions who are addicted. And the Centers for Disease Control and Prevention estimates there are at least 15,000 deaths from overdoses occurring every year, and that's more than cocaine and heroin combined.
BLOCK: Now, we mentioned Vicodin as one of these drugs, but that's not the only drug that they're talking about here, right?
STEIN: Right. They're talking about any drug that includes hydrocodone - that's an opioid, with another product that - they're called combination hydrocodone products. And there are lots of products like this that - on the market. They have names like Lortab. And their - estimate is that there are about 136 million prescriptions written for these every year, and that's the most widely prescribed prescription drug of any kind.
BLOCK: Now, what does the Drug Enforcement Agency want to happen with these drugs?
STEIN: Right. What they want to happen is, they want these drugs put in the same legal category as other prescription painkillers, like Oxycontin and Percocet. And that would have fairly wide-scale implications. It would have all sorts of new restrictions; including, for example, doctors would be limited in how much of the pills they could prescribe at any one prescription. And certain medical professionals, like physician assistants and nurse practitioners, would no longer be able to prescribe these drugs.
BLOCK: We mentioned, Rob, that some doctors and their patients are quite concerned about this. What is their concern, exactly?
STEIN: The concern is that there are an estimated 100 million Americans out there who suffer from chronic pain. And this can be quite debilitating. These are people who have terrible pain all day long - never goes away - and they are really dependent on these drugs to exist, to function on a daily basis. And they're worried that these restrictions really could make it difficult - if not impossible - for them to get drugs they need. It could mean that they could not afford the extra visits to the doctor that they would need; that some doctors may just stop prescribing them because they're afraid of getting into trouble with the DEA; or insurance companies might stop paying for them.
BLOCK: And what do the people who are pushing for the restrictions say to that?
STEIN: What they say is that, you know, if a doctor has a patient who really needs these drugs, they still could get them the drugs. They'd still be able to prescribe them. They could do things like give them several prescriptions at one time, that are dated in the future. So they couldn't fill it all at once, but they could - when they run out, they could fill the next one and then the next one.
BLOCK: OK. Well, the FDA was hearing this today. What happened at that hearing?
STEIN: You know, I've covered a lot of these hearings; and this was one of the most intense, one of the most emotional hearings that I've actually encountered. You know, there were the usual experts - the pain specialists, the addiction specialists, the government officials. But then there were - lots of testimony from individual patients; you know, parents who lost their children through overdoses and, you know, recounted the stories, and they were crying, and very angry and upset; and also, lots of pain patients who were describing what it's like to live with this terrible pain, and the fears that they had, that what they would do if they just couldn't get the drugs they needed?
But in the end, the committee voted fairly lopsided - 19 to 10 - to endorse the new restrictions; and they decided that the benefits of that would outweigh the risks.
BLOCK: OK. NPR's Rob Stein. Rob, thanks so much.
STEIN: Oh, sure. Thanks for having me. Transcript provided by NPR, Copyright NPR.
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