FDA May Modify Painkiller Labeling

FDA May Modify Painkiller Labeling

fda-logo4The head of the Food and Drug Administration says her agency is considering a change in the labeling requirements for opioid painkillers –- a move that many pain patients fear will make opioid analgesics harder to get.

In a speech this week at a national drug abuse summit and on her blog, FDA commissioner Margaret Hamburg called the abuse of prescription drugs “a public health crisis of enormous and devastating proportion” and said her agency would take a number of steps to prevent abuse, including “modifying opioid labeling.”

“We recognize that some are calling for further limitations on the use of these products, particularly in the context of non-cancer pain, including limiting the recommended duration of treatment; setting a maximum daily dosage limit; and restricting the use of these drugs to patients with severe pain,” Hamburg said.

“If additional improvements could make the labels more effective, it’s important we explore them as part of our overall efforts to improve the safety of opioids.”

The FDA is under increasing pressure from Congress and some public health officials to take stronger measures against prescription drug abuse. In 2010, over 16,000 people died from overdoses associated with opioid painkillers.

Recently the U.S. Drug Enforcement Agency sent a letter to the FDA expressing support for a citizen petition filed last summer by Physicians for Responsible Opioid Prescribing (PROP). The petition calls for major changes in the way opioid drugs are labeled and prescribed.

The DEA letter expressed concern about the slow pace of FDA action to address prescription drug abuse.

“DEA previously requested FDA to consider additional regulatory measures such as restrictions on prescribing, marketing practices and clinical indications for these opioid products,” wrote Joseph Rannazzisi, deputy assistant administrator of the DEA’s Office of Diversion Control.

“The DEA hopes that FDA will implement suitable measures, such as labeling revisions, to help mitigate the adverse impact on the public health resulting from abuse of these products.”

The FDA currently approves most opioid analgesics for “moderate to severe pain.” The PROP petition would eliminate the word “moderate” and would restrict opioid prescriptions to no more than 90 days for severe non-cancer pain. Doctors would still be able to prescribe opioids “off-label” for pain patients, but critics contend many physicians would be unwilling to do that.

FDA Commissioner Margaret Hamburg

FDA Commissioner Margaret Hamburg

In her speech to the National Rx Drug Abuse Summit, Hamburg called the development of tamper resistant drugs “a clear and pressing public health priority,” but said more evidence was needed to see how well they work. Tamper resistant formulas are harder for drug abusers to crush or dissolve for snorting or injecting.

“We all know from sad experience that sometimes it is just a matter of time before those who are dedicated to abusing an opioid will find a way to do so even if it requires overcoming the latest abuse-deterrent technology,” Hamburg said. “Given these issues, it is essential that every abuse-deterrent claim be grounded in science and that they really work.”

In January, the FDA allowed Impax Laboratories (NASDAQ: IPXL) to begin selling a generic version of Opana (oxymorphone) that is not tamper-resistant. And this month generic crushable versions of OxyContin (oxycodone) are also expected to reach the market.

Under a bipartisan bill recently introduced in Congress, generic painkillers would be required to have tamper resistant formulas if one is available.

“We require drivers and passengers in cars to wear seatbelts, why is the FDA not requiring these technologies that can protect people – especially children and teenagers – from easily tampering with and illegally using these drugs?” Rep. Bill Keating (D-Massachusetts) asked during the keynote speech at the drug abuse summit.

Keating, who had a private meeting with Hamburg at the summit, is co-sponsoring the Stop the Tampering of Prescription Pills (STOPP) Act, which would require the FDA to stop generic painkillers from coming on the market unless they are tamper resistant.

But Hamburg said the agency already has the authority to do that.

“We have concluded that, if FDA finds a new formulation to be abuse deterrent, then the Agency has the legal authority under the Food, Drug and Cosmetic Act to require that generic versions of that product have abuse-deterrent formulations as well,” she said.

“In addition, under certain circumstances, we believe that we would have the authority to refrain from approving non-abuse deterrent formulations of that drug and to initiate procedures to withdraw non-abuse deterrent versions already on the market.”

Authored by: Pat Anson, Editor

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This will give insurance companies an excuse to DENY prescription drug coverage for chronic pain coverage.

Breanda Bynon

You NEVER know the wretched pain and misery someone who hurts every single day until you ARE the one hurting!! Drug addicts are going to get their drugs however they have to. But to make the people that actually NEED them in order to function on a daily basis not be abke to have them is disgusting!! It’s hard on those of us that do what’s right and have to jump through red tape to get them. Makes me wonder if its worth it. But I look at my daughter and I want to be there for her for the rest of her life. It’s stressful enough to know what I have is MORE painful then terminal cancer but I have to suffer with no death and peace in sight.

jana gallatin

All boils down to money and politics. The DEA needs to continually justify their reason to exist, when most thinking citizens know they are a waste of time and treasure. They are more harmful than good and should be disbanded.

john rubano

Lets just say that everything she ( margaret hamburg or the fda) is asking for they get. I can guarantee you, that they are going to create the biggest black market for pain pills that will flow in from canada, mexico, europe, and even fakes from china and you will see heroin use skyrocket, Like i said this will create the BIGGEST black market for pain pills and if they cut people of that genuinely need them they will get them. There’s other ways to do this than taking it out on the ones that need pain medicine. Im not knocking people that have cancer (My mother died from cancer) but there is cancer patients that have none to moderate pain but this wont affect them and there are people that have a severe arthritis that is very painful and if not for pain medicine they wouldn’t be able to function,and numerous other painful diseases. lets just pray that they don’t take it out on the ones that need cause because of the ones that screwed it for the ones that needed it. They (drug abusers) are going to find a way to get it anyway and by doing this the fda is just making the war on drugs harder to fight.

Kim Miller

I never thought that one day I would be in a situation where I have multiple chronic conditions that necessitate taking pain medications in order to have any semblance of quality in my life. Then again, I never thought there would be a time when I would be told that I must now suffer because, even though I have done nothing to deserve it, my pain medications must be withheld to stop others from overdosing and killing themselves (which they will find a way to do with heroin or something else anyway). I did not sell or give away my medications. I never misused the medications myself. I take and pass a drug test every time I am required to. I go to the doctor every month. What did I do to deserve to be treated this way? Now that I: played along with excessive doctor visits, taken drug tests, been treated like a criminal with no jury of my peers passing judgement, kept the same pharmacy, signed a boatload of threatening-sounding papers; now, NOW you are going to tell me that it’s not enough. My pain is not supposed to be severe because 5 chronic, degenerative disorders will never add up to 1 cancer. After all it says so in a book! Certainly the government knows better how a patient feels than their own doctor. I can’t believe people don’t care about others to this degree. How can you not realize the consequences of this legislation are much worse than what you’re trying to stop. The people abusing these drugs did so voluntarily, what you’re doing is mandating the suffering of millions of innocent people, like me.

Terri Patrick

I wonder when everyone has health Insurance and can afford to go to the doctor’s for treatment will this lower the number’s? There will always be addicts, but now there are so many people who cannot be treated. Some of these people can get off medication, then there are those like me. I will never get any better, so pain medication is part of my life. If you look at the McGill Pain scale, there are actually things that are more painful than cancer. It is not the number 1.


I would be willing to bet that the individuals calling for these ridiculous rules, do not suffer with chronic pain. These rules will only make the lives of chronic pain patients much more difficult. Those people who choose to abuse drugs will find a way to do so whether or not your rules are more strict. Politicians have no place making health decisions for people. Why not make the punishment worse instead of punishing innocent people?? How some of you get into positions of power is beyond logic.


It’s a real shame that the FDA never talks about the discrimination and emotional turmoil that legitimate pain patients have to go through because of those that abuse prescription medication. I feel such despair sometimes (even though I’ve had the same dr. and same dosage for 9 years) that I’m not sure I want to keep on living. It would be great if the people making these decisions paused for a second and realized that many of the decisions they are making are causing those of us that aren’t abusing the medications more stress which we do not need. Also, if we do get to a point where we want to stop taking the medication it would be good if the doctors were all trained in how to do this. When I asked my doctor about it a few years back he seemed at a complete loss as to what steps we would take so it scares me to think about going off of this medication. Not because I am addicted, because I am not. Rather, because anyone taking opioids becomes physically dependent and going off of them is the worst possible feeling you can imagine that can last for months. Please, if anyone from the FDA is reading this, think about those of us that have legitimate pain and how your decisions are affecting us. We need less turmoil in our life and not more. All we want is to try to function as much as possible and without pain medications many of us can’t do anything except lie in bed and feel like we want to die. I do not understand why this is so hard for people to understand.

It would be a sad day in America if chronic pain sufferers where limited to 90 days of pain relief then cut of of all opioid medication. What is a suffering person to do then suffer the rest of their life or just end their life because they know medications are available to make life more comfortable but are being withheld from them because of a flawed petition put out by PROP.

To say Moderate chronic pain is not worth treating with the same opioid medications as severe pain is like saying you can not get medication for moderate cancer but when the cancer gets severe that’s when you will be able to get treatment. Moderate chronic pain will eventually become severe if not treated in a timely fashion.

I do believe these time released opiates should be tamper resistant but then again they need to work and not turn to sludge like OxyContin does making people sick to their stomach, when this happens the medication is then not worth taking and is ruined.

People can easily stop at the nearest liquor store and pick up any intoxicating product ,consume it and cause a fatal car accident. Yet we don’t have strict enough laws preventing this from happening. Deaths continue to happen every day from drunk drivers.

This statement, ( “We require drivers and passengers in cars to wear seatbelts, why is the FDA not requiring these technologies that can protect people – especially children and teenagers – from easily tampering with and illegally using these drugs?” ) reason is children and teenagers are not suppose to tamper with medications not prescribed to them. We cant police the U.S. from abuse and meantime chronic pain patients should not have to pay the price in pain for people who abuse. Someone could easily tamper with thousands of other prescription medications and die as a result why are we singling out opiates, the only medications that give suffering people relief of their ongoing pain.

When these long lasting opioid medications are made in to a tamper resistant formula this abuse will then go away and people that abuse opioids will go back to heroin. We still have the instant release opioid medications people can turn to and abuse, its a never ending saga , we cant make all opioid medications tamper resistant and we cant protect people who abuse these medications ,only so much can be done.
Meantime chronic pain sufferers are finding it harder and harder to find medications that help them be as pain free as possible. Us that suffer from chronic pain are being treated like common addicts and criminals ,we never asked for this type life and it can happen to you in a flash.
One mistake by another driver can make you a chronic pain sufferer is a instant, just like that your life could be changed forever.