FDA Announces Next Move on Opioids: Will Pain Sufferers Have a Say?

FDA Announces Next Move on Opioids: Will Pain Sufferers Have a Say?

The FDA recently requested that Endo Pharmaceuticals remove its Opana ER pain medication from the market because of the risk for addiction.  An already nervous nation of people who rely on opioids to treat pain, and the health professionals that prescribe them, has its eyes on what may become a slippery slope.  The Agency’s request to voluntarily remove Opana ER, was a first-of-its-kind by the regulatory body.  Now patients and providers are asking, what’s next?

The Agency is also reportedly looking at two other generic opioids – oxymorphone extended release and oxymorphone immediate release – stating that the agency “is currently assessing the latest available data on abuse patterns” for the two drugs, according to FDA spokeswoman Sarah Peddicord.

FDA Commissioner Scott Gottleib, MD issued an announcement stating that the agency is taking new steps to “help assess opioid drugs with abuse-deterrent properties.”

Here is the announcement in its entirety.

Last month, I asked my colleagues at the FDA to identify what additional and more forceful steps the FDA can take, on top of the vigorous work the agency is already doing, to address the crisis of opioid addiction. Everyone at the FDA is committed to focusing on all aspects of the epidemic. The new policy steps that we announced included the formation of a steering committee to examine additional regulatory and policy actions that we can take to combat this crisis. This steering committee will place particular emphasis on evaluating efforts we can take to reduce the number of new cases of addiction.

The FDA is committed to looking at all facets of this complex issue and collaborating on various approaches, as there are no simple answers to reverse this epidemic. In my prior communication, I noted that one of these approaches would be asking the public, through various forums, to share additional steps and information that the FDA should consider in addressing these challenges. Today, we are announcing a public meeting that seeks a discussion on a central question related to opioid medications with abuse-deterrent properties: do we have the right information to determine whether these products are having their intended impact on limiting abuse and helping to curb the epidemic?

These products – opioid formulations with properties designed to deter abuse – are each intended to deter abuse by particular routes (like snorting or injecting), depending on the drug.  For example, some make crushing or manipulating the tablet to dissolve in liquid for injection more challenging; others combine the active opioid analgesic ingredient with drugs such as naloxone, which if snorted or injected will block the high of the opioid. This has been an important area of innovation that the FDA continues to support. However, we recognize that there is a gap in our understanding of whether these products result in a real-world, meaningful decrease in the frequency and patterns of opioid misuse and abuse.

To address this need, after approval, we have required companies marketing these products to conduct studies in a way that will provide the most meaningful data possible to address this issue. But these studies are challenging to conduct, and we need the most reliable data we can get to make the best regulatory decisions. Therefore, we are taking steps to get the answers we need to inform our approach.

At the meeting, which will be held July 10-11, we will engage external thought leaders in a discussion about how we can better leverage existing data sources and methods to evaluate the impact of these products in the real world, as well as what new data sources and study designs could be developed or enhanced to ensure these efforts result in the best possible answers to inform regulatory decision-making. To make this discussion as productive as possible, we have made public an issues paper outlining some of the existing regulatory and public health challenges we face.

Opioid formulations with properties designed to deter abuse are not abuse-proof or addiction-proof. These drugs can still be abused, particularly orally, and their use can still lead to new addiction. Nonetheless, these new formulations may hold promise as one part of a broad effort to reduce the rates of misuse and abuse. One thing is clear: we need better scientific information to understand how to optimize our assessment of abuse deterrent formulations; and I look forward to a productive discussion on how to best tackle this challenge.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”

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Charles Haws

The FDA is a biased, monster cooperation funded government organization. Just do a little research yourself on “who funds the FDA?” When you look at the medical side of that, big pharma runs the show even down to the patient advocacy groups. Huge, huge, huge contributions from big pharma. And when you look at the food side of things, it’s the ginormous food companies. The opioid issue in this country is going to get worse before it gets better because future people suffering from chronic pain aren’t going to be able to get any medicine that truly works. With the FDA just yanking pain meds they think are addictive of the shelves, doctors that are scared to death to prescribe and pharmacists who won’t fill a perscription patients who suffer day in and day out from pain will turn to more harmful and addictive street narcotics like black tar heroin. Which who knows, the cartels may be in the government’s pocket as well, but the point is that this epidemic is being exasperated by the FDA and big pharma.
The solution? More funding for treatment and prevention, and educating chronic pain patients and doctors to take medication properly so it doesn’t run lives but improves them.


Yes it true, us pain patients are being screwed by the gov and fda and doctors, I bet scoliese, the Congress man that got shot, and I am not picking on him for my heart goes out to him for what happened to him, but i can bet he’s not hurting! I’m sure he’s getting his pain medication that us tax payers are footing the bill, and we are suffering, thus sounds terrible I know, jerk him off his pain meds, and let him see how millions of us feel everyday by being told we have to suffer because these meds are bad for you, but these meds have keep me from ending it, these meds have kept me off disability and these meds have made it were I could make a living for my child,so I don’t need the gov to tell my doctor how to treat my pain.i need my gov to fight the hard drugs that are destroying people’s lives way more than the little pain meds I get every month, if they spent half the Entergy fixing other more important issues america faces, we would be a way better nation,

For us legitimate pain patients the removal of opana from the market could potentially be very very bad news. This situation has the possibility to create a very slippery slope that ends with us having no access at all to pain relieving medicines. I just picked up the last Oxymorphone my pharmacy had. They told me they could no longer get it. Oxymorphone has helped my pain more than anything else I have ever taken. I wish there was something we could do.

I was on Opana Er and on a high dose. I decided I didn’t like being so drugged up so with supervision I decreased my dose. It wasn’t that hard to do. But I learned it was a combination of my psychic drugs and muscle relaxers and Opana Er and that I had gastric bypass and my stomach absorbed medicines too fast that caused me to feel no long relief. I’ve suffered chronic pain for 43 yrs. At 53 I am extra pain and can barely walk I’ve tried physical therapy and acupuncture and everything I can. Now the doctors at pain management are restricting my drugs even though I only use when necessary This has to stop We matter too!!! Let doctors care about us again and do their jobs.


Jane, I am horrified that happened to you! You were treated like a criminal for one tiny slip up after all those years of being the perfect patient. That is sickening. What a jerk.

Amy Andrews

Reading this article & especially the comments has made me literally nauseated. The DEA has the Dr’s scared to death of losing their licenses and legitimate pain patients are just waiting for the last shoe to fall – Being cut off our meds. The desperation is palatable just reading the comments. People are considering suicide as a result of these new laws! I’m heartbroken for everyone who is suffering from this disgusting political overreach. I pray that none of us will ever resort to killing ourselves because of our pain. This is outrageous and terrifying.


I have suffered from CRPS (or RSD, what it used to be called) since 2005. In 2013 it went total body, prior it was only in my arm. CRPS is a horrible burning pain that makes you literally feel you are on fire. That’s when I finally gave in and started pain management. It didn’t completely take the pain away because nothing does, but at least I can take care of myself, my cat, and enjoy my house in the woods. Like some of you, I rarely get out and when I do have to run errands or go to the doctor, I pay for it the next day with increased pain. But it sure is better than before because I have Pain Meds. Studies have shown when the body is in constant pain, the brain reacts as though you are being chased by bears, or the DEA, or whatever other horrifying situation you can think of. So those of us in Chronic Pain are also in chronic fight/flight/freeze/fear mode. That’s how our brains interpret it. Of course if any extra stress is added on, we are really in trouble. People die from chronic pain. Not from suicide, but from the heart giving out, the stress after months and years of chronic pain shuts down the adrenal gland and we have no cortisol which then screws up all of our hormones, the whole pituitary- adrenal- thyroid axis thing. I find it highly confusing. When it comes to gun control, we hear, “The bad guys will get guns anyway, you’re just making it harder for the good guys to get guns.” And any thought of a regulation is thrown in the trash. Didn’t trump just undo a regulation so mentally ill patients can buy guns now? How many gun deaths are there per year? It’s a daily occurrence in my midsize town. So why don’t we as a population take the same attitude toward drug control as people do gun control? The addicts on the street will still get it. It will come from somewhere, unregulated and unclean. Why should we as patients who use our drugs to get through life, be punished anymore than those who use guns responsibly? Think this could be part of our argument to protect us from too many regulations? As someone else stated, we need Lawyers and doctors on our side to help us fight this. Practical Pain Management tells of multiple deaths of chronic pain patients where the Medical Examiner assumed patient died of OD because of drugs in the blood even though the lungs were not filled with fluid, etc that indicate overdose. Fortunately the physician of the patient had drawn blood levels that showed the patient was perfectly functional with an even higher dose in the patients’ system, so the physician was not charged. What HAD happened was Sudden Death Syndrome when a CRPS patient has a pain flare. Heart stops. It can happen with any chronic pain patient but it is… Read more »


This is so ridiculous at this point I do not even know what to say anymore. I do not know if anyone remembers but a few years ago our government went after all the allergy medications with pseudoephedrine in them for the so called “Meth Epidemic”. Well I guess they solved that “war” so they decided to go after pain medications. This is all to make it look good and have a reason to keep the so called DEA around. The DEA did not even exist until Nixon declared the “War On Drugs”. Then Reagan kept it going. Everyone knows that was a complete joke. So now we all who need pain medication to have any quality of life have become the new “Villain” for the DEA to go after. I have had back and neck surgeries. As of now i have 4 severly herniated disks in my lower back. 3 are pressing on my spinal cord. The pain is blinding. I am 50 years old and have a 16 year old daughter i can not enjoy life with. I was on my pain meds for a 14 years from my doctor who I had a great relationship with. I moved to Indiana a year ago. I can not even begin to tell you how I am treated. This state has some laws that are crazy and now they have introduced an other law similar to Ohio’s law of prescribing a 7 day supply of opiate medication. What your supposed to do the other 3 weeks of the month i have no idea. I was just terminated by my pain doctor because I did not disclose I taken xanax. I was in the middle of a stressful move, and started having panic attacks. I have a bottle of it for just in case days. I hadn’t taken it in a really long time and honestly forgot about listing it as one of my meds. I had an appt with my pain doc the same day i had movers at my house. Went to my appt i was told I had to do a drug test(I had not done a drug test for 4 months), didn’t think anything of it and went about my move. My next appt which was this past Monday i was told I was being terminated because i had a Benzo in my system. I was so shocked i was speechless. I told my doc yeah I had taken one 2 days before my appt and in the midst of the move and my appt being the same day it didn’t even dawn on me to say anything. Well he told me good luck with finding anyone else to treat me now as according to him i lied and he was putting that in my chart. So now I am going thru opiate withdrawal and so depressed I can not stop crying because after 15 years of being a good patient I took .25mgs of xanax. Oh… Read more »

A 4 Part TV series called War on Drugs is airing soon and it starts with ” The CIA introduced LSD to the American public ”

” The Drug War fuels Enforcement and that means Billions in revenue every year. ”

This – Opiate Epidemic – is a new battle for our anti drug government agencies and they don’t plan on loosing!

Victimized by our own government but if we are the Bad Guys we can’t be victims.

The series starts soon.


John S

It’s all about the money. Does anyone actually think that any government agency actually cares about anyone. They want their pockets padded and the drug companies will do it. If you don’t believe me just look it up for yourselves. In the mean time all of us who follow the rules will get stepped on and forgotten. If the study they did was to be fair and they really wanted to know the facts they would not have loaded the group with anti opioid people.

Audrey L.

I have already had my breakthrough pain meds eliminated and my fentanyl dosage lowered thanks to the original “guidelines”. Now they are asking a maker of a drug that is mostly abuse-proof to stop making it so they can assess its abuse-proofness? That’s supposed to be what happens *before* a drug is brought to market! Not to mention that most abusers are not chronic pain patients. We need our meds to get us through the day; we can’t afford to waste any to snort up our noses or inject into our veins.

When the pill mills were greatly shut down and it started to stem the tide of pills that was coming up the East Coast, did the government do anything to grant better access to treatment programs, build new treatment centers, or even put one more bed in an existing facility? Nope. Rehab up here is still in the we’re-sticking-you-in-the-psych-ward stage. That helps neither the psych patients nor the addict trying to recover.

Unfortunately, I don’t think the government will get it until too many chronic pain patients commit suicide due to lack of prescribed medications. And I’m afraid by then it will be too late for those of us currently struggling; hopefully, it would help newer patients get the medications they need. Part of me is scared that the data will be misconstrued and we would be addicts post-mortem to prop up the government’s stance, but they would have the same abuse rates, if not higher….

A quick note about mmj: I use it. My doctor recommends it. No, it is not a cure-all, but when you find the right strain it helps immensely. Yes, I still need all of my other medications until I can have a steady enough supply from growing my own, and then perhaps I will be able to reduce the dosage on a couple of my meds.


The government surely can put two and two together (or maybe not), I just think this is their “chance” to go after the legal lawful use and “damned be the consequences”. They don’t care. They’ve been fed lies from fanatical anti-opioid special interest groups, and “pain experts” produced from veritable yoga and acupuncture schools of thought.

The bottom line, is it is severely inhumane. The DEA, now like the SS from Nazi Germany. A political orchestrated genocidal movement, and it really parralels the time of “eugenics” where they performed trial of sterilization of those they considered to be possesive of ill-genetic makeup. Not to mention, it is basically prohibition all over again (Don’t forget history, less it be repeated).

I truly think this is, and could be the tipping point to where we need find a Lawyer (or team of Lawyers) willing to take on the FDA, CDC & DEA. Our government no longer serves the best interest of the people and is found to be inhumane towards their citizens (wait, we are now just like Russia).

The “War on Drugs” is a war on it’s own citizens, therefore; I would think those of us damaged, or any sustained casualties should result in the prosecution of the state for war crimes. They started a war that has led to innocent civilian casualties, and I think maybe a lawyer could argue that it is, in fact a war crime.

It’s certainly worth researching.

I would be interested in a legal coalition that we could get behind, perhaps here on NPR. Maybe an article or declaration/call out for legal help. Something we can all get behind to start coming together and organizing.

It’s a thought.

vicki connor

This is insanity. This is not going to stop those who wish to abuse medicine. It will only hurt those the medicine was intended for in the first place. Addicts will get what they want they always have. Who will help those of us with unrelenting chronic pain?

DJ Headley

Danny R Harris

It might work for you but what about those of us that are allergic?


Changing the formulation of some of these opiod medications would be disastrous. I have been suffering with chronic pain since 2009 with a botched neck surgery after a nasty accident and back surgery that didn’t work like stated. I was given different meds until something actually worked. My meds keep me walking, allowing my blood sugar to stay withing norms, allowing me to keep my heart disease in check.
I still suffer with pain, BUT with my meds can live a halfway normal life and enjoy my children and grandchildren most days. We as chronic pain sufferers, the majority anyway, follow the rules and guidelines. So why should we be punished for something we haven’t done? Get it right people! We are normal, tax paying, citizens who suffer daily, living with physical pain and play by the rules, no matter how invasive, even though some (most in some cases) look at us with accusing eyes and speak of us in accusing tones.
My life may not be great with the pain suffered daily, but my meds do make it good.

Disabled & house bound at 40 because I live in low income housing,can’t drive from failed fusion & legs numb & weak .I’m in Ohio & even though my MRI documents everything I’m ignored & shoved aside. It isn’t fair what chronic pain patients have to deal with & in California they have a law for intractable pain .I have had to be happy & settle for very little relief but never complain or ask for a dose increase. The politicians don’t care

Chronic pain is the real epidemic here. You are taking away our much needed medication because others misuse . You need to be going after the illegal drugs like heroine and the meds coming from Mexico laced with fentynal. We are losing our much needed medications that allow us to have some resemblance of a normal life. You are forcing us to consider things we have never thought of before. We are stranded dealing with this with others who understand. Taking away our pain meds is going to cost you plenty. Be sure of that. Many will no longer be able to work, many will no longer be able to take care of themselves, more will be fighting for disability. Some won’t be able to care for their children. This is ridiculous. It’s cruel and inhumane. How many people do we need to lose to suicide before you people open your eyes. Well I’m fighting tooth and nail. It’s on

mitchell wall

There’s no easy answer to the opioid abuse. Those who truly need it for relief have already felt the pain of restrictions in some states, and it will only get worse.
While I don’t doubt that some doctors have prescribed opioids when they were not the best choice, that should in no way cause the vast majority of chronic pain sufferers to suffer because of someone else’s bad decisions.
As long as drugs exist, people will abuse them, the same way they abuse alcohol. But alcohol’s sole purpose is for pleasure, while prescription meds are absolutely vital to chronic pain sufferers, giving them levels of relief that they otherwise could not receive.
Hopefully those in control will understand this, and take steps in such a way as to keep the negative effects on those who depend on pain meds to a minimum.

Mark Ibsen MD

FDA could require a traceable marker on each Opioid pill made in America.
We may find the answer to the opioid crisis:
Counterfeit, imported and stolen pills are killing people.
Less likely to be from Doctors Rx pads.
Massachusetts found only 8% of OD deaths had recent Rx.


This so called new “War on Drugs” is absolutely INHUMANE. People do hurt from chronic pain and already are having to adjust there life to living in pain. Prescription medications do help and the legit chronic pain patients are being punished for no reason.
I do agree with legalizing Medical Marijuana but in AL. I am pretty sure I can say there isn’t much hope for it here. The DEA, Government and whomever else needs to realize that people that have health issues should have rights, however, they seem to being taken away more every day that passes. This is so unfair. Of course, people will say life isn’t fair and they are correct. Just look how they are treating chronic pain patients..


People with Intractable Pain need to be considered. Without opiod medication my quality of life is so poor just being hurts let alone getting up to brush my hair or take care of basic needs. I wish people were better educated on the type of suffering that exists. We would be the first to sign up for non addicative medication if it worked. Suicides for folks like me will definately increase without opiods or new breakthroughs for pain like the pain pumps which still have complications that need to be worked out. I am so sick already. I hope and pray someone out there knows what is happening to people like me and can help. May god help all who suffer

Stephen M

Why must we suffer because of addicts? Addicts are addicted to dopamine, not opioids.

Opioids aren’t highly addictive, poverty is:

I’ve been suffering needlessly for years, since the FDA implemented the REMS program for IR fentanyl​ and I lost access to Actiq. Since then, I also lost my low dose methadone and my Duragesic.

I now have an Intrathecal pump (specifically a Medtronic SynchroMed II) that is under dosed and my doctor refuses to switch from​ morphine to fentanyl, sufentanil, alfentanil, remifentanil, methadone, or even hydromorphone despite terrible results with morphine.


External hought leaders are part of the problem and not part of the solution. There modernistic morally disengaged self serving greedy technicism is too far removed from people in pain and those with addiction. And so the fda cdc doj have become a side show . a one act monologue that repeats and repeats ad nauseum.
Our society is in serious trouble for government and experts no longer have the morals or compassion to serve society. In fact they act as if society should serve them and 9bey them without question.
1984 and Brave New World are what our society has become. Like the saying goes life imitates art more then art imitates life.


I am in a lot of pain every day. My Pain Dr. Already will not up my medication. He is scared of losing his license. That right there is wrong in so many ways. I have been on the same meds for over 2 years. My pain goes up but my meds don’t. And I am on a fairly low dose right now. In the last 10 years I have only had my meds upped ONCE. I never take more than is prescribed. But I am always have pain. Granted prescription pain meds are a problem. But making us feel like criminals is not the way to go about it. There has got to be a way to let us prove that our pain is chronic and permanent. And then just leave us alone. So thank god I live in a state that MMJ is legal and I have a way to lessen my pain in the evenings after I have landed for good. The only problem with that is that it may be legal but since my insurance provider is pushing my doctors. (All my doctors! Even the once who don’t prescribe meds to me, my like my chiropractor) to do a drug screen on me. So if I do get screened and I have both in my system I will get cut off. No matter how responsible I am about it. And if you saw me you would be able to tell that I am in pain. But would never know I take anything for it. My chiropractor made me copy’s of the paperwork they got which were the same as my pain dr showed me before he thru them in the trash.


They would have to make them all to where they could not be abused by the abusers!!! they really need to leave the responsible patients and the responsible doctors alone…I’m a chronic pain suffer I need to keep my job I need to keep food on the I need to pay for the car that I drive… do they honestly think that we want to be on medication??? NO I would prefer it if I didn’t need it but it makes me have a normal life… it makes my pain go away so I can work… I would give anything for my fibromyalgia and my bad back, shoulders and Knees you name it my whole body is a mess,this is pain I did not ask for… and when I was younger it was easy to work with a slightly bad back,but as I stayed with my hard physical job things just got worse,25 years know still with the same company and at 52 I feel 82 most days,and if all the pain would just disappear I wouldn’t need my pain medication,but that’s not the case,i take my medication like it says on the bottle,and I also get injections and I have a responsible doctor so they just need to leave us alone!!!

Christine Cook

Danny Harris

Your point would be valid if cannabis was a wonder drug that treated pain as well as it alleviates nausea in cancer patients. Your view is entirely overly simplistic. Cannabis treats many symptoms, but it’s not a cure-all. No medications are. I’m a chronic pain patient and my pain is angonizing. Pot doesn’t touch it. It improves my appetite and sleep, but I still need a pain killer. My medication used to treat my pain adequately before doctors became terrified of the DEA, FDA and now the CDC. I’m down to 3 meds that barely cover my pain, insomnia, and anxiety. My last appointment I was told that I’m to be slowly removed from all three. So, thanks to the government, I have three choices: live in pain and agony, buy illegal streets drugs, or commit suicide. Option 3 is looking really attractive. I’m probably going to lose my healthcare insurance soon anyway, so I might as well die.


I think the FDA CDC and DEA really need to re-evaluate the people in Chronic pain. I was Born with a congenital birth defect and acquired debilitating arthritis and bursitis in my limbs as a result of this in my late teens. I went thru thirty years of suffering and trying everything to get rid of the pain, or at least minimize it to a level where I could function. I now have a good balance of vitamins, herbs and opioid pain meds and I will end up in a wheelchair if my meds are done away with. I already have to use carts when going shopping that is motorized and a walker for short distances. I do NOT want to be confined to a chair and I really wish some of the people making these decisions for us would experience our pain and know what it’s like and not just address statistics( which really aren’t even accurate!!) It makes me mad as hell!!

Mary Lenz

I hope they still have opana re 40 left by the end of July as opana we has been my best friend for 6 + yrs. I was on Fentanyl and oxycontin 80. My house was broken into. Drugs and other things were stolen. All fentanyl and oxycontin did was make me a recluse that slept all the time couldn’t remember anything. Because of opana re I finally have a life after 5 + failed back and neck surgeries. Let the drug addicts suffer, not those of us in
chronic pain that use and need opana we the correct way.

Stupid is – as Stupid does.

Adulterated street drugs are killing people NOT Prescription meds !

Will they ever learn or do they just not get it ?


John S

Candi Simonis

What they are doing is fighting chronic pain disease patients who use legitimate prescription medications for a disease. The crisis is that they are targeting the wrong people. Chronic pain is now the epidemic. We are being caterogized, for a medication we require to reduce our pain. No other chronic disease patient is targeted for the medication they must take.
What about the good of opioid medications. They are lifesaving medications for millions of Americans who live in constant, debilitating chronic pain. The addiction rate of legitimate chronic pain disease patients is .02-.6 %.
The FDA, DEA, CDC and all other Government agencies need to go after the illegal fentynal and heroin producers and manufacturers, also, methamphetamine, cocaine and all other illegal drugs.
The targeting is wrong! It is discrimination against legitimate chronic pain disease patients who use our MEDICATION responsibly.

Danny R Harris

If they do that to one they will have to do to all, they all have the potential to create addiction! Why not do away with all and prescribe cannibas in its place?


The statistics that the fda and other agencies use are fatally flawed. They will never reach their objectives of reducing addiction and overdose as the only ones truly affected by their actions are legitimate pain patients who use these medications as directed by the prescribing provider!