Gottlieb: Next Steps in Opioid Crisis May be ‘Uncomfortable’
In testimony before the House Energy & Commerce Committee on Wednesday, FDA Commissioner Scott Gottlieb said that the next steps in efforts to combat the ongoing opioid crisis will be difficult, but necessary given the spread of the epidemic.
“We’ll need to touch clinical practice in ways that may make some parties uncomfortable,” Gottlieb said, pointing to restrictions on prescribing and mandatory education for physicians as possible steps.
“Long ago we ran out of straightforward options,” he added.
Gottlieb’s remarks come as the US continues to struggle with overdoses that claimed the lives of at least 64,000 people in 2016, according to provisional data from the US Centers for Disease Control and Prevention (CDC).
Gottlieb also said the agency will be taking another look at the benefit-risk framework for opioids in light of the ongoing epidemic to inform its regulatory decisions, “including recommending that products be withdrawn from the market.”
In July, Endo Pharmaceuticals voluntarily withdrew its reformulated Opana ER (oxymorphone hydrochloride) from the market less than a month after FDA requested that the company pull the drug due to public health concerns over abuse.
Medication-Assisted Treatments
Gottlieb announced several steps FDA will take to promote the development and use of medication-assisted treatment (MAT) for opioid addiction.
The agency is also working to draft guidance to promote the development and use of non-abstinence-based endpoints for addiction treatments and support the development of drugs that address symptoms of addiction, such as cravings.
And Gottlieb said that FDA will do more to promote the use of existing addiction treatments such as naltrexone, buprenorphine and methadone.
“One concept that FDA is actively pursuing is the research necessary to support a label indication for medication-assisted treatment for everyone who presents with an overdose, based on data showing a reduction in death at the broader population-level,” he said, adding that the agency is also considering updating the labeling for such drugs to reflect that they may need to be taken for long periods of time.
Lastly, Gottlieb said that FDA will take steps to address the stigma associated with MATs.
“The stigma reflects a view some have that a patient is still suffering from addiction even when they’re in full recovery, just because they require medication to treat their illness,” Gottlieb said.
Access and Affordability
During his testimony, Gottlieb said that inadequate insurance coverage is part of the reason some people with opioid addictions do not receive necessary treatment.
Gottlieb also raised the point that currently the vast majority of opioids dispensed in the US are inexpensive, immediate release formulations. Going forward, Gottlieb said that insurance coverage and reimbursement could be an issue for new abuse-deterrent or non-addictive pain treatments.
“It will be the case that some of those newer drugs will be more expensive than the older formulations, and I think we need to think about how we provide incentives for those to be used—perhaps preferentially—if we think the public health outcome is going to be better,” he said.
Filed under: General Problems
Gottlieb, how can you not understand that far more people, including myself, entered the world of pain management because we have chronic pain that cannot be relieved by aspirin. We don’t like pain meds, they make you constipated. We do take pain meds so that we can live lives without crushing pain that leaves life not worth living. Most of us don’t dare misuse our drugs for fear of losing them. Most of us would love to be pain free so we are not dependant on drugs that are now being vilified by our government. Count the bodies one by one when you take away the drugs that work for us. It is not our fault, nor the fault of our understanding doctors, that people out there abuse these same drugs. But we will pay the price for what others do. Find another way to stop people from abusing our medicine. Those of us chronic pain patients will be faced with the choice of suicide because of our pain. Choose to not cripple us, we should not have to pay for the crimes of the people who choose to be addicted. Help them if you can, but don’t let chronic pain patients pay for thier problems that they CHOOSE. You will, after the death by suicide of chronic pain patients, change your mind, the pendulum always swings backwards at some point. How many chronic pain patients have to die until you see the folly of this choice. Wake up now, before you kill those that have no other options. This is how governments work, Try to fix one problem by creating another. Stop and think! Study the pros and cons of this action before you make a devastating decision. Let us LIVE! We are down on our knees begging you. PLEASE don’t take away our lives by taking away what makes them worth living.
Judy U.
It makes zero sense to prohibit chronic pain pTients from the medications that allow them to function. Surely, Trimp is not this stupid!!!
So in other words, the only ones who would have access to an opioid are recovering addicts. In case some of you were not aware, buprenorphine is an opioid about 40 times stronger than morphine. Buprenorphine is the active opioid in Suboxone and other medication for MAT. If we purposely abused our prescription opioids or decided to go to the streets, we could then have some access to an opioid. Does anyone else think that sounds about as effed-up as possible? Our country is no longer going to hell in a handbasket cause we’re already there. This SOB and the scums who support this opiophobia will one day have to answer to God as to why their love of money (aka greed) was more important than showing compassion towards other humans.
AMEN!!!m
To who ever it concerns thank you so much. please feel free to publicly post and use this my story and grief of this horrible malady and the the Hell the now uninformed Public and some of the Media are putting us legitimate Chronic Pain Sufferers through! It is no more than local emotional Abuse ( and border line Domestic Emotional Terrorism )!on a scale with only Biblical proportions!To the Editor and Associates I have taken this opportunity to share my heartbreaking story in hopes these witch hunting Opiate ill informed skeptics will read and understand that we as Millions Of Legitimate Chronic Pain Sufferers would have no life without Medically prescribed Opiates by a physicians care and strictly monitored monthly urine and blood test. Please remember that An Opinion Before A Thorough Investigation Is The Epitome Of Ignorance! And that a little more compassion from the Medical Field and its representatives could have saved my beautiful Stepdaughters life. Let me say this! A person who has a addictive personality will abuse anything that helps them feel better. I have taken Oxycontin for 12 years , I have had 20 major surgery’s in 9 years. I have so much physical pain I can not even get out of bed with out pain meds and when I run out I run out and just lay in bed praying the Lord relieve me of this horrible condition and I pray God you pain med skeptics never go through what I go through everyday of my life when the only thing you have to do is threaten what help I get, Shame on them! There will always be drug abuse and as the so called war on drugs has failed all this will! All you do is stoke and aid the drug pushers business to knew heights in the Black Market of Heroin while trying to deprive folks as me to this horrible movement! My Stepdaughter committed suicide 4 years ago because of being treated like a drug addict by her family and doctors when all along she suffered from Lupus and Fibromyalgia which I believe was brought on by a deadly car crash at 18 , she told me between that which I was being put through and what they were putting her through she was not going to be able to live her life in such a hell brought on by people like the Biased Uniformed Skeptics that are on a witch hunt to out law Opiates and pain meds that give us some sort of a life . As a retired Police officer and worked indirectly close to the DEA, you people do not have a clue how thrilled you are making the illegal opiate trade and think of my Late Stepdaughter as you continue on with this 2017 Version of the ( 1940s Propaganda Film named REEFER MADNESS )movement to outlaw opiates! Just like the slaughter of children at Sandy Hook if there would have just been gun laws , my God they were Gun Laws , the guns that murdered all those 20 children were all registered and owned by a school teacher! You fight Drug Addiction in Elementary education by teaching all children the dangers of Booze and Tobacco which if these witch hunters want for us to know the real truth but they do not. I miss my Stepdaughter so much and some of us will continue on the fight to protect our right to feel better and function without fear of these witch hunters trying to convince us to commit suicide . And they are trying to do exactly THAT and are now being successful in this under the table practice of Human Genocide!
The under line real truth it seems THESE witch hunters would rather us Chronic Pain sufferers commit suicide are and DRINK all the BOOZE we can drink! The Federals legalized it ( ALCOHOL) knowing its a more deadly drug than Strychnine. And just because the DEA has miserably failed with their witch hunt type movement on drugs why do they continuous fully deprive us sick people of our Constitutional Rights to be Happy in that pursuit of with Professional Physicians to take meds that give us relief of this horrible malady of Chronic Pain ! May God have mercy on their miserable souls they that seek to destroy us Chronic Pain Sufferers only and little hope of temporary relief of this horrible sickness.
UNCOMFORTABLE? Now that is the understatement of the millennium! GRRRRR!
Gottlieb is so full of himself that it makes me sick! Make sure we treat addicts but those who require opiate medication for chronic pain through no fault of their own can just rot? He’s high on my list of people who karma needs to bite hard!!