Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction; Public Hearing
2019-368 CDER Standards for Future Opioid Analgesic Approvals and Incentives New Therapeutics to Treat Pain and Addiction Public Hearing Open
2019-09-12 2019-10-30 2019-09-16 2019-11-05 2019-10-24 2019-10-24 2019-08-07 2019-09-12 2019-08-28 2019-07-15
FDA-2019-N-2514-0057 FDA-2019-N-2514-0090 FDA-2019-N-2514-0060 FDA-2019-N-2514-0095 FDA-2019-N-2514-0084 FDA-2019-N-2514-0086 FDA-2019-N-2514-0023 FDA-2019-N-2514-0037 FDA-2019-N-2514-0034 FDA-2019-N-2514-0005
04:00:00 04:00:00 04:00:00 05:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/FDA-2019-N-2514-0057 https://api.regulations.gov/v4/comments/FDA-2019-N-2514-0090 https://api.regulations.gov/v4/comments/FDA-2019-N-2514-0060 https://api.regulations.gov/v4/comments/FDA-2019-N-2514-0095 https://api.regulations.gov/v4/comments/FDA-2019-N-2514-0084 https://api.regulations.gov/v4/comments/FDA-2019-N-2514-0086 https://api.regulations.gov/v4/comments/FDA-2019-N-2514-0023 https://api.regulations.gov/v4/comments/FDA-2019-N-2514-0037 https://api.regulations.gov/v4/comments/FDA-2019-N-2514-0034 https://api.regulations.gov/v4/comments/FDA-2019-N-2514-0005
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
I am a chronic pain patient. Opioid restrictions have hurt me and many of my friends, and killed some we know. Doctors are cutting their patients off cold turkey, or forcefully tapering them against their will extremely quickly. They are citing the CDCs 2016 Guidelines, which are for ACUTE cases, not chronic cases. The DEA is actively prosecuting doctors for treating chronic pain patients at appropriate levels, to the point that so few providers remain that we have a pain epidemic in our country. We have 25 million americans with high impact pain, pain that debilitates them. Another 40 million with chronic pain. Pain is the NUMBER ONE reason people go to the doctors. And you cant even get it treated anymore. At least 1 in 10 suicides are associated with chronic pain. Pain kills. Pain ruins lives. And we so highly prize preventing addictions that arent even occuring from prescriptions - a long term study of chronic pain patients found .56% became addicted after 6 months of use. Less than 1% - and acute patients rarely get pain medication outside of surgery and often not even then, now. Our government is publishing LAWS about the amount of MME that a drug can have - are our politicians doctors, then? How is this their job? Statistically speaking this is an illicit FENTANYL and HEROIN crisis, not an opioid crisis. Restricting prescription pain medications this heavily, when the prescription pain pill problem has been solved and over-solved for years, only hurts pain patients and doesnt help addicts. We need to address illicit heroin and illicit fentanyl. We need people to understand that illicit fentanyl isnt the same as fentanyl in a hospital, and that illicit drugs are extremely unsafe and contain pollutants. We need to address the problems underlying drug addiction and decrease access to street drugs, not conveniently slap on a band-aid that sounds good by restricting pain pills even more. Many individuals cant even get their medication, thanks to federal opioid budget cuts of up to 80% in the case of some opioids this year alone. Pharmacies run out. Individuals are left in terrible, life threatening withdrawals or in agony for days. Insurance companies no longer feel compelled to pay for opioids since physicians are uninclined to prescribe them and no one is likely to enforce punishment on a doctor for NOT giving pain medication. In fact, when I was with a chronic pain friend during her hospitalization for severe, hard to treat pain, she asked for a lidocaine IV. This is non-opioid, non habit forming. They told her that they couldnt do her IV, and then they cut her pain medication in HALF. She was in so much pain she wanted to die already, and now her pain tripled and she was going through withdrawals. They left her like this for over a day. They did not care. They cared only that their asses were covered and they werent prescribing more than 60 MME. This is essentially a genocide against pain patients and chronic illness patients, who are dying by the thousands of heart attacks from pain and suicide. Did you know the number one condition putting someone on disability is chronic pain, most often back pain? I wish our country luck when the economic impacts of this many additional disabled individuals, unable to work, hits. Pain meds help maintain functionality, the ability to work, and quality of life. Please include pain patients properly using medication in your panels, so our voice is heard. Our need for these medications should not be threatened due to others actions, and it has been, unintentionally or intentionally. Impact is greater than intent. Please make EXPLICITLY clear  in any future legislation that these bills do NOT apply to chronic, intractible pain patients. I have a genetic disease. There is no cure. There is no treatment. My joints dislocate multiple times a day, my brain pressure rises causes agonizing headaches. My bones ache due to inflammatory conditions and autoimmune conditions. I spend every waking moment in pain, and I am 22. Pain medication gives me the ability to go to school and have some quality of life. Without it, I would be home bound. And it is constantly in threat. We live in fear. Help us.  I can agree that there needs to be new methods of pain management researched to help combat the terrible opioid crises that this country is going through. I do wonder though what potential ingredients would be used in this analgesic, and if though the FDA says there is no risk of addiction, there could be a dependence on the analgesic as well. I also question how available this type of pain management will be since opioids are more readily available, thus the reason we have the crisis we do. In the risk-benefit analysis are we also taking those who are already addicted to opioids into consideration and are we also considering that addiction is a disease and the possibility that even with the treatment of pain will the dependency on the opioids be combated?  I can appreciate that the FDA is having this meeting to discuss different options, but are the voices of those addicted or their families voice going to be heard or will it be overshadowed by the opinions of those in the medical field or in pharma sales. I do hope that there can be a real resolution to this crisis and perhaps the suggestion of a non-addictive analgesic is the right answer. I also hope that in finding a solution to the opioid crisis, we can then work on the treatment of those on other addictive drugs without the use of suboxone. Living in an area where the opioid crisis is very prevalent I would like to see more ways to help combat this, and I would like to see more people be open to the discussion of different treatments for those in pain. I think too many times we overlook the reasons why people become addicted in the first place. The pharma company, yes I do know it was one particular family, that created oxycontin and hydrocodone that is the substances that are at the very heart of this crisis, should be held responsible for the crisis that was created, and hopefully have no part in creating new ways to combat pain. I also have the hope that this forum will be able to show that not all persons are receptive to the same type of pain management and can in some way look at individuals when coming up with solutions. Yes, the analgesic is a great start but there are some who may not be receptive to topical treatments. The FDA needs to research how to take what non-addictive properties are in the analgesic that they are trying to develop and apply those to an oral type of medicine. 2. Should sponsors of new opioid analgesics be required to demonstrate some comparative advantage relative to existing analgesics? If so, what new authorities would be necessary to impose a comparative advantage requirement for opioid analgesics?3. If so, how should that comparative advantage be defined?a. Can it be quantified?b. Should the assessment encompass any potential comparative advantage, including, e.g., safety advantages that reduce the prevalence or consequences of abuse or misuse by non-patient populations?c. For any given application, to which existing products should the proposed new product be required to demonstrate comparative advantage? Any other opioid approved for the same analgesic indication(s) for which approval is sought? What are the implications if the new product only offers a comparative advantage over some of the other opioid products approved for the same indication(s)?......These questions that are being asked are going in the right direction, and I agree that the advantages of the analgesic should be defined. I do also like that the patients are actually being thought of, though it does still seem like they see patients as just a number and not actually as a person. Human beings are at the core of this problem and there is a need to make sure that we look at the patients, addicts, and those who will need pain management in the future as such. We have to look at them as humans not just as some numbers or as some statistics.  Im a CHRONIC PAIN PATIENTS WHO SUFFERING in UNBEARABLE PAIN BECAUSE of BEING DENIED PAIN MEDICATIONS that work to make my life bearable. Why take a way what has worked FOR so MANY years for so many ..if you had CHRONIC PAIN you would know what Im talking about. But you dont. How can anyone live with them SELVES knowing what you ARE doing to US. Letting us SUFFER UNTIL WE CANT HANDLE ANYMORE pain and are forced to  COMMIT SUICIDEYou know its not PRESCRIPTION DRUGS that is the problem ITS ILLEGAL DRUGS that ARE KILLING PEOPLE..And you continue to let us SUFFER UNTIL Death. Someones going to be RESPONSIBLE FOR our DEATHS and SUFFERING. This is the WORST CRIME in HISTORY AGAINST CHRONIC PAIN PATIENTS AND VETERANS WHO ARE SUFFERING in UNBEARABLE PAIN BECAUSE WERE DENIED the LIFE SAVING PAIN MEDICATIONS AND MORE SUICIDE DEATHS BECAUSE WE CANT HANDLE the PAIN  These comments are submitted in response to the Federal Register notice Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction, Docket FDA-2019-N-2514.  This is a written version of comments made orally at the September 17, 2019, Food and Drug Administration (FDA) public hearing on this topic. This is an anonymous post.I have read many of the comments for this issue. I have lived with chronic pain for many years. I have seen the damage that the CDC requirements have done to pain patients. It has decimated entire medical clinics, pharmacies and families all across the United States. I ask the reader this; if you took this issue and superimposed it to say, car accidents, would the results be the same? Would there be as passionate a response?Car accidents kill many more people a year then overdoses.People purposely abuse their privilege, not right,  to drive. People completely control their texting or drinking or using drugs or being tired that affects their driving capabilities that end both theirs and innocent peoples lives. Why hasnt the public demanded that individuals cars be taken away? That cars become illegal? Demand stricter regulations on cars? You dont even hear people complaining about it in the same fashion. Look at gun rights. After a severe shooting, activists demand the restriction of gun laws, etc.The NRA states its the people but not the guns. And the fact is, taking away a persons ability to own a weapon, a person who follows ALL the laws makes little sense when the bulk of criminals could care less about gun laws and acquire their weapons illegally. Hurting law abiding citizens by punishing them for merely following the law makes little sense. Unless its about the STATEMENT and not the actual action. The SAME can be said for what is happening all across America now. The fact is, if all of these governmental agencies and nurses and the CDC and everyone who is calling for and achieving the taking away of pain medicine from legitimate pain patients and pain clinics and pharmacies were truly interested in fightingTHE WAR  ON DRUGS, wouldnt they want their efforts to yield results? Attacking legitimate pain patients or even considering prescriptions legally acquired to be in any way related to the elicit fentanyl and heroin overdose deaths and current opioid crisis would be like comparing drunk driving deaths to heart attacks . They are COMPLETELY DIFFERENT issues and the current culture would be like attacking heart surgeons ability to perform to correct and curb drunk driving. It makes little sense other then as a political statement in a political environment. Just because legitimate pain medication can be be used to overdose on  and the fact that opioid medication is technically related to heroin or fentanyl, does not mean destroying pain patients ability to get medicine will stop fentanyl or heroin from being brought in and abused. In fact, it makes it WORSE! To compare the two is like saying that heart attacks and drunk driving deaths both deal with people dying and trying to cut off the head to cure the head ache . Because what is happening in the United States right now is madness and is ONLY helping the entities making the statements. Its not helping people in pain for legitimately documented injuries and conditions that have NEVER abused their medication ever. Its not helping people that are being denied pain relief during surgeries. Its madness. Its not helping doctors offices just trying to help people compassionately. I talked to a doctor that told me he was bringing the ENTIRE medical office down to a 60 MG morphine equivalent. Not for any medical purpose but only a legal one. So every single patient is considered the same. All addicts. ALL being accused of being just like the heroin and fentanyl dealers and junkies. All being lumped together. It would be like saying a murderer and a war hero that has taken lives are both the same. Technically the actions are related, but the INTENTIONS are light years apart. So unless we are going to start putting war heros in prison for life, we need to STOP THIS MADNESS NOW. There are so many other ways to look at this situation. The point is that punishing people for treating pain with medication that is merely scientifically related to the drugs being sold illegally and causing the MAJORITY of the deaths is not rational,  or appropriate. We are never going to eliminate pain. We are not going to stop the headache by cutting off the head. By what is happening now accusing people of selling their prescriptions without any proof or reasoning at all. It MAKES NO SENSE. Even if we made pain medication illegal it would not stop the drug crisis. AT ALL. It will make it WORSE. The rationale that taking legitimate prescriptions off the street simply because someone following the rules could be lying or diverting their medication is like saying that we should eliminate cars because someone could get drunk and kill someone. Many more people are driving without killing someone. Many more people are using their medication because they NEED it. And lets say we take all the cars away? We would not be able to go to work, to live to eat to survive. THE EXACT same thing happening to legitimate pain patients out there.  Why should people with chronic pain or cancer be denied pain relief because a segment of the population has no will power or self-control? People need to be held accountable for their choices. The government loves to enable people so that they do not have to face the consequences of their actions. I have rarely taken an opioid because I dont like how they make me feel, but I dont want to be denied access to them, if I ever do need them for pain management. Gabapentin prescription renewal now requires me to visit my prescribing doctor every Three (3) months. This is a difficult requirement for we senior citizens who have spinal stenosis. I spent 2 hours in my doctors office today filling our paper work and will be required to return to my prescribing doctor in 3 months to get a refill prescriptions. The FDA should be more aware of the administrative burden they place on drugs like Gabapentin which can not possibly be a candidate for drug abuse. Looking for new treatments or releasing new meds is a good thing to do.  Ignoring what the CDC, FDA, DEA HHS and more did to Chronic and intractable pain patients needs to be fixed.  You need to do more then release a clarification that no one paid attention to.  What happened was the  opposite of what you intended to happened.  A new more aggressive and intimidating campaign against the chronic pain community to force new tapers and doctors to stop the pain medication and abandon their patients.What will you do to fix this or help the over 50 million chronic pain patients you caused and destroyed the lives of these patients.  Like an addict its not about the person its about the friend, family and anyone who knows this person.  There are millions of us some say as much as 50 million to 100 million of people living in chronic intractable pain.In 2016 CDC in section on how to continue treatment of a patient on LTO. They were asked if they wanted to taper and if the answer is no keep the patient on the same does.  The CDC guidelines said to offer a slow taper and go over the risks.  This did not happen did it?What else happened?  Suicides and driving patients to the street for relief. A huge amount of death because no one read the guidelines.  Go back and fix this before you attempt new treatments and pain medication.  The guidelines were written to help primary care physician to start a chronic pain treatment for new patients.  It was never meant for patients taking LTO.Go back and let the doctors treat their patients with the same pain medication for years.  Give us back our doctors, let them out of jail, give us back our medication and stop the DEA.Most of all admit what you did.  Admit in 2015 you were warned what would happen if the guidelines were released as is and you did it anyway.  Admit you inflated the number of overdose deaths related to prescription pain medication.  Admit you released the correct numbers 1 year after reviewing the death certificates.  Admit it took you 4 years to release clarification to the 2016 guidelines and you have known it for 4 years and you are causing more problems and hurt to pain patients.  Admit to the propaganda released and you set back on your asses and let it happen.  Go before congress and admit what you did to us.  My storyI was with my pain doctor for 20 years at the same clinic and on the same dosage when on 4-23-17 the medication that controlled my pain were stopped.  I arrived for routine follow-up when a new doctor I have never seen walked in to tell me he is stopping all pain medication for each person within one month.  It took me six months to find clinic to accept me as a patient and he treated me like a new patient.My worst pain is from 4 different migraines including chronic cluster migraines, several ruptured disks from a back injury and severe disk degeneration.  Spinal Bifida, Scoliosis, Fibromyalgia , chronic kidney stones and more.8-23-2018 I had one of the worst cluster migraines on its 5th day, the pain, a flair up from my disk rupture was acute and my chronic kidney stones started dropping.  This was my 4th kidney stone episode this year.  I was in horrific pain.I have a pain contract so my son called the clinkic to let them know he was taking me to the ER.  He was told he could take me but under no circumstances could they give me any pain medication. My son called 3 more times; on the 3rd call was told we needed permision from the doctor and he already left for the day.  No one told him about me.  The next day he was told the same and the next appointment we were told the same.No one should suffer horrific pain. Our doctors abandon us pharmacists profile us and refuse to fill our prescriptions even for cancer.  A family pet would never be allowed to live in pain. The family would show mercy and let the pet go to sleep.Before April 2017 I was happy, able to work, involved in many craft projects and saw my daughter and grandchildren often and they live 40 miles away.  Because of the migraines my husband created a dark room and I spend most of my time in there.  My back and other causes make me change positions every hour.  I do not get much sleep.  After months of appointments I said to that doctor I think about suicide every day sometimes every hour because of the pain.  He did not evan look at me and walked out the door.Help me before I become a  statistic.As chronic pain patients (CPP) most of us live in terror, horrific pain, anxious, depression, torture, sick, dark, isolation, anger, sad, cry, worthless, alone, jobless, misunderstood, fear, insomnia, helpless, broke, scared, scared of surgery, hopeless and at times hopeful.We have a disability and because of that disability we suffer discrimination just like every group of people.  Our doctors abandoned us pharmacist profile us and the public treats us as addicts.  No pharmacist wants to fill a prescription fo pain medication even for cancer.  I am having irreparable damage being done to my health after being forced off a medicine dosage, I have been prescribed safely for over twenty-six years. I need to be tapered off this drug SAFELY so as to cause NO HARM to the genetic bone disease, Alkaptonuria/Ochronosis, rare genetic disease which causes bones to go black and brittle  hence why its also called black bone disease.AKU is caused by a missing enzyme which means patients cannot fully breakdown a toxic acid called homogentisic acid (HGA). HGA attacks bones and cartilage, causing severe pain and disability as life progresses. The way I have been forced off a medicine I had taken for so long is hurting my heart along with causing the HGA levels to attack my bones even more than they already have, causing this disease to spread even more through my body. OCHRONOSIS causes bones to grind against each other cutting off nerve endings its a severely painful disease, only treatment that is listed, for this disease is taking pain medicine- there is NO other treatment listed for this disease, except a medicine that has just came out but is not attainable as of yet, which does not take away the pain of the disease, but, helps with the cause. I am on a list to get it one day- I am trying very hard to stay healthy enough. Ochronosis is perhaps the oldest known metabolic diseases on the planet- found in Female Egyptian Mummies, yet there is no cure. I am TIRED of being treated like a criminal -because I was born with a genetic disease! I have been abandoned by my doctor, and he did not refer to to another doctor, as he had always promised me. I have been treated like a criminal at my pharmacy, that I had gone to for over thirty years, one day they are my loyal store and the next, they were treating me like a crook. I was forced off my medicine dosage and NOW the rare incurable bone disease OCHRONOSIS/Alkaptonuria, is getting worse and worse everyday! I do not want to become totally bed ridden suffering a life with the pain of this disease that turns your bones black after it eats away all the cartilage between the bones causing them to grind and scrape against each other , it has attacked the valves to my heart, my kidneys and liver. And, now my entire cervical spine has been totally damaged. The doctor I had for 32 years was able- thru having me change my diet, do chiropractic help and cortisone shots, was able to keep this disease from spreading, it had stayed in my neck and hip for over twenty-six years, but, now it is spreading down my spine. By being denied my pain medicine dosage without being able to ween off of it at required 10% at a time , and made to live in total pain day and night. I can no longer get the exercise I need that kept this disease from building up in my joints, it is now eating away all the cartilage-turning my bones black, causing my urine to turn black. I am praying I can find doctor who will help me lower my need for the opioid medicine, that I was put on for twenty-six years in a SAFE way, the harm being done to me now, there is no cure from, which makes me desperate! I do not wish to become dependent and more sickly, when I was so independent for so many years. I have no where or one to turn to. PLEASE I NEED HELP! I bought my own home in my early thirties, I was the first female camera operator doing ENG field work in Los Angeles, I have a FCC 1st Class Radiotelephone License that entitled me to run and operate any television or Radio station in America. Yet, after I bought my land and home, I found out after five botched surgeries that I had a rare genetic bone disease that was non operative and has no cure. I still was able to stay independent, Until, the misapplied CDC Guidelines forced me off a medicine I had been taking responsibly and safely for over twenty-six years- This has caused this disease to now, start attacking my heart and rest of my cervical spine. I pray that revision of CDC Guidelines and allowing doctors to do their jobs without being persecuted  will give me back my life and I can grow old with dignity. Please contact me and let me know if you can help. - its means everything to me. Please watch this video if you have any questions about my disease : https://www.youtube.com/watch?v=7PpQU3wrdlMt=30sCDC and the FDA has put out warnings to never force a patient off a medicine they have taken for as long as I have been made to take this medicine. The irreparable injury being done to me, I am scared, I will end up totally cripple. I ask you to please help me to live the decent life I WAS LIVING without the pain of this disease. I have MRIs and X-Rays and any other records you are welcome to view, I thank you for your time and help in this matter. = Mahalo Nui Loa,    Hello  My name is Dennis Shivers  Im 66 years old and was injured while working back in 1994. I will try to keep this short and to  the point.. I injured my neck and had pain in neck,arms and shoulders. I searched for a year with endless amount   of   Drs. to find relief from this pain. I layed on a couch or bed during this time literally crying from the pain.I thought to many times ofending my misery.   I had one more appointment with a Dr. He recommended I see a specialist,which I did. His answer was to burn the nerves in my neck,shoulders and arms. When I went back to Dr. he asked what I thought of the specialist. I told him the guy was nuts and I wouldnt do it. He then prescribed a pain medicine and told me to try it. He explained he was starting at a lowdosage and would adjust until it took care of pain. After roughly a month we had the dosage that we felt was right. When I  wake up in the morning it feels like I never injured myself!  I was able to do things again. I could do work around my house,play with my kids, I had 85 % quality of life. I could not believe the difference.I was taking 80mg of Oxycontin three times a day and had 20 mg of Oxycodone for break through pain. And it was needed. I was active my whole life. Im not the one to sit. So when a day came and I pushed to much the breakthrough med was a life saver.  So for 25 years I had a quality of life, I was able to function play with my kids. I never thought I would be able to do this  again.   And then this crisis came about. This is where I will condense. First off CDC.FDA. and other agencies all jumped to  end this crisis One of the first things they did,was take pain medicine away from me and the 100 million Chronic Pain  Patients across the country. You all blamed prescription pain medicine for the over doses across the country. Some Bozo  came up with a formula that renowned scientists called junk science. Im referring to this absurd Morphine Milligram Equivalent scale. There is no research or any scientific study to back this ludicrous law. Beside cutting back on our pain  medication,politicians ran to make this law. So now you can only get 100 mg of a pain medicine,which is absurd. You cant group patients together and use a one dose fits all on them. Everyone metabolizes medicine differently. So what painmedication and dosage that works for you,doesnt mean it will work for me. The other problem is the grouping of all the over doses. First off with said agencies storming and threatening Dr.s for writing pain medicine scripts,Drs. wont write scripts for patients for fear of going to prison or losing their license to practice. So pain prescriptions dropped drastically,but over doses climbed. Something isnt right. ODs should have dropped to according to the agencies. The problem is95% if not more over doses are caused by illegal heroin and Fentanyl. Now if we wanted to be transparent the govt would say it was a heroin OD or Fentanyl OD  But they dont,because it wouldnt fit the agendaSo because of this myself and 100 million C.P.P. are suffering because we are being deprived our medicine.   Im back to where I was 25 yrs ago. Laying in bed or on a couch with no life,in pain and wondering if I should just end the misery. Im not only in physical pain now,but because of the anxiety and stress of worrying if I will get my little bit of medicinenext month or will my Dr. stop writing in fear of being arrested etc etc.  Im asking first off if you could add a grandfather clause to any new laws where patients that were on a set dosage for years and were able to live as close to a normal life as we could be exempt from new restrictions. And if you could please reconsider the MME. Please listen to DRs and researchers who know about this. Please dont listen to these self proclaimed experts ex: Kolodny who has punked everyone and might out do Bernie Madox in fraud.   Thank you for allowing me to express my opinion. I hope we can fix what has been blown up and is hurting the ones  hurting already,the Chronic Pain Patients. We didnt ask to be injured. We are asking for the pain medicine we deserve  so we can live as close to a normal life as our injury will let usRespectfullyDennis Shivers  