Abuse-Deterrent Opioids Evaluation and Labeling
cder CDER2012192 draft guidance abuse-deterrent opioids evaluation and labeling opioid analgesic 2014-643
2019-04-19 2017-05-10 2016-07-27 2016-01-19 2013-03-08 2013-03-08
FDA-2013-D-0045-0038 FDA-2013-D-0045-0037 FDA-2013-D-0045-0035 FDA-2013-D-0045-0034 FDA-2013-D-0045-0002 FDA-2013-D-0045-0003
04:00:00 04:00:00 04:00:00 05:00:00 05:00:00 05:00:00
https://api.regulations.gov/v4/comments/FDA-2013-D-0045-0038 https://api.regulations.gov/v4/comments/FDA-2013-D-0045-0037 https://api.regulations.gov/v4/comments/FDA-2013-D-0045-0035 https://api.regulations.gov/v4/comments/FDA-2013-D-0045-0034 https://api.regulations.gov/v4/comments/FDA-2013-D-0045-0002 https://api.regulations.gov/v4/comments/FDA-2013-D-0045-0003
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
I am a legitimate pain patient NOT an addict. Ochronosis/Alkaptonuria is what I am suffering with-this disease is definitely in the intractable pain category! The irreparable injury being done to me is, in equity, the type of harm which no monetary compensation can cure or put conditions back the way they were. What has been done to me is SHAMEFUL and I am going to find a lawyer so they can never do harm to disabled Americans again!! AM NOT SURE HOW MUCH LONGER I CAN GO ON LIKE THIS! For thirty-two years I only saw one doctor along with the surgeons he sent me to, in all that time ,I have tried and tried seeking a specialist for the genetic bone disease they diagnosed me with called Ochronosis/Alkaptonuria- a Rheumatologist who could also help me live with this disease. But, every doctor that my old doctor referred me to- rejected seeing me - saying they could not help, especially now, when they see my medical records and see there is no cure for this disease, that only treatment that is listed for my disease- is pain medication - they have expressed they do not want to risk their livelihoods by taking me on as a patient. THIS DISEASE IS INTRACTABLE PAIN, its turns my bones black, brittle and eats way all the cartilage and the disc between my bones -my body over-produces a homogentisic acid  that literally nukes my vertebra and makes them inoperable black bones that look like a Mummies bones , it causes the nerves down my arms to become paralyzed and eats away at the valves to my heart, attacks the kidneys etc etc etc, BUT beyond all that I was doing as well as a person could. I have to have a chore service person because I can not lift anything more than 10 pounds, and if I sleep wrong I wake wake not being able to use my arms - But I changed my diet I kept my body as strong as I can And most people would never know the pain I live with every day! The irreparable harm that has been done to me and STILL BEING DONE TO ME has NOW caused this disease to spread even further down my back and they only let me have half the medicine I was on, the pain of going without medication has done irreparable damage me!!ALL this is causing my nerves so much stress, that my disease gets worse and worse everyday. why is it they can not see a legitimate patient from a patient who just wants to abuse it. Dont my medical records mean anything?! PLEASE if you know of anyone who could or would help me - would you show them this letter - I do not want to die or end up committing suicide - like all those veterans shooting themselves in the head everyday from being denied their medicine! mahalo nui loa, Virginia Leigh FDA-2017-N-1094Guidelines need to address legitimate prescription of opioids to people with chronic pain disorders.  They SHOULD NOT bepenalized!  Any one of us at any time can have an illness or injury that puts us in this situation! It should not be made more difficult for anyone with legitimate reason to receive relief from pain to live a functioning life. The whys of abuse/addiction need to be addressed for the remaining population before any cure can be realized andadministered. Lower socio-economic, ethnicity, race are factors for all drug and alcohol abuse.The areas of the country where this is prevalent have seen extreme economic downturns in the last 8 years or more.People are in despair! We need MORE research on Marijuana and its chemical makeup as it shows promise to help chronic painwithout the THC high, we need STEM cell research to find a way to help cure people who have chronic pain.We also need to be screaming to have our tax dollars go to support these efforts at both State and Federal levelsRebuilding infrastructure that would create jobs for the ones lost due to factory closures etc.,would infuse life back into these communities, people WANT to work and support themselves.Health care needs to be available at a cost that is affordable!  A sliding scale based on ability to pay!Our country appears to be stifled in arguing over these important issues that will affect EVERYONE.We need to remember you cannot teach a closed mind! I am a long time chronic pain patient and I am extremely concerned  afraid of what my future will be because of how the new prescribing laws  regulations have affected millions of chronic pain patients ability to get adequate care/medication treatment for their life altering pain conditions. How in the world do you plan to win the war on drugs by eliminating access to medication for people with horrible,  debilitating illnesses? Doctors no longer want to treat us because we are too hi a risk  its much easier to be pushed away or just not take the risk. Lets face it,  Doctors have plenty of patients!  If opioid medications can include a deterrent  to stop abuse and/or improper use, yet still be effective at controlling pain,  I believe everyone would support that.  But in the crusade to stop abuse,  you have successfully removed or significantly reduced, millions of chronic pain patients access to *effective* pain medication dosages that actually have a positive impact on patients lives.  Millions of chronic pain patients are on the opioid treatments were on as a *last line of defense!* Weve already had the treatment alternatives,  the NSAIDS, the injections, the holistic  even the surgeries! Isnt that in fact the definition of chronic pain,  pain that is ongoing, pain that persists in spite of treatment and there is no known cure ? While other treatment therapies may help  I encourage any treatments that are helpful,  I know that MOST chronic pain patients would NOT BE ABLE to get themselves washed, dressed  driven to their alternative treatment appointments without the help of their opioid medication!  If you want to make opioid medications safer...do it, if you want to provide education to Doctors  Clinicians. ..do it, if you want to improve the drug epidemic provide quality,  afforable help for those with abuse and addiction issues! However, limiting/removing patients access to opioid medications which is the only thing left for millions of people, that provide any true quality of life,  many of whom otherwise, would in all probability contemplate suicide, is beyond my ability to understand! My final comment, is that the approach to this so called drug epidemic will never be successful. The reason? The people whose lives this effects to their very core: It IS the people who suffer with daily, chronic pain issues  BUT, WE have been COMPLETELY left out of all of these discussions,  regulations, treatment protocols  the media! People who are legitimate chronic pain patients with life altering pain conditions, just want to have a life thats actually worth living! Believe it or not, that can mean having the ability to do the simplest things that are unattainable without the relief opioid medications provide !  Thank-you for allowing me to comment on this very important topic.  I have Fibromyalgia.  Thus I am very concerned with the Opiods conversation and new regs.   The facts that doctors are pulling back from prescribing meds that worked for me and now I will be in pain again and pushed back into bed because of the pain.  I will go fighting to keep myself from that fate.  I spent almost ten years there and no longer wish to see that happen again.I am in support of changing the Opioids to not work propery if not used in the proper way.   I just want to use the meds the way the doc perscribe them.    Make the meds so you cant snort them or whatever those people do to them.  Im all for it.  This way my doc can perscribe my meds to me and I can live at least a life where I manage life carefully.  Please do this before you pull Opioids off the market.  To whom it may concern.  After over 20 years of chronic unrelenting pain, I am now taking an opoid painkiller.  Since that going on this medication two months ago, I am able to get around better, exercise over two hours a week and attend church.  I have done physical therapy, cognitive behavioral therapy, meditation, tai chi, muscle relaxers, antidepressants and so forth with minimal results.  I am asking you to consider that some people need this type of medication in order to function.  If the FDA wants to help us, develop medication that is not addictive. While I totally understand the need for regulation on Opioids, I hope that there is much thought and consideration taken into the pact that chronic pain patients cant be placed in a one size fits all box. Addiction is a huge issue but so is not being able to live a somewhat normal life without pain medications. I have Chronic Pancreatitis due to a birth deformity. Im 27 years old. Even with proper pain management I cant live like a normal person. If access to pain medication was limited to less than what I need for my condition my quality of life would be hugely impacted. There would be days I ended up bedridden, ER trips and hospitalizations would be increased and I would lose any ability to have a somewhat stable life. Ive worked in the mental health field so I have seen addiction first hand and I totally understand how terrible it is for the patient and their loved ones. Im not sure there is going be ever be a great solution to this issue but I hope that a balance can be found. 