Requests that the FDA refrain from approving any pending or future application for an opioid product submitted pursuant to section 505(b) or 505(j) of the FD&C Act, including NDA No. 22324 submitted by Pain Therapeutics, Inc., with a proposed indication or any other labeling that suggests that the product is appropriate for chronic use.
Citizen Petition CDER refrain from approving any pending or Pharmaceutical Manufacturing Research Services, Inc future application for an opioid product submitted pursuant to section 505(b) or 505(j) of the FD&C Act, including NDA No. 22324 submitted by Pain Therapeutics, Inc., with a proposed indication or any other labeling that suggests that the product is appropriate for chronic use OPEN
2018-12-13 2018-12-13 2019-02-07 2019-02-07 2018-11-28 2018-12-13
FDA-2018-P-2851-0030 FDA-2018-P-2851-0031 FDA-2018-P-2851-0035 FDA-2018-P-2851-0034 FDA-2018-P-2851-0029 FDA-2018-P-2851-0032
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https://api.regulations.gov/v4/comments/FDA-2018-P-2851-0030 https://api.regulations.gov/v4/comments/FDA-2018-P-2851-0031 https://api.regulations.gov/v4/comments/FDA-2018-P-2851-0035 https://api.regulations.gov/v4/comments/FDA-2018-P-2851-0034 https://api.regulations.gov/v4/comments/FDA-2018-P-2851-0029 https://api.regulations.gov/v4/comments/FDA-2018-P-2851-0032
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
Just so you know. After 7 surgeons 4 neuro, 3 ortho medical science cannot fix me. I like so many people and conditions are left with a small glimpse of what our lives used to be. All that can be done for me now is to control the pain. Now so many of you irresponsible people want to take away the only thing I have left? Limited mobility? I have been taking opiates for my pain for 5 years. Never built a tolerance, never odd, never been to a hospital for complications with the medicine. You have (you should have by now, studies have shown it, why dont you read?) My brain does not associate a reward with  medicine. My pain eats it all up. It would be equal to you taking a Tylenol. To me is all it is  a glorified Tylenol but after months of suffering and trying everything under the sun the opiate was the only one that could take it. The irresponsible actions of the CDC (which may very well be illegal, irresponsible at best) have already killed scores of innocent patients when at your command there Dr turned their back on them and their pain. That blood is already on your hands, how much more do you need to soak in the blood of innocent Americans. They are dying as I write you. The mind and body can only take so much.  I hope you never have to experience it. If you do it may already be too late for you as you will get no reprieve from your pain because of your recent actions. The thing about pain is, it comes for everyone, no one is immune. Dont matter how much money, how important, how great you feel today. You may very well be next. Thats when you will understand that Americas Drs and health system turned their back on you or maybe your mother,father,son,daughter. Its coming, maybe not today, not tomorrow but it will affect someone close to you. When they cry in agony you need to tell them you did that. You had to re-brand the heroin epidemic by telling people that Drs did it. You have to suffer too protect someone that will find a way anyway and any drug to abuse. Dont believe me? What was common at the beginning of the 20th century? Idiots were shooting up peanut butter oil.way. I would like to comment on the citizens petition : Refrain from approving any pending or future application for an opioid productsubmitted pursuant to section 505(b) or 505(j) of the FDC Act, including NDA No.22324 submitted by Pain Therapeutics, Inc., with the proposed indication ofmanagement of pain severe enough to require daily, around-the-clock, long-termopioid treatment and for which alternative treatment options are inadequate.There are enough pain medications available to the public without it being necessary for the FDA to approve any other opioid for pain control. It has been noted that every day, more than 115 people in the United States die from overdosing on opioids, and last year 72,000 Americans died last year due to overdosing on drugs (National Institute of Health, 2018, p.1).  The total number of overdoses in annually exceeds deaths from HIV, guns, and car accidents.  Moreover, 21 to 29 % of those who are prescribed opioids abuse them, and 12% will develop an opioid disorder, while 6% who use opioid will eventually transition to heroine.  Statistics show that 80% who abuse heroine first abused opioids.  It has been further noted that the Midwestern region saw opioid overdoses increase 70 percent from July 2016 through September 2017, and opioid overdoses in large cities increase by 54 percent in 16 states in 2017 (National Institute of Health, 2018, p.1).  Despite these facts,  the Food and Drug Administration approved an especially powerful opioid painkiller despite criticism that the medicine could be a danger to public health. The drug Dsuvia, is an opioid that is 10 times stronger than fentanyl, and has been used in the military for soldiers in severe distress, as it can be dissolved for quick pain relief under the tongue (silverman, 2018, p.1).. This is certainly not necessary, especially with the nationwide opoiod epidemic and continued deaths from this terrible disease.  Many children are born to parents who are addicted to opioids and face a long journey ahead of them ranging from withdraws to in and out of foster homes. This needs to be stopped immediately and refraining from approving any future opioids is a start.  References:The Opioid Crisis. (2018). The National Institute of HealthSilverman, E. (2018). Despite criticism and concerns, FDA approves a new opioid 10 times more powerful than fentanyl I am writing in strong support of the section of the petition that reads that the FDA should refrain from approving any pending or future application for an opioid product submitted pursuant to section 505(b) or 505(j) of the FDC Act, with the proposed indication of management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. As stated in the CDC Guideline, Although opioids can reduce pain during short-term use, the clinical evidence review found insufficient evidence to determine whether pain relief is sustained and whether function or quality of life improves with long-term opioid therapy. While benefits for pain relief, function, and quality of life with long-term opioid use for chronic pain are uncertain, risks associated with long-term opioid use are clearer and significant.1The CDC Guideline noted the real lack of longer-term trials of opioids for chronic pain. The recent year-long SPACE Trial at the Minnesota VA Hospital2 meets the criteria that the CDC was looking for in determining longer-term efficacy.  Nonopioid treatment was associated with significantly better pain intensity than opioid treatment. While the result was probably not clinically significant, it certainly did not provide support for efficacy of opioid treatment. It is time for the FDA to reconsider this indication (management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate) for existing drugs.  The standard of safe and effective is simply not met.  References:1.Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain - United States, 2016. MMWR Recomm Rep. 2016 Mar 18;65(1):1-49. doi: 10.15585/mmwr.rr6501e1.2.Krebs EE, Gravely A, Nugent S, et al. Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis Pain: The SPACE Randomized Clinical Trial. JAMA. 2018;319(9):872882. doi:10.1001/jama.2018.0899 I fully agree with and support this petition.  I do not believe it goes far enough as further opioid, manmade or organic, should not be licensed for manufacture, distribution or prescribed, but, until such time as that occurs this petition is areasonable step in a logical direction leading to the removal of opioids and derivatives from circulation. Are all yall just evil idiots? First of all its a proven fact pain is pain, cancer has nothing to do with it. Pain is all relative to the person and disease or injury. Im a professional with a broken back who functions fine on an opioid. Why arent hypocrites like yall trying to stop the soring alcoholism problem by banning scotch. You cant govern morality and governing something you dont personally suffer with is just immoral and ideological wrong. You understand that some patients have been using opioids for 20 plus years without any issue whatsoever. That includes children with horrific diseases such a spina bifida, grandma with arthritis the veterans with bullet holes and missing limbs from Vietnam. All use an opioid for many years to take away enough pain to manage their days, without addiction or incidents. Its time the cdc came clean on lying to the public with there false information along with the FDA! We have an illegal illicit heroin and illicit Fentanyl and illicit drug crisis,  we have never, until the manufactured one had a prescription drug crisis! Marijuana a class 1narcotic is now legal, and patients under the care of a physician are told to think through your pain or use hypnosis or some sudo bs! I say my body my choice! The rest of yall can go F yourself! I hope the very people pushing this no opioid nonsense is in a horrible car accident or their children get cancer, we will see how you think about pain control then you hypocritically stupidity morons! If you read this, Ive usec an opioid for years, I work I function because I have relief , take it away Im done.Any physician would fall for this crap should have their license removed! Your oath said do no harm meaning treat me that includes pain!  FDA:I have been following FDA approvals and activities concerning opioids since the loss of my son and have researched oxymorphone extensively.  This citizens petition sums up many of the failures that have led to this horrific epidemic.  I am unclear as to why the FDA will not take action.  I do not understand why the FDA will not protect public health and ensure drug safety!  1)Enriched Enrollment was an industry driven decision for profit (not based of efficacy or safety) 2)The original approvals were not proven to be effective with the indications allowed3)ADF  Is nothing but a marketing scam and proven to NOT be a valid label4)Oxymorphone should have NEVER been put back on the market!  Clinical trials were manipulated, and the effects have been devastating. 5)Opioids have been marketed and distributed inappropriately and NOTHING has been done! Many years from now looking back at this what will be said about this Federal Agency in history books?  No one stopped it, no one cared enough to protect the citizens of the United States of America from greed and despair.  Lives have been lost that could have been saved if only those who were put in positions at the FDA had integrity and morals to do the right thing. What will it take?  How many have to die?   