Request that the FDA designate Morphine Sulfate Extended Release Tablets, 100 mg from Rhodes pharmaceuticals LP (ANDA# A074769) as reference standard (RS) for the subject drug product to conduct in vivo bioequivalence studies.
CITIZEN PETITION CDER Aurolife Pharma LLC Reference listed drug (MSCONTIN NDA # 019516) Purdue Pharma LP discontinued MS CONTIN Referencing Approved Drug Products in ANDA Morphine Sulfate Extended Release Tablets 100 mg Rhodes Pharmaceuticals LP (ANDA# A074769)
2018-05-01 2018-03-28 2018-04-17
FDA-2017-P-6307-0006 FDA-2017-P-6307-0003 FDA-2017-P-6307-0005
04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/FDA-2017-P-6307-0006 https://api.regulations.gov/v4/comments/FDA-2017-P-6307-0003 https://api.regulations.gov/v4/comments/FDA-2017-P-6307-0005
Anonymous Anonymous Anonymous
Anonymous Anonymous Anonymous
Goals  for Chronic Pain Patients to receive adequate pain relief; * For correct misinformation online and in Media about chronic pain patients and opioid therapy be amended and corrected!* * institute a Chronic Pain Patients Bill Of Rights. -We all have a right to relief from our debilitating  pain and discomfort. * United Nations policy states PAIN MANAGEMENT IS A FUNDAMENTAL HUMAN RIGHT, under treatment or not treating is a crime against humanity and considered torture! That is what is being done to chronic pain patients all over this country right now! I being one of them as I am experiencing abandonment of care from my doctor. who has refused to treat me. Thus, I am in a very precarious state right now! I looking for a doctor. However, all pain management specialist are booked for at least a four month window! My pain is chronic 24/7, 365 days a year. I cant wait that four months. I do not want to end up as a statistic on the suicide list!Since the narrative of the opioid epidemic has taken hold, some/ many doctors are refusing pain relief, in fear of retribution, imprisonment or loss of livelihood!Many hospitals are implementing after surgery a spinal block and Tylenol, many patients are dying attributing it to cardiac arrest which is not the case!#2 Collateral damage Because of the innumerable, severe, and long lasting effects of constant pain, I believe that treatment for chronic pain is a human right. It impairs every part of a persons entire life, career, family, mind, body, spirit and soul. From financial hardships due to being unable to work and the family issues as we cannot be the parents, grandparents  partners  that we  would have and should be. Many chronic pain patients are hypo metabolizers or hyper-metabolizer ... I suffer with malabsorption I had a surgically inserted port in my chest.I had tpn pumped into to my body for 12 to 24 hours a day for 8 + years. I could not absorb the proteins in my food this is the way I sustained my life. It makes sense since food did not absorb either did my medication that is why I had to have higher doses For it to work. We are not a one-size-fits-all society.This creates, a lot of collateral damage to the family  because  we are not able to function  in a fashion  that our family needs us to !  It also  starts to deteriorate  our childrens  mindset  as they are continually worried  as to our health, expectancy of life/  longevity of life ! I know this first-hand has changed who my four children could have been !  It put too much weight  on them while trying to go through school  and life in general !Because of all the family issues in addition to other health issues like brain and organ damage from lack of sleep, medications, and the rewiring of your brain from constant stress. Air condition, heating our sensory capabilities are all screwed up we need to help chronic pain patients get better treatment, education of the public on the complexities of chronic pain, lobby the government to make changes that will benefit chronic pain patients, and to foster a better understanding of chronic pain patients struggles day in Day Out with daily life. After reading so many frustrating stories of chronic pain patients dealings with the healthcare industry, I decided to create a foundation that would serve the needs of chronic pain patients everywhere. By first educating the public on what chronic pain really is, how it affects us and our families, and what is missing in our treatment. Then I would like to focus on changing how government views chronic pain patients and writes guidelines and legislation that affects them. For those of us who suffer day in and day out 24/7, 365 days a year Relentless, cruel, aching, affliction, agony, burn, catch, convulsive, cramping, crick, discomfort, distressing, fever, gripping, hurting, illness, injury, irritation, laceration, malady, misery, pang, paroxysm, prickling, sickness, smarting, soreness, spasm, stinging, stitching, straining, tenderness, thro, tingling , tormentous, torturous, troubling, twinging, wounding always present, horrendous, debilitating pain sharp, exacerbating,There is a need in the chronic pain community and it is not being addressed, please we need to reduce the suffering as much as possible, of people suffering from chronic pain.Suicidedue2pain Malabsorbtion -TPNMusic therapy Massage Behavior therapy Physical therapy Biofeedback Acupuncture etcThree options - reform of opioid guidelines3. Campaign/Organizational Goal and Key ObjectivesEducating the public about chronic pain and how it affects chronic pain patients.-Fight preconceived notions on pain medication and those who need it.-What is missing from treatment of chronic pain?-Changing governmental views-Get new guidelines on pain medication created for chronic pain sufferers.-Explain how the war on opioids is killing chronic pain sufferers! Dear Readers,I am not certain how to write this letter, but I feel I must respond and comment on these regulations and have a voice in federal making of decisions.I have been in chronic pain since 1984. In all these years since a respiratory infection ended with widespread body pain, I have not had one day without pain. The original disease has increased from musculoskeletal to inflammatory and degenerative arthritis throughout all my joints. Every X-ray is filled with arthritis and bone spurs, even bone in locations bone should not be. An MRI of my spine sent me to a neurosurgeon who said the only surgery that might work would never permit me to bend over again. I take both diazepam and hydrocodone, in addition to medications you might not consider opioids or narcotics. These two are not high dosage, but they have worked and allowed me an active life. Daily I take care of horses, my own home, animals, and I work. I work as a writer and have had 16 books published while taking these medications. My main publisher has been WW Norton in NY. And for poetry, I have used a smaller, independent press. I also travel frequently to read my work, do workshops, and lecture on a variety of topics. This is with my medications.Without them, I am unable to get out of bed. I have had screams that are involuntary. I cannot bend or do any movement or work. My hands do not work, will not type, nor can I walk without severe pain. Without these medications, I will have no life, orat least not one worth living. The Dr. has changed. Even he has fear. He does not wish to prescribe medications like the ones I take, swears they would kill anyone else, all the exact same stories as the numerous other pain patients say they have heard. I feel sorry for those of us in pain, but I also feel sorry for those in the medical profession who are unable to really help their patients.Many pain patients have been committing suicide rather than living a life suffering. These deaths are worse than the ones of addicts who are shooting up because they are created by the governments regulations and fear tactics. They are going after the wrong people.Most of us are taking our meds at the right times, not asking for larger doses, and are responsible with our meds. We do not misuse our medicines. For us they are not addictive drugs, but healing agents that allow us to live full lives.Please consider this in your Regulations. We do want to live. We do not overdose. We are not the criminals. We want to be free from pain, as anyone else also would.Sincerely,Linda HoganProfessor EmeritaU of Colorado, Boulderwww.lindahoganwriter.com Id like to start out by saying Im a 39 yr old mother of 6. And have had chronic pain for over half my life.I was 11 yrs old when I first started having back pain and then went on to knee pain. I was cative throughout school I was involved in track n field, volleyball, cheerleading  basketball. I had to wear 2 knee braces and was on a very high does of anti-inflammatory prescription from my knee doctor at age 12. After giving birth to my 3rd child at age 20 I had my 1st knee surgery, every year after that 1st surgery i had knee surgery after another for 5 years... I had been sent to neurologists and physical therapy chiropractor and differant doctors ect.Finally at age 28 i found my dr and he referred me to a spine specialist and he diagnosed me with Schumanns disease which is very painful my spine was 69% curved on top and 69% curved on the bottom. They did surgery October15th 2010 and it was a very long recovery.Ive been on Percocet for 7 yrs and dont abuse it. I cant even get out of bed, walk or do basic self care without it. Ive seen what drug addiction has done to our community and people i love.But dont punish us that need our medication to live our basic daily lives.