General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drugs Products
2015-181 General Principles for Evaluating Abuse Deterrence of Generic Solid Oral Opioid Drugs Products 2016-932
2016-05-09 2016-05-26 2016-06-06 2016-06-08 2016-06-08 2016-04-29 2016-06-06 2016-06-08 2016-07-07 2016-06-08
FDA-2016-D-0785-0008 FDA-2016-D-0785-0016 FDA-2016-D-0785-0025 FDA-2016-D-0785-0043 FDA-2016-D-0785-0056 FDA-2016-D-0785-0003 FDA-2016-D-0785-0023 FDA-2016-D-0785-0071 FDA-2016-D-0785-0078 FDA-2016-D-0785-0033
04:00:00 04:00:00 04:00:00 04:00:00 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-2016-D-0785-0008 https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0016 https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0025 https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0043 https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0056 https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0003 https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0023 https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0071 https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0078 https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0033
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
 My name is Jennifer Ford, and I have fibromyalgia. Including chronic pain, chronic fatigue, depression, anxiety, degenerative disc disease, COPD, just to name a few. I am able to barely maintain some level of a normal life with pain levels of a 5-6 on a good day. This is with the use of three hydrocodone a day. No more, no less. I receive a prescription of 90 per month. Thats 3 a day, for 30 days. Take that away from me, and I have no idea what Ill do. Please leave chronic pain patients alone. We are patients, not addicts.13 No more opioid guidelines that hurt the Chronic Pain community. My doctors are refusing medications they themselves put me on. We matter, the quality of our lives matter and our voices need to be listened to. Addiction within our community is very rare.  I have taken opioids on and off for 30 years responsibly and safely. I have adhesive arachnoiditis. Without these meds many chronic pain patients will have no quality of life. What the government is doing is outrageous. You can buy codeine over the counter in Canada. It is not a gateway drug to heroin. Although the money grubbing addiction industry would like you to think so. The problem is heroin coming into the country from Mexico and China. If you want to fix the drug problem fix that. A new study shows that opioid overdoses peaked in 2012. Even if you take opioids off the market you will still have addicts acquiring it on the streets. You are throwing the baby out with the bath water. Patients who suffer everyday with excruciating pain rely on these medications to bring the pain down to a tolerable level. We take our medications responsibly. Any physician who says to take oxycodone off the market has no compassion. There is a place for opioids in medicine when the are prescribed responsibly. Pain patients are just getting warmed up! If you think were going to tolerate this treatment you are wrong!  I my name is James I have a chronic pain disease called rsd or crps. I use some of these drugs to control my pain and help me get through my day. There are many of us in the same position as I am. If you put uncentsable regulations on this we are going to be the ones that suffer from this for others stupidity pleases stop and think about the people that need this to get though our days and nights and to be able to spend time with our families. There are other ways to weed out the people that are abouseing theses drugs. I know we as the people of this country dont really matter to you people on any of these maters, but maybe just maybe for once in your time in office you will do the right thing and help the people that put you there. If you all had to spend one day in any of our shose you would understand where we are coming from. PLEASE PLEASE STOP AND THINK BEFORE YOU TAKE ANY ACTION ON THIS. If you were one of use you would be doing all you cant to take a different position on any of this. Dr. Glapinski, I am a chronic pain sufferer and one who is DEPENDENT on oxycodone for a QUALITY OF LIFE. In reading your comment, you are aware that chronic pain pts depend on opiods and are in agreement, and then you turn around and say ban oxycodone. Just because you are against it for what ever reason, there are MANY LEGITIMATE chronic pain pts who retain a QUALITY OF LIFE by taking oxycodone. I have tried nearly all of them over the course of ten years. Opiods were my last resort, first came years of physical therapy, massage, chiro, accupuncture, epidurals, discographies, OTC AND NSAIDS that tore my stomach and liver up, facet injections, trigger point injections, nerve blocks, steriods, nerves burned, TENS, and two FAILED spinal fusions that left me with severe nerve damage. Oxycodone happens to be the one medication that agrees with me and takes my unbearable pain to a tolerable level, when I was on the right dose. Because of all these INHUMANE restrictions by the CDC, FDA, DEA and the government, Legitimate pain ots are having their once stable dose lowered to INEFFECTIVE DOSES or totally stripped of them, leaving many in agony and severe withdrawal. Shame on any of you doctors who abandon their patients. We are suffering from incurable conditions that cause severe pain, I beg God to take me daily. Would you do that to your Mom? Could you sit back and watch your loved one be at war with their body, stabbing, burning, crushing, piercing, pains, the emotional and mental toll it takes on a person, If your loved one got relief by taking opiods, would you want them to have some QUALITY OF LIFE and enjoy what they can or strip them of the only treatment they gave them some relief, force them to remain bedridden, shut off from society, many are turning to suicide to escape the pain. You doctors took an oath to do no harm. I get the DEA is targeting all our drs, there is way more harm being done to the chronically ill, we are being FORCED to suffer, to exist in hell, All the doctors thruout this country who believe in helping the suffering, especially when weve tried the alternative therapies OUR BODIES could take, its physically, mentally and emotionally exhausting fighting this battle, then the stigma that is thrown on our backs, shame on all of you dra for not standing alongside the suffering. Perhaps if you treated each person as if you would your mom, maybe there would be compassion and empathy brought back into the dr/patient relationship. I see and hear nothing but NEGLECT, ABUSE, DEGRADING, DISCRIMINATION AGAINST LEGITIMATE PAIN PTS. Another fact is there is no opiod epidemic. The CDC used false data, even admitted to MISCLASSIFYING MANY heroin and fentanyl deaths, doubling and tripling one persons death, legit pain pts who committed suicide were listed an overdose, if alcohol or any other illicit drugs played a part the CDC looked the other way, they created mass hysteria that the media and government took off with, constantly demonizing a chronic pain pts LIFE SAVING MEDICATIONS. The CDC created FALSIFIED STATISTICS MADE TO FIT THE GOVERNMENTS ADDICTION DRIVEN AGENDA. Chronic pain pts are LAW ABIDING citizens who have DEBILITATING INCURABLE CONDITIONS, who have tried whatever was put in front of us by the medical community to get relief. We dont BREAK THE LAW, WE DONT ABUSE, SELL, SHARE, SNORT, OR ANYTHING ELSE TO OUR LIFE SAVING MEDS. WE ARE SICK FOR GOD SAKE. We are treated HORRIBLY by the medical community, treated like everyone is a pill seeking junkie, addict, and criminals. I am so fed up with paying the high price with my health and overall well being because of those who CHOOSE TO ABUSE, people who CHOOSE TO BREAK THE LAW, WHO CHOOSE TO POP DRUGS, OR GET DRUNK OFF ALCOHOL, PEOPLE WHO CHOOSE TO DESTROY THEIR BODIES, Addicts are given all kinds of opportunities to get help, all kinds of doors open for them, hell even the government passes out clean needles to shoot their drug of choice up with and safe houses to go get high and shoot up. When an addict, someone who CHOOSES TO ABUSE , fails a drug test during treatment they are given  chance after chance, they arent kicked out and turned away, A LEGITIMATE chronic intractable pain pts are turned away, judged and labeled as addicts, pts who have been with their drs for years and were on the same stable dose that worked for them are having meds reduced or taken away thru no fault of our own, for following the rules, getting drug tested monthly, shamed at the pharmacy, if you even find a pharmacy to fill your LEGAL lifesaving medication. Nearly all chronic pain pts have suffered for years and have years of medical records documenting their DEBILITATING INCURABLE conditions, usually has had many MRIs scans, tests, etc.These debilitating conditions only continue to worsen over time, so why are we decreasing legit pain pts meds when the doses really should be increased. How would it make you feel if your own mother were so poorly neglected!? 1.Although the theme of the guidance seems, as expected, to proof that tested generic formulation (T) is not inferior to an approved AD reference formulation (R) and some studies were designed to test T against R directly, e.g. syringeability, introducing the control formulation (C) in some studies, e.g. extractability, created some confusion between qualifying an original brand name AD formulation (R) and a generic.  We believe that, for generics, T should be tested directly against R, with no need for a third formulation (control), unless one route of abuse was not considered/listed on the R label.2.There is no clarity if in-vitro testing need to be done or at least verified by a third party laboratory to avoid manufacturers bias which we have noticed as a third party lab.3.The draft guidance, as well as the previously approved AD guidance, focus on opioids but we believe that it should cover, also, non-opioids of potential abuse, e.g. amphetamines or molecules that can be precursor for recreational drugs, e.g. pseudoephedrine.4.Smoking simulation study listed 233C as a definite temperature for heating but from our experience, this temp was not good to volatilize morphine or oxycodone and for which we needed to optimize the heating conditions.  Not sure why the paper ignition temperature was used to set up this figure noting that different heating techniques including direct heating a drug on a piece of aluminum foil or putting a drug directly on ignited charcoal, e.g. hookah, have been used.  We believe that, smoking simulation studies should be optimized first using pure compounds and select the most effective heating condition/temp to test an AD formulation. 5.The guidance did not mention core separation as a part of physical manipulation for formulations with API is enclosed in a core within a hard shell.6.The guidance did not mention saline solution for extractability or syringeability where its a potential solvent that can be easily obtained by a drug abuser and safely injected.  In this regard, for generics, we believe that all or representative solvents which were used to qualify an R should be used for T.7.For particle size distribution following physical manipulation, 500 micron was used as a cut-off; does this mean no particle size characterization is needed below 500 micron?8.Free base isolation; 233C for 2-15 minutes was listed to dry up a precipitated base without a rationale.  From our experience, different temperatures and/or different heating times can be needed and noting that 233C was already suggested for smoking simulation, heating some compounds at this temp for 15 minutes may cause significant loss.9.Liquid-liquid extraction was not listed but from our experience, after proper optimization, it was an efficient tool to isolate some opioids.10.The guidance did not handle AD formulation which depend on conjugation of an active moiety to a pharmacologically inert side chain which needs to be cleaved inside the human body for slow release of the active molecule.11.The guidance suggest 28 to 18 for syringeability and we suggest to consider either 28 or 27 as the latter is common and such small bore size should not make a difference compared to 28. I dont understand why you think that going after physicians  their patients, specifically chronic pain patients is going to somehow make this heroin epidemic lessen or disappear. I am a woman who was born with severe JRA at 15 months old, have had several surgeries,  other diagnoses along the way........Fibromyalgia, CFS, seemingly untreatable bi-lateral hip bursitis, constant back spasms,   the list goes on.  I have for over 10 years been under the care of my wonderful rheumatologist  have ALWAYS listened to her, followed all directions,  more importantly NEVER, EVER given her reason to think I was doing anything otherwise.  I am a perfect patient.   My pain meds make my life liveable  when I say that....I mean my kind of liveable.  I am permanently disabled so nothing is perfect, BUT being able to make dinner for my family at night  do some light housekeeping is only because of my pain meds.  And now you want to make it harder?  For what? Why?  To eliminate what you think is the reason for heroin?  Look around, do some more research.  We have above pharmacy grade opiates coming across our borders  drug dealers are selling it to addicts. Thats NOT us. Under 5% of the chronic pain community become addicts. Do we depend on our meds?  Yes, but for living, for function,  so we are not bedridden.  We arent getting high, we are getting some relief.  Theres a HUGE difference between physical dependence  psychological dependence. We are not in the latter group. Diabetics rely on their insulin, we rely on pain management. There is really no difference. Every medication comes with risks. You overdose on an over the counter medication too. Its called personal responsibility  because some dont practice that, you make ALL pay?  You have already made getting our meds tougher with changing the scheduling class, breathing down the necks of our doctors, making them so scared to actually treat their patients now, pain contracts, random urine tests,  pill counts, etc, etc......  What else do you want??  After all those things were implemented NOTHING changed with the addicts. In fact in one city next to me the drug use  overdoses have actually doubled since then!  Seems like you are barking up the wrong tree.  I get my meds, keep them in a fire safe locked box  practice good medication safety, but now I feel that at any moment my rheumatologist could pull the rug out from under me because of fear, or because you come up with some other crazy rule/regulation.  She has already stated that it is out of her hands  she actually told me she will not longer prescribe pain meds to new patients, only the ones that are already on them. Really?  Find another way to control this epidemic, because last I checked drug addicts dont hang out at rheumatologist, neurologist, or oncologists offices.  Go after the drug dealers  the border. Please leave those of us that do nothing wrong alone. Will you release the suicide rates in the chronic pain community when they go off the charts?   Because I have already read of SO many,  in many cases it happened because a physician got scared  just stopped their meds cold turkey, which is incredibly dangerous  in my opinion medically unethical. Those people end up in the ER  are treated like subhuman beings. Wow, thats really good medical care. Let the rheumatologists,  neurologists, oncologists,  pain clinic physicians do their job. None of us want to be on these meds, but we have come to them because we have tried everything else. I have done physical therapy several times  got cortisone shots every 3 months for over 4 years. Give me a break!  Until the scientists  researchers come out with some other medication and/or treatment that works as good as opiates, leave us alone. There are also so many of us that cannot take the conventional medications for our diseases because we have really horrible side effects,  opiates end up being our safest most effective treatment.  Why punish the innocent people just trying to live a semi-normal life? When are you going to stop punishing the wrong group of people?  Why should we pay for others bad decisions? I am disgusted  I dont deserve to be treated like this.  The way pharmacists look at us, treat us,  even lie about how they cannot fill our prescriptions is beyond ridiculous. Thankfully I have a wonderful pharmacy.  I ran a chronic pain support group on line for over 4 years  I heard the horror stories. They have been so bad I was forced to stop running the group.....between the stress  my own illness, well.....I just felt I had nothing left to give my members. Everything looks dim for them,  thats a sad state of affairs for people that have no choice,  who were born with horribly painful diseases  illnesses. They arent addicts, they are patients. Shame on the medical community, the government, the DEA,  the CDC. You arent doing your job, you are just creating another problem. Looks good on paper maybe? Horrible! We are real chronic pain patients with real pain...........not drug addicts! The regulations against opiate pain medicine has been devastating to my family, to people I care about and to myself personally. I am not a pain patient or user of opiates but my husband who has been disabled for 20 years is a chronic pain patient. These regulations put him through on-going trauma, and pain. Our basic human  rights are violated. We are not allowed to live where we want to, or in the state we want to, because we are prisoners to proximity to a doctor who will prescribe the essential medicine. To get this medicine he must submit to urine tests which violate his 5th amendment rights. Law enforcement doesnt belong in doctors offices and hospitals! Basic human rights are disregarded in this failed War on Drugs created by Nixon for racist and evil objectives. Stop restricting medicines! Stop your war against the American people! Leave pain patients alone. Stop blaming suicides on pain medicine and look at the patients in chronic pain who are told that their only source of relief has been outlawed! Stop criminalizing self-medication. You are not supposed to control other peoples choices with their own bodies. Citizens of the United States are back to having to reclaim their rights to self ownership. Why are you not going after other patients medications? Start taking  medications for those suffering from all other conditions too!  SMH!!  