Please Send the FDA Your Comments
New Opioid Policy Steering Committee
On September 29 of this year, the Food and Drug Administration (FDA) published a notice — Opioid Policy Steering Committee; Establishment of a Public Docket; Request for Comments — in the Federal Register, The Daily Journal of the United States Government.
The FDA is seeking comments from members of the public, including chronic pain patients and their families, healthcare professionals, academic institutions, and industry relative to the FDA’s new Opioid Policy Steering Committee (OPSC).
FDA Commissioner Scott Gottlieb, M.D. has expressed his commitment to confronting the opioid crisis and reducing the possibility of opioid addiction. He established the OPSC, and charged the committee with seeking input from the public.
How to Send Your Message
Let OPSC know your story and hear your concerns. To do this electronically, click here, and then click on the “Comment Now” button on the top, right of the page.
Or you can go to https://www.regulations.gov/, and in the window beside the “Search” button, type in “FDA-2017-N-5608” (without the quotation marks). Then click the blue “Search” box. Click on the “Comment Now” button to the top, right of that page.
All electronic comments must be received by December 28, 2017.
Alternatively, you can snail-mail two copies of your comments to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For confidential submissions, you can only use the snail-mail option. All written communications must be postmarked by December 28, 2017.
For More Information
For additional information, please contact: Kathleen Davies, Office of Medical Products and Tobacco, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 2310, Silver Spring, MD 20993, 301-796-2205.
I would encourage you to let the FDA hear your suggestions, concerns, and hopes. Please do so as soon as possible to ensure you meet their deadline.
As a person who suffers from multiple diseases causing intractable pain I cannot express enough the importance that the DEA stay out of Doctors offices. There is a huge problem with regards to illicit fentanyl and heroin. The Federal government really needs to address this issue and not treat pain patients and their physicians like criminals.
Amen. I sincerely believe that these congressmen and others in authority should have an elephant step on their back and then be denied opiods for pain and then they can see what it is like to be in severe pain and unable to get the proper medication.
I commented as follows on October 17th.
This comment responds to the questions posed below in the context of opioid analgesic prescription:
1. Should FDA consider adding a recommended duration of treatment for specific types of patient needs (e.g., for specific types of surgical procedures) to opioid analgesic product labeling? Or, should FDA work with prescriber groups that could, in turn, develop expert guidelines on proper prescribing by indication?
<<<<There is no one-size-fits-all patient or treatment. FDA should make clear that any recommendations it makes to physicians on prescribing by indication must be tempered by the physician's professional knowledge of the patient as an individual. Also very much needed is an explicit acknowledgement of genetic polymorphism as a mechanism which greatly affects opioid and other analgesic metabolism by six key enzymes in the liver. FDA already recognizes hyper metabolism and poor metabolism as relevant factors for Codeine in children. The same recognition needs to be extended to all opioid compounds in all patient populations.
2. If opioid product labeling contained recommended duration of treatment for certain common types of patient needs, how should this information be used by FDA, other state and Federal health agencies, providers, and other intermediaries, such as health plans and pharmacy benefit managers, as the basis for making sure that opioid drug dispensing more appropriately and consistently aligns with the type of patient need for which a prescription is being written?
<<<<Recommended duration of treatment can only be at best an educated guess, in light of variable metabolism between patients. Drug packaging already contains summaries of trials data. FDA should be advocating actively for funding of long-term studies of opioids applied in management of chronic pain.
3. Are there steps FDA should take with respect to dispensing and packaging (e.g., unit of use) to facilitate consistency of and promote appropriate prescribing practice?
<<<<Advise physicians whose patients seem refractory to opioid treatment, to conduct genomic testing and examine pertinent hormone and enzyme actions to assess the patient's ability to benefit from specific opioid analgesics.
4. Are there other steps that FDA should take to help promote the prescribing of treatment durations that are appropriately tailored to a clinical patient need?
<<<<FDA needs to recognize explicitly that distinctions between acute, chronic, and terminal pain are largely artificial and often destructive to patient welfare and health. In each category, the objectives must remain the same: to alleviate suffering while promoting quality of life and patient function. Particularly with respect to opioid analgesics used to manage conditions assessed by a doctor to be chronic and thus by definition unlikely of cure, it is entirely inappropriate for FDA to set limits on either treatment duration or dose levels.
Parenthetically, I strongly suggest that FDA needs to advocate publicly for recall of the 2016 CDC opiod prescription guidelines for a major rewrite. In their present form, the guidelines are being interpreted by governments and medical practices as mandatory restrictive standards. As a consequence, hundreds of thousands of patients are being coerced into tapering down opioids which have long been effective in maintaining the quality of their lives. Doctors are leaving pain management practice in droves, sometimes deserting patients in unsupervised opioid withdrawal. Suicides have happened among patients driven into agony and disability by refusal of care and referral. The guidelines themselves are widely understood to be biased against opioid pain relief, unsupported by science, and unsafe by their omission of genomic factors as elements of pain management practice.
Are you serious?? A pain management doctor should have full latitude in prescribing what medications are necessary for the patient. Period. Maybe you people in charge should have your back and spine crushed by a bulldozer and then be denied opiods to manage the pain . Then maybe you might have a different outlook on this subject.
I have been in the healthcare profession for 30 years. Recently, I was diagnosed with a chronic pain condition called arachnoiditis. A doctor has turned his back on me because he simply wants to discredit this condition, as it may hurt his profits if I decide to announce that steroid injections to the spine are NOT FDA approved and if given improperly can trigger this painful lifelong progressive intractable pain condition. Arachnoiditis is a dirty word to an interventionist pain management doctor. I take two medications for pain and my PCP asked me to ask the PM doc to control these. Keep in mind they’re not the strongest ones by any means. The PM doctor treated me terrible. I have never abused narcotics in my life but if I need these I would hope that I can get the stronger ones in time. Please research all of the chronic pain conditions and allow patients with these chronic documented conditions to obtain the narcotic meds that they need to survive in comfort. No one should have to be in pain that has an identifiable documented chronic pain condition. This is simply inhumane!
My daughter suffers from severe pain. She has tried all other methods to help her but they don’t help. Many people need these meds just to lead a somewhat normal life. Please take people with chronic illness in mind. Many are suffering everyday and taking their life because of unbearable pain. Please listen to a mother’s plea and help my daughter.
FDA
RETIRED RN with 38 yrs experience including palliative care. Not necessarily care for the dying but those of us dying everyday from severe chronic pain. Without my pain meds I cannot live a normal life land even with them them I am not totally out of pain. I have severe OA in SI JOINT and pain in low back and down both legs. No pain meds and I could not live. I fear end of life would be an option! God be with all those who don’t wish to push us to that brink of the idealation of suicide. Please take care of us chronic pain patients and help us stay alive!!
I was diagnosed with Adult Tethered Cord Syndrome and Chronic Pain Syndrome , osteoarthritis of the spine and bone on bone
Osteo of both knees15 yrs ago . I had surgery 2005 to untether the spinal cord , as well as a Discectomy and Laminectomy. I also have buldging cervical disc’s . I am in constant pain every day ! I have no quality of life . I was stable on medication and able to tolerate day tp day lifemore. I usually go shopping to get out of the house , only because i can use a cart to get around. . Now i lay in bed mostly. You know im still alive when i scream in pain.
I have tried every treatment there is. I am tired of being a surgical pin cushion. I say this because , there are greedy Drs that dismiss you or withhold scripts when you refuse to have more of their ( not approved by the FDA ) painful Steroidal inijections . I did the Spinal Cord Stimulator trial twice . Hated it ! i have lots of DrsI I went to Physical therapy on and off for 2 yrs. I was asked to do the Prialt trial which i refused and My PM Dr turned on me by claiming i failed a urine test (None exist) and refused to continue my scripts and flat out abandoned me . What happened to do no harm ??? What i have witnessed as a patient, has caused me to lose all faith in Pain Management Drs. I have come to the realization that we are nothing but a dollar sign to them. Look how many closed up shop to hop on board the rehab train . If my medical records were reviewed , you would see lots of reports by several Drs stating ” No drug seeking noted” repeatedly. I have several MRI’s and various tests over the last 15 yrs. I am not a drug addict , yet i am treated as one ! Where is the compassion and empathy ??? It saddens me that my country has turned its back on me . No one cares about the miserable existence i suffer everyday of my life. I am in pain ! Care about me ! Stop inflicting torture on the Chronic Intractable Pain Patients ! We are patients not addicts !
I was diagnosed with 5 Brain anyeurisms last March . I Had a craniotomy and clipping of 3 of them . 2 were left as is because of calicification of the artery making them to be very fragile . Now i am rendered high risk for any kind of surgery in the present or future. I know i can’t go on much longer like this. I need someone to care .. Its a Heroin Fentynal epidemic .That’s where the focus should be !
These people have ruined two years of my life, when my forced tapering began, I was looking for a part-time job. Cooking meals three or four times a week, going to grocery store by myself etc etc. I became disabled 10 years prior with intractable nerve pain, I have several other things wrong with me as well. I’ve tried everything the medical community has to offer. The only thing that really works is opioid pain medication. My PC tapered me way too fast, caught myself almost committing suicide, ended up at a psychiatrist office which did nothing. Went back to my pain doctor, he didn’t say anything about tapering me back further for about 6 months,he must have seen what kind of shape I was in. then finally told me either you’re going to cut them back or we’re going to part company. I had no choice I have to do what he says or I won’t have a pain doctor at all. Anyway now I’ve been tapered too far I can no longer control the pain, so I just lay in bed all day, everyday because my main triggers are walking, sitting or standing, anything that puts pressure on my feet. I’ve missed a lot of my grandkids ball games, there’s no more cooking meals, I have to take my daughter to the grocery store with me, I don’t take showers anymore, the list goes on and on of things I can no longer do. Chronic pain patients had nothing to do with the opiate crisis we aren’t the ones dying of overdoses, except the ones that are committing suicide because they don’t have enough pain medication. CDC FDA DEA medical licensing boards I’ll have to know by now what’s happening to Chronic pain patients, yet nothing is being done about it. So we’re literally dying, committing suicide, seeking illegal drugs or living a life so painfully stressful it’s killing us. What has this country come to. Now they know people are dying they should be charged with premeditated murder.
All my research recently is finding that pain management doctors are now scared of losing their license or being investigated by the DEA so they are cutting back on much needed opiod prescriptions. All the media frenzy about the opiod crisis is drastically affecting how they prescribe to their chronic pain patients. I am reading many comments from patients that their pain meds are being cut back or denied completely and now they have no option but to consider suicide or buy pain meds off the street. This does not surprise me. I would move to another country before I would do that. You have no idea what you are getting. When the pain becomes too unbearable you just curl up in bed and moan all day like I do. I have been told of several people that have put a gun to their head because the pain was too much to bear. I just pray that I do not get there.
Margo,
I agree with your comments along with everyone else’s comments posted here to date.
Anyone who refuses to accept that the examples of above comments are indeed the norm and prevailing persona of what today’s CPP’s beface daily needs an introduction to the real world. Everyone wants to run the show for CP treatments and choices. Reality: Only 2 key players are required: The CPP and the CPP’s pain practitioner.
As CPP for many years, as CP and rare dz advocate for nearly 35 yrs., as health pro for nearly 40 yrs, intricately involved in NP health and human service arenas, I hear the painful truth every day. It’s disgusting. It’s a travesty. It’s 100% uncalled for and I’d define the travesty for treatment of CPP’s as criminal.
Addiction is a completely separate disease, needs to be handled by addiction specialists. Legit. CPP’s are not the least respondible and are an entity all their own. Regs. and politicians do not grasp any delineation between CPP’s and addicts. CPP’s are noe construed as nothing but drug seekers, illicit users, addicts, all lumped together. Well, guess what? The leg. CPP’s only “crime” has been and is to seek pain relief. This used to be “legal” last I knew…