Fda Taking Public Comments On Opioid Treatment Guidelines Through October 7, 2018 (Page 2) (Top voted first)

On August 6th, 2018 the FDA released an article drafting the endpoints for demonstrating the effectiveness of drugs for opioid-assisted treatment, more or less, as a form of guidance for the medical industry at large. Ref: fda.gov/downloads/.../UCM615743.pdf The letter begins by stating that it's being distributed for comment purposes only and that any comments or suggestions regarding this draft should be submitted within 60 days of publication in the Federal Register of the notice. The publication date is scheduled for 8/7/2018. I share this information in a timely manner so that chronic pain patients and others facing related challenges can take action by voicing their thoughts, concerns and opinions before the end date (10/7/2018) - 60 days from 8/7/2018. Federal Register: Guidance - Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment The FDA says that we will have to submit any electronic comments to regulations.gov, & to submit written comments to the Dockets Management Staff (HFA-305) at: Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. [Docket No. FDA-2018-D-2382] All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. [For your convenience I went ahead and posted it above]. For questions regarding this draft document, the FDA suggests contacting Silvana Borges at 1-(301)-796-0963. I encourage anyone who wishes to comment on their agenda to first have a look at the PDF link above where it outlines clinical endpoints for opioid treatment, adverse outcomes, changes in drug use patterns and more. I hope this message finds you well as we all strive to make pain management a better option for all of us who may be requiring opioids for treatment.

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Re: Hop63 (# 22)


uspainfoundation.org is one of the groups that u can join and they are really on the forefront of advocacy for the pain patient.

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Re: Marjorieson (# 26)

I'm very interested and staying in touch with you about this subject! I've been very concerned about it for several years now. There are many of us that go to pain management and I actually need our pain medication without the abuse of it, however because of the wide abuse and distribution of the medication illegally it's making it very hard on those of us that truly need it and are not criminals! Have been extremely frustrated over this situation and also treated horribly by many doctors now when I discuss my pain and pain level after having six Orthopedic surgeries since 2013 and I'm about to turn 64. So I definitely want to stay in touch so that I can do my part in signing petitions writing to the powers-that-be that are making these decisions and signing off on them! I want our congressmen and legislators to know that there's many of us who have a voice an opinion about this opioid crisis and we want to be heard and definitely understood! Thank you so very much!

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Re: David (# 2)

That was so well put! I've been saying for years there is a Difference between an opioid and those that live with chronic pain!!

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Re: Claude (# 1)

Thanks David. I did not read it from that point of view.

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Thank you for sharing this! I am happy to see that finally someone is willing to hear from those that rely on opiates for pain and addiction treatment, it's about time.

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Re: Marjorieson (# 19)

We need your guidance so we can present as a unified group regardless of what state we live in and who our legislators are. Proceeding as a group sounds like a good idea, strength in numbers, etc. I am more than willing to put in the time but need some assistance on best way to proceed. If my meds are taken away I won’t leave my house.

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Re: Hop63 (# 22)


The group in the state of Alabama is working as a task force with the Attny General. I'm sure ur state has some form of this type group.

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On September 18th from 12:00-2:00p there is going to be a “do not punish pain” rally in almost every state. Go to “your state” dontpunishpainrally.com and the city or cities that are having a rally will be listed. Bring as many people as you can! For Ohio it is in Cleveland, Columbus and maybe Cincinnati. If they don’t SEE us we don’t exist!!!

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Re: Concerned handicaps of the US (# 15)

Oh thank God!! I'm behind you all the way!!! I was a dental asst for 12 years and pharmaceutical reps brought in huge bolts of drugs and gave them to us so we would promote them!! I am sure that's where a Big Leak is!!!

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Re: Lisalandry (# 4)

When will the 'powers that be' finally understand that it's not an opioid or opiate crisis, it's a fentanyl crisis. Drug gangs easily find eager pharmaceutical chemistry students to mix a 'bathtub gin' version of fentanyl. Of course, fentanyl is also mixed in the 'dope' that crosses our southern border. Unfortunately, fentanyl kills and as they say in the newspaper biz, 'if it bleeds, it leads'. Forty years ago I was in an auto accident in upstate NY and was put on 4 mg dilaudid PRN for a month and I've been requesting it ever since. I never had a problem referring to myself as an addict. Without my opiate or opioid (there is a difference) or it's analog I suffer diarrhea, cold sweats, restless legs, etc. If you suffer any of the aforementioned symptoms, then my friend, you too are a junkie.

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