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

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The letter begins by stating that it's being distributed for comment purposes only and that any comments or suggestions regarding this draft should be submitted within 60 days of publication in the Federal Register of the notice.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.

REPLY

REPORT

I've been dealing with some autoimmune diseases, in addition to a pain condition for many years. I have never, EVER abused the medication I was given. When the crackdown began, I was no longer allowed any decent pain medication (I was on Roxicodone). Now I'm on Percocet that barely takes the pain away. Barely! And I need to take every single pill I'm allotted, whereas when I was on the Roxi, I ALWAYS had extras left over. Why? Because I'm responsible and ONLY take them for pain, not a "high". The gov't lumping all pill takers as "junkies" is unfair and cruel. Not to mention, Percocet can be very damaging to the liver. While you *think* you're helping us not become so-called "junkies", you're possibly allowing liver failure to become a new health crisis, even beyond what alcohol does. And speaking of alcohol ... why can *anyone* of legal age (or not) still get this *deadly drug*? Is that because the gov't actually LIKES to drink? We all know it's certainly not "needed".

This pain condition has COMPLETELY changed my life, and not in a good way. Anyone suffering like this needs understanding, not lectures or assumptions (like "get over it", "deal with it", or "it can't be THAT bad"). You can't get over it, we're trying to deal with it, and yes, it CAN BE that bad. Please stop this ridiculously cruel practice of not allowing us access to what works. Please!!

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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)

Go online to your state governments website and look for your current legislatures. Some will have their own websites linked to which will have contact info. You can email them a letter. Also call them and let them know your feelings on the subject. Make sure you contact your senator and your house representative.

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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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Re: Hop63 (# 22)

I will research and see if we can go in with a registered group of pain patients and send in letters or comments.

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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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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: 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: 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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