THE PROP PETITION: Oh boy, CRIPES for anyone with CRPS; THAT OTHERS SCREW IT UP not US doesn't matter?

(that is not in a bottle charged to your VISA)

http://www.regulations.gov/#!documentDetail;D=FDA-2012-P-0818-0001


Toxicology, Rheumatology, and Pubic Health submit this petition under Section 21 CFR 10.20 and 21
CFR 10.30 and other pertinent sections of the Federal Food, Drug and Cosmetic Act or any other
statutory provision which authority has been delegated to the FDA Commissioner to regulate labeling of opioid analgesics.

At present, the FDA-approved indication for nearly all instant-release opioid analgesics is "moderate to
severe pain". For extended-release opioids, the indication is for "moderate to severe pain when a
continuous, around-the clock analgesic is needed for an extended period of time." These overly broad
indications imply a determination by FDA that they are safe and effective for long-term use. As outlined
below, an increasing body of medical literature suggests that long-term use of opioids may be neither safe
nor effective for many patients, especially when prescribed in high doses.
Unfortunately, many clinicians are under the false impression that chronic opioid therapy (COT) is an
evidence-based treatment for chronic non-cancer pain (CNCP) and that dose-related toxicities can be
avoided by slow upward titration. These misperceptions lead to over-prescribing and high dose
prescribing. By implementing the label changes proposed in this petition, FDA has an opportunity to
reduce harm caused to chronic pain patients as well as societal harm caused by diversion of prescribed
opioids. In addition, FDA will be able to reinforce adherence to dosing limits that have been
recommended by the United States Centers for Disease Control1
, the state ofWashington2 and the New
York City Department of Health and Mental Hygiene3
.
The Federal Food, Drug and Cosmetic Act established that a drug intended to treat a condition must be
proven safe and effective for use as labeled.4The current label on opioid analgesics does not comply with this law. By taking the actions requested in this petition, FDA will be able to exercise its regulatory
responsibility over opioid manufacturers by prohibiting the marketing of opioids for conditions in which their use has not been proven safe and effective.

920 48th Street, Suite 1510
Brooklyn, NY 11219
Office: 718.283.7557
Fax: 718.283.6540
www. responsibleopioid prescribing.org
info@responsibleopioidprescribing.org

SPECIFIC ACTIONS REQUESTED FOR CHANGES TO OPIOID ANALGESIC LABELS:
1. Strike the term "moderate" from the indication for non-cancer pain.

2. Add a maximum daily dose, equivalent to 100 milligrams of morphine for non-cancer pain.
I disagree because everyone's body is different: you can have someone who is 300 pounds not be able to tolerate 20mg of morphine/day, or someone who is 80 pounds not get much relief from 300mg.  You need to find the right drug for the right patient, at the right dosage.  You can't apply rules like that across the board.  MAJOR problem with this deal, right here, I am am against this for this very reason, forget dosages: it doesn't matter.  What each person can function at maximum on is the best for them.  Not striking down a dosage because it's "equivalent" to something.

I have bone pain: in addition to CRPS, to nervous system pain: I am sorry that at present my lack of cancer doesn't satisfy you: but really, go get some, since you force everything else down my freaking throat, you jerk!

Moron, only in this country would anyone see such idiocy.  








3. Add a maximum duration of 90-days for continuous (daily) use for non-cancer pain.

STATEMENTS OF SCIENTIFIC BASIS FOR PETITION:

1. Over the past decade, a four-fold increase in prescribing of opioid analgesics has been associated
with a four-fold increase in opioid related overdose deaths and a six-fold increase in individuals
seeking treatment for addiction to opioid analgesics. 5

2. Prescribing of opioids increased over the past 15 years in response to a campaign that minimized
risks of long-term use for CNCP and exaggerated benefits. 6·7·8

3. Long-term safety and effectiveness of managing CNCP with opioids has not been established.9

4. Recent surveys of CNCP patients receiving COT have shown that many continue to experience
significant chronic pain and dysfunction. 10·11

 5. Recent surveys using DSM criteria found high rates of addiction in CNCP patients receiving
COT.1z,13

6. A large sample of medical and pharmacy claims records found that two-thirds of patients who
took opioids on a daily basis for 90 days were still taking opioids five years later. 14

7. Patients with mental health and substance abuse co-morbidities are more likely to receive COT
than patients who lack these risk factors, a phenomenon referred to as adverse selection. 15

8. Three large observational studies published in 2010 and 2011 found dose-related overdose risk in
CNCP patients on COT. 16'17'18

9. COT at high doses is associated with increased risk of overdose death18, emergency room visits19
and fractures in the elderly0.

There is no environmental impact associated with this Citizen's Petition and we wish to be excluded
under 21 CFR Sec. 25.24.

The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition include all information and views on which the petition relies, and that it includes representative data and information known to the petition which are unfavorable to the petition (21 CFR Sec.l 0.30b ).



anyone wanting the PDF?  LEAVE ME A COMMENT, and I will drop you a note.


Last minute CYA:

RSDSA Clarifies its Position on the PROP Petition

In a recent electronic alert, the RSDSA incorrectly characterized the PROP petition to the FDA that seeks relabeling of opioid pain medications.  Our email alert stated that under the new labeling, if adopted,  opioid medications would no longer be prescribed to treat (1) ‘moderate’ pain, (2) for longer than 90 days, or (3) in doses greater than the equivalent of 100 milligrams of morphine.  RSDSA apologizes to PROP and to our constituents for the error.   FDA labeling regulates advertising and how pharmaceutical manufacturers and distributors describe and promote the use of their products; but the FDA does not regulate physician prescribing.   Physicians are free to prescribe according to their education, training, and experience and for the best interests of their patients.  To say or imply the PROP seeks “prohibition” of any prescribing practice is incorrect.  Nevertheless, RSDSA is concerned that a change in labeling might adversely affect insurance coverage for medications prescribed for conditions that are no longer listed in the FDA-approved labeling.  Such prescribing is called “off- label” use.   Off-label prescribing is common and accepted.   Denial of coverage for off-label prescriptions, if it occurs, would limit access to opioid pain medication.   No one can state with certainty how the health care insurance industry or regulatory agencies, other than the FDA, will act in response to altered labeling of opioid pain medications.   Over 60% of people with chronic pain due to CRPS depend on opioid pain medication.   RSDSA seeks to protect CRPS patients’ access to opioid pain medications covered by health care insurance. Yeah, too bad anyone is afraid to even take a PEE without a consult now, thanks to them-the FDA thing!