Request to FDA to Change Opioid Labels
Posted on October 1, 2012 by Rita Wilson
To those who may not know, PROP (Physicians for Responsible Opioid Prescribing) http://www.supportprop.org/ is an organization comprised of practicing physicians whose mission is “to reduce morbidity and mortality resulting from prescribing of opioids, and to promote cautious, safe and responsible opioid prescribing practices.” I follow PROP regularly and use many of their resources to educate my staff on opioid use as it relates to long term prescribing and the MSA.
As a PROP follower, I recently received the email below asking for my support. I responded immediately and am forwarding to each of you in the hope that you will do the same.
Dear Friends and Colleagues,
As you may know, PROP filed a request to FDA for changes to opioid labels. Specifically, we asked them to add a suggested duration of use, a suggested upper dose and to limit (on-label) use to severe pain. You can read about this here: http://supportprop.org/advocacy/index.html.
If FDA implements our request, opioid manufacturers will be prohibited from advertising long-term use of opioids for chronic non-cancer pain and the medical community will be informed that this practice has not been proven safe and effective. (However, clinicians will still be permitted to prescribe long-term opioids). We believe that this will help reduce overprescribing of opioids. And since it’s overprescribing that’s harming pain patients and fueling the opioid addiction epidemic, the label change could help bring this unprecedented public health crisis under control.
FDA is seeking public comment about the Petition. Thus far, they have received about 200 comments supporting the petition and 130 opposed to the petition. Not surprisingly, industry-funded pain groups (and pain patients misled to believe that this is an effort to ban opioids) have weighed in against the Petition.
Submitting comments to FDA is easy… just click here: http://www.regulations.gov/#!submitComment;D=FDA-2012-P-0818-0001.
A couple of sentences is all you need. Please make sure to state clearly in the first or second sentence that you support the petition.
For example, you can write:
I support this petition. Drug companies should not be permitted to advertise long-term and high dose opioids for moderate chronic pain because this treatment has not been proven safe and effective. The medical community should be informed by a revised label that risks may outweigh benefits when opioids are prescribed long-term.
Please try to do this ASAP. As soon as FDA takes an action on the Petition (which could be very soon), they will close the comment period.
If you are interested in reading comments that have already been posted, you can do this here:
Thank you for your support!
Andrew Kolodny, MD
President, Physicians for Responsible Opioid Prescribing
Chair, Department of Psychiatry
Maimonides Medical Center
920 48th St., Brooklyn, NY 11219
Tel: 718 283-7557; Fax: 718 283-6540
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