I received this message via Facebook from my friend Carolyn Noel of the American Pain Foundation. This is very serious and will affect many of us with chronic pain conditions if the FDA gets their way. Please read and do your part so that we don’t lose the right to have our pain medications. Thanks Carolyn for this message and for keeping me aware of the current American Pain Foundation news.
DEADLINE – JUNE 30TH
The Food & Drug Administration (FDA) may remove important pain medications from the market or could very likely limit access to certain pain medications that are currently legally prescribed to millions of Americans suffering from pain.
The FDA needs to hear how vital access to these medications is to people with pain and what tragic results could occur if they were denied access to these medications or if additional barriers were created making access more difficult for people who are legally prescribed these medications.
Send a letter to the FDA sharing your story about how their decisions would impact you or your loved one. The FDA MUST receive your letters by Tuesday, June 30th, so don’t delay.
Please review the following to assist in your letter writing and to provide further information on the issue:
• Frequently Asked Questions (http://www.painfoundation.org/Publications/REMS_FAQ.pdf)
• Risk Evaluation and Mitigation Strategy (REMS) Consumer Talking Points (http://www.painfoundation.org/Publications/REMS_TalkingPoints.pdf)
• American Pain Foundation’s Position Statement on REMS (http://www.painfoundation.org/PositionStatements/REMSPositionStatement.pdf)
• American Pain Foundation’s Recommendations on REMS (http://www.painfoundation.org/PositionStatements/REMSTaskForceRecommendations.pdf)
Click here (http://www.regulations.gov/fdmspublic/component/main?main=SubmitComment&o=090000648095e49e) to go directly to the FDA comment submission page to submit your letter electronically or mail your letters to:
Division of Dockets Management (HFA305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Please Note: All letters sent electronically or through the mail must clearly include the following information at the top of your letter: Docket No. FDA-2009-N-0143. Please send a copy of your letter to email@example.com so we can also have an opportunity to hear your commentary.
Testimony of Pain Advocates at FDA Hearing, May 27th and 28th. These testimonies may also help you write your letter.
• Mark Maginn (http://www.painfoundation.org/PositionStatements/REMStestimony_MMaginn2009.0527.pdf)
• Carolyn Noel (http://www.painfoundation.org/PositionStatements/REMStestimony_CNoel2009.0527.pdf)
• Teresa Shaffer (http://www.painfoundation.org/PositionStatements/REMStestimony_TShaffer2009.0527.pdf)
• Mary Vargas (http://www.painfoundation.org/PositionStatements/REMStestimony_MVargas2009.0527.pdf)
FDA’s REMS Information (http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-8992.htm)
THANK YOU FOR SUBMITTING YOUR LETTER AND ALLOWING YOUR VOICE TO BE HEARD!
American Pain Foundation