Urge FDA to Protect the Rights of People with Pain

Please sign this petition TODAY to help protect the rights of people with pain to make sure they continue to have access to effective pain care, including prescribed opioid medications.

Your voice and the voices of other pain advocates are needed to remind decision makers that the lives and livelihoods lost to pain are worth no less than victims of drug misuse or abuse. 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 legitimately prescribed these medications.

Pain is a serious public health issue affecting more Americans than diabetes, heart disease and cancer combined. More than one-quarter of Americans, age 20 years and over, or an estimated 76.5 million people, report that they have had a problem with pain.

The U.S. Food & Drug Administration (FDA) is currently working with makers of long-acting opioid pain medications to develop a plan ensuring the benefits of these medications continue to outweigh the risks, including misuse, abuse and accidental overdose. This plan is known as Risk Evaluation and Mitigation Strategies, or REMS. The FDA is currently accepting comments from the general public until June 30, 2009 surrounding this issue. Some of the comments the FDA has received have called for an outright ban or moratorium on certain opioid pain medications.

The petition is designed to harness the collective voices of the pain community, including patients, providers, family members and friends, and urge the FDA to consider the recommendations provided by the pain community and endorsed by the American Pain Foundation. These recommendations encourage the FDA to use a balanced and rational approach when creating a REMS plan for opioid pain medications in the attempt to curb misuse, abuse, diversion and intentional or unintentional overdose of opioid medications while, also protecting patient access to and safe use of these medications for people who need them.

Please join with the American Pain Foundation in sending an important message to the FDA.While abuse and misuse of opioid medicines are serious public safety concerns, the agency must protect the rights of the millions of people who rely upon prescription opioid medication in order to get up each morning and face their day with some semblance of worth and dignity. Curbing abuse must be balanced with the need for legitimate access!

Petition Urging the U.S. Food & Drug Administration to Protect the Rights of People with Pain

Target:  U.S. Food and Drug Administration (FDA)
Sponsored by:  American Pain Foundation (APF)
Petition to:  Protect the rights of people with pain

With this petition we, the undersigned members of the pain community, support a multi-modal approach to pain treatment and advocate for access to opioid pain medication when legally and legitimately prescribed. We urge the FDA to protect the rights of the millions of people living with pain and take a balanced and rational approach when finalizing their Risk Evaluation Strategies (REMS) plan for opioid medications. We strongly believe FDA decisions must not cause harm to one substantially larger group of Americans in order to attempt to protect another group from harm. We encourage the FDA to listen to our voices and finalize a REMS plan that is equitable to people who medically require these important pain medications to function each day.

We implore the FDA to consider the following recommendations:

 1)  REMS should not interfere with the ability of prescribers and other appropriate healthcare practitioners to responsibly develop, provide and adjust pain-care management regimens for their patients.

 2) REMS elements should be designed so they can be measured to determine their effectiveness in reducing risk of abuse, misuse and overdose. A pilot program is advised to determine effectiveness of the REMS plan before it is finalized.

3)  Appropriate metrics are needed to determine successful outcomes for patient care as well as abuse, misuse and diversion. Success thresholds should be predefined, reasonable and achievable.

4)  Short-acting opioids should also be subject to the class-wide REMS. Focusing only on extended or long-acting medications will result in prescribers switching to less regulated, shorter-acting medication at the cost of effective pain relief.

5)  New patient registries should NOT be included as an element of a REMS for opioids. Registries will place an unnecessary barrier to pain care and additional burdens for healthcare providers.

6) Prescriber and dispenser risk mitigation education should be conducted as effectively as possible, and tied to DEA registration requirements or otherwise incentivized to encourage responsible prescribing and ensure compliance.

7) Patient education materials can be developed for individual products to assist prescribers and dispensers in providing patients with appropriate use, storage and disposal information, as well as any specific precautions relating to individual products.

With over 76.5 million Americans struggling with pain, people in pain deserve access to effective pain care.  Do not impose barriers preventing this care!

The above recommendations have been delivered to the FDA with full explanation of each recommendation. Please read these recommendations in their entirety at http://www.painfoundation.org/PositionStatements/REMSTaskForceRecommendations.pdf

For more information on REMS, please read APF%u2019s Frequently Asked Questions at http://www.painfoundation.org/Publications/REMS_FAQ.pdf

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