ACTION ALERT:

On February 6, 2009, the FDA sent letters to 24 manufacturers of opioid analgesics (both long and short-acting) to let them know that that they would be required to develop comprehensive Risk Evaluation and Mitigation Strategies (REMS) plans. According to the FDA, the purpose of the REMS would be to ensure that the benefits of the drugs continue to outweigh the risks (misuse, abuse and accidental overdose).

In the several months since the FDA’s announcement, some medical professionals have stepped up to form the Pain Care Forum’s Opioid Risk Evaluation and Mitigation Strategies Task Force. This group, headed by its Executive Director Lennie Duensing, recently expressed several key concerns and recommendations to the Academy.

Duensing wanted to ensure that the FDA understood that chronic pain is and one of our nation’s greatest public health problems as today, more than 33 million Americans—men, women, and children— live with serious pain that has lasted one year or more. Unfortunately, this pain often goes untreated, undertreated, or improperly treated.

With this in mind, Duensing wants the FDA to take measures to ensure that these and future citizens have the right to have access to the safest and most effective treatments available. This includes conducting research to ensure that these REMS are prepared to help the individuals and areas of the country most at risk.

The Task Force has spoken out against including patient registries as a part of the REMS, as current evidence shows that the benefits of such implementation are not sufficient enough to warrant the potential stigmatization patients would feel. Instead, Duensing wants enhancements to the existing and growing state Prescription Monitoring Programs infrastructure as a means to achieve the REMS goals.

The group is also focused on including the entire class of opioid medications in the REMS plan, as if only a portion of the medications are included then potential patients will move to the less regulated and potentially dangerous class of medications.

Such a lack of inclusion would thus not diminish abuse or misuse and will very likely result in some patients not getting the medications that are most appropriate for their needs.

Lastly, the Director wants to maximize participation and quality by integrating RMS prescriber and dispenser education the DEA registration process and develop REMS education programs with extensive expert input, across a wide variety of print and virtual platforms.

Similarly, in an attempt to further develop and enhance these strategies, the FDA is urging members of the public to submit its own written or electronic comments, opinions, and/or recommendations on the issue. In particular they are seeking input on the issues of  certifications of opioid prescribers and dispensers, patient education, REMS system restrictions, distribution controls, and metrics to measure the success of REMS.

Hopefully with sufficient public input combined with the efforts of the Pain Care Forum Task Force, there will be an assurance that the legitimate medical uses of opioid analgesics will be given consideration equal to or greater than that of the criminal misuse of these valuable medications.

We urge patients and concerned members of the medical community to discuss these potential changes with their doctors and to express their opinions immediately.

Members of the public should submit their electronic comments at: http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=090000648095e49e

Or by direct mail at: 

Division of dockets Management (HFA–305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852

All comments should be identified with the docket number [Docket No. FDA-2009-N-0143]

You may also want to express your concerns to your congressional members, whose information can be found at https://writerep.house.gov/writerep/welcome.shtml