JULY 15, 2018

Contact the Food and Drug Administration (FDA) and ask them to maintain access to opioids in low total daily doses for patients with refractory RLS

Decision makers at the FDA are requesting comments by September 10, 2018 from patients who utilize opioid therapies to manage their chronic conditions. Agency officials want to hear from refractory RLS patients on how they manage their condition and barriers that are affecting their access to treatment.

Background

On Monday, July 9th, the Restless Legs Syndrome (RLS) Foundation participated in a Patient Focused Drug Development (PFDD) meeting hosted by the FDA. The goal of this meeting was to incorporate patients’ voices as the agency develops guidance on opioid therapies for chronic pain, refractory RLS, and other conditions that utilize these treatments.

RLS is not considered to be a chronic pain condition, because its underlying mechanisms and neuropathology are very different. The Foundation urged regulators to appreciate the differences. This is why it’s important for the RLS community to take part in these discussions, because the perspectives shared will inform the FDA’s decision making on regulations that will affect refractory RLS patients who utilize low total daily doses of opioids to manage their condition.

At the July meeting the FDA welcomed input from a variety of people using opioids to manage chronic conditions. The FDA is now seeking input from patients who were unable to attend in person. Written comments will add weight and depth to the presentations made at the meeting.

Given the high level of concern about opioid related deaths, it is critical that RLS patients make their voices heard at this crucial moment in the policymaking process! In response to these questions, always make sure to note that RLS is different from chronic pain and requires any regulations or legislation take this difference into account. Now is your chance to speak up, to share your experiences and frustrations.

Take Action

• Go to the FDA’s online portal for submitting electronic comments to submit feedback at https://www.regulations.gov/document?D=FDA-2018-N-1621-0001 and click on “Comment Now” at the right of the page. 

• Tell the FDA about RLS, how you manage your symptoms, and what kind of barriers have affected your access to treatment. You can use the suggested discussion topics below to inform your comments.

Feel free to answer the questions directly or simply review them to help guide your response:

Topic 1: Symptoms and Daily Impacts

1. How would you describe your RLS symptoms? (Characteristics could include location, radiation, intensity, duration, constancy or intermittency, triggers etc.)
2. What are the most significant symptoms that you experience resulting from your condition? (Examples may include restricted range of motion, muscle spasms, changes in sensation, etc.)
3. Are there specific activities that are important to you but that you cannot do at all or as fully as you would like because of your condition? (Examples of activities may include work or school activities, sleeping through the night, daily hygiene, participation in sports or social activities, intimacy with a spouse or partner, etc.)
4. How has your condition changed over time? (Considerations include severity and frequency of symptoms and the effects of RLS on your daily activities.)

Topic 2: Patients' Perspectives on Current Approaches to Treatment

1. What are you currently doing to help treat your RLS? (Examples may include prescription medicines, over-the-counter products, and non-drug therapies.)
a. How has your treatment regimen changed over time, and why? (Examples may include change in your condition, change in dose, or treatment side effects.)
b. What factors do you take into account when making decisions about selecting a course of treatment?
2. How well does your current treatment regimen manage your chronic condition?
3. What are the most significant downsides to your current treatments, and how do they affect your daily life?
4. What challenges or barriers to accessing or using medical treatments have you or do you encounter?

Electronic comments must be submitted on or before September 10, 2018. Make sure to let the RLS Foundation know you participated in this campaign!