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Jennie Spotila Appointed as FDA Patient Representative

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By Jennie Spotila • www.ProHealth.com • May 8, 2013


SOURCE: Occupy CFS

Editor's Comment: Jennie Spotila, long-time CFS/ME patient advocate, former board member and chair of the CFIDS Association of America, and founder of Occupy CFS, has just been appointed to the FDA’s Patient Representative Program. Jennie personally attended the FDA’s recent workshop, where she contributed vital information about establishing viable parameters for measuring treatment outcomes. You can watch her presentation HERE.

By Jennie Spotila

As of today, I have been appointed to the FDA’s Patient Representative Program. This has actually been in the works for a while, and I’ve been anxious to tell you about it, but it finally becomes official today.

The FDA Patient Representative Program selects and trains patients (or family members) to serve on advisory committees and to provide FDA with the perspectives of people affected by serious diseases. I learned of the program last October while researching information about FDA. I submitted an application on October 23, 2012, and received provisional training in December. But the conflicts of interest screening process takes months to complete, and I was not notified until March that I was officially accepted. My appointment begins today, May 6th, and will run for five years.

What does this mean? First, I am now eligible to serve on advisory committees convened by FDA to evaluate drugs or biologics for the treatment of ME/CFS. You may recall that Alaine Perry served as the patient representative on the advisory committee that reviewed the Ampligen application in December 2012. Second, FDA offers ongoing training to its patient representatives so I will have the opportunity to learn more about various issues (like risk mitigation programs, etc.), and to share the perspectives of ME/CFS patients with FDA and my fellow representatives. I have already learned a great deal about FDA through this program and I look forward to learning more.

Federal ethics rules for service on advisory committees are very strict. I would be disqualified from service by even the undue appearance of a conflict of interest. I won’t be able to comment on products that may come up for review, or accept compensation from companies that make those products (of course, no one has ever offered me such compensation!).

My sincere hope is that there will be multiple opportunities in the next five years for me to serve on committees evaluating treatments for ME/CFS! In the meantime, I will pass on what I learn through this program. I also hope that you will help me educate FDA about ME/CFS by sharing your perspectives and questions with me, so that I can share those views with them.

You can help me educate FDA and other patient reps about ME/CFS by sharing your thoughts with me on treatments, burden of illness, and other issues as they arise. Also let me know if you have questions about FDA and I'll try to get answers for you.

You can contact Jennie at Occupy CFS




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