Patient Representative

As of today, I have been appointed to the FDA’s Patient Representative Program. This has actually been in the works for awhile, 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 mean time, 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.


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15 Responses to Patient Representative

  1. Rivka says:

    Please, Jennie, in this position, make our lives better. I know that is why you joined. So I know you will work at that. Since the FDA meeting, I have been very very very sick. In other words, the little energy output I gave to work on this meeting (and not even attend), has set me back for weeks? Months?…. Well, I have no idea how long. We so need movement in this area. — Rivka

  2. Sasha says:

    Well done, Jennie, and congratulations. I know you’ll represent us well.

    Thank you!

  3. John says:

    Congratulations, Jennie!

  4. Gabby says:

    Congratulations, Jennie. We are proud of you and are sure that your work there will have a positive impact.

  5. york gorzolla says:

    Thank you very much for applying to take this position, and congratulations for getting selected. It feels as if there is finally some forward movement on this horrible disease/condition. We understand your conflict of interest position, but hopefully you will be able to relay FDA information regarding any progress on the ME/CFS front.
    Take good care,

  6. Kathy says:


    Congratulations! This is wonderful. I hope it doesn’t tire you too much, but you will really good for this position!


  7. Bob says:

    Hi Jennie. Congratulations on this. Great work on your part. Looking forward to seeing your input at the FDA. I have been very impressed with the recent FDA conference. Bob

  8. Great news! you bring us all hope! Look after yourself though! x

  9. Jane L. says:

    Thank you!

  10. Andrea says:

    Congratulations Jennie! I know you will do well at serving at this new position. Thank you for making a difference even though you are so ill. Thank you for speaking up for patients like me.

  11. Sue Jackson says:

    Congratulations, Jennie!

    I know you will do a great job representing the patient community – they couldn’t have chosen a better person for this position!

    Thank you for using your very limited energy to try to move things forward for all of us.


  12. Holly says:

    Congratulations. I know it will require sacrifice on your part to participate in this position. Thank you for being willing to be a patient representative.

  13. Beverly says:


    Please let the FDA know that many patients would prefer to use natural alternatives such as supplements and herbs, whenever possible, to deal with ME/CFS. We tend to be sensitive to drugs and their side effects. The emphasis seems to be placed on drugs without the exploration of alternatives.

    • Jennie Spotila says:

      Yes, I completely agree that we are sensitive to drugs and side effects. That has been my experience as well. However, I have heard many stories of patients who displayed extreme sensitivity to supplements and herbs as well, so patients should approach all treatments with caution.

      This bumps up against a regulatory limit on FDA. FDA regulates products that are marketed for a specific disease or medical condition. Supplements and herbs that claim to boost the immune system, for example, are not subject to FDA regulation. This means that FDA cannot require clinical trials to prove that a supplement boosts the immune system, and generally does not get involved in regulating such products unless a specific safety problem arises. That is why you see an emphasis on drugs – FDA simply does not cover most supplements.

  14. Chris Heppner says:

    Congratulations, Jenny, on now being on the patient list for CFS Advisory Committees! I am sure you will do a great job on our behalf.

    I just want to express one area of concern, though–that the search for existing drugs to treat symptoms may replace the perhaps more difficult task of spending serious research money to find out the root cause(s) of this and similar diseases. If, for instance, it proves that the now huge almost omnipresent ocean of high frequency (and hence high energy) RF has a causal impact, damage will continue despite partial control of some of the symptoms. I am taking this only as a possibility.

    However, it is also true that anything that decreases the burden of our–and your–symptoms is also worthwhile. Best wishes, Chris Heppner

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