Bringing the FDA Stakeholder Meeting Home: One More Push

June 7, 2012

Posted by Cort Johnson

(Things are finally starting to move…The FDA is responding but no meeting dates are set. Stop now and we risk losing our chance; keep working and we can bust this thing wide open.  We are on the brink of getting a historic meeting at the FDA…

The FDA can be very pro-active in the drug approval process – we’re simply asking that they be pro-active with the only major disorder they’ve never approved a drug for. – ME/CFS! Let’s keep the pressure on by emailing the feds every day until the 25th….Cort.)
_______________________

To All who took ACTION requesting THE FDA TO HOLD A STAKEHOLDERS MEETING for ME/CFS. Great job and Thank You! …

Your Emails / Letters are having an effect. Patients have been meeting with Congressional offices and support is being gathered from key Representatives. We do not yet, however, have a meeting set with FDA regarding the ME/CFS Stakeholders Meeting.

Therefore, we ask everyone to send in a follow up email / letter. This letter is directed to FDA Commissioner Margret Hamburg, ensuring that the stakeholder meeting is held. We urge Dr. Hamburg to direct that this critical meeting take place.

PLEASE EMAIL YOUR LETTER DAILY UNTIL June 25th and urge your relatives and friends to do the same. A sample template letter and email addresses are included below. Copy, Paste and Send. We will keep count of emails using mecfsaction@yahoo

YOUR LETTERS COUNT. Remember – LOBBYING & ADVOCACY is how AIDS/HIV got $3 BILLION a year for research, CFS gets $6 million. AIDS/HIV sufferers now have multiple drugs to fight the disease. We have NONE.

Your previous letter/emails did generate a response, just no confirmed Date. WE MUST KEEP THE HEAT ON, Those who work for our benefit need to Act!

Thank you everyone for taking ACTION for YOUR HEALTH! __________________________________________________________________

Copy & Paste email addresses into the To: Slot of your email – margaret.hamburg@fda.hhs.gov ; Kathleen.Sebelius@hhs.gov ; janet.woodcock@fda.hhs.gov ; monica.volante@mail.house.gov ; matthew_prowler@casey.senate.gov; mecfsaction@yahoo.com __________________________________________________________________

From:( Your Name ) June  , 2012

To: FDA Commissioner Margaret Hamburg, M.D cc: Janet Woodcock Director CDER FDA, Secretary of Health Kathleen Sebelius, Senator Casey and Congressman Pitts

Subject: Request for FDA Stakeholder Meeting on Chronic Fatigue Syndrome Dear Dr. Hamburg

As patients suffering from Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), we believe your commitment of the FDA holding stakeholder meetings is critical to the FDA understanding and evaluating treatments, particularly to those of us suffering from debilitating/devastating chronic illnesses.As a patient population we are long overdue for treatments and the movement through six divisions at the FDA has contributed to ZERO treatments being available.

We are asking you to convene a “true” stakeholder meeting to examine the treatments currently in use for ME/CFS both in trial and those being used off-label. We anticipate that this meeting will be at least a full day meeting in order to accommodate the experts, clinicians, researchers, patient advocacy groups and patients as well as FDA expertise from a variety of divisions to ensure understanding of this complex illness.

With millions of patients suffering from ME/CFS at a cost to our nation of $23 billion, it more than outweighs any cost to the FDA to convene such a meeting. The goal of the meeting is to examine benefit/risk and develop a pathway for the acceleration of treatment, a pathway that can be agreed upon by the ME/CFS community with a commitment by the FDA to change the course of this disease.

As one of the millions of people suffering from ME/CFS, I cannot even dream about a better quality of life because there is simply no avenue to get there. I live every day with a disease that the CDC has said is as disabling as multiple sclerosis, heart disease, end-stage renal disease and similar chronic conditions; AND YET THERE ARE ZERO TREATMENTS TODAY. As this falls within your responsibility to address this “unmet medical need”, Please Act Now.

(Your Name) (Address) (City, State) – ( Zip code )

_______________________________

(Thanks to Bob Miller, Mary Dimmock, Pat La Rosas, Denise Lopez Majano et. al. for creating this letter.)

7 comments

{ 7 comments… read them below or add one }

ggingues June 7, 2012 at 9:40 pm

so we are not emailing to these people anymore?: Alex Stern <Alex_Stern@mikulski.senate.gov>; howard.koh@hhs.gov; brian_ahlberg@harkin.senate.gov

GG

Brelliott June 8, 2012 at 11:07 am

This is excellent news, Cort, regarding the response from the FDA. I urge everybody who uses a computer and has access to this website to put forth every ounce of effort and energy in sending these daily letters to the FDA and others involved in the process of getting medication requests reviewed. It sounds to me that this is one of the most important issues we can hope to move forward in the advancement of treatment for ME/CFS. Obviously, Cort has faith in us, as ME/CFS patients/advocates/caregivers, to have a major impact on their decision to elect a specific full day or more for a stakeholder meeting sometime soon. We are the ones who can make that difference people.

As an eight year sufferer, I know quite well how this illness has robbed us of a normal, productive and satisfying life. I URGE each one of you to take the bull by the horns on this issue today and every day until we receive productive results.

Sincerely, Brenda Elliott

CJB June 8, 2012 at 11:24 am

Bump. Time to send out today's letter.

CJB June 9, 2012 at 10:35 am
medfeb June 10, 2012 at 6:05 am
ggingues

so we are not emailing to these people anymore?: Alex Stern <Alex_Stern@mikulski.senate.gov>; howard.koh@hhs.gov; brian_ahlberg@harkin.senate.gov

GG

ggingues
That's right. The new email is not being sent to these people.

To all,
If you have not done so yet, please take a few minutes to send in another letter. Your letters really can make a difference.
Thank you!
Mary Dimmock

Tally June 10, 2012 at 6:07 am

Is there anything that non-American citizens can do to help?

justinreilly June 12, 2012 at 10:18 pm

Thanks everyone spearheading this important effort as well as everyone sending their letters in! This is crucial!

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