ATTENTION ME/CFS COMMUNITY

We the “FDA Team” are asking you to send the message below to the FDA and to listed members of Congress.

The FDA Stakeholder’s Meeting was helpful did not even begin to produce its major goal: providing a clear regulatory pathway for drug development in ME/CFS

The recent patient-focused drug development meeting held by the FDA was a start – but only a start. The FDA stated that their goal was to support treatments for the chronically ill, particularly where there is a drug deficit, yet the meeting fell short of meeting that goal.

The original goal of the FDA Stakeholders was to provide a clear regulatory pathway that would support faster drug development for ME/CFS. That obviously did not happen.

Now Bob Miller and others on our team are continuing communication at the top level, including with Dr. Janet Woodcock, Director of the Center for Drug Development and Research at the FDA. We have informed her that your messages will be sent to one of her staff members, David Banks PhD, of Special Health Issues.

We want them to hear from you, family and friends. This keeps critical channels of communication open.

NUMBERS COUNT!

AIDS patients demanded one thing: “Treatment,” and they got it! We must demand the same.

Please email the following to David Banks and myself Bob Miller. (I am monitoring how many emails are sent with other FDA team members.) Also, we ask you to cc others in the Department of Health and Human Services and congressional staff members so they can influence the FDA.

Just copy and paste, please add your name and address or email information at the end. (As always, this is just a suggested template for your convenience):

To: David.Banks@fda.hhs.gov, 511bobmiller42@gmail.com
Cc: howard.koh@hhs.gov, Sara_Mabry@casey.senate.gov, Karen_Wade@hagan.senate.gov, Eamonn_Hart@blumenthal.senate.gov, Carolyn_gluck@reid.senate.gov
monica.volante@mail.house.gov, robb.walton@mail.house.gov, rebekah.armstrong@mail.house.gov, eric.fox@mail.house.gov, christopher.Stewart@mail.house.gov, ryan.mcBride@mail.house.gov

Subject: ME/CFS Treatments

Dear Dr. Woodcock:

Over 1 million Americans and their families continue to suffer with ME/CFS. Patients have no options as there are no FDA-approved treatments. One drug has been stuck in the pipeline for two decades (Ampligen), and there are no others likely to be reviewed for years to come. The recent patient-focused drug development meeting fell short. By the end of this year, FDA must convene a follow-up meeting to engage pharmaceutical and biotech companies to assist the FDA in establishing a regulatory pathway for drug approval.

The meeting held on April 25th and 26th opened the FDA’s eyes to the severity of our condition and the enormous Unmet Medical Need. FDA has the power and the authority to waive traditional regulations when healthcare demands, particularly when the disease is serious/life-threatening, as ME/CFS clearly is. We need access to treatments NOW. Please act now for us! Don’t stop the progress; let’s keep it going. We cannot wait another decade for relief. People are suffering and dying; they are invisible to you, but they are dying.

Thank you,

“Place Your Name Here”:
“Place Address and/or Email Here”
– – – End of your email message – – –

The FDA Team includes:

• Cort Johnson, patient and principal of Health Rising
• Robert Miller, ME/CFS patient /activist  and (Courtney Miller, patient wife FDA Team support)
• Lori Chapo Kroger, patient and president of PANDORA Org.
• Pat LaRosa, patient / patient advocate
• Billie Moore, parent of patient lost to ME/CFS & patient advocate