by Jody Smith
The Food and Drug Administration has deemed ME/CFS to be one of 39 conditions that may receive their special consideration. But of these 39, only 20 conditions will be picked. If ME/CFS is one of those 20, patients’ comments will be heard through public meetings and through mailed and emailed messages.
The FDA evaluates and approves drugs before they can be put on the market. They may also create incentives that will encourage companies to turn their focus to ME/CFS.
The FDA is holding a public meeting and is looking for input from ME/CFS patients about the FDA’s patient-focused drug development initiative. The goal is to hear patient perspectives on various conditions. The FDA is interested in knowing what symptoms patients deal with as well as how effective the available treatments are for the condition.
MC/CFS is one of the conditions on the preliminary list of nominated disease areas for this initiative, that may potentially be visited at a future public meeting. The FDA invites comments through a public docket and at a public meeting.
Public meetings will be conducted to talk about such matters as the condition’s impact on the patient and the severity of symptoms. Patients are asked to communicate what matters to them most. They are asked to evaluate how adequate the present treatment alternatives are for them.
You can also contact the FDA and share your story by mail or email. You have until November 1, 2012 to let the FDA know your thoughts.
What should you tell them? Whatever is important to you.
Describe the effects of ME/CFS on your health. Let them know what types of treatments have helped or hurt you, or did nothing for you. Pass on the names of doctors and researchers that have been beneficial to ME/CFS. Whatever is on your mind, whatever your biggest concerns, fears or hopes are, let your voice be heard.
People from outside of the United States are welcome to comment.
Write to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Be sure to include the docket number FDA-2012-N-0967. Submit your comments at https://www.regulations.gov/#!docketDetail;D=FDA-2012-N-0967
Time is running short if you want to attend the public meeting. It will be held Oct. 25, 2012. You must be registered by Oct. 18, 2012.
The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. To register, send an email to PatientFocused@fda.hhs.gov with your contact information. Include your name, title, affiliation, address, email address and phone number.
It costs nothing to register, but space may be limited. Your registration will be confirmed.
To learn more, contact Andrea Tan or Robert Yetter.
Andrea Tan can be reached at the Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1168, Silver Spring, MD 20993, 301-796-7641, FAX: 301-847-8443. You can email her at Andrea.Tan@fda.hhs.gov
You can reach Robert Yetter at the Center for Biologics Evaluation and Research (HFM-25), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-0373.
Tell FDA why ME/CFS should get special attention by NOV 1:
me/index.php?threads/tell-fda- why-me-cfs-should-get-special- attention-by-nov-1.19584
Prescription Drug User Fee Act Patient-Focused Drug Development; Public Meeting and Request for Comments:
gov/articles/2012/09/24/2012- 23454/prescription-drug-user- fee-act-patient-focused-drug- development-public-meeting- and-request-for