You All Rock! We've Overwhelmed The FDA!

I want to start this post with a bazillion thanks!!!!!


It is difficult to get any accurate information from the FDA. The fact that every time a person calls the FDA, s/he is given different email addresses or information would be funny if this wasn't such a scary situation. However, my friend and 'midodrine buddy' wrote the following regarding her husband's call to the FDA this morning:


Will called the FDA too. The lady he spoke with...said that they have gotten so many calls, emails, and letters that they are overwhelmed and can hardly get any other work done. And apparently we have frozen up the FDA's website more than once from submitting letters via their online comment form!

They had no idea that 100,000 disabled people could put up such a fight, or that we had such loyal friends who will fight for us when we can't.

In other words: You all Rock!!! 

I really don't think the FDA expected such a fuss over midodrine. I think they figured that such a small group of patients would not be able to put up such a fight, that midodrine would be an easy drug to pull off the market, and they could pat themselves on the back for 'enforcing the rules' without getting called out on the carpet for their purely political move.  But they were wrong! Seriously, reports from fellow friends keep coming in that we have managed to freeze the commentary website multiple times and clog the phone lines!!!! Your calls, emails and snail mail are making a HUGE difference!

I'm wrapping up my political action posts for now.  For those of you whose political action muscles are still flexed and not completely worn out from this midodrine stuff, the last method of speaking up to the FDA is via snail mail. This has been recommended by the FDA (You will likely see it in the response you get from the CDER form you send) and by the DYNA (Dysautonomia Youth Network of America) group. DYNA has great, great instructions and a pre-written sample letter which I have posted below. You can also contact your representatives (information posted below DYNA letter).

You may choose to cut and paste the letter to the FDA into a Word document or go to DYNA 's link on this topic to download the letter yourself into Word.

Some folks have asked about contacting the manufacturers of either the name brand ProAmatine or the generic manufacturers of midodrine, but at this point I don't have any information as to whether or not this would be helpful. Action efforts have been focused on inundating the FDA and contacting our representatives about the issue.

Instructions from DYNA and Sample Letter:

Write the FDA. Written correspondence to FDA may be posted to the public docket (FDA-2007-N-0475). Include 4 copies of your letter.

Send to: FDA-2007-N-0475 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852

• Entitle your letter: A Response to the FDA proposed withdrawal of Midodrine / Proamatine.
• Clearly and efficiently state your concern and ask your questions.
• Be sure to provide your contact information.
• Include 4 copies when you mail it and be sure to save a copy for yourself.
• Sample Letter
  This letter was provided by a DYNA Youth Ambassador. Please feel free to download it. Please make sure that you mail 4 copies of your final letter (do not staple them together).

Name

Street Address

City, State, Zip

Date

FDA-2007-N-0475

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

              

RE: A Response to the FDA proposed withdrawal of ProAmatine/Midodrine (FDA-2007-N-0475)

I request that the FDA reconsider the proposed withdrawal of the medication ProAmatine/Midodrine.  The drug is not being pulled because it is unsafe, but due to a technicality that can easily be addressed.  The positive results and outcomes of this medication have already been well documented by the dysautonomia medical community. 

Dysautonomia patients require this medication in order to stabilize their blood pressure and heart rate.  The withdrawal of this drug will significantly impact their quality of life, and also that of many others diagnosed with Dysautonomia conditions.  Many patients will literally be bedridden without ProAmatine/Midodrine. 

CONSIDERATIONS:

1. What will be the cost to the US government for disability for these patients if they lose access to their medications?  Many will end up bedridden or housebound due to symptoms.
2. Dysautonomia patients do not transition between medications easily and any change in their treatment plan creates tremendous stress on their systems.  Even switching from brand to generic can be quite complicated for these patients.
3. The ability for patients to maintain a quality of life that allows them to pursue their education and employment should be an essential consideration, especially in the incidence of a procedural technicality.
4. What kind of paperwork will the already overwhelmed doctors have to file for extended access for their patients? 
5. Can the FDA guarantee that all patients currently taking ProAmatine/Midodrine will be approved for extended access? 
6. Are you aware that young patients with dysautonomia conditions sometimes require higher and more frequent dosages and in certain cases patients are often medically recommended to utilize the brand name rather than the generic?
7. To expect the brand name provider to conduct post-marketing clinical trials in this particular situation is not financially feasible.

Pulling either of these medications from the market will be a travesty for this population of patients.  Please reconsider.

Sincerely,

SIGN NAME

Enclose 4 copies. 


Contacting your Congressmen:


At this time I do not have a generic letter for contacting your congressmen. I sent one to both of our senators and to our representative. What I wrote is posted below if it would be of any help to you. Click here to find contact information for your congressmen.




I am writing to ask you to intervene on my behalf regarding the FDA's recent decision to withdraw ProAmatine (midodrine hydrochloride) from the market, effective at the end of September.  Please follow the link below to see why this issue is so incredibly important to me and how it will affect my life. My story is one of only hundreds of thousands who rely on ProAmatine to get out of bed every day. Imagine if a drug was available to safely treat a condition of yours, allowing you to continue to serve the people Pennsylvania, only to be removed from the market. The decision to remove ProAmatine from the market was purely political and failed to account for the patients.  I ask you to take action on my behalf to remedy this travesty. Remind us that patients matter.

http://adancinglight.blogspot.com/2010/08/goodbye-magic-midodrine.html

Thank you for your service, 

Thank you again to all of you who have used your precious energy to speak up on behalf of myself and others who desperately need this medication.

I have definitely completely exhausted myself working on all of this stuff, and am hoping to check out a bit from things over the holiday weekend. I have scheduled a HAIRCUT for myself next week, and hope to be able to make the outing. Thought I'd better go while I still had midodrine.  I'm very excited to get a real haircut.  Hopefully I'll be back with some blogs soon, and they won't be all about midodrine (unless it is to tell you that IT IS BACK! :))

Wishing you all a good Labor Day Weekend!

Blessings, 

Emily