Monday, August 30, 2010

The Midodrine Battle

People have been asking me if they can contact the FDA about the withdrawal of midodrine from the market.  Yes, you can!  And thank you so much!  I appreciate your effort on my behalf, and on behalf of the many thousands of people who depend on this medication daily.

If you would like to call the FDA, you can use this number: 1-888-463-6332. I am told that you will need to select #4 Speak to a representative, then #3 for Human Drugs, then #1 for Human Drugs (again).

If you would like to send an email to the FDA, please send them to both of the following email addresses.  Just remove the spaces first.  Those are added in to help prevent spam.

norman.stockbridge @ fda . hhs . gov

janet.woodcock @ fda . hhs . gov

If you would like to send a letter through the mail to the FDA, please send it to both addresses below.

Dr. Janet Woodcock
Director FDA/CDER
10903 New Hampshire Ave
Silver Spring MD 20993

Dr. Norman Stockbridge
Director Division of Cardiovascular and Renal Drugs
10903 New Hampshire Ave
Silver Spring MD 20993

If you want to contact your congressman, you can find their information here:

Here is a sample letter that can be sent to the FDA.  Feel free to use this, edit as you please, or write your own.

I strongly urge you to reconsider the withdrawal of midodrine from the market. The withdrawal of midodrine was not the result of a safety issue, but rather a procedural argument between the FDA and the makers. While I understand that the FDA has an obligation to enforce its rules and regulations, the decision to withdraw midodrine from the market fails to take into account the 100,000 people who will be left unnecessarily suffering with debilitating symptoms of Orthostatic Intolerance.
The FDA is recommending that patients talk to their health-care providers regarding alternative treatments, but at the same time is keenly aware that midodrine is the only FDA approved drug to treat Orthostatic Intolerance. There are no reasonable substitutes for it.

It is completely cost-prohibitive for any of the manufacturers of midodrine to benefit from doing the follow-up studies required, and hence keep the medication on the market. Please take into consideration the fact that thousands of lives will be devastated by the withdrawal of midodrine. 

I ask you to find a solution that allows all involved to benefit--the FDA, the manufacturers, and the patients who rely on midodrine to help them work, care for children, and engage in normal activities of daily living.

Thank you for your time and consideration.

A big thank you to a dear friend who helped me to compose both this blog post and my previous blog post.  Your help has been tremendous on these days when I can barely think and function.  I thank the Lord for you.

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