How to Help, Step 1: Contact the FDA

In my latest exchange with Dr. ANS he made it clear that the best thing we can all do at this time regarding the withdrawal of midodrine is to make our voices heard, by contacting both the FDA and our representatives. The decision was about politics, not patients.


I contacted the FDA on Wednesday. Many of you have asked about writing letters and where to send them.


The form is simple. It requires your name, email address, and desired text.  


If you are interested in helping to speak up about midodrine and the devastating effects losing it is going to have on my life and that of others, I have included two versions of a letter below, so that you may choose to cut and paste the text of the one with which you are most comfortable. I simply made a few edits to the letter I emailed.  There is no paragraphing because that is the way the letter gets sent via email.

Letter 1: Includes a 'personal story' about me. You need to substitute in your relationship to me. I have marked this section in bold. Otherwise you only need to cut and paste.


Letter 2: Does not include the 'personal story' and is just the facts.


I am not putting pressure on any of you to do this. I am simply making the process as easy as possible for those who are interested in helping.


The link to contact the FDA is:


http://www.fda.gov/AboutFDA/CentersOffices...DER/default.htm 


At the top of the page, you will see the headline: CDER Contact Information. Click on the first hot link you see, the "Contact CDER Form".

It will take you less than two minutes, I promise!

Over the next week, I hope to finish the letters to our representatives and post those if you are also interested in helping with that task. 

Thank you in advance for helping. I express my gratitude on behalf of myself, the doctors who prescribe this medication, and the other patients who take this medication (some of whom are my dear friends).

Blessings,

Emily

Letter 1:

I strongly urge you to reconsider your withdrawal of ProAmatine (midodrine hydrochloride) from the market. While I understand that the FDA has an obligation to enforce its rules and regulations, the decision to withdrawal ProAmatine from the market completely fails to take into account the hundreds of thousands of people who will be left suffering with debilitating symptoms of Orthostatic Intolerance. My [friend, daughter, niece, etc.] is one of those people. Midodrine has significantly improved her quality of life. Over the past 12 years, she has tried over 70 medications to treat her various health conditions which include Postural Orthostatic Tachycardia Syndrome (POTS) and Neurally Mediated Hypotension (NMH). None have been as effective OR free of side-effects as midodrine. While you are recommending that patients talk to their health-care providers regarding alternative treatments, you are keenly aware that ProAmatine is the ONLY FDA approved drug to treat Orthostatic Intolerance and there are NO reasonable substitutes for it. In addition, you have chosen to withdraw a medication that has NEVER been called out for any safety issues since it was first approved in 1996. You have made it completely cost-prohibitive for any of the manufacturers of midodrine to benefit from doing the follow-up studies you are requiring, and hence keeping the medication on the market. If the FDA is truly doing what is right for those who take the medications you approve and monitor, you will take into consideration the fact that lives like hers will be completely devastated by the withdrawal of ProAmatine. You will find a solution that allows ALL involved to benefit--the FDA, the manufacturers, and the patients who count on ProAmatine to help them work, care for children, and engage in normal activities of daily living.

                  -----------------------------------------------------------

Letter 2:

I strongly urge you to reconsider your withdrawal of ProAmatine (midodrine hydrochloride) from the market. While I understand that the FDA has an obligation to enforce its rules and regulations, the decision to withdrawal ProAmatine from the market completely fails to take into account the hundreds of thousands of people who will be left suffering with debilitating symptoms of Orthostatic Intolerance. While you are recommending that patients talk to their health-care providers regarding alternative treatments, you are keenly aware that ProAmatine is the ONLY FDA approved drug to treat Orthostatic Intolerance and there are NO reasonable substitutes for it. In addition, you have chosen to withdraw a medication that has NEVER been called out for any safety issues since it was first approved in 1996. You have made it completely cost-prohibitive for any of the manufacturers of midodrine to benefit from doing the follow-up studies you are requiring, and hence keeping the medication on the market. If the FDA is truly doing what is right for those who take the medications you approve and monitor, you will take into consideration the fact that lives will be completely devastated by the withdrawal of ProAmatine. You will find a solution that allows ALL involved to benefit--the FDA, the manufacturers, and the patients who count on ProAmatine to help them work, care for children, and engage in normal activities of daily living.