Fda Withdrawing Proamatine/midodrine?!

[MomtoGiuliana]

I got the same response from the FDA.

[DancingLight]

I sent the following letter to the FDA today:

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. I am one of those people. Midodrine has significantly improved my quality of life. Over the past 12 years, I have tried over 70 medications to treat my 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 mine 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.

I wanted to add a personal story about how the medication has helped me. I can't wait to get my response! Haha!

[erik]

Anybody know details on the nature of the dispute? It appears the drug manufacturer claims they did the necessary studies and the FDA deemed them unconvincing or missing? Would it happen to be something like a dispute over whether "surrogate markers" are sufficient evidence in lieu of "clinical indicators"? In other words, I suspect there is ample evidence of BP elevation after midodrine administration... but perhaps the FDA is insisting on scientific evidence of specific patient symptom improvement. I hope this is not the nature of the dispute, because for O.H. or O.I. it sure seems to me like a "surrogate marker" can be take as supportive evidence.

[Chaos]

I called my cardiologist last week to ask about getting a 90 day prescription. The secretary called me back to say "he didn't believe it was going to be withdrawn from the market." I sent her a copy of the email response I'd gotten from the FDA (just like everyone else has gotten). Today my doc called and left me a message saying "oh! they are withdrawing it, but the electrophysiology cardiology group is lobbying to get the FDA to come to it's senses on this." He also said they are trying to get the FDA to accept info from "the over 100,000 patients who are currently being prescribed Midodrine" as a substitute for further studies. (He never bothered to answer my question about getting the 90 day prescription however. Yeesh!

[Noreen]

Apparently the FDA has assigned someone to receive letters. Now whether this helps the generics stay on the market or allows those who write in to be on the case-by=case' list they alluded to in their press release, I couldn't say.

this is from the Facebook campaign to keep midodrine on the market_(the she is someone higher up at the FDA)-

"We need to write to the Director of the Division of Cardiovascular and Renal Drugs and send it to the FDA center of drug research and evaluation. Send it directly hand signed with your address a to: Dr. Norman Stockbridge, US Food and Drug Administration, 10903 New Hampshire Ave., Silver Springs, MD 20993.

She said to write a short story, tell how you felt before taking pro/mid. and then tell how it has heped you.and how it will effect you when it is taken off the market. Like I told her we are sick and doing a diffcult petition will be hard for most of us to do. She agreed and said, for us to all send in our complaints this way and assured me that this would be the most effective thing for us to do.... yes I am so glad I got her on the phone this time..."

I wrote my letter and am resting before finding an envelope and mailing it. I think I will include this information when contacting congress rep and senators.

[DancingLight]

Nina,

Your letter is FANTASTIC. How would you/do you feel about me or others using parts of it? I am trying to get letters together from my perspective, and also a template together for friends and family to send. I don't want to use parts of your text without you feeling completely comfortable with it being used by me and others.

Thanks to everyone who is fighting this.

I'm trying not to panic!

Emily

[MightyMouse]

Thanks, use to your heart's content. I actually started with the base letter that was posted here by MomToGuiliana a few days ago, and then I added/edited my own content. You can copy and paste whatever you like from it.

[Noreen]

Health Science Administrator in the Office of Orphan Products Development at the

Food and Drug Administration said that The FDA Office of Special Health Issues has indicated that all comments/complaints/concerns regarding the proposed withdrawal of midodrine from the market should go to one number or website: 1-888-INFO-FDA (888-463-6332) or DRUGINFO@FDA.HHS.GOV. They are keeping track of all phone calls and e-mails.

The decision to withdraw the approval of the applications will be made by the Division of Cardio-Renal Drug Products following receipt of the comments to the Notice for Opportunity for a Hearing. So it's not for certain that a withdrawal will occur but knowing the level of impact will be important to document that decision.

The Doctors at the FDA that are in charge of removing Proamatine from the market are Doctors Woodcock and Stockbridge. If you want to send them letters:

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

Even if you have sent a letter to the FDA, you might want to print a new one addressed to these individuals.

[MightyMouse]

Thanks Reen, I went to the feedback site, referencing this url

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm222580.htm

and then sent a letter addressed to the two people you listed using the following form:

http://www.accessdata.fda.gov/scripts/email/cder/comment.cfm

[Crow]

The orthostatic hypotension drug, Northera / Droxidopa, that Chelsea Theraputics is trying to get approved, is for neurogenic orthostatic issues. Would that work for non neurogenic orthostatic issues as well? It's a psychoactive, and from what I understand, midodrine doesn't affect the CNS.

Thanks.

[houswoea]

I got my midodrine refilled today without any problems. No one said anything, and they even had to call my cardiologist to approve the refill. Maybe it won't be so hard to get after all?

[nmorgen]

Health Science Administrator in the Office of Orphan Products Development at the

Food and Drug Administration said that The FDA Office of Special Health Issues has indicated that all comments/complaints/concerns regarding the proposed withdrawal of midodrine from the market should go to one number or website: 1-888-INFO-FDA (888-463-6332) or DRUGINFO@FDA.HHS.GOV. They are keeping track of all phone calls and e-mails.

The decision to withdraw the approval of the applications will be made by the Division of Cardio-Renal Drug Products following receipt of the comments to the Notice for Opportunity for a Hearing. So it's not for certain that a withdrawal will occur but knowing the level of impact will be important to document that decision.

The Doctors at the FDA that are in charge of removing Proamatine from the market are Doctors Woodcock and Stockbridge. If you want to send them letters:

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

Even if you have sent a letter to the FDA, you might want to print a new one addressed to these individuals.

I found their email addresses if you want to email them and write them a letter. norman.stockbridge@fda.hhs.gov & janet.woodcock@fda.hhs.gov

[Crow]

I wrote the http://www.checkorphan.org/ folks and the National Organization For Rare Disorders http://www.rarediseases.org/ to see what their respective stances are regarding this issue, since POTS is considered a rare disease.

[Noreen]

"The orthostatic hypotension drug, Northera / Droxidopa, that Chelsea Theraputics is trying to get approved, is for neurogenic orthostatic issues. Would that work for non neurogenic orthostatic issues as well? "

It actually sounds promising.

They are running clinical trials with Droxidopa on chronic fatigue, fibromyalgia, dialysis patients, and more. http://clinicaltrials.gov/ct2/results?cond=%22Hypotension,+Orthostatic%22

It has been in use in Japan for over 10 years. The company makes 5 million dollars on it in Japan for neuro othostatic dx. I have been unable to find out how many patients in Japan are on it so really wonder about the cost.

The issue, assuming it is approved next month, is what dx will it be approved for (the fibro, CFS trials have not completed all phases yet). If it is approved for othostatic intolerance, will those of us with dx of NCS and POTS be unable to get it?

Would our doctors prescribe it? Would our insurance companies cover it?

Many of us have very complicated medical histories which would disqualify us from clinical trials. Until the drug is in the real world with real numbers of people taking it, it will be impossible to know how it will interact with other drugs.

[MightyMouse]

I think droxidopa will be like all of the meds--it will likely work for subgroups but not for all of us because the etiology (how the low bp or bp dysregulation happened) differs among us. Just one skim through the "mechanisms" section of the main dinet website and you can see the variety of paths leading to autonomic dysfunction.

Nina

[Noreen]

I think droxidopa will be like all of the meds--it will likely work for subgroups but not for all of us because the etiology (how the low bp or bp dysregulation happened) differs among us. Just one skim through the "mechanisms" section of the main dinet website and you can see the variety of paths leading to autonomic dysfunction.

Nina

I am sure you are right as to it not working for everyone. The mechanism by which it works seem promising, though.

"Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally. "

[MightyMouse]

I called and left my message with the FDA today registering my objections to their proposed withdrawal of midodrine from the marketplace. Here's the number I used:

1-888-463-6332, then I selected #4 Speak to a representative, #3 Human Drugs, #1 Human Drugs. Some of my friends got a real person, but I got sent to voicemail and I just left a message saying what I wanted to say. At least I feel like I "did" something on my own behalf today.

Nina

[Noreen]

I called and left my message with the FDA today registering my objections to their proposed withdrawal of midodrine from the marketplace. Here's the number I used:

1-888-463-6332, then I selected #4 Speak to a representative, #3 Human Drugs, #1 Human Drugs. Some of my friends got a real person, but I got sent to voicemail and I just left a message saying what I wanted to say. At least I feel like I "did" something on my own behalf today.

Nina

Good for you Nina.

I hope you are beginning to feel better.

[DancingLight]

I am working on my letters and also working on 'directing' friends and family as to how to speak up. The squeaky wheel gets the grease, right?

I got the automated reply from the FDA to my email, and noticed they had made a couple of changes to the letter. They are below. They have added in yet ANOTHER contact address.

I am confused about what the best way is to make our voices heard. Is it to have people call, email the FDA, email the doctors, mail letters to the two doctors listed in earlier posts, OR send a letter to the address below. I realize that maybe some of us here on the board will do all of them, but I was wondering if anyone knew the best routes to direct friends and family. I think they would be willing to do ONE of the things.

Anyways, here is the stuff that was added to letter and the new address they sent.

Would love to hear your thoughts, Thanks!

Although we cannot disclose the full regulatory history of this drug, we have exercised some regulatory discretion in retaining ProAmatine and the generics on the U.S. market for this long. Orthostatic hypotension remains an important problem for people who have it and we note that, even now, no FDA-approved alternative treatment exists to treat the condition.

We appreciate your comments regarding the midodrine withdrawal. The Docket number for the FDA proposal is: FDA-2007-N-0475. FDA is monitoring the comments and will be discussing the potential impact of such an action as withdrawal. Written correspondence to FDA may be posted to the public docket (FDA-2007-N-0475).

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

(FDA-2007-N-0475)

* Clearly and efficiently state your concern and ask your questions.

* Be sure to provide your contact information.

* Save a copy for your records.

[cnm1]

I have mailed letters, emailed and called Shire, generics, 2 people at FDA, my congressman/women, one FDA petition. I can't even believe this is happening - it is a critical drug for my daughter. Very frustrating!!

Louise

I am working on my letters and also working on 'directing' friends and family as to how to speak up. The squeaky wheel gets the grease, right?

I got the automated reply from the FDA to my email, and noticed they had made a couple of changes to the letter. They are below. They have added in yet ANOTHER contact address.

I am confused about what the best way is to make our voices heard. Is it to have people call, email the FDA, email the doctors, mail letters to the two doctors listed in earlier posts, OR send a letter to the address below. I realize that maybe some of us here on the board will do all of them, but I was wondering if anyone knew the best routes to direct friends and family. I think they would be willing to do ONE of the things.

Anyways, here is the stuff that was added to letter and the new address they sent.

Would love to hear your thoughts, Thanks!

Although we cannot disclose the full regulatory history of this drug, we have exercised some regulatory discretion in retaining ProAmatine and the generics on the U.S. market for this long. Orthostatic hypotension remains an important problem for people who have it and we note that, even now, no FDA-approved alternative treatment exists to treat the condition.

We appreciate your comments regarding the midodrine withdrawal. The Docket number for the FDA proposal is: FDA-2007-N-0475. FDA is monitoring the comments and will be discussing the potential impact of such an action as withdrawal. Written correspondence to FDA may be posted to the public docket (FDA-2007-N-0475).

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

(FDA-2007-N-0475)

* Clearly and efficiently state your concern and ask your questions.

* Be sure to provide your contact information.

* Save a copy for your records.

[MightyMouse]

The fastest way to get your letters about this docket to the FDA is to use their website via the CDER which I noted in an earlier post. I spoke with an FDA rep today and she suggested 1) contact Shire directly (I don't think that's going to make any difference) and 2) contact the CDER team, referencing the docket number that Em mentions).

Nina

[MightyMouse]

Dynakids has a good explanation of who, what, and how to contact... if that's something readers here are inclined to do.

http://www.dynakids.org/midodrine.jsp

[DancingLight]

Oh, that DYNA Kids link is fantastic! Thank you!

And thanks for the direction on what to tell people to do. My friends have been very generous in their efforts to call the FDA or email...so it is good to know that works!

[Rachel]

Thank you, Nina. The DYNA Kids link was a very helpful one.

I have been confused about just how to contact the FDA since there are so many options! I have contacted them in a couple of different ways, and now I will contact them again.

I have many family members and friends who are also contacting the FDA and their congressman. At least we won't go down without a fight!

[wareagle]

Just a quick update.

I spoke with Leslie at the FDA this afternoon. She said that they are going to have a meeting regarding this issue at the end of the week. They are counting all calls, letters and e-mails. She indicated that the best way to contact them at this time would be to send an e-mail to:

druginfo@fda.hhs.gov

They are printing these e-mails for the meeting.

Apparently there is a public docket available but it has been so over-run with people contacting them that it is not accessable right now. They are still awaiting an official response from Shire but believe, as I do, that the future of this Medication is now in the hands of the generic manufacturers and the FDA.

Every little thing we can do at this point helps...so don't give up yet!