More On Midodrine And The Fda Standoff

[MightyMouse]

Can I just say how proud I am that despite us being a tiny, tiny group of patients with a rare diagnosis, we've caused the FDA commentary website to seize up a few times. I know how hard it can be to muster the energy to do even simple things each day, like get a meal, so if you took the time to advocate for yourself, good on ya! Good for all of you who took the time to make a stand. In this post, I'm going to try to summarize the methods of contact, for those inclined to do so (certainly a personal choice, and I'm not trying, in any way to say you should do so... just sharing what I've done and trying to put all the info in one place rather than spread on 8 pages of a thread below).

To call the FDA to lodge my opinion, I called:

1-888-463-6332, select #4 Speak to a representative, #3 Human Drugs, #1 Human Drugs.

regarding Public docket (FDA-2007-N-0475)

Then I emailed re: Public docket (FDA-2007-N-0475) to druginfo@fda.hhs.gov

the other way I contacted them was via a webform on the CDER here:

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

And lastly, although probably late for now is to write directly using the old fashioned paper and envelope method here;

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.

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

and I welcome anyone to copy/paste my letter, or use it as a base and alter it to meet your own personal requirements.

I am very concerned by the decision of the FDA to withdraw the marketing approval for Shire Development Inc.'s midodrine hydrochloride product, Proamatine. The FDA is requiring that Shire conduct additional testing, which will cost millions of dollars, and apparently the company would rather stop producing the drug at all than go through with this testing. This is *NOT* a safety issue, but rather a procedural argument between the FDA and the makers.

The problem is that this drug and all generic versions are also now at risk of no longer being available at all in the US, or only possibly on a very limited basis. The generic makers have been given a few weeks beyond the limit for Shire, late September, to provide the FDA with additional testing results. However, this is cost prohibitive and it is likely there will soon be *NO* source for this medication in the US.

Midodrine is a prescribed drug for the conditions that result in low blood pressure, such as Orthostatic Intolerance (POTS [postural orthostatic tachycardia syndrome], NCS [neurocardiogenic syncope] in particular). I have a genetic collagen defect that resulted in a diagnosis of POTS, NCS and global dysautonomia (dysfunction of the autonomic nervous system). I also have been the volunteer administrator of a medical support group at DINET.org (Dysautonomia Information Network) for the past six years. I have come to know more than 6000 active members with this condition, many of whom depend upon this drug for quality of life and the ability to function independently by stabilizing blood pressure; without access to this drug, hundreds of thousands of US patients are facing the prospect of losing their jobs, their ability to care for family, participate in daily life, and function without disability.

There is no substitute drug for midodrine. Midrodine is not a widely prescribed drug in the general population, except that is is the primary first line of intervention for patients with low blood pressure, so it is not in the economic interest of the manufacturer (Shire) to conduct extensive additional testing. A recent email from Shire indicates their intention to cease production rather than comply with the FDA for financial reasons. I am imploring you to work with the FDA regulators to keep this drug available in the US, as there is no other similar option in the marketplace. Midodrine (ProAmatine) has more than a decade of safe use in the United States.

As someone who relies heavily on prescription medication in order to function, to work full time with children with autism, and teach part time to prepare new teachers to serve children with severe disabilities, I am trying to remain hopeful that you, my elected government officials, will advocate on my behalf. I am relying on you to represent me, and the thousands or other NJ patients who will likely be unable to work, and possibly become completely disabled and fully reliant on others for daily needs if this drug is withdrawn from market.

http://www.ashp.org/import/news/HealthSystemPharmacyNews/newsarticle.aspx?id=3387

Okay, hope that provides help to those of you who've been trying to work on this issue (I know it's not everyone's issue, but for those who want to take a stand, I'm hoping to just give you a one-stop-shopping post).

Nina

[janiedelite]

Thanks Nina.

[DancingLight]

Thank you Nina!

I just got this information and link from the CFIDS Association and thought it was helpful too, as it lets us know what the medical community is saying/doing.

The Heart Rhythm Society has written to FDA about the hardship that removing midodrine from the market will cause to individuals with OI. You can read their letter at http://www.hrsonline.org/Policy/DevicesDrugsFDA/Drugs/FDA_Midodrine.cfm . We will be posting an alert on our Grassroots Action Center with a template letter to FDA on this topic. You will be notified about the opportunity to add your voice to others.

I agree....we really made a huge effort when it comes to this! Thanks for all of your work!

[Rachel]

Thank you for consolidating all of this contact information, Nina. It is very helpful.

Good link, Emily. Thanks for sharing that.

It has been very frustrating to learn of the FDAs proposal to withdraw midodrine, but I must say that it has really been exciting to seen everyone work so hard together to fight this! In the past week there have been so many facebook statuses and posted links to get the word out about the devastating impact this would have. I even had friends repost the FDA contact info and ask their friends to fight for us too.

I think it is so great that such a small number of patients were able to gather up such an army. The FDA had no idea what they were in for.

Now I'm just hoping and praying that it works.

Rachel

[Stace915]

I just got a phone call from Debbie who runs Dynakids, she said the NY times is writing an article about this whole Midrodrine issue and they were looking for a patient in NY to come and take a picture of. Unfortunately I no longer live in NY so I am not able to do it, but the fact that the NY times is running a story on it is definitely a good sign.