Action Alert: Write to the FDA Supporting Chelator Application

August 15, 2011 – As previously reported, on September 14, an FDA committee will be reviewing the new drug application for Ferriprox, an oral chelator that is also known as deferiprone or L1. CAF encourages interested individuals to contact the FDA Committee to express their support for this chelating option.

Below is some information that might be useful to you as you write your letter. Please note that the deadline for submission is August 30.

1. The letter should go to:

Caleb Briggs
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Building 31, Room 2417
Silver Spring, MD 20993-0002

If you want to email it, the email address is If you want to fax it, the fax number is 301-847-8533.

If you can send us a copy of your letter/email, that would be great. (

2. Deadline for letters is August 30. They must be received at the FDA by that date.

3. Your first paragraph should say something like this:

“I am an individual with thalassemia who is writing in support of the new drug application (#021825) for the oral chelator Ferriprox, which is to be discussed at the September 14 ODAC meeting.”

If you want, you can be more specific about your diagnosis
If you want, you can be more specific about your diagnosis – beta thalassemia major, beta thalassemia intermedia, e beta thalassemia, Hemoglobin H, etc.

4. Here are some points that you should make. (Please phrase these in the way that works best for you.)

• Thalassemia patients need to have as many chelating options available to them as possible.

• Not all patients are able to adequately remove iron with the current chelators (Desferal, Exjade). This might be for any number of reasons: the difficulty of administering the drug, side effects, insurance coverage that keeps a person from getting the drug, or simply that some people simply don’t get the desired results with a particular drug.

• Heart iron continues to be a big concern for people with thalassemia. Because studies indicate that Ferriprox can play a significant role in helping to reduce heart iron, it is important that U.S. patients have ready access to the drug.

4. If you have used Ferriprox, it’s important that you talk about your experience with it – explain why you needed Ferriprox, and how it benefited you.

5. If you have had any personal adverse experiences with Desferal or Exjade which demonstrate the need for further options, please include them. If you have not had any personal adverse experiences but still have concerns – for example, about recent label changes with Exjade which warn about the possibility of renal or hepatic failure in some patients – you might share these.

6. If you have strong feelings, it’s important to get this across without “ranting.” Your passion is heard much clearer when you write in a strong and convicting manner. The FDA respects patient/consumer opinions and is giving you the opportunity to be heard. Make your points knowing that your voice is heard with respectful and open minds.

Thank you again for helping to let the FDA know about the importance of Ferriprox to the thalassemia community. If you have any questions, please contact Gina Cioffi ( or Craig Butler ( and we will be glad to help. (Please note that Craig will be out of the office from August 20 – August 28, so if you need help during that time, please contact Gina.)

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