Nov. 05, 2012
Posted at November 5, 2012 2:58 pm by Mary Dunkle

2 Responses to The Firestorm Over FDA’s List of Diseases

  1. Dean Suhr says:

    Greetings Mary. Thanks for keeping the community updated on this very important topic. I attended the meeting at the FDA, testified orally, and submitted written comments as well. I also called for some careful thought as to how the 20 diseases are selected.

    But I respectfully disagree about the “firestorm” label. The oral comments were very reasonable with some specific disease lobbying, but I felt the overall attitude was quite respectful. There was no bickering or hostility – just a good group of advocates sharing perspective. We all know that every one of the 7,000+ rare disease cannot fit into a 20 meeting schedule and were trying to make sure that above all, rare disease was represented to address the unique issues of research with very small disease knowledge and small patient communities.

  2. Mary Dunkle says:

    Thanks for your thoughts, Dean. Our concern was that patients were not given a chance to provide input into the creation of the original list of diseases. The conversation at the Oct. 25 public meeting was reasonable, which is important and good. But several patient representatives have expressed concern about the list and the fact that it focuses on some specific diseases along with other much more general disease areas.

    We understand that FDA has been given a huge challenge in trying to assure that all voices are heard, and that there will be many more opportunities for patient input through the Rare Disease Initiative. We pledge our support to the agency in this process. But we also feel it’s important to send a strong message of inclusion early in this process, and we hope FDA will consider alternatives to the current list such as those suggested by NORD and other patient organizations in their written comments.

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