FDA Writes Back

Voices from all across the United States are being heard by the Food and Drug Administration (FDA) in Silver Spring, Maryland.

Help 4 HD International issued a call for action to the Huntington’s disease community on January 28 of this year. We asked as many people as possible to send a letter to the FDA addressing three big questions:

  • Why is there only one treatment approved for Huntington’s disease?
  • Why are clinical trials moving to other countries?
  • Does the FDA understand that time is something we simply don’t have?

We provided a pre-written letter on our web site and invited people to download the letter, add to it or change it or leave it as is, and mail it to the FDA.

Hundreds of people responded to our call, and the FDA is listening. Those of us who sent letters began receiving responses this past week, and the responses are promising. Though the letters appear to be computer-generated, they speak directly to our concerns. In part, the letter I received reads:

Your letter serves as a powerful reminder of the kind of strength it takes patients and their families to battle Huntington’s disease every day.

We understand that Huntington’s disease is a hereditary, debilitating disease with many physical and emotional symptoms that have devastating impacts on patients and their families. We also recognize the critical unmet medical need for new safe and effective treatments for Huntington’s disease.

FDA is committed to working with drug companies and the Huntington’s disease community to facilitate the development of new drugs to treat this devastating disease. We are prepared to use all expedited development and approval pathways available to us to further this mutual goal.

Thank you to everyone who sent letters, and a special thank you to WeHaveaFace.org for partnering with us in furthering our mission and to CIRM (California Institute of Regenerative Medicine) for helping publicize it. We are hopeful that this marks the beginning of a new chapter in the relationship between the Huntington’s/Juvenile Huntington’s disease community and the FDA. We’ll be keeping a close watch to see what happens with current and new clinical trials! For now, it’s important for all of us to realize that our voices CAN make a difference!