Sending Office: Honorable Mike Coffman
We have made great strides in treating many life-threatening diseases, but treatment for ALS (Lou Gehrig’s disease) has lagged behind. Unfortunately, this rare but devastating disease is fast-acting once diagnosed and affords little opportunity for study.
Families are often left scrambling to adapt and have little time to advocate for federal policy changes. Yet I, and many of my colleagues, have had the opportunity to get to know victims and their families, and it’s up to us to advocate on their behalf.
Fortunately, there are opportunities to make a difference.
Please join me in sending this letter to the Food and Drug Administration. It urges FDA to quickly finalize guidance for ALS drug development, a project it has been working on for several years. The ALS Association has participated in developing the proposed
guidance using proceeds from the ice bucket challenge. The letter also urges FDA to create guidance for drug sponsors and physicians under the Right to Try Act. At present, drug manufacturers have some concerns about how adverse reactions among Right to
Try patients might affect approvals of the drug; FDA should clarify how it will look at these developments so that it’s easier for drug sponsors to participate. Finally, the letter asks that FDA appoint a specific point person to serve as a liaison with the
It is my hope that, with renewed attention, we can start making strides to find effective treatments, and eventually cures, for this terrible disease. Please contact
Jeremy Lippert in my office with any questions or if you would like to sign on.