In re INDs for ALS Patients
- Case Date: 3/5/2009
- Project Name: Health Care Project
On February 19 and again on March 5, 2009, WLF filed formal appeals with FDA on behalf of clients who are suffering from a life-threatening disease, urging it to grant them access to a promising drug for the treatment of their disease. FDA had denied their applications (known as INDs) to use Iplex, because it claims to be concerned that no clinical study has established that Iplex is safe. WLF's clients are suffering from ALS ("Lou Gehrig's Disease"), a life-threatening disease for which there is no known cure. They sought access to Iplex, a drug in development that has shown promise for treating ALS. They have the support of both their doctors and the drug's manufacturer. WLF's appeals charged that the denial violates FDA�s own regulations, which promise liberal access to developmental drugs to patients with life-threatening illnesses and who lack any other effective treatment options. The FDA on March 10 overturned the previous denial and granted access.
More Information and Downloads:
Press Release: FDA Urged to Grant ALS Patients Access to Promising New Drug