American Epilepsy Society Letter to the FDA for Speedy Approval of Antiepileptic Medications and Devices

February 8, 2018

 

Scott Gottlieb, M.D.
Commissioner, U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD, 20993-0002

 

Dear Dr. Gottlieb,

The American Epilepsy Society requests that the U.S. Food and Drug Administration (FDA) support the rapid approval of new, potentially lessexpensive drugs and devices for the treatment of epilepsy. This is particularly important for the treatment of rare or “orphan” indications, where antiepileptic drug (AED) options are very limited, and the costs can be extremely high, potentially limiting access to some of our most vulnerable patients.

We support your statement that "no patient should be priced out of the medicines they need." The American Epilepsy Society will work with the FDA in its efforts to streamline the development of new drugs and devices, improving the range of treatment options available to patients.

Sincerely,

Shlomo Shinnar, M.D., Ph.D.
President
American Epilepsy Society