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