Monday, February 11, 2013
Senior biopharma executives and
patient advocates hope the next director of FDA's Division of Neurology
Products will have both the inclination to accept higher levels of regulatory
uncertainty as the price for developing treatments for devastating diseases,
and the stature to overcome inevitable opposition from within the agency and
second-guessing from politicians and the media.
To make real progress against
Alzheimer's and Parkinson's diseases, multiple sclerosis, epilepsy and other
neurological diseases, drug developers and patient groups want FDA to approve
drugs based on new endpoints, including some that haven't been as rigorously
evaluated as has traditionally been required.