04/09/2013
https://congress.gov...
"We need to ensure that we don't force FDA into a position where its approval standards are lowered."
"I strongly support the development of drugs to enhance therapeutic options for patients with rare diseases."
"I both understand and support that goal, but I also want to ensure that in seeking to accelerate drug approval that we do not expose patients to unnecessary and unacceptable risks."
"It seems to me that most of the claims about FDA's poor performance have in fact been disproved."