04/10/2013
https://www.congress.gov...
"Congress charged the FDA, not CMS, to be the agency responsible for evaluating the safety and efficacy of biomedical products."
"We have had a great success, I believe, and we have got another agency of the Federal Government that just absolutely cut our legs out from under us."
"What concerns me in this case is not FDA's approach. I think you stayed within your lanes."
"Dr. Esham accelerated approval is a critical regulatory pathway that provides timely review of treatments for patients with serious and life threatening conditions for which there is an unmet need."