05/08/2012
https://congress.gov...
"The problem with exclusive arrangements is that they would let some companies block their competition from similar advantages."
"You don't have to settle for weak open Internet rules if you exercise your full powers."
"I think it is important to state that the intention of the limited population pathway is to still operate within the confines of safety and efficacy, and that is not altered."
"The PCAST report's fourth recommendation is the creation of a new pathway that manufacturers could choose to use for initial approval of drugs shown to be safe and effective in a specific subgroup of ..."