"the House recently passed H.R. 2112, the fiscal year '12 agriculture appropriations bill, which would cut the FDA budget by roughly 11 percent, or $285 million."
"if the proposed cuts to the FDA budget included in H.R. 2112 are enacted, will FDA have to lay off employees? Yes or no."
"will the proposed cut jeopardize the number of review staff that FDA is able to employ at the center? Yes or no."
"will the proposed cut have a detrimental impact on any efforts to improve reviewer training at the center?"
"one of the complaints that my office consistently receives is that medical device approval process has a certain inconsistency from reviewers at the Center for Devices and Radiological Health."
"Now, there are some areas of improvement in the current medical device approval process but I would ask my colleagues here, does anybody remember the Dalkon Shield?"
"So is there anybody around here that wants to return to what President Ford called the horse and buggy days of device regulation?"
"We face huge risks. We talked earlier about pharmaceuticals that kill people and cause children to be born with flippers."
"It makes it very hard to reach civil penalties and apply them to serious misbehavior, does it not?"
"I am concerned this may preclude the Secretary from considering other information..."
"Should it?"
"Starting with you, Mr. Black, yes or no, is this something the industry is doing already?"