Senate Proceeding 06-02-09 on Jun 2nd, 2009 :: 0:27:25 to 0:31:15
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0:27:25 to 0:31:15( Edit History Discussion )
Speech By: Richard Burr

0:27:26 to 0:27:46( Edit History Discussion )

Richard Burr: quorum call: mr. burr: mr. president, i ask unan the quorum be vitiated. i ask unanimous consent the call the presiding officer: without objection, so ordered. mr. burr: mr. president, i come to the floor because the united states senate this week is considering a if you

0:27:47 to 0:28:07( Edit History Discussion )

Richard Burr: regulatory bill for the tobacco there will be members who come to the floor and say we've tried to do this for 10 years. this isell passed due. well, in part, they're right. this bill was produced 10 years ago. it hasn't changed. it's exactly what was but let me try to fill in some history for the members of the

0:28:08 to 0:28:31( Edit History Discussion )

Richard Burr: united states senate. 1998, we modernization act. i was the lead sponsor of that bill in the hou representatives. spent bill to modernize the food and drug administration. now, most americans don't even realize what the food and drug administration is. it's an agency in the federal

0:28:32 to 0:28:53( Edit History Discussion )

Richard Burr: government that regulates 25 cents of ery $1 of our economy. it assures the american when you go to the pharmacy and get a drug a federal agency is there that determines that drug is, one, safe; and, two, effective. when you hospital or hospital and they take a medical device that, maybe,ermits them to go insid your body without cutting you

0:28:54 to 0:29:15( Edit History Discussion )

Richard Burr: open, that device has gone through an stepsive review by the -- extensive review by the f.d.a. and in some cases pharmaceutical products take up to 12 to 14 years for approval with the amount of clinical trials to prove safety efficacy on humans and animals and it assures every american that the gold standard in the

0:29:16 to 0:29:38( Edit History Discussion )

Richard Burr: world exists here in the united states of america. we put manufacturers and their products through a test that the world. as a matter of fact, when the euro there were efforts to harmonize our approval process in the united states with that of europe, what we found europe's adoption, then, of 15 countries, was that they take

0:29:39 to 0:30:01( Edit History Discussion )

Richard Burr: any of the 15 countries approval process. what we found in the unitedstates was that it was hard for us to find one that had as rigid a requirement as the united states of america. therefore, we didn't harmonize. and for that reason there are drugs approved in the european the united states because they either haven't met the test at

0:30:02 to 0:30:24( Edit History Discussion )

Richard Burr: the f.d.a. or they've chosen not to go through the test. now, the reason i sharehat all with you is for 2 1/2 years there were two focuses of those of us that worked on f.d.a. modernization. one was to make sure that we had an agency that could perform their task more efficiently. and, two, that we did nothing to

0:30:25 to 0:30:47( Edit History Discussion )

Richard Burr: change the assurance that the american people had that e got a prescription, every time there was a device, that that gold standard was that it was safe and that it was effective. now, mr. president, says on the f.d.a. part of their mission statement. the f.d.a. is responsible for

0:30:48 to 0:31:09( Edit History Discussion )

Richard Burr: protecting the public help by ensuring the safety of human and veterinarian drugs or biological products, medical nation's food supply, cosmetics and products that emit radiation. we meet the gold standard. we have questions about the nation's food supply.

0:31:10 to 0:31:15( Edit History Discussion )

Richard Burr: this body is taking up three or four different pieces of because of the fact that the