Senate Proceeding 02-16-06 on Feb 16th, 2006 :: 0:00:00 to 0:20:00
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0:00:00 to 0:00:00( Edit History Discussion )

. adminis?trationis doing a lot of. other?,?@b -things but? more. peaceful sort @ the who?le middle. east.partnership. i?initiative. for?example. which is.~ aiming. at ?strengb.thening @ the>? civil.societies and. the roots andbthe 7 skills that. one wouldb

0:00:00 to 0:00:14( Edit History Discussion )

hope would be. a more @.democratic order in. the .middle east.bit's a very long-term i.bem?@phasize, very. long-term.effortb ,? , esiding. officer:. the assistant democratic leader-mr db.urb.bin: i ask unanimous ?-consen?t the quorum call. be -suspended-the presidin g officer: withoutb-objection-b-mr. durbin: i risev. to. speak?`?@ about.b2

0:00:14 to 0:00:29( Edit History Discussion )

. s.2271 % senator? ? sununu's.b&b&?-bill to the. patriot?@ act i. wan?rt to commend senator jb.ohn a?:b&b&? -sununu of ne?;w. h&?ampshire for his?`b-extraordinary. efforts on. this ?-bill for. over. two years he has. been.b-part of. ab bipartisan. coalitionb&?-working. tb.o. reform. the pb.atriot |b2 act&b&b.

0:00:29 to 0:00:44( Edit History Discussion )

we?@ support the?a patot act we wanted to. incb2lude checks and a?lances to. protect theb`?&ba constitutionalb.bq rights. of americb.anb.s-in other wordsb., we want. to [?2b -improve. the patriot act notb &?-abandob.n. it.b& we came. together. across. par?tyb.b-lines. for this. effort

0:00:44 to 0:01:00( Edit History Discussion )

. because?-our. national. security. and constitutional rights. areb.b-important. to every american-and the. patriot act should. not?i ?-b.be a? politicb.al football`?-wh?@en we. launched. tb.his. effort. twob-years. ago the administration&b-said that. chab.nging. even.h one word&b-of?~ the patri?iot?@ act wasb @bi?&?{ b.unacceptable?-i'.%ve sai

0:01:00 to 0:01:15( Edit History Discussion )

d. that when it? comes?z to.b`?-writing laws, wiith the. exception ?-of the tenb commandments. handed&?, down on. stone tablets, there. is`b&b-no p?erfect? law we should. always. try to @ improveb-it ?&@ now with. senator? sununu's bil l b-and the. patriot act conference.b`b-report we. will. reauthorize the &b -patriot. act with

0:01:15 to 0:01:30( Edit History Discussion )

significantbi ?-reforms, reforms we proposed as long as. two yearsb2 ago let. me.z3 say up. front this :? outcome ?-is far from perfect there is still a lot of. worik to ?-be done &?-but the. administratiob.n was q wi?lling to let the?i@ patriot act?@ b`?&?-:expire rather. than. accept some b -of the reforms we bh

0:01:30 to 0:01:45( Edit History Discussion )

proposeb.d`b-we wouldn't. let that happen.h ?-the. patriot act will. not expire i b-b-on our watch we're. going to. reauthorize the patriot. act with new checks b.and `b&?-balances that. will help. protectb&b-innocent americans but we. won't?-stop our?2 fight forb additb.ional ?-necessary. refbaorms?

0:01:45 to 0:02:00( Edit History Discussion )

-let. me. t?2ake. a few minutes? to review the history of. the patriot.~? act?3 b.past time. of. national crisis,?2 ?`?-shortly after september 11, the president. came to us. asking. ? @congress for new toolsb2 a?nd new b-authority to fight?b terrorism ?-

0:02:00 to 0:02:15( Edit History Discussion )

whil?ie the. ruins of. the world tr?ade center were. still smoldering, co ngressba responded2b`?-on a bipartisan. basis with @ ?@ dispatch to. give. this -administration just. what theybq b-b-wanted, to be. able. to. fightb`?-terrorism. b.b&b-we understand @ - understood b.it was @ a unique. moment

0:02:15 to 0:02:30( Edit History Discussion )

. in. history bi b-we had tb.o act quickly even then we were. concerned that &?- maybe we went. too far?ir`-maybe in the heat of the moment`? -in our eb.motion, we were. giving.b`?-the. government. mor?ie. authority b-than we. should`?2 and. so. we. included. sunsets so we?`?2 b-b-could review?h this law from timeb&b-zto time. and r"?eflect

0:02:15 to 0:04:10( Edit History Discussion )
Speech By: Russell Feingold
Bill: S. 2271: USA PATRIOT Act Additional Reauthorizing Amendments Act of 2006

Bill

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on. whether?-b-web.'d made 2 the rightb : decb.ision&2 four years laterv? there's now ab&?-b.widespread biparb.tisan. cb.onsens<a that the patriot a?ct? wenbxt too-far in several specific. areas?@ ?-the vast. majority b.of the?-provisions of the. patriot?; act have not? even. been.b

0:02:44 to 0:02:59( Edit History Discussion )

.b`b2 controversial, but?h in. a few specific provisions there have?`?`?&?-been arguments that ~ we. wenb.t. toob`?-far `b ; as a result, i join. wit?@h.@ senatorb -larry. craigb. of idaho andb severalvi>: ?@b i others ?@ senators s ununu,b."`b-b-feingold v?

0:02:59 to 0:03:14( Edit History Discussion )

murkowski and?i salv?azar?@?-to introdub.ce the security.b&?-freedom. e?rnhancement act also.b`b-known. as. the "safeb " @ act b-we?2 crossed a broad and wide-political divide to. come3 together this is. really. gathering of h b -political. odd

0:03:14 to 0:03:29( Edit History Discussion )

fellows that. we -would. join. in. this. bipartisan-effort but we.~? all shared. the&&b-same?y goal `b-b-protect constitutional values&-and. freedoms. while?@ still protecting the@ security.ba of i?-america-the administration threatened t?o -veto the "safe". act if it. ever `?&?-came before. them`?&b& ther

0:03:29 to 0:03:44( Edit History Discussion )

e was. a lot o?xf q? heated 7?&b-etoric back. andz: forth b s we didn'?et. wan?@t. t~?o. repeal. anyb&-provision of the patriot act we wanted. to. make. what we?`-thought. were. sensi?@ble v? changes?-the. bill.ba had an. enormous. amount`b-of political support across. the b-spectrum from the most skefrbgt-to the most. liberal groups. in

0:03:44 to 0:04:00( Edit History Discussion )

&-washington i've never seen. another bz6ill.b&?-like ~ our?@ "safe" act that-attracted that kb.ind. of ba support?-it also was. supb.ported by @ theb&v2 b-american library assb.ociation v-because it prevented the ?& government from. snooping tz6hrough b-library records of. innocent-americans.| i. want a to thank itbq b2 v? the

0:04:00 to 0:04:15( Edit History Discussion )

lib rarians.b-for their. efforts and tell. tb.hem.b-that it paid. o. they werb:e. not b-taking the hysterical. position-as some.randedv{?@? them&-they were. taking. the right ?-b-position for the free v2? free! free trade&b-agreement. domz. that. we. hold dear-in it. countryb-the. conference. report. includes. a-number of chec?aks and?2 balances.b

0:04:15 to 0:04:30( Edit History Discussion )

-that are ?ased on provisions in b-the e "safage." on the patriot act the f i?-is permitted to ~? obtain. a john b-doe. rovin g. wiretap a sweeping &-authorv?ity. never before &? -authorized? bv?y. congress h the john? doe roving. wiretap does-not. specify the person. or. phone b-to b2e.v7 wiretapped-in other words the f i

0:04:30 to 0:04:46( Edit History Discussion )

canb-obtain a wiretap without tellingb&>~ a. cb.ourt who they. want a wetapb-or where they. want. to ~?2 wiretap like the "safe". act the patriot act conference. report : wouldb.b&b-continue to. allow roving.z[>?-wiretaps but i?at. pb.laces a b-reasonable limit on. these? -so-called john doe roving

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-wiretaps?@ in order to. obtain. a john doeb.b-rob.ving wiretap the government-uld. have. - would now be.b`?-required tov? describe. the ?&?: specific target of the wiretap to the judge who issues. the.i order-this wv?ill. help. protect innocent @-americans ib &b-under. theb.

0:05:00 to 0:05:15( Edit History Discussion )

patriot? acts,? the f i. could search. your. home.v6b 2 b-wib.thout even telling youz2 until ?-some later date -these sneak-and-peek searches b`?-were not lz3imited to just.b`?-terr?>orism cases?`"-like the?h? "safe"? act the-conference report. would requireb -the ?government to. notify. i person who is. subjected to bq ab

0:05:15 to 0:05:29( Edit History Discussion )

@b-sneak-and-pe?ek search. within. a?zz6 b-specified period o?@f time 30 `-b-days, rather thab.n the. undef. inedb`bq delay. currentlyb permitted by theb-patriot @b act ba a court. could allow additb.ional`?-delays of notic.%e. underb`b&?-compelling circumstancesb-so if. the f i goes. into. your -home while

0:05:29 to 0:05:44( Edit History Discussion )

you're. at. works gets -into your. computer e draws out?&? -all the information doesn'tb&?-leave a @ fb.ingerprint doesn't?~b&? -leave any. evidence. and? walks out ?-7the front. door. will. you ever.ba ?-b-knowb @?`b&b-under. this. provision of.v2 theb`?-b-patriot. act as changed you must `b-be notified

0:05:44 to 0:05:59( Edit History Discussion )

within 30. days`b-unless there'sr7 some extenuatib.ng ?@ circumstance which the court woul d. recognizeb `b-that was? not the case. under the b.b-b.orbriginb.al patriot act?{?@"-2:?15 - 215 of. the patriot act@b is often called 7 the library?`?-records.

0:05:59 to 0:06:13( Edit History Discussion )

division &b -this section has been. the focus ?@ b&? x of a lot of.z effor"?t.b&b-under. that. section 215 the b.f i. can obtain. your. library,`b&b-medical, fvinancial or. gunb -recordb.s. simply. by. claiming.b`b-they're. looking into. a terrorist b-investigation ?-if? the f i makes this cb.laim,-the court. must. issue a subpoena

0:06:13 to 0:06:27( Edit History Discussion )

` b-it has nb.o. ability t3o."@ even.b-question the f i about why they want to look into yb.our `?-b.sensitive personal informationb `b-this type. of court approval. is.b&b&?-b-nothing more thab.n? a ru?ber. stamp~9.9 ?!?-stamb.p&?-defenders. of. this. s ecti"?on often ?hcompb.are. it. to. a sub poena by.

0:06:27 to 0:06:41( Edit History Discussion )

a grand jury ib.n a. criminal case b`?&?-bub.t it couldn't. be. more &?-different.b`2 ?&b-in a?@ g@rand jury r criminal. case`b-situation. az person. who heceives.b`b-the. s?@ubpoena. can challenge a b-court. n?>ot under secti7on 215b `?p ?-courts have. held. that it's.b&?-uncob.nsb.titutional.

0:06:41 to 0:06:55( Edit History Discussion )

. to. deny. someo?qne b-the right. to. go. to. court to @ b&b&b-chalb.lenge. an.br order"? in an`@ ordinary crimi?na2l. proceedingb-also ?a unlb.ike. az7 person. who ?-brreceives a grand jury r subpoena,b b&b -the recipient.bq of a? sectib.on 215b&?-b-gaz6g. order -- pardon me, 215bq order. is. subject to an. aut?omatic

0:06:55 to 0:07:10( Edit History Discussion )

b-b-permanent. gag orderb&b-mr. president, i see that`?-senator grassley is. ob.n the.loorb&b-and bii know that. he. is. anxious to @b -attend a -- an important?(b.z. eventb3 ?i in? a few?a ?b moments and i have &?-about. four. more. pages?@ here. which -i woul~d. like. to. make. part of theb.z-record here. without? reading them`b&b-in so i. canba.

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. giv e. himb 6 the floor?ib-and. he. canb:bq keep @ hisb importantb -appointment&b-i knowenator baucus. is. here as?-wellb&b-so i ask unanimous consent that-the. remainder of my statement be &?-ma@de a part of the record. ?`b&-the presiding officer: w?aithout b.o?jection.b&b-mr. durbin:. i'd just. conclude. by`?&b-sayingb i?believe that we have-b-achieved s

0:07:24 to 0:07:39( Edit History Discussion )

omething positivbrb.b-with ab @?@ bipartisan. "safe". act ?@ seb.nator.~? craig sununu. and ob.thers `?&?--have joined @ me in. improving the?&b--patriot. act? as br originally ` written b-b-it has notba reached thebh@ lev?@el that i had hoped forbhb &b-it never reached the level o?

0:07:39 to 0:07:53( Edit History Discussion )

.f`?&?-quality. as. the senate. bil?l. did?&?-which. we. enacted b-but i. measured. the original&?&e patriot. act?% against this -conference report. with. senator?@b`?`?-sununu's changes and i think?`b&?s it's a positive e step forward b-and that is. why?@ i'm supporting.b`b-it"-but i. pbhromise

0:07:53 to 0:08:07( Edit History Discussion )

b.ba as. they. say b.bsb-eternal vigilanb.ce watching. this b.b&b&?-administratiz7on?a and eb.veryi-b-admib.nistration to. make. certainb -they db.on't go too. far f they &?-bhoverstep if. they. step intov`b&?r b-areas. of privacy and?`b&b&ba b-constitutional rights, ib @ will`b-b-sp eak out. and do. my @ best. to

0:08:07 to 0:08:22( Edit History Discussion )

&b-change tbrhe patriot act andv? make b.b-it a etter @?b lawbq~?`?a i. will. suppo".rt this. versionb.b&b-later. i'll enter into. theb @ record @ ?-a colloquy between myself. and ?-senator. sununu relative to the@ ?-important library provis?zions in-this act and i yield the floorb

0:08:22 to 0:08:37( Edit History Discussion )

?~?`b -mr. grassley:. mr presideb.nt?`b`b&b&?-the presiding officer: the senato?@r from iowa@bib-mr. grassley: i want to. address my fellob.w. senators. and~. also.~? in

0:08:37 to 0:08:52( Edit History Discussion )

&?-cob.operation. with. my friend,? -senator. baucus ) from. the statev of @?-montana, on. an. issue? that.bh our?-respective staffs i have. been 2: work b9[.9?! ?! b&b-working. together. for a long-period of time?"? b.bib

0:08:52 to 0:09:07( Edit History Discussion )

?b `b-we're. - as. chairman of the fi?inance cob.mmittee. and as rankingb-member that have committeeb.~?b."l?2 - or -ranking member baucus @ of that same committeeb ? we're releasingb ?-today. a report &b-we come to

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the floorb with. our?b.b-duties"? in. mind. to. ourb&-b-constituentsb.b2 to medicaid and ?`?-b-medicare beneficiariesb and to-all americanb.s and to speak of ?-urgent matters that > should.~ -concern. all of. us.

0:09:21 to 0:09:36( Edit History Discussion )

?r` b-for more than. two yearsb , b.i. have`b-followed with increasing. concernz>?h b-the. performance of the food bzand @ drug administration `-it seems like. everyb week, if. notb`b-everb.y day r some.b

0:09:36 to 0:09:51( Edit History Discussion )

. new danger. or b`b&?-risk is. brought to @ light abouta anb f.d?a approved drug.bi or.b&b-b-deviceb.b.b`b&?-as chairman. and ran?king member `?& of the committ"?ee senator bb2aucus&b-and i have a?{b ;i responsibility to 2 ?-the. american taxpayers t

0:09:51 to 0:10:05( Edit History Discussion )

o. ensure a ?-that?h medicare r and medicaid ?b.b`?-programs pay forb hrb medical?-products that. have. been.b` -appropriately approvedb in.3 ?`?&?-acovered answer. with. all? laws -in accorda?nce. with. all laws? and?i

0:10:05 to 0:10:20( Edit History Discussion )

`b-regulations.b-whether or not a product is. safe ib.b9?9 ?r safe, ?whether or not? a productb-is effective is b.v3 not only a major ?-public safety v? concern but it &b&?-also has important financialb

0:10:20 to 0:10:34( Edit History Discussion )

b`b-concerns b&&b-we understand a?i there" 6 is. a human ?&b-element to b: the food and drug ?-administ?ration's approval.b-process a?2 ?-as a? society we q recogb.nize the?`?&?-anguish of families. who musbqt`?`?&?-rely o

0:10:34 to 0:10:50( Edit History Discussion )

?n. the development of @?&b&?-innovativebq experimental. new?-medical products and treatmentys-that may or may. not save b.@ theb&?-life of. a loved oner ?-our. nation. is lucky to @ have. a ?&?@ private. markeb.tpb.lace that

0:10:50 to 0:11:04( Edit History Discussion )

is incredibly resourceful?@b and?``b-prolific in. the fb.ield of.b`?-b.medicine`b-an integral. role of the food ?and-ug ab.dministration 2b is to getb-these. potential?lyv@ lifesaving`?-products to the. market

0:11:04 to 0:11:18( Edit History Discussion )

without undue delayb&b-b-and we also. have. a?a government 6s?@?@ ?! ?&?h govern?@ment-regulated system` -where patients have. the tb.option&b-receive.[ potential - the?~ option.> b-to receive potentially lifesaving but unproven. prob.ducts `b`?-by partici?pati?ng?h volun

0:11:18 to 0:11:33( Edit History Discussion )

tarily in v&b -clinical trials &?3 b-in the end however our?;b-nation's well-founded medical`b-syb.stem?hz;.7b ; ba?~? des?pite its?b weaknesses,?-must always. roast sou?nd scienceb

0:11:33 to 0:11:47( Edit History Discussion )

--- always. res?t. on. sound science ?-the report that we'reb releaseing -on the floor today focuses on b-the.2 f.d.a.'s. approval. process?[?@ for medical. devices?@b @b `b`b&^~ ?-it is indisput?able@ that. a llb-medib.cal. devices carryb bh?: risks

0:11:47 to 0:12:02( Edit History Discussion )

brh but ?-food and?@ drug administration approval is. still?> considered theb`-go?sld standard. f?or safety a ndb.b-effectiveness 2v;b&b-however,b our committee staff report^7 raises. bh legitimate 2?&b-questions. about the?

0:12:02 to 0:12:17( Edit History Discussion )

.q?b f.d.aba's ?-decision to. approve a specific.{b.b2b`?&?-medical. device-last february @ a number. of`&?&?-aconcerns?i were i raised. to. our committee b.b; about? ab.n implantableb&

0:12:17 to 0:12:33( Edit History Discussion )

implantable-device called th?ae. vegas nerveb`?- stimulb.ator?~b ; or vbn.s as. i'mb`ba going to refer to that&?-this product v?n.s h is.b`?-manufactured by. a company calb.led b`b-cyberosnics?

0:12:33 to 0:12:48( Edit History Discussion )

-senator. baucus. and i asked our committee. staff to. review. those-concerns that a were given. to : us 7?-and for ourb committee staff~? to report their findings. to us b&b-this report. has three majorb.

0:12:48 to 0:13:03( Edit History Discussion )

?-findings?a which i wilb2l >? summarize ~2 b-very briefly?-first, the? food and drug administrationb; approved. v.n.s -for. treatment7b resistant depression b-a new. indication.2 for this.v`?-surgically implanted device 6b7.

0:13:03 to 0:13:18( Edit History Discussion )

.b-and that was based upon. a senior manager 3i overruling more than. 20 h?:b&?@ food and drug. administration.b-scientistsb a b7 m?edical ? and safetb b-officers? as well as.~ managers.bq.4?@ who?` -reviewed the data

0:13:18 to 0:13:34( Edit History Discussion )

?q"?ba on. v.n.s?;b 7b-the. high-level official. approved. thb device.v despite a resolute -conclu sion by many at. the.% f.d.ab -that the device 2 did not demonstrate

0:13:34 to 0:13:49( Edit History Discussion )

.v a reasonable &?-assurancof safety. andb-b-effectiveness rb-second?@?@ b.bh the food and drug administration has nb.ot made.b`b-public the level of. internal -dissent involved. in. this device -approval~. despite the facv2

0:13:49 to 0:14:04( Edit History Discussion )

t. that-b-the. f.d.a? has?ublicized&v&b idifferences. of scientific.b`?-opinion. within the agency h when.v`b-it hasb> annb.oub.nced otherb -controversia.l. regulatory -decisions

0:14:04 to 0:14:18( Edit History Discussion )

-third, the food and drugb&b-administration has not?a ensb.ured&?-that the publiv.c. has all tb.he accurateb.bi scib2ence-basedbib&?-information on the safety. and?b >b-effectiveness of the?{?@? v?n.s2 forbb`? -treatment-resistant. depression.>~.

0:14:18 to 0:14:32( Edit History Discussion )

b-so?@ health. care providers relying ? on the f.d.a.'s. informationb-b-about r this. device may? not? be `b&b-b-able to. convey. complete risk? -information.zb t?o b 2b each patientz7?`?; so in. the endb.,

0:14:32 to 0:14:47( Edit History Discussion )

. this. senior.7b.>? food.b`?&b-and drug?> administration ?@ officiaal b`b-not over - not? only overruled b-mo@re than. 20 food and drug ?`?--administration?r employeesb but he &?@ stb.ated to. our committee staff?2b& ?-that the public. would not be

0:14:47 to 0:15:01( Edit History Discussion )

h b.made aware of the scientific `b&b&"-dissent over whether theb device.~:b.2?-is reasonably. safe b v? and effective?h.9.9 ! b-effective.b&?-until today. this officialsb.b-deta?riled?a?i?

0:15:01 to 0:15:15( Edit History Discussion )

. conclusions? remain-confidenti?ial andb % unavailable?@"2z; to.b-the publv?ic?b.>?`b-we are?@ releasing theseb -confidential conclusiob.ns in. the?`?@ ? apv?pendix to the. report ~-some of his own? conclusb.ionsi ~ -raise serious. questions?@

0:15:15 to 0:15:30( Edit History Discussion )

in our"`?`b&b-b-minds b-for. example, i. want. to. quote~3b-frombi hb.is?2 override memorandum z2?>x&b-quote -- "i. think it. needs to. be`?&b-stated cleb.arly?ab.b

0:15:30 to 0:15:45( Edit History Discussion )

? andb @~? unambig?uouslyb-that cerztain? v?n.s data failed-to reachv> or. even. come. close to r ?-reachingb statib.sticalb &?-significance? with. respect to its primary. end pointb`b&b-i b.think. that one. has tb.o. c

0:15:45 to 0:15:59( Edit History Discussion )

onclude @ that basedv? on. that. data x either p>b the. device. has no. effect.~~ or. if -it does 2 hav?e. an. effect b.bq that inb-b-order to measure that. effect, aib[ longerb.i period. of i follow-up is 7b

0:15:59 to 0:16:14( Edit History Discussion )

-required."b b& the events. and circumstancespb`b-surrounding the food and drug administration's review. and?; a roval of v.n.s for treatment?~9.9 ?! v: b&?-b.treatment-resistant. depression&b-which. you will. find a detailed. in`b`&&z> b-this report 7 that. we'?re

0:16:14 to 0:16:28( Edit History Discussion )

? releasing raises critical. q?ruestions?@b aboutb 2 z`b-the food. and drug's -administrati?ve so-calledb -authoritative. device. approvabl`?-process.brb bxb.~>~-i'm a greatly concerned that

0:16:28 to 0:16:42( Edit History Discussion )

. the food and drub.g administration b[?@'sb`?-standard for approval may not.bq b-have?@ been.z> met here.2b rb , and. if @b&b-b-that?'s the case @, it?2 raises.b&b-b.further. dif ficu?2lt questions&?-inclb.uding whether or not -medicare and medicaid 2 dollars ?-should be.

0:16:42 to 0:16:57( Edit History Discussion )

useb.d. to. pay for this`~&b&b-device now?@v?~?b&?--accordingly. ?, we are forwardin?>g-thz2e report. to. secretary leavittb @?b`?-b-administrator. mcclellan and?-actingv2@ commissioner.~7?a.

0:16:57 to 0:17:10( Edit History Discussion )

. vaughn.y s b.b`b -sschenbach?2 fb.or their?@ comment ?&b-these.z are difficult matters tha t`?-deserve their. attention brivment &?-clos>?e, i want. to commend the

0:17:10 to 0:17:24( Edit History Discussion )

?xb`"-commitment and dedb.ication of the ?&b-more than. 20. f.d?a scienti~?sts-b.who tried to @ do. the right thingb`b`b&-z>in this. case @ as @ they probably. do &b&?2 ?-in?2 every cb.ase and not?@ stray from.b`? ievidence?-bb.ased science b`?a b&?-i. applaud t?aheir effort.b:.

0:17:24 to 0:17:38( Edit History Discussion )

. ob.n. behalf-of the american. peopl e ab.b-mr? president, i ask for?-unanimous. consent that my b&?-prepared?@ remarks be. submittedb&?-for. the record. in. their entirety brb.br?`b&b-and. also. the executive summary z&?-of theb report rbi?@

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i thank you and i now yield the`?-floor. to. my. colb.league&?-the presiding officer: without ?&b -objection, the remarks will beb.b-submitted2 b-the senab.tor. from. montana is&b&b-recognized?:b

0:17:53 to 0:18:08( Edit History Discussion )

b ib i ?6 ?@ z7 b:b.b&b-mr baucus: mr presidentb., i`?`?-b-join the chairman of the financeb-committee. senator grassley, in`b-commending our finance

0:18:08 to 0:18:22( Edit History Discussion )

bx committee?`b-staff on the report. that. we `ba b -release. today?`b&-b-this report deals with an &?-important public safety. matterb 2b -the food and drug administration?a?@b.ba and. approval. process of. the?-f.d.a. has long. beeb.n. considered `?@ the gold standard. in 7 this

0:18:22 to 0:18:37( Edit History Discussion )

z`b&b-country`b -we rely. on. thea f.d.ab to. review-drugs. and to. review. medical?`-devices b.b`?&?-we rely on the f.d.a to tell us b-by providing itseal. of. ?`?-apb.proval that. drugs and devices-are safe? and?s that.ba they'rezsb @ effective.

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b 6 ?-how ~? allz7 drugs carry some @ risk,?&?&?-b-some are? more. risky than. others b`?-but if. the f.d.ab i determinez7s`?-that a drug or. device. is. safe. to.b`?&?&?-brinb.g to the market ? americans b-nerally. feel that we could? use ?

0:18:51 to 0:19:06( Edit History Discussion )

-the treatment. without undueb-concern i?@?`b&?-we americans rely. on @ the fbd.a to ensure @ that.@ managers.z7 by &b-f-sufficient warnings. of. the?irb&?-products?r risks sb.o. their health`-care providers ab.nd patieb.nts. canb`b-make informe?d. health. care -decisions.b&b-

0:19:06 to 0:19:20( Edit History Discussion )

the. f.d.ab has a complex approval process ?@?@^7 a.eview team, includingb`?&?@ scientisb.ts and? doctorsbr? andb.b-specialistb.s. surveys all theata-and. makes a recommendation`b-regarding. whether to. approve the drug or. device |.".bab

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-the. review team. then. forwards i?`b-b-b.its. recommendation. to.z management-for review.~?b.b&b-th?is process can be.bh~ lengthy and?`b-intense @?@b.b&b-la st year @ conb.cerns. were."? brought b&bi to t?he?@ finance committee?-regarding. how thev review.zw process

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had unfolded. in. the case. of a ?device known as hb v.n.s?b therapyb.b`?-systemb.:?`?-crieberonics makesb the system.ib `?-anb.d ~~was seekingb ba approval. forb b the b

0:19:48 to 0:20:01( Edit History Discussion )

&-device for patients with 2b.b.b-depression b-senator.i grassley. a?nd i asked our?-staff i to. loobpk. ib.n what. had goneq?@-on the. finance?~ committee has?&b -responsibility for medicare. and?b&-medicaid programs. ab.nd t he ?`?-millions of. americans that.