the presiding officer: is there a sufficient second? there appears to be. the yeas and nays have been ordered. the clerk will call the roll. vote: vote:

vote:

vote: the presiding officer: are thrp any senators wishing to vote or change change their vote? if not, on this the yeas are 92, the nays are three, and the nomination is confirmed. under the previous order, the

motion to reconsider and laid on the table, the president will be notified of the senate's action and the senate will resume legislative session. under the previous order, the senate stands in recess until senate stands in recess until he indicated the flood insurance extension may run into trouble

over amendments. here's what he said. >> mr. president. we have accomplished a lot. everyone knows how grateful i am to senators stab know and done stabenow for working through the farm bill. i'm grateful for the great work of the finances committee, the commerce committee, banking committee, working through the highway bill. there's a possibility we can get that bill done. i think the chances today are better than 50-50 we can get a bill done. but we're still looking at speaker baner to help us get that over the finish line. so we'll see what happens on that. mr. president, we have the fda bill, we'll complete that tonight. a very important accomplishment for us. we have the student lone issue

we're working on that. we hope to get that done soon. i think there's a general feeling that we have work out a compromise at that time is seasonable. with the help of senator bachus and harken and others. i talked about the highway bill. we need to get that done. mr. president, the remaining issue is flood insurance. and we are doing fine on flood insurance, except i'm told last night that one of the republican senators wants to offer an amendment on when life begins. i think that this -- some of this stuff is just -- i haven't -- i have been very patient working with me republican colleagues and allowing relevant amendments on issues and sometimes we even do

nonrelevant amendments. but really, on flood insurance? are we going to have to start dealing, as we did with the highway bill, for weeks and weeks, with contraception? now we have another person wants to deal with when life begins. i don't understand what this is all about. i want everyone to know, this flood insurance bill is extremely important. the big pushers of the bill or republican senators, veteran republican senators, and they better work on their side of the aisle, because i am not going to put up with that on the flood insurance. i can be condemned by outside sources. my friends can say, let them have a vote on it. there will not be a vote on that with flood insurance, we either do flood insurance with amendments that deal with flood insurance, or we will have an extension. after all the work put into this bill, this is ridiculous, somebody says i'm not going to let this bill go forward unless

i have a vote on when life begins. i'm not going to do that and i think i speak for the majority of the senators. now, if the republicans won't stand up to the person that's going to do that, i'm not going to i've tried my best to deal with these issues that have nothing to do with 'a piece of legislation. but with the end of the month stairing -- staring us in the face, so many important things. student loans will be doubled. flood insurance will disappear. highway program will disappear if don't get it done. fda bill would create all kinds of problems. i think this is outlandish. let somebody if they feel move to talk about when life begin, have them come give a speech here. >> senator oregon hatch is facing his first primary challenge today. since winning office in 1976. a few months ago the utah

republican was considered vulnerable but the 78-year-old hatch is now viewed as the heavy favorite in today's matchup against a former state senator. it's been the most expensive and detailed campaign operation in utah's history. another key primary today in new york, representative charlie rangel is running for a 22nd 22nd term. the first time he faced voters since the house censored him 18 months ago for failing to pay taxes and filing misleading financial disclosure statements. the pentagon is facing about a half billion dollars in automatic spending cuts starting in january. the cuts referred to as sequestration will be the result of congress unable to agree on alternative cuts. brookings is discussing the situation this afternoon, and the top republican on the senate armed services on subcommittee on readiness will speak.

live coverage starts at 1:30 eastern on c-span 3. this evening, jamesman, talks about the president's foreign policy decisions and profiles the people advise him. book tv.org will have live coverage at 7:00 eastern. >> washington journal continues its spotlight on magazines wednesday with former bank of america president, sally crutch, who has written an article how to improve the banking industry. the article is linked on c-span.org and we'll talk with her life wednesday morning. >> sunday award-winning author and historian is our guest on book tv's in depth. his passion for u.s. presidents and the great american pastime, baseball, has resulted in a dozen books, including 1920, the

year of the six presidents, 1960, lbj vs. jfk verse nixon, and rothstein, about the fixing of the 1990 world series. join us live with your calls, e-mails and tweets, sunday, out noon eastern, on book tv's in depth on c-span2. >> armed services committee ranking member senator john mccain and other republican senators held a briefing on the obama administration's national security leaks. senator mccain and other senators are calling for an independent investigation regarding the leaks. this is about 30 minutes. >> good morning. i'm joined by my colleagues, senator chambliss, the ranking republican on the intelligence committee. senator john corn enis a member

of the armed services committee and senator wicker, member of the armed services committee, senator graham is unable to join us. it's important for us to recognize the gravity and the seriousness of this issue. according to senator feinstein, the chair person of the intelligence committee, i quote here, this disclosures have seriously interfered with ongoing intelligence programs and have put in jeopardy our intelligence capability to act in the few tumor each disclosure puts american lives at risk, makes it more difficult to recruit assets, strains the trust of our partners and threatens imminent and irreparable damage to our national security in the face of emerging and rapidly adapting threats worldwide. those are the word of the chair person of the intelligence commitee. that is an indication

how serious this issue is and i understand that immigration and health care and a number of other issues are getting the american people's attention, but unfortunately, apparently, these leaks go on and on and on. so, in "the new york times," mr. sanger in his book, says, almost every single member of the president's national security team was generous enough to sit down and take through their experiences more than once. he goes on to say, some of the sources in the recent publications specifically refuse to be identified because what they were talking about relateed to classified or ongoing programs. in his book, which describes the administration's use of drones in yemen, numberweek journalist writes, quote, when i quote president obama or other key characters, i do so only if that quote was relayed to me by a source who personally heard it. earlier this month, the president of the united states

said, and i quote him, the notion that my white house would purposely release classified national security information is offensive. it's wrong, and people, i think, need to have a better sense of how i approach this office and the people around me approach this office. well, let's see how the people around him approach the office. according to, again, david sanger, almost every single member of the president's national security team was generous enough to sit down and talk through their experiences, some most -- more than once. most were willing to place at least some comments on the record. as an example of how incredible, how bizarre, this entire situation is, is one an next dote i'd like to quote in his book, mr. sanger depicts a

curious meeting that occurred in the fall of 2009 in pittsburgh at the g-20 economic summit, and this is mr. sanger's book. as often happens when the president travels, there was a dinner organized with a number of other reporters and several of obama's political aides, including david axlerod, and rahm emanuel. the talk was mostly politics and the economic downturn. just as coffee was being served, a senior official in the national security council tapped me on the shoulder, after dinner, he said, i should take the elevator to the floor of the hotel where the president had his sweet, quote, we'll talk about iran, he whispered. obama was not back at the hotel when we gathered outside his suite but most of the rest of the national security staff was present and armed with the intelligence that had been collected over many years about iran's secret site, as they laid it out on a coffee table in the

hotel suite. via satellite photos, the united statessed a mapped the construction of the building, useful if it ever had to hit it. it was clear from the details the united states interviewed scientists who had been inside the underground facility. we spent an hour reviewing the evidence. well, maybe the president of the united states was not present at his own suite in pittsburgh when obviously the notion that his white house would purposely release classified national information is offensive, is contradicted by the facts. and to think that two people, appointed as prosecutors from mr. holder's office, overseen by mr. holder, is also offensive. we need a special counsel. we need someone who the american people can trust, and we need to

stop the leaks that are endangering the lives of those men and women who are serving our country with valor and courage and they deserve a lot better. and finally, throughout these books, both of these books, and the other information that has been leaked, the latest which saying that the cia was vetting weapons that may go into syria, always have, at the end of the day, one purpose, and that -- or one effect, and that is to make the president of the united states look like a brave, strong leader on national security. this, what has taken place, i have never seen anything like in the many years i have been here. i've seen leaks. and i've seen things happen that endanger our national security. but on a continuous, ongoing, unrelenting basis, that puts in words of senator feinstein, puts american lives at risk, is of

the highest priority and it requires the appointment of a special counsel. senator champ bliss. >> thanks for continuing to lead this effort. i have been involved in the intelligence community for an excess of ten years. i dealt with intelligence leaders who are partner of the united states in virtually every part of the world, and i can just tell you that our partners are very concerned about what is happening in washington right now, with respect to these leaks and the reaction of the administration to these leaks. we've never, even though this town is known for having leaks from time to time, we have never seen the number of leaks coming out of the intelligence community, nor have we seen the level of the leaks that are now being reported in virtually every paper in the country. it seems like almost on a daily basis, even though it may not be.

but for the president of the united states to come out and say that it is offensive to him, to think that his white house would intentionally leak classified information, frankly, offends me to no end. what the president ought to be saying is that this is very damaging to the country, and we're going to do everything we took get to the bottom of it, whether it involves my white house or wherever in the intelligence community, but for him to be politically offended by this makes no sense whatsoever from a national security perspective. let me just quote some of the statements that appeared publicly in these articles and in a couple of books out there right now. first of all, president obama is quoted from inside the situation room. now, the situation room is located in the white house. you do not go in the situation room unless you have the highest

classified rating. so, somebody within that situation room, who is associated with the national security council, obviously is quoting the president. secondly, obama aides quoted as to what transpired in the situation room. senior administration officials were quoted time and again in these articles, the national security adviser is quoted as talking about a covert action program. now, we as members of the intelligence committee can't even confirm whether these programs exist, and yet you have the national security adviser talking bat covert action program. three dozen current and former administration officials within the intelligence community were interviewed, according to one of the articles. david axlerod, who is not part

of the national security team, was apparently in the situation room on a number of occasions. this is a political adviser to the president. and then lastly, the deputy national security adviser, john brennan, goes on "good morning america" quoted as saying we had the device are in control, talking about the bomber. folks, this is all classified information and yet we have folkness the white house going on tv and talking about it. now, while these are part of news stories, these are direct accusations towards the white house with respect to the source of the leaks. some of them are pretty direct. some are indirect. we all know that this town is about politics, but this is not about republicans pointing the finger at the white house. these are news reporters, just like you folks in this room, very professional, but out to

get a story that is quoting white house officials on disclosure of classified information. now, i have no question about the competence, integrity or the intelligence of the two u.s. attorneys who have been nominated by the attorney general to investigate, and this is important. to investigate only two of the supposed leaks. one, the iran issue on the interruption of their gaining nuclear capability, and secondly, the issue of the underwear bomber. there are other leaks in addition to that, and if you notice what clapper said yesterday, is that he has asked his i.g. to investigate those scenarios or those leaks that the attorney general is not investigating. now, do we really think, in spite of the capability of these two u.s. attorneys, when you

have somebody who is appointed by the administration, are they really going to be unbiased in their investigate of the administration that appointed them? one of these individuals apparently worked on the obama campaign, was involved in the vice president's selection, so he was not just a casual volunteer in the campaign. he obviously was a pretty important member of that campaign team. i was told by attorney general holder, when he called me, friday two weeks ago to say that he was going to name these two u.s. attorneys to do the investigation, that if during the course of this a conflict of interest developed, then he would consider the appointment of a special counsel. well, guess what, the more we find out about the folks that are going to be doing the investigation, the more common sense determination is, there is a conflict of interest today,

and because that conflict of interest exists, a special counsel should be appointed. senator cornyn. >> i agree with senator mccain and senator chambliss a special counsel should be appointed because this administration cannot be trusted to investigate itself. since 1999 when the independent counsel statute expired, the special counsel provision has been create red, and unfortunately, as currently written, the special counsel, these two u.s. attorneys, political appointees of the obama administration, are tasked with doing the investigation and reporting to, guess who? to attorney general eric holder, who has not demonstrated any sort of independence on his behalf as the chief law enforcement officer of the united states. i won't go into the long litany

of those but many of them are in the news this week and have been since the administration started. and let me just call to your attention the double standard under which our democratic friends operated during the time that president bush was in the white house. during the valerie plame affair, patrick fitzgerald insisted upon a letter from james comby, acting attorney general, after attorney general ashcroft recused, delegating all of the investigative authority of the department of justice to the special counsel, and declined to exercise any sort of supervisory control over mr. fitzgerald, the special counsel. so, that was an independent investigation. this is not. and if in fact attorney general holder and the administration continue to promote this pretense of an independent

investigation, my hope is that congress will take up the responsibility to do what is constitutionally authorized and obligated to do, and that is to investigate this matter ourselves. i've talked specifically to senator collins and senator lieberman of the homeland security and governmental affairs committee that would have jurisdiction over some if not a substantial portion of this, and my hope is that we will have a truly independent investigation, because you cannot investigate yourselves and claim you have no conflict of interest, which the administration and attorney general holder are claiming presently. >> where is the outrage? in this administration. where is there any indication that within the obama administration officials are outraged at the criminal leaks

of classified information that put our agents and our friends at risk? here is what has been disclosed obviously by members of the administration, classified details of the navy seals' raid to kill osama bin laden. missions in pakistan. aem eny -- yemeni double agent has been outed and is of no use in the future. the predator drone protocol, the cyberwar involving iraq, and overt operations in africa. all of these sensitive pieces of administration have been spread out in a book by mr. sanger, and we have yet to hear any outrage from the president of the united states. any other administration in my

memory, democrat or republican, would have been absolutely looking for the culprit, trying to find out who were the people who actually committed these criminal leaks. instead the president is offended that someone would suggest such a thing, and frankly, members of the administration sort of smugly happy that information has come forward that appears to make the president seem tough. as peggy noonan said last week, national security doesn't exist to help presidents win elections. it's not a play thing or a tool to advance one's prospects, and yet this administration, it seems-is more interested in advancing the pros does

prospects of the president's re-election than being outraged be criminal leaks. this is a bipartisan concern, at least in the senate. and senator mccain quoted chairman feinstein -- let me quote further. she says, this has to stop. when people say they don't want to work with the united states because they can't trust to us keep a secret, that's serious. amen to senator feinstein. she further said, as she read the book, her heart stopped at points during the reading of this book. she said, you learn more from the book than i did as chairman of the intelligence committee, and that is very disturbing. to quote the chair of the intelligence committee, this is

not going to be adequately investigated unless we have an independent special counsel. senator mccain is lot. there's a lot going on in this building this week and a lot going on the rest of the year. we had immigration decision yesterday. we had a reaction by the administration. we had healthcare coming within 48 hours, trying to wrap up for the 4th of july. there's a number of things we need to get done the rest of this year. there are people in this city who are hoping the issue of criminal leaks of classified information will go away. we're here today to say that it will not go away. we continue to press or -- for a sincible and adequate investigation and we hope that bipartisanship will prevail and

a special independent counsel will be appointed. >> senator mccain, there was mention of what was announced yesterday, the polygraphs -- do you think those steps were sufficient and what's your opinion? >> no. but i think they're important, and i would point out that the professionals in the intelligence community, not the plate cal appointees, are beside themselves. they're just distraught because of the betrayal of things like the inside informant in the underwear -- latest underwear bomber. the doctor that obviously has just been -- in pakistan that was sentenced to 33 years. the information about seal team six and other methodology which compromises their ability to carry out future missions. so the professionals are outraged, and i know that the

director of national intelligence believes that within his realm of authority, this is the best and most that he can do, is increasing the polygraphs and checks on information that may have been leaked. it still means we have to have an independent counsel to look at how all this happened. >> senator, the administration has said that by appointing u.s. district attorneys now, that it would make this move more quickly, since it is sensitive information, instead of the time it would take for an outside counsel and staff. is that reasonable? >> if you believe a member of the obama administration has credibility with the american people, i guess. so we already have been told that this investigation by these prosecutors could take month if not years already.

... >> whether they're going to be the chief law enforcement officer of the country, or whether they will be a political arm of the white house. time and time again, given the opportunity to make that choice, the attorney general has made the political choice. so there is no credibility here and that's why we believe an

independent investigation is so important. >> senator, if this is a bipartisan concern, why is that there are no democrats standing up here today? >> senator lieberman has called for the appointment of an independent counsel, and clearly everything that senator feinstein and several others have said, in my view, lent itself in that direction. but this is a tough town. there are pressures being brought to bear on the democrats not to call for an independent counsel. the fact is that senator obama and senator biden called for an independent counsel in the boundary case. that case was a terrible thing. but when you look at it and its consequences as compared to these, there's no comparison. >> but hasn't this administration been tougher -- [inaudible] spent at the lowest level. they've done very good with the private and the army. they have done very well and some others, but when you look

at where this comes from, look, how does a person be brought up to the presidential suite and briefed by quote, national security personnel, unless they are at the highest level? i mean, a private doesn't bring people up to the presidential suite to brief them on iran. so, all i can tell you is that, that the level of prosecutions is miniscule as compared to the level of what is obviously where these leaks came from. [inaudible] >> we leave this pre-record if it to go live to the pentagon. the defense department general counsel will give the keynote address at the pentagon's first lesbian, gay, bisexual and transgender pride month event. general counsel johnson co-chaired the pentagon's review of how to implement the repeal of don't ask, don't tell.

following the keynote address, there will be a panel discussion on the value of open service and diversity. this month, defense secretary leon panetta issued the department's first lgbt pride month message in a video that prays gay and lesbian servicemembers, and address his own pride at the with the military had implemented repeal of don't ask, don't tell over the last nine months. [inaudible conversations]

>> [inaudible conversations]

>> [inaudible conversations] >> [inaudible conversations] >> while we wait for this event to get underway, the senate is on a short lunch recess. when senators return, continue

debate on a bill to continue food and drug administration fees on prescription drug reviews and approval. they also cover medical advice is and would be expanded to include generic drugs, and biopharmaceutical products. before breaking for lunch, senators approved a federal judge nomination in florida. senate majority leader harry reid said this morning that there is a better than 50% chance congress can pass highway and transit programs before the fourth of july break. he indicated the flood insurance extension may run into trouble over amendments. >> [background sounds]

>> present arms. ♪ ♪ ♪

♪ ♪ [background sounds]

>> ladies and gentlemen, -- for the president's lb gt pride month video message followed by secretary panetta's pride month message. >> i've often said the true genius of america is that america can change. we can pass laws to right wrongs. we can soften hardened attitudes. our union can be made more perfect. but here's the thing. change never happens on its own. change happens because ordinary people, countless, unsung heroes of our american story, stand up and demand it. the story of lesbian, gay, bisexual and transgender americans is no different. as we celebrate lgbt pride

month, we remember the activists and advocates who refuse to be treated like second class citizens. april like harvey milk who marched and protested, and believed in a better future. we also remember the unsung hero's. the millions of lgbt americans for whom everyday acts require an extraordinary courage. young people who came out as gay or transgender to the parents, not knowing what to expect, the two moms or two dads who went to an open house or a pta meeting, not knowing how they would be received. the couple that got married, even if their bosses or neighbors wouldn't approve, at least not right away. most of these heroes didn't set out to make history, but that's exactly what they did. bit by bit, step-by-step, they didn't the ark of the moral universe towards justice. now it's our turn. so this june let's take some time to celebrate teachers and students, and take a stand against bullying, openly gay and

lesbian servicemembers who defend our country with honor and integrity -- [inaudible] and we can renew our commitment day in and day out to be the kind of people who make change happen. [applause] >> as we recognize pride month, i want to personally thank all of our gay and lesbian servicemembers, lgbt civilians and their families, for their dedicated service to our country. before the repeal of "don't ask, don't tell," you faithfully serve your country with professionalism and courage. just like your fellow service members, you put your country before yourself. now, after repeal, you can be

proud of serving your country, and be proud of who you are when in uniform. pursuit of equality is fundamental to the american story. the successful repeal of "don't ask, don't tell" proved to the nation that just like the country we defend, we share different backgrounds, different values, different beliefs. together, we are the greatest military force in the world. it also reminds us that integrity and respect remain the cornerstones of our military culture. the army, navy, marine corps and air force, implemented the repeal with a focus on respect and individual dignity. as secretary of defense, i am very proud of how we implemented repeal. going forward, i remain committed to removing as many

barriers as possible to make america's military a model of equal opportunity. to ensure all who are qualified can serve in america's military. and to give every man and woman in uniform the opportunity to rise to their highest potential. diversity is one of our greatest strengths. during pride month, and every month, let's celebrate our rich diversity and renew our enduring commitment to equality for all. [applause] >> ladies and gentlemen, please welcome the honorable jeh johnson, general counsel for the department of the defense. [applause]

>> thank you all very much. can everybody hear me in the back? you know, i have to say i look around this standing room only crowd, and i'm sorry we didn't sell tickets las. [laughter] thank you for being here. this afternoon i want to share with you some insights on the process that led to the repeal of the "don't ask, don't tell" law in the summer 2010. the implementation of that repeal between december 2010 and now, and where i think we're going from here. as recently as three years ago it would have been hard for many of us, including me, to believe that in the year 2012 a.d. man or woman in the armed forces,

could be honest about their sexual orientation. that 10 usc 654 the "don't ask, don't tell" law would be gone from the books, and that the process of repeal would have gone even smoother and less eventful and general ham and i predicted in our report. it's a remarkable story, and it's remarkable because of the strength of the u.s. military and its leadership. this is the overall message i hope to convey in these remarks today. we have the mightiest military in the world. and not just because of our planes, guns, tanks and ships, but because of our people. they're a. their ability to adapt to change and their respect for the rule of law, the commanders and their civilian leaders. this has been a remarkable thing about the last nine months. but for anyone who knows the men

and women of the armed forces, it is not a revelation. at the outset, a personal disclosure. and 2010, general ham and i did an assessment. we did not advocate for a particular result. our only goal was a comprehensive and accurate report of the risk to military effectiveness if "don't ask, don't tell" were repealed. i do not consider myself an activist on the matter of gay men and women in america. we are all a product of our circumstances, and part of my circumstances include my formative years in the 1970s at morehouse college, an all-male, all black southern baptist school. in the 1980s, a good friend of the law firm in which i

practiced as a young lawyer in new york was openly gay. but it was at least a year before i knew that. and only because someone else told me. i asked my friend why he had not told me directly that he was gay. and he said to me, and i still remember his exact words, because i didn't think you could handle it. for the next 27 years i asked myself what gave my friend that impression. but it did not preoccupy me. and 2009, we never talked about "don't ask, don't tell," except in groups no larger than about three or four people. secretary gates new the president had pledged to seek repeal of "don't ask, don't tell," but both of them believed that if repeal was to occur, it should happen in a careful and

deliberate manner. they did not want the issue to spin out of our grasp. then in a state of the union address on january 27, 2010, president obama pledged to work with the congress and the military that year to repeal "don't ask, don't tell." which is exactly what happened. several days later secretary gates and admiral mullen testified before the senate armed services committee on the subject. it was there that admiral mullen gave his remarkable statement in support of repeal. and secretary gates announced the formation of a working group to be headed by the general counsel of the defense department. and army general carter ham, to conduct a comprehensive assessment of the risk of repeal of "don't ask, don't tell" and overall military effectiveness. we were to take 10 months, and

we were told to systematically engage the force on this issue. in effect, go have a conversation with the entire u.s. military about this issue and report back to me, the president and the congress, what they told you. i did not know carter ham, then commander of u.s. army europe, now commander of u.s.-africa command, at all before admiral mullen volunteered him for this assignment. but over 10 months i got to know carter and his wife extremely well, to the point where my wife and kids spent thanksgiving 2010 with them in germany. where we visited wounded warriors at the hospital. carter began as a private in the army in 1973, and he knows the army about as well as anyone. he was just right to navigate this sensitive assignment. and ended government of our report, i never let my own civilian legal thinking stray

far away from his military perspective, or his own voice. the study we undertook was the most comprehensive engagement ever of the military on any personnel related matter. over the course of 10 months, we surveyed 400,000 service members, and received 115,000 responses. surveyed 150,000 military spouses, and received 44,266 responses. solicited and received 72384 e-mails, conducted 95 information exchange forum, and 51 bases around the world, and talk face-to-face to over 24,000 service members, many of them, general ham and myself. we conducted 140 smaller focus group sessions with

servicemembers and their families, visited the military academies, solicited the views of congress, veteran groups, foreign countries, and groups for and against repeal. and, finally, a working group engaged in an online conversation with 2691 service members on a confidential, anonymous basis and thereby gave a voice to those who, by virtue of the very law we were reviewing, had no voice as self-identified gay activists duty servicemembers. the results of the report are now well known. the bottom line conclusion was this. based on always saw and heard our assessment is that when coupled with a prompt and limitation of our recommendations, the risk of repeal of "don't ask, don't tell" to overall military effectiveness was low.

as the basis for this conclusion there was of course the survey results. they showed among other things that 69.3% of those in today's military had already worked in a unit with someone they believed to be gay. and that if "don't ask, don't tell" were repealed, 70% of today's military said they thought they would have either a positive effect, equally positive, or negative effect, or no effect at all on their units ability to perform as a team. also key to our conclusion was this, quote, in the course of our assessment, it became apparent to us that aside from a moral and religious objections to homosexuality, much of the concern about open service is driven by misperceptions and stereotypes about what it would mean if the service members were allowed to be open about their

sexual orientation. repeatedly, we heard service members expressed the view that open homosexuality would lead to widespread and overt displays of feminine behavior among men. homosexual promiscuity, harassment and unwelcome advances within units, invasions of personal privacy, and an overall erosion of standards and conduct, unit cohesion and morality. based on our review, however, we conclude these concerns about gay and lesbian service members who are permitted to be open about their sexual orientation, are exaggerated, not consistent with the reported experiences of many servicemembers. in communications with gay and lesbians, current and former service members, we repeatedly heard a patriotic desire to serve and defend the nation, subject to the same rules as everyone else. in the words of one gay service

member, repeal would simply take a knife out of my back. you have no idea what it is like to serve in silence. most said they did not desire special treatment. to use the military for social experimentation, or to advance a social agenda. some of those separated under "don't ask, don't tell" would welcome the opportunity to rejoin the military if permitted. from them we heard expressed many of the same values that we heard over and over again, from servicemembers at large. love of country, honor, respect, integrity, and service over self. we simply cannot swear the reality of these people with the perceptions about open service, end quote. and last but not least was this noteworthy brick board which seems to be the favorite of a lot of people. we have a gay guy in the unit.

he's big, he's mean, and he kills lots of bad guys. no one cared that he was gay, end quote. [laughter] finally -- [applause] >> finally, key to my own views, no were reflected in this report, the military members of the working group who worked side-by-side with me throughout dozens of large group sessions told me that in the course of the 10 month review they had started off as skeptics and have become satisfied that our military can do this. by the end of the 10 month study, during which i think we actually saw attitudes shift as we stirred the pot on this issue, we had the overwhelming sense that with proper education and leadership, the military could be ready for this change. the report was issued publicly on november 30, 2010, in the

middle of a lame duck session of congress. repeal of "don't ask, don't tell" was passed by the congress three weeks later, signed into law by the president on december 22, 2010, and took effect on september 20, 2011. how has the military accepted this change? better than we anticipated. i attribute this to the strength of our military, and its army, navy, air force, mean and coast guard leadership. and i know i speak to these leaders when i say we hope this process continues in the professional and sober manner that it has taken since last year. in december 2010, as congress was considering repeal, the commandant of the marine corps testified to is honestly held professional military view that repeal of "don't ask, don't tell" was not a good idea for the marine corps. but at the time, general amos'

personal and public message was if my leaders give me in order to do this, your united states marine corps will get it done and get it done smartly. following repeal, general amos, like each of the other chiefs, stepped up and personally delivered messages as part of the education and training of their respective forces. the commandant's message was simple. we will step out of smartly to faithfully implement this new law. we will continue to demonstrate to the american people that discipline and fidelity, which have been the hallmarks of the united states marine corps for more than 235 years, will continue well into the future. the marine corps was the first service to complete the education -- [no audio] for all the four-star generals, as part of the chain teach

method of training by which the commander is personally responsible for training the subordinates. the admiral of the navy said this. leadership, professionalism and respect are the basis for executing the change in the law. as always we expect sailors to continue to exhibit the highest degree of professionalism and to treat each other with dignity and respect. general schwartz of the air force, by following our core values we will successfully implement this change with the same unparalleled professionalism. we have demonstrate with every transformation with undertaken in both keys and war. and the commandant of the coast guard, i need you, commanding officers, supervisors and every coast guardsmen to create command climate that foster retention. the repeal of "don't ask, don't tell" will also require your leadership, and i'm counting on you to exercise it.

if every coast guardsmen's job to make the workplace one of respect, you must value your shipmates, no matter what their background. since repeal, within each service, there have been isolated incidents, but almost no issues or negative effects associated with repeal on unit cohesion, including within were fighting units. as general amos testified before congress last year, he and his staff were careful to look for issues during the training, and told congress to be honest with you, we have not seen it. from the front lines in afghanistan, one marine major general reported to the commandant, sir, quite honestly, they are focused on the enemy. going forward, the personnel and readiness community is now in the midst of reviewing which military family benefits can be extended to the partners and other family members of gay and

lesbian servicemembers. the repeal of "don't ask, don't tell" exposes certain inequalities between similarly situated couples in the military community. this troubles many of our leaders here on the other hand, we must comply with current law, including the defense of marriage act. though the department of justice has said it will not defend the constitutionality of doma in court, into a final of that issue, adherence to the law is basic for the military, and central to our efforts. because of a number of benefits that are provided to our military community, the complex legal and regulatory framework, the process has been comprehensive and time-consuming, but it will get done. now, one final note about today's event before i close.

this type of event, during the month of june, has occurred in civilian society, and in civilian agencies of the federal government four years. cia, for example, hosted a gay pride event 12 years ago. this is the first time in history such an event has occurred at the pentagon. within the military, events such as this must occupy a different and qualified place, because in the military, individual personal characteristics are subordinate to the good of the unit and the nation. service above self. from all that we learned in 2010 about the struggles and the sacrifice to remain in the military, i believe gay men and women in uniform readily agree with this. so what should we honor today? for those service members who are gay and lesbian, we lifted a

real and personal burden from their shoulders. they no longer have to live a lie in the military. they will no longer have to somehow teach a child to lie to protect her father's career. as one army chief warrant officer reported, her commander told her, this policy capped me from knowing you. for all of us we should all be professional near flawless manner in which our entire u.s. military implemented and adapted to this change. and welcomed their brothers and sisters to an unconditional place at the table. thank you very much. [applause]

>> ladies and gentlemen, ladies and gentlemen, ladies and gentlemen, please welcome captain jane campbell, united states navy. [applause] >> good afternoon. it is my great pleasure to serve as your moderator this afternoon for the panel discussion. mr. johnson, thank you for your remarks. most specifically, thank you for providing that behind the scenes perspective of the repeal of "don't ask, don't tell." before we begin our discussion this afternoon, i'd like to take them and to provide a brief introduction of our panelists. when i finish these introductions, i think you'll see why we are extremely pleased to have these men and women seated in front of you this afternoon. our first panelists is sue, a u.s. army veteran.

she's a 1980 graduate of the united states military academy. the first class of women. sue is one of six -- [applause] >> sue is one of six presidential appointees to the 2012 west point board of visitors. she served on active duty for five years as a signal corps officers, her tours in germany included platoon leader, staff officer, and company commander. after leaving the army, sue work in brand management at proctor and gamble, and church & dwight. she also took two years to work in parish renewal programs for the archdiocese of new york. she currently serves as the executive director of nights out, and the communications director of outserve. our second panelists is captain

matthew phelps, united states marine corps. he most recently served as the commanding officer receiving company support battalion, recruit training regiment marine corps recruiting station san diego. it is a mouthful, i know. [laughter] and i say most recently, sir, because we pulled out of their just after his change of command that took place late lastly. is headed down the road to quantico we will start the expeditionary warfare school shortly. he is a prior enlisted marine. after earning a bachelor's degree in music from the school of music at rochester university in 2001, he enlisted in the marine corps. he was promoted to the rank of sergeant one member of the marine corps air ground combat center and. at the time he applied for and was accepted into the enlisted commissioning program. he earned his gold second

lieutenant bars back in august 2005. he has held a variety of assignments since earning his commission, including a combat deployment to iraq with first battalion, 11th wearing regiment, in support of operation iraqi freedom. our third panelists is gordon o. header. a career civil servant and an air force veteran. a member of the senior executive service, mr. cantor is a principal deputy director counselor of the air force and worked here in the pentagon. he provides oversight, guidance, direction and guidance regarding legal advice on all matters arising within the air force. mr. tanner earned his bachelor's degree from the university of alabama, and his jurist doctorate from vanderbilt university. he was commissioned in the air force, judge advocate general corps and served on active duty

for four years. while spending some time at private practice, mr. tanner continued his military service in the air force reserves, ultimately retiring as a colonel. now, while i'm not a lawyer and i definitely won't make any lawyer jokes because i know there are more than a few of you in this room -- [laughter] i do want to point out that it's significant to note that mr. tanner is a member of the u.s. supreme court bar, abc, tennessee and alabama bars. and i'm not going to pressure him too much, but it's important to point out that our event here was the sign for the pentagon workforce, a workforce of military and civilian personnel. and i do want to look to him to provide that civilian perspective, even if it might have a hint of air force blue. [laughter] with the introductions complete, i'd like to begin this discussion. i'm going to ask each of our

panel members to tell their own personal story, and then i'll come back to them to see if there any other points i think that you might find interesting. so now without further ado i'd like to turn it over to sue fulton. [applause] >> thank you. this is an extraordinary, extraordinarily special day. standing room only in the pentagon auditorium. but not because lgbt people are special, but because the service, the sacrifices of gay and lesbian service members are being recognized as equal to the sacrifices that straight soldiers, sailors, airmen and marines and coast guardsmen make every day. [applause] >> you know, a lot of people came to pride -- were surprised that "don't ask, don't tell" went so smoothly. for a moment i was one of them.

but i think back to when i arrived at my first duty station in 1980, many, many years ago, you can all do the math, fresh, wet behind the ears butter bar with my shiny airport wings, hoping that would get me through, one of the first people i met was our personnel nco, and forgive the stereotype, but he was about six or and he was the fiercest most fabulous, you know, take no prisoners, flamboyant gay man i had ever seen. [laughter] and yet, all of the captains and majors and colonels defer to him because he could play -- he knew his job inside and out. he know better than anybody else. and there was widespread respect for. when he would ask and i'll and how you, you doing, man?

[laughter] the other folks would say, that's just riley. and i think so many of us knew right is out there, whether it was the female motor sergeant who could fix anything, and by the way, could lift a tire by her self. or the training nco who a snappy one-liner for everything. the notion, and certainly the vast majority of gays lesbian folks in military are stereotypical, but so many of us knew both gay and lesbian soldiers, and we knew that at the end of the day that this wouldn't be hard. icon in fact, when i was come to a command on a little base in germany, actually they were actually for gay commanders on that base at the same time. and we were all successful, but none of us stayed in the army. because it was too hard. even before "don't ask, don't

tell" we were told, we knew there were things that we couldn't talk about. don't tell anyone about your crazy fun weeke, don't tell anyone about your bad breakup. don't tell anyone about who is waiting for you at home when you get back from deployment. the army redacted our lives. and i think at the end of the day one of the things that those of us working on this realized, and when i say those working on it, i mean all of the military folks, gay and straight, is that being gay isn't about sex, it's about life. it's about buying a house and bickering over chores, sorry, that is my partner over there. [laughter] it's about deciding whether to have kids. it's about moving to a new place and figuring everything out. it's about life. and i do want to say that thanks to the leadership of this administration and the pentagon,

and so many unit leaders at every level, we can have those lives now and still serve the country we love. thank you so much for having me here. [applause] >> you know, as i listened to the biographies of the distinguished panel, the first question that comes to my mind is why the heck am i here? [laughter] i enlisted in 2002 because after the events of 9/11 i just could not imagine anything else that i could do with my life than to serve my country. and as i was sort of bound and focus on that idea i thought there was no better way to do that and as a marine. the interesting thing, a complicated back at the time was i had come out gay to my parents

when i was 18. and here i was, 25 years old, faced with the feelings so deep within me that there was absolutely no denying it that i had to be a marine. and i enlisted in the marine corps, and i listen to my recruiter stumble his way through, explaining the "don't ask, don't tell" policy that was in effect at that time, that at the time in 2002 there was no chance of a going away. and as he stumbled to the policy, and he asked me, well, are you gay? because if you're not, then this doesn't matter. okay fine, then i will sign the paper and let's do it. and i realized at that point that the problem, the problem with the "don't ask, don't tell" policy was that it asked us to live when nobody even realized that we were lying. nobody even realized they're asking us to lay. that's what we have to do though. it really hit home for me when i

was on deployment in 2007 and then in iraq and and every saturday night the officers used to get together and smoke cigars and watch movies, usually band of brothers or something, that's the way the army did it. [laughter] >> but as we would sit there, of course the thoughts would alter its two home. and everyone would talk about their family and their wives and the letters they got from the kids. and i sat there in the back of the room not talking to anybody. because not only was it so hard to have left somebody at home, just like it was hard for anybody else, but when everybody was getting together and growing closer as a you know, by virtue of the fact that i wasn't allowed to say anything, i was actually growing more distant from my unit. and we hear people talk about unit cohesion and how the repeal

of "don't ask, don't tell" what effect unit cohesion. i would affect that it got better. because now you have a whole portion of the military who is able to be honest with the people that they work with. and when somebody says, you know, do you have anybody at home, we can say yes. as a matter of fact, we do. when the repeal happened on september 20, 2011, it came at an interesting point in my career. i had already been selected as a company commander and as our serving as a company commander down at the recruit depot. and i went into work on the 20th of september, thinking that my life was going to change. and i went in and i sat down at my desk come and i kind of braced myself on the desk waiting for everyone to come and ask me if i was gay.

[laughter] believe it or not, nobody did. [laughter] i didn't get any e-mails, i didn't get any phone calls. in fact, the phone didn't even ring but i was waiting, like somebody please talk to me today. because i felt like i was going to work for the very first time. after almost 10 years, matthew was going to work. as a marine. in uniform, doing my job, doing the job that i thought i had been doing for 10 years or but i had only sort of been doing. and as we progressed since then, i have found myself sort of cast into little spotlights, because all i've done is acknowledged the fact that i am gay, the fact that i love my country, that i love being in the ring.

that's it. that's all that i have done. and somehow that is news your country and. i can imagine having a panel where we would say congratulations, these are all male marines, let's give them a round of applause. i happen to believe -- i happen to be gay, but more important i am a marine. and if i could just touch on one more point, if i've learned anything, it's the reason that i am here is that it's still kind of is news. that there are still relatively few of us wearing the uniform who are willing to go on record and say, this is my life, i am proud of my life, and i will serve as a leader with integrity, with openness, and serve as a role model for our younger troops, for our younger marines, far younger servicemen, and for those who come after us to show them that is not nearly a big deal that anybody thought this was going to be.

thank you. [applause] >> terrific. just terrific. you know, it is wonderful to be here to represent the 8000 or so civilians who work here in the pentagon, together with those of the civilians and our military workforce around the globe. but i'm also awfully proud of the military connection that we all have. because we have one mission together, and that's the important of the repeal of "don't ask, don't tell" i think and the importance of today. i did retire as a reserve jacket, and i remember the fear and concern i had about

potentially being outed during that period. and it would've been awful. and i can imagine what a relief, i can't imagine what a relief that is now. but we have a great deal to be thankful for. we have a great deal, i personally have a great deal to be thankful for, in that my husband, robert, racial hand, robert, is down here. [applause] we have been together nine years and married almost two. i'm thankful that we are being joined today by military members, civilian and military, from around the world. you may have already heard we had a request just earlier this week from a group in afghanistan that wanted, of soldiers in afghanistan who wanted to be sure that they could tie in and participate by video in this conference. what an outrage that is for us, for each of us to them as a

service on the front lines. also think without the use this opportunity to remember that we are standing on the shoulders of giants. there are huge numbers of people who have gone before us, and worked on this issue. many of whom are in this room today. and while we can't go through all their names, i'm half of all of us, connected with the military services. i want to say thank you for what you have done to make today awesome. [applause] >> now, like a good lawyer, like i'd been trained by mr. johnson and others around the room, i have this laundry list of all the civilian benefits that we have now, working on getting, we have some. if you want that list, i'll be

glad to e-mail that to you. it might be helpful actually, and it is available. but what i really want to talk about today is what we, what each of us can do in our own day-to-day lives to make a difference. first of all, and most importantly, we need to be as visible as we can be. everybody has a different comfort level. everyone is in a different place. [no audio] >> first of all, we have straight allies, colleagues and friends who absolutely support us. one, because it's the right thing to do, and second, because they have loved ones, friends, neighbors, sons, daughters who they want to know more about

their lives. and we may be the bridge to helping them understand that. let us be the bridge to our straight allies. we civilians, for those of you in the room and in tv land out there, we have military colleagues who are not yet comfortable about being more open. we as civilians have a unique opportunity to be that bridge, to help them if they find themselves in a climate that is not as comfortable yet as it should be. we can be there for our military colleagues. finally, we in the pentagon here are often face-to-face with the policymakers, the people who are looking at the benefits, and how those can be, we have one class of marines, and not first and second class marines, or airmen

and sailors or soldiers. we can be there for the policymakers. i want to ensure that our visibility is open, and it shows, it shows that we can become, we can become one marine corps where a marine can perform his mission, and not be treated as second class because he receives lesser benefits and is straight college. we can be one air force where deployed air men can perform her mission and not worry about her partner and children living in shabby, off-base housing because they work in eligible for on base military housing. we can be one nation where a case either can focus on his mission and not worry about the school that is children are forced to attend because they didn't qualify for certain dod school benefits. we can be one army were a

soldier and focus on her mission without her worrying about her partner back home not being cared for by the members of her unit that are back home. spousal support is critical for our success for our deployed soldiers, sailors, air men and marines. and our spouses, our partners need that support as well. so that we, we can focus on their mission. i'm not going to kill my own coming out story, but i do want to tell you, i want to tell you about mr. will and mrs. mildred albright. shortly after i came out, i was on the osha team at st. mark's church in san antonio, texas, where i was stationed. actually i was the chicken on that team, if you can believe it. the usher team must have been 70 and 80 years old. they had been on the same team for ever.

and i was the new kid on the block. one of the usher team members, mr. will, came up to me after church one sunday morning, and asked if he could talk with me privately. he was a little sneaky about it. had no clue what he wanted to talk about, but, of course, i agreed to talk to him. he came up, he looked around to make sure no one was listening, and then he began talking to me about his grown son and his sons partner who lived in houston. mr. will and his wife, ms. mildred, loved both their son and that partner. they spent thanksgiving with them. the best cook you can imagine, but mr. will and ms. mildred, although they've been active in the church for their entire lives did not feel they could tell one person about their son and the experiences. not one.

and they were just afraid that the french would completely reject them because they had a gay son, and that they actually liked him. well -- [laughter] i think maybe the first gay person they'd ever talk to you. i didn't do anything. i just was there. i was out, and i listened. welcome based on my just being there, they began to open up to their friends, their church friends and colleagues who, and brockton in to the rest of their world. i have to tell you that mr. will and ms. mildred's son died a few years later, and they brought him back from houston to san antonio to be buried at st. mark's. and i wish you could've seen mr. will and ms. mildred bring that partner, arm in arm, up to that front row. and when that partner finished

speaking, giving eulogy at the funeral, there was not a dry eye in that house. everyone in the packed congregation was right there with mr. will and ms. mildred. what does that have to do with us today and the military? it has a lot. all we have to do, to whatever extent you can do, is be visible. you can be the bridge, you can be the face, you can be the breath. thank you ipod bac. [applause] >> now, was there any doubt that we had the right folks to be appear to talk to you this afternoon? what i'd like to do, i'm cognizant of the time and i realize that some of you may be fighting a busy schedule this

afternoon, but what i'd like to do is just go back to each of our panelists and ask probably just one at this point in time, for one point that i think may have been something that they to out from the comment. so for mr. tanner, as a career civil servant, what is the most significant thing that you have seen in this building, aside from the stories that you've shared with us, that has been a key indicator, that kind of lead up to this transition from the military side. as you stood from your civilian perspective, albeit with that one foot in that reserve side. >> just quickly, i think, i'm drawn to the fact that people become visible in different ways. it may be simply putting a photograph of a loved one in

your cube. it may be talking about, and, just a summit would talk about a straight couple would talk about, or individuals talk about what they did on the weekend. people are in various places, and i think that you have to come from a place where you are comfortable, but you have to stretch that a little. so i would encourage everyone who is thinking about becoming more visible to stretch a little and to take the step that you believe could help you be that bridge that i mentioned. >> thank you, sir. for captain phelps, i don't think there was anybody who, in this audience or anybody watching, you know, around the world, who was not moved by your words, by the strength of your passion as a marine, first. i would just ask, has there been

anything anecdotally, and the lasso but as you said, every once in a while you been thrust into the spotlight, i'm trying to counter, aside from the 12 that are blinded you at this point in time, is there any significant event, post-repeal, post that day when the phone didn't ring that you would like to share with this audience? >> i would say they were probably, i would say the most significant event to me, i mentioned that way took command of my company in june of last year, i was in the closet. i was at a point in my career where, if anybody had found out that i was gay, even though the law had been signed, repeal it not gone all the way through, if anybody had found out that i was gay at the time i could have lost my job. a year later, in fact, last friday, a week ago last friday, on the 15th, the president

hosted a reception at his house, you know, the white one -- [laughter] and i was, i was invited to attend. i, captain matthew phelps was a invited to attend this private reception at the white house. and i thought how amazing is it over the course of a year, i could go from being fired, for being who i am, to having champagne with the commander in chief, on cocktail napkins with the presidential seal on it. so i would say for me personally that was probably the most significant event, you know, the fact that although there is a certain distance were still to travel before we find for equality, the fact that the surface of gay and lesbian service members is finally being recognized on that scale i think

is, that's just an amazing thing to me. >> i would like to tap into one thing that i think a number of folks may be interested. one, you have describe your experience -- [inaudible] >> with knights out. so from my chair to his chair to his, what can you tell us about that next generation of leaders that is now changed because of how they serve at one of our military academies, and how they will serve as leaders with our next-generation? >> well, the academies, they are learning institutions, and i think that, you know, repeal was more there than anywhere else but one nco said to me, you know

we raised -- brace for impact and it wasn't even a speed bump. the repeal. so i mean, our students, the cadets, midshipmen, they have this preparation going to high school with gay and lesbians, you know, by and trans kids. so it's much less of an issue with this generation. i think it's again not even a speed bump at west point. and on the board of visitors, it just hasn't been an issue. we have much bigger fish to fry, to handle at west point. so it really hasn't. but i don't want that to be taken as something we've all said, look, generationally this generation that is coming up now that you serving, they are the ones who get this pic is just the older folks, right? but, you know, there is some things to that, too. i can tell you how many stories, outserve members that i've seen whether talking about, you know,

crusty old sergeant major old crusty old man came up and said i heard you were gay but if anybody gives you any crap, you come see me. or, you know, chaplains. this past weekend i met not only the navy lieutenant commander lutheran chaplain who conducted a ceremony for a young air force sergeant and his boyfriend to get wedded, and she was wonderful, beaming the whole time, but to me more importantly in the back of the church, and i spoke with him later, was another chaplain, a senior chaplain, air force, southern baptists, and asked him why he was there. and he said i just want to make sure everything goes smoothly. it's just, i just want to make sure there aren't any problems. and you know, the folks, there are a lot of folks who are senior, who our allies, who get this, that this is about readiness, that this is not taking care of our troops, and

mission accomplishment. and getting this finished so this is never an issue again is so important. and so i think, i know i jumped off the topic, the academies, but the academies are doing great. [laughter] they have other issues but they have no problem with it. [applause] >> well ladies and gentlemen, we have creeps past the hour of two, past 14 it, so it is my responsibility, and my honor to thank our three panelists, and to thank you. thank you for being in a standing room only audience in the pentagon for this first ever event. so thank you. have a good afternoon. [applause]

>> ladies and gentlemen, thank you for your participation. this concludes today's events. >> this evening, james mann, a talks about the president's foreign policy decisions and profiles the people who advise him. booktv.org will have live coverage from the politics and prose bookstore in washington, d.c. at 7 p.m. eastern. "washington journal" continues its spotlight on magazines tomorrow with former bank of america president. she has written an article for harvard business review on how to improve the banking industry. the article is linked at c-span.org, and we will talk with her life wednesday morning at 9:15 a.m. eastern on c-span.

the u.s. senate is about to gavel back into session. senators will continue debate on a bill to continue food and drug administration fees on prescription drug reviews and approval. fees also cover medical devices and would be expanded to include a generic drugs and biopharmaceutical products. this morning before the lunch break, north dakota senator kent conrad went to the floor to say that the "washington post" misinterpreted facts in its story on congressional insider trading. senator conrad was mentioned in one of the stories this week. his comments are about 10rth minutes. >> mr. president, i rise today to answer allegations made by the "washington post" in a front-page story in yesterday's edition. here is the story, high level talks and changes to holdings. first, i want to say i havengs. great respect for the "ashington post" it in manyanys ways the post is a national

treasure. but even great newspapers maken mistakes. and in yesterday's story they made assumptions that are sentps to the t wrong. wife the story said my wife and i her shifted savings in her retirement accounts, mutualoney funds to lower risk money market accounts on august 14, 2007. that is true. they showed that we made those a changes a day after a call pauln to me. that is also true. but their suggestion that the two are related is absolutely false. they have made the same error in logic that we studied in college. the case in faulty logic involved an observer who noted that people were fainting and street pavement was melting. that led the observer to

conclude that melting pavement caused people to faint. of course that was wrong. it was 106 degrees outside. the proper conclusion was that heat was causing pavement to melt and people to faint. that error in logic was about causality, and that is precisely the error "the washington post" made in their story with respect to me. what the "washington post" missed in their graphic -- and to be fair to them, they largely had the correct context in the story. if you read the whole story, it was fairly balanced. what was not balanced was the graphics that accompanied that story. let me show you the graphic. this is from "the washington post" of yesterday. here's a picture of immediate. quite a nice picture. i appreciate that. it says "senator conrad, chairman of the senate budget committee, was in contact with paulson about the nation's

economy during the crisis." that's true. they then show a time line with only two points on the time line. they show august 13, secretary paulson called me at 4:30. and they show the next day, august 14, that my wife and i shifted from her retirement accounts, money from mutual funds to lower-risk money market funds. that's true. what they've not shown on the time line are what was happening in the previous days. so let's go back to the friday before. here's what happened on the friday before. the dow jones industrial average dropped 200 points within minutes of opening -- of the opening bell and closed the day down nearly 400 points. that's not on the time line of "the washington post."

if they were going to be fair -- and i don't begrudge them writing the story. i think if i were the editor i would have certainly written the story too. it certainly has an appeal. there are members of congress talking to people in influential positions and then changing their holdings. but to be fair, you've got to provide the context within which those decisions were made. and the context within which my wife and i made our decisions is pretty clear. the friday before the market drops nearly 400 points. what the "washington post" also didn't put in their time line is their headline on that friday. "credit crunch in u.s. upends global markets." and in that story, the friday before, they showed that in the weeks leading up to our decision to diversify our investments in my wife's retirement account, the market had dropped in two

days more than 500 points, leading up then to the friday where the markets dropped almost 400 points. and "the washington post" in their story also didn't put on the time line what the headlines were in their own paper on the weekend leading up to our decision to make these changes. this is just one of the headlines: "looking for footing on shaky ground," talking about the turmoil that we saw globally. so the truth is that what made my wife and i decide over the weekend to shift some of her retirement accounts from mutual funds to less risky money market accounts was what was happening in the markets themselves. that is what led us to make these decisions. the paulson call was not about markets.

notes from my staff indicate that secretary paulson was calling a number of members about the importance of raising the debt ceiling. the secretary of treasury was not calling me to give me stock market tips. he wasn't talking to me about the stock market. he was talking to me about the need for a debt limit increase. so i want to say clearly and unequivocally to my friends at "the washington post" and anybody who read this story the call from secretary paulson had nothing, had nothing to do with my wife's and my decision over the weekend to shift some of her assets into less risky money market accounts. those decisions had everything to do with what was happening in the marketplace itself which was widely reported even on the

pages of "the washington post." and what was happening in the markets was readily available to every investor. we were not shifting my wife's retirement accounts based on some secret inside information. it was -- let me get back to the headlines, if we could. it's "the washington post"." credit crunch in u.s. upends global markets." stock markets in the two days leading up dropped 500 points. in the days leading up before we made our decision, the market dropped almost 400 points in a day. "the washington post"'s own story. they had a big story. this is the story showing the dow jones industrial average dropped 200 points within minutes of opening and dropped almost 400 points for the day. why didn't they put that -- if they wanted to be fair, why didn't they put that on the timeline? that's what i asked them to do.

i didn't ask them not to run the story. i asked them put in the context in which the decisions were made. be fair. so the fact is there is nothing mr. paulson could have said to me about market risk that have been more persuasive than the drop of 400 -- almost 400 points in the market the previous friday. that provided all the motivation that my wife and i needed, along with the 500-point drop that had occurred several weeks before, that provided all the motivation we needed to make a decision to move some of her retirement assets to lower risk investments. to "the washington post," i respect you, i have had a very good relationship with you for a long period of time, but your story was unfair to my family, story was unfair to my family,

>> we will go now to the senate floor. they are just gaveled back into session. senators will continue debate ol a bill to continue food and drug administration fees on it all prescription drug reviews and approval. this is live senate coverage on c-span2. mr. president, we just considered this bill in the senate a few weeks ago, passed it 96-1. following the conference with the house, the house passed the bill unanimously last week. today i trust that we will finish the job. mr. president, i'm genuinely proud of this legislation. it will ensure that the f.d.a. has the resources to speed market access to drugs and devices while continuing to ensure patient safety. for the first time, it will make new resources available to allow the f.d.a. to clear its backlog of applications for generic drugs, which will help ensure that patients have access to less expensive medications.

it will make sure that the f.d.a. has the funds to prevent there ever being a backlog in applications for biosimilars. this is vital to the med product industry's ability to make these products and most importantly to patients who need both access to drug and devices and assurances that they are indeed safe. this legislation has benefited from input from a diverse range of interested parties. as senators on both sides of the aisle here, our colleagues in the house, consumer groups and patient groups. well over a year ago, parties started bringing policy ideas to the table and we worked together in bipartisan working groups to reach consensus on these policy measures. and where we could not achieve consensus we didn't allow those differences to distract us from the critically important goal of producing a bill that could be

broadly supported. as a result of this bipartisan process, we have a bill that advances our shared goals: patient safety, patient access and a strong business. we enhanced patient protections. we modernize f.d.a.'s authority to ensure that drugs and drug ingredients coming to the u.s. from overseas are safe and to ensure that our domestic companies compete on a level playing field with foreign ones. we address drug shortages and incentivize drug development for life-threatening conditions. we reauthorize incentives for studying drugs in children, finding we increase transparent at f.d.a. the bill helps keep our regulatory system in pace to adapt to technological and scientific advances. it will create the conditions to

foster innovative advances in medical technologies and, againen, it will do all of this wiewwithout losing sight of ensg patient safety. it has been a long road. we have been working on this bill for well over a year and three or four months with the help of senators on and off the committee. again, i want to thank my colleague, the ranking member of the help committee, senator enzi, for all of his diligent and hard work on this and that of his staff for helping to bring all the different parties together and to make sure that we had a consensus bill that really responded to all of those inputs. so we've got a great collaboration, i think we have an excellent bill and i'm hopeful that we can have our comments and discussion this afternoon. but i urge all of my colleagues

to vote today to pass the f.d.a. safety and innovation act. it is critically important to the agency, the industry, to the patients that we get this done. and this will be the final step, i would say. as i said, the house passed it unanimously. after we pass it today, it can go to the president for his signature as soon as we pass it this afternoon. with that, i would yield to -- whatever time he may consume to -- before i do that just a second. mr. president, i ask unanimous consent that sergio perez, peter bots and sean o'connor of my staff be granted floor privileges for the duration of today's session. the presiding officer: without objection. mr. harkin: with that, i would yield whatever time he may consume to the ranking member, senator enzi. enzi. mr. enzi: mr. president? the presiding officer: the senator from wyoming. mr. enzi: i thank the chairman of the committee, i thank him for his leadership on this issue. we've had a great teamwork

effort both between the senators and between the staff. and this isn't something that just came together a couple of weeks ago. this is something that's been worked on for about a year and a half. and pretty constant meetings on fridays of all of the interested groups and then stakeholders and it takes a tremendous amount of work to put something like this together and have it be in a bipartisan way like this. and it's largely because it came to committee. and in committee we took a look at all of the amendments that were suggested, and we got the people together that had very similar amendments and they usually were able to work out something to satisfy everybody in that instance, a understand we came up with a -- and we came up with a bill. and as senator harkin mentioned, it passed 96-1 here. and anytime that we get something to pass, it is kind of a landmark thing.

but when you get something that bipartisan, it's even more landmark. well, we've been trying to get this bill wrapped up you before the supreme court decision came out on health care. the reason we've been trying to do that is, who knows what it's going to say or what kind of ideas people will come up with when that happens? from both sides of the aisle, you know, this is a group of 100-idea generators. so we wanted this cleared up by that time. and we're on the path to get that done right now and a path that will keep the people employed who are taking a look at new drugs and devices and generics and biosimilars and continue to get those on the market so that people will have the latest innovations. and of course one of the things that we included in the bill was some use of foreign clinical trials, if they were approved by the f.d.a. and that should even speed up the process. of course, when you go to

conference, there are a lot of things that people want to have -- you know, that they've brought up as amendments, and it's very critical in the bill, and you get some of them and you don't get others. i know that senator alexander played a huge role in this, and he had six items in the bill -- seven items in the bill, and we've got six of them. senator burr had 12 items in the bill, and we've got 11 of them. and i've got to mention, of course, that that one that we did not get is a particularly important but particularly difficult issue that's going to take more time to get it worked out. but it's one that deals with drug distribution security, and that's something we cannot avoid, we have to do, but it's going to take longer to work that out, and it deserves some extra time and some more understanding on both sides of the aisle on that one in a number of different states, and

it doesn't just involve the senate. it doesn't just involve the drug companies. it also involves the whole chain that these things have to go through, including the local pharmacists, who we don't overload with work, and the people who have to transport these drugs, who we don't want to overload with work or make it extremely difficult when they cross state lines to do different kinds of reportreporting senatoing. senator hatch had six and we've got all of them, senator mccain had two and we've got one. senator roberts had two and we've got both of those. senator kirk had two, and we got one of those. senator grassley had two and we got one of those, and senator portman had two, and we've got both of though, and senator coburn had two and we have one of those. senator corker had two and we got both of hoaxes so there are a lot of things that we did on the senate side that became

possible on the house side. and there are a number of things that they did on the house side that we couldn't agree with on this side either. but we did reach agreement, and we reached it in pretty much record time, and we now have a bill that can go ahead and be passed and go to the president for signature, and assure that the level of safety that we have in our drugs not only continues but improves, and that drugs can get on the market faster than they have before by streamlining the process and also making sure that there are better foreign inspections so that the ingredients that go into drugs don't cause problems. so this legislation reauthorizes the food and drug administration's user fee programs and it ensures that the americans get better access to safe, innovative medicines and medical devices. it'll make significant changes. it'll improve the f.d.a.'s review and approval of new drugs and devices. unfortunately, f.d.a.'s current process for reviewing and approving medical devices too often creates delay and u

unpredictability. this in turn threatens patient access to the best possible treatments for their conditions. in some cases this has forced american patients to travel overseas to obtain access to lifesaving, new devices that f.d.a. has not approved in the united states. the bill goes a long ways toward solving these problems and makes the most significant changes to the law governing f.d.a.'s review of devices in decades. this bill will speed the approval of devices by reducing the red tape associated with the -- quote -- "least burdensome" -- unquote -- standard that f.d.a. uses to approve such devices. the bill will also make it easier for f.d.a. to approve devices for patients with rare diseases who might not otherwise be able to have their conditions treated most effectively. it will also enable f.d.a. to expedite safety determinations, to resolve appeals, and to

improve their post approval surveillance activities to detect problems as they occur. it is not good just to get it approved. we want them watched after they're approved. the bill also contains important reforms to foster drug innovation and patient access to new therapies. it modernizes the approval pat pathway for drugs. and it formalizes a new process to expedite the approval of breakthrough therapies. these changes are particularly important for patients with rare diseases where there are no therapies available and it's not feasible or ethical to require large, conventional clinical trials. nobody wants to be the one that's a test case when there might be something that would really work for them and there aren't the size of populations to be able to do the clinical trial anyway. the patient community strongly supports these improvements because these will save lives. the bill also contains important

reforms that will help mitigate the problems associated with drug shortages. it'll require better coordination within f.d.a. as well as the other federal agencies, like the d.e.a. it will also allow f.d.a. to move faster to take actions, to address shortages through expedited reviews and approvals. the bill follows what i call the 80- rule. when we focus on the 80% of the issues that we can reach agreement on rather than focusing exclusively on the part -- exclusively on the parts, the issues that we can never resolve, we can achieve amazing results. over a year ago staff began to work on identifying the 80%. a group of staff from republican and democratic offices on the health, education, labor, and pensions committee began a series of standing meetings and proceeded to meet for several months. they discussed policy solutions that each member thought would solve the problem.

after much discussion of the benefits, costs, and possible unintended consequences, members agreed on a list of policy concepts. if there was not a consensus on a particular policy, it wasn't included. this is the 80% rule of action. as this process has progressed, my staff also met with the republican staff on the help committee for at least two hours every week to keep them informed and seek their input. i also personally met with the members of the committee before markup to ensure that i understood their priorities. this bill reflects the work of every member of the health, education, labor, and pensions committee. all of them have at least one provision included in this legislation. many members off the committee worked with us to find consensus measures that addressed their priorities as well. as i mentioned, not everyone got everything they wanted. we did, however, find the 80% of each solution that we could all agree would help solve the problem. and the bill passed the committee by a voice vote.

this legislation could be a model for how the process can and should work, regardless of the political environment. we followed this model as we transitioned from the committee process to the senate floor. we worked with members who filed amendments in committee to address some of the concerns in the managers' amendment. we also worked with members who filed amendments on the senate floor. we did the same thing in our discussions with the house. you can see that the results are very positive. we preserved and improved policies to foster drug innovation and patient access and to promote accountability and transparency at the f.d.a. we also made significant improvements to the senate's medical device reforms for stars-up and emerging growth companies and with respect to the 510-k process. we'd like to thank senator harkin for his tireless effort on this bill. i know he spent countless hours and attended dozens ofs meetings working with senators and stakeholders and advocates to

address their concerns. this bill would not sister had such broad bipartisan support without all of his work. senator harkin's staff has worked tirelessly on this bipartisan bill. their knowledge and graciousness were instrumental in addressing all of the issues in this bill. they worked late evenings, through weekends, they worked through countless working group discussions to be able to get the bill where it is today. and specifically i want to recognize ebb elizabeth youngman, bill mccon ahue, kate wise for all their work, pam smith, senator harkin's staff director for her leadership in getting this bill to the finish line, i especially want to recognize janelle krisshnamorath i who

made sure all the members of the staff are reflected in the bill. i'd like to thank the legislative counsel and the food and drug administration for all of their technical assistance. again there were people in those groups who worked through the weekends as we were finishing up. finally lied ied like to thank my staff, keith flanigan, grace stones, katie spanningler, rob walton and my health policy director chuck clapton and i'd be remiss if i didn't thank my staff director, frank macciarola for his work as this progressed from the help committee and discussions with the house. my staff has been wogd around the clock for days and weeks and months and i sincerely appreciate their dedication to getting this bill passed and for helping to work with the 80% rule. i urge my colleagues to support this bipartisan bill that makes important changes to the f.d.a. and i ask them to support this

process that expedites getting the conference done. we will have a real and meaningful impact on millions of american patients. i thank the chair and yield the floor. a senator: mr. president? the presiding officer: the senator from north carolina. mr. burr: mr. president, i'd like to start off by thanking the chair and the ranking member for the great work that they have accomplished with what has always been a very delicate piece of legislation. their staffs have been tireless on both sides at trying to work out differences, and we wouldn't be here today if it wasn't for their commitment to this legislation. let me say to the chair and the rab practices i plan to go on

for some time. if i were you, i would take the opportunity to leave for a while because i will go for an hour or two or maybe three. and it's not all going to pertain specifically to this legislation, but i've got a lot to say. because i've heard some of the opening statements, and i've heard statements like our goal was to finish before the supreme court. i got a question, why? why did a crucial piece of legislation that affects so many americans and ultimately so many patients around the world, why did it have to be done before the supreme court? i'm not sure that anybody can give an answer, but somebody started that as a goal and it just sort of was adopted. and i heard that the legislation was accomplished at record speed. i don't see that as something to herald. speed is indicative of something

that we rushed our way through. and i know on behalf of the chairman, staff, and ranking member's staff, they've been og on this for a long time. so has my staff. but from the standpoint of when we marked up the legislation and came to floor, how fast we went to the floor, we did it because there was an understanding that we were going to try to hold the senate product together. now, i don't want to take issue with the numbers. i had two amendments that were dropped in conference so i'm not sure how i had 12 and got 11 but that's irregardless. the question that we're here to do, the purpose of this legislation, is that this is supposed to drive innovation in america and bring lifesaving drugs, devices and biologicallics to patients here in america first but around the world. that's the goal behind this legislation. and i've got to take issue with

my ranking member. i don't think the 80% rule applies to health care. i can't look at a patient and say if we can get 80% of the right policy, i'm going to feel good. if i'm in the 20% that's left out, i'm going to be really pissed off. one of the reasons that our health care costs are so high today is that we've been able to innovate as a country to where we maintain disease extremely well. but we are right on the cusp of being able to cure things like breast cancer, diabetes. it's not going to be cheap. it's not going to be fast. you're not going to find it in the 80% category. you're going to find it in the 20% category. it's going to take a while. it's going to take people investing capital in companies that are committed to their shareholders that they're not going to have the returns because they're investing on something important and that's the long-term future of this

country and our country's health. that's what i see in a five-year pdufa bill. this is not a one-year reauthorization of something. and granted, this is not a piece of legislation that this committee drafted from scratch. it's important that everybody understands that this legislation or the negotiations between drugs, devices, biologics, generics industry with the food and drug administration. there is not a member of congress and no staff of congress in the room as they negotiate what fees they're going to pay to the f.d.a. to actually process their applications. so the focus of this committee was to look at what happened in the negotiations and try to figure out how could we make this bill better, how could we assure ourselves that there was a level of transparency that we could understand, that the negotiations they had entered into in fact benefited american

patients? if this doesn't benefit the health care cost and the health care of americans, then we've missed the mark. so the whole objective is to put america in a better position after the passage of this bill. now, mr. president, i'll be boring because some of what i'm going to talk about, a lot of people in this institution know. but i'm not sure that the american people understand the background that's here. the food and drug administration is responsible for assuring the safety and the efficacy and the security of human and animal medical products. one element of f.d.a.'s statutory mission is to promote the public health and the f.d.a. accomplishes this mission in part by timely -- timely -- approving lifesaving, life-enhancing innovations that

make medicines safer, more effective and in many cases more affordable. f.d.a.'s broad regulatory authority crosses a range of products and has resulted in the agency overseeing products that amount for 25 cents of every dollar of the u.s. economy. let me say that again. the f.d.a. regulations extends to 25 cents of every dollar spent in the u.s. economy. therefore, the f.d.a.'s review and decision process is not only -- does not only impact our nation's innovators, it has impact on many sectors of the economy. the american people have serious interest in ensuring that the f.d.a. is accountability bill, transparent, efficient, and making sound decisions in a timely fashion as possible. you see, that's why i'm on the

floor today. if the goal is to have transparent, efficient, sound decisions in a timely fashion, you don't rush through it. you make sure that there's a matrix in place, not one that was designed by the agency, and not one that was designed by the industry, but one that's designed by the body that's responsible to do oversight over federal agencies, the congress of the united states. the help committee. it's our job. that's why concerns about timeliness and predictability of f.d.a.'s regulatory process must be taken seriously and they must be addressed. unfortunately, too often congress is guilty of not paying close enough attention to how well things are working or not working. at the f.d.a. on behalf of patients, the very people for whom the most is at stake.

every five years, drug and device industries negotiate their user fees that are then sent to congress with the expectation that we will quickly act upon to ensure the continuity at the agency. and let me assure you, this year is no exception. they dropped these agreements on congress' lap and said would you pass these as quickly as you can with no changes. to their credit, the chair and ranking member said no, congress has a role to play and staff's had tremendous input at what the final product was. unfortunately, rushing the bills through the house and the senate has resulted in bipartisan track and trace provisions not being included in the bill we have before us today. now, as the ranking member said, i'm very disappointed that these important bipartisan provisions were sacrificed at the expense of speed. i understand the difficulty of the lift.

i acknowledge that to my colleagues and to their staff but i also question how hard we really tried on an issue that we knew going in was tough. there's no such thing as spending too much time when it comes to getting something as important as drug distribution security right. i want to assure all my colleagues that my friend from colorado, senator bennet, and i will continue to work together to get these important provisions done. and i might add i've had the commitment from the chair and the ranking member to work with us on other legislation to try to address this. but let me say today it won't be any easier then than it was right now. it may be tougher then because this was a vehicle that had to go, therefore, people would have swallowed a lot more than

in this bill. as my colleagues know, f.d.a. and industry tell us not to make any changes because it would -- and i quote -- "open up the agreement." think about that. the industry and the f.d.a. told congress don't put anything else in here because we would consider that as opening up our agreement. when did congress become so irrelevant that a federal agency would suggest that we not get involved? yet it requires our passage for this to go into statute. so i've explained before, congress is told to tiptoe around the agreements and we focus our efforts on the belt and suspenders policies to complement the agreement. this does not make for the most consistent and deliberative process in considering how congress can work with f.d.a. and industry to strengthen and

improve f.d.a.'s drug and device work on behalf of our nation's patients. but this is the process that members have to work within, which is why it's so important to assure that the right policy riders including transparency and accountability, are included in the final passage. now, one thing that has been made quite clear over the past few years is the importance of f.d.a. reporting on the right matrix. i can predict with some confidence since this is a five-year bill we will be here five years from now, and hopefully there will be at least one member of the senate that steps up and says how did the f.d.a. hold up against what they said they were going to do in the agreements? well, that's at the heart of transparency and accountability. if we haven't got a matrix established that everybody

understands, here's where we are and here's where we've promised we're going to get to, now howe in the world five years from now do we measure this? how do we know then if you raise the user fees, that it's justified, that the beneficiary of it is the american patient? i'm going to say something that's candidly obvious to everybody listening. when drug companies, device companies, biologic companies, generic companies, pay more money to get their application approved, who pays for it? the consumers. the people who buy the drugs, use the devices, buy the generics -- this is the first time we've ever had a user fee for generic pharmaceuticals. generics were called that because generics were created after the patent life expired, so that we could bring low-cost products to the market. and now what are we doing in we're creating generic user

fees, which is going to raise generic cost priceprices the americans. it may alter whether in fact it is cheaper to go in and pay for their generic prescription or whether it is cheaper to get their co-payment do it on your insurance card. that's the reality of what we're dealing with, and i'm not suggesting that it's bad. but why would you rush through it without understanding what the impact is? that's where we are today. now, reporting only on the negotiated user fees performance goals agreed to has not provided a complete picture of howed f.d.a. is working to fulfill its obstacles. what gets measured gets done. so it's got to be measured. the "wall street journal" op-ed

this year, former f.d.a. commissioner andy von eschenbach highlighted what is at stake if congress does not get the user fee reauthorization package right and fix the underlying problems at the f.d.a. he writes, and i quote, "the stakes couldn't be higher for our health." "the stakes couldn't be higher for our health." the u.s. biomedical industry is one of the crown jewels of the american economy. it employs 1.2 million people directly and over 5 million throughout its supply chain with a total outout-of-$519 billion -- output of $519 in 2509. many of the firms are among the world's most innovative. from 2001 to 2010, the 2011 mill ken institute showed that -- millikin institute showed that u.s. companies produced more than 60% of the world's new medicine. u.s. companies produced nearly

60% of the world's new medicines. up from 42% the previous decade. but u.s. firms won't continue to lead unless the f.d.a. retains its role as the world's gold standard for evaluating new medical products. many people establish the gold standard as being the hurdle you have to pass to be approved. i would tell you that the gold standard is also how difficult is the process you have to go through and will the capital be there to finance the research and development so that approval is something that you see as light at the end of the tunnel? these all have to be weighed in the policies that you put in place, and i would tell you that we've come up somewhat short. last year the national venture capital association released a report that underscores america's risk of losing its standing as the world leader in medical innovation.

their survey clearly showed that the f.d.a.'s regulatory challenges, the lack of regulatory certainty, the day-to-day unpredictability, unnecessary delays are stifling investment in the development of lifesaving drugs and devices. instead of deterring investment and innovation in lifesaving treatments in areas such as cardiovascular disease, diabetes, and cancer, we should accelerate. insteadf deterring that capital to come in, we should be finding policies to accelerate that capital to chase cures in heart disease, diabetes, and cancer. working with america's innovators on behalf of patients depending on the next breakthrough drug or device. our nation's health care system is unsustainable. we all agree we must lower health care costs in america.

predictable regulatory pathways that facilitate products reaching consumers in a timely manner is key for lowering our health care costs. this survey is another call to restore regulatory certainty and predictability at the f.d.a. but comb through this bill -- two amendments that were voted and accepted in the senate markup of the bill were dropped, discarded because somebody was too concerned with requiring too many reports. there is a reason you get grand already a with what you -- with grand ualready a with what you put in legislation and more importantly what you require an agency to produce. predictable regulatory pathways that support products reaching

patients in a timely manner will lower our health care costs. it's clear that the f.d.a.'s global leadership in innovation is at risk. a 2011 report by the california health care institute and the boston consulting group highlighted this. in recent years the environment for medical innovation has deteriorated in the most critical factor -- and the most critical factor habit f.d.a. -- has been the f.d.a., the food and drug administration. let me repeat that. the report found the environment for medical innovation has deteriorated and the most critical factor has been the food and drug administration. the report states, "for the agency's policies and activities exemplify president obama's critique of a regulatory system whose rules have gotten out of balance, placing unreasonable burdens on business, burdens that have stifled innovation and

have had a chilling effect on growth and jobs." now all of a sudden we're talking about a piece of legislation that we rushed through the process because we wanted to beat the supreme court rule on thursday -- decision on thursday. we did it at an accelerated pace, faster than we've ever done through the united states senate, and we realize, this legislation affects the economy and jobs. it's not just about health care, it's not just about patients, it's about jobs. dr. david galler, present korea of the california health care institute, raises a clear alarm in his report that we should all heed. he concludes, "the result of the uneven performance of the agency

has been to increase the risks associated with regulation, dampening investment in companies whose products face f.d.a. regulation. meanwhile, as global competition in high-tech industries other nations have adapted their regulations to outcompete the f.d.a. the flight of medical technology products launches to european union countries should be a serious cause of concern for policy-makers and patient advocates alike. " what's that mean in lay man's terms? we're losing them here and the e.u. is attracting them there. why? because their policies are easier to understand. it's not that their threshold for safety and efficacy is i lower. but think carry on an honest partnership with the applicant e

applicants and most would tell you, dealing with the f.d.a. is like invit -- exporting innovation overseas and the jobs that come with it won't help patients or our economy here at home. it erodes our nation's standing as a global leader in medical innovation and results in america's patients have to wait longer for lifesaving therapies or jeopardizing their steeks them at all. i'm not sure in america we ever thought that we would go to another country where they had approved a new therapy, that we couldn't get in the united states. but i'd be willing to pet that every family-- --but i'd be willing to bet that every family in america knows someone who's gone outside of the country to get some type of treatment that we haven't approved here.

the likelihood is that those productproducts never even applied for f.d.a. approval. why? because the process has become so unpredictable and so expensive that a company has to justify the potential sales of a product to meet the billion-dollar cost just to get through the f.d.a. application process. exporting lifesaving innovation overseas and the jo, that come with it -- and the jobs that come with it, erodes our nation's standing as a leader in medical innew englandvation and -- innovation and results in america's patients having to wait longer. the f.d.a. is supported by both user fees and taxpayer dollars so congress has a critical oversight role in ensuring that f.d.a. is meeting its requirements under the law. moreover, as elected representatives of the american people, congress institutionally

has a duty to ensure that the f.d.a. is broadly fulfilling its mission in promoting the public health through its review, regulation, on a range of medical products. the reauthorization of the drug and device user fees agreement is an important opportunity for congress to ensure -- ensure -- that the f.d.a. is fulfilling its mission. why would we in any way water down the accountability and transparency if in fact we are the ones to ensure f.d.a. fulfilling its mission? but closely examining these issues once every five years is not going to help address the underlying problems at the f.d.a. that we all know must be fixed. the only way that's going to happen is with the f.d.a., congress, patientspatients, innovators consistently working together with the right data points. the bottom line is you don't know what you don't measure. you don't know it, how can you

ensure that it's right? another report by the california health care institute and the boston consulting group in 2012 underscores the importance of reliable data at the f.d.a. and how f.d.a. performance is a function of management. the report finds that there would be great value in regularly gathering and analyzing the best possible data and updating performance metrics during this pdufa cycle in order to track performance consistently and longitudinally with the goal of the most accurate possible measures of agency performance. do you sense a trend here, that every outside group -- not industry, not f.d.a., not congress -- every outside evaluation of thuresser fee agreement -- of the user fee agreement is basically saying,

hey congress, don't miss this opportunity. if you want to track the performance, then you've got to set up the matrix and collect the data. why in the world would we drop from the bill the transparency and accountability provisions that get the granular data that we need to make this assessment? i guess we'll never know. congressional oversight can help highlight the process that is working well at the f.d.a. recent g.a.o. reports over the past year have underscored these points and why that right matrix must be reported to paint a full and complete picture. now all of a sudden we've got the general accounting office -- the g.a.o.

they're saying the same thing that all these third parties have said. why in because they're the ones that we turn to when we want to ask them to do an evaluation of the f.d.a. and they are taling congress, hey, don't miss -- and they're telling congress, hey, don't miss this opportunity to get this stuff in there. you actually can get the data that we can't get because it's not in the statute. every five years when we pass the final user fee package, f.d.a.'s authority and responsibilities grow. think about that. more employees, higher costs. it seems like things would be getting b but without the may treks -- it seems like things would be getting better. but without the matrix, without transparency, without accountable, we don't know. f.d.a. is is going to get an unprecedented level of user fees and more new authority, billions in user fee dollars. with this unprecedented level of

user fees, there must be unprecedented transparency, oversight, and accountability. it does not exist. let me be clear. there are good provisions in this bill that should help to improve transparency, accountability, and regulatory certainty. however, throughout the committee's work on various issues, i repeatedly raised the point that if we did not fix the underlying issues at the f.d.a., the new responsibilities and expectations, we are going to create with this bill would not achieve the desired outcome. so quite simply, that's why i'm disappointed that some key transparency accountability provisions included in the senate bill did not survive the final bill, while key g.a.o. reporting provisions may have been removed from the final bill. i want to take this opportunity to inform my colleagues and the f.d.a. that i personally intend on pursuing this oversight

analysis outside of this bill. just because it's not in this bill doesn't mean i'm going to go away. what this has done is speed his trump policy, the attempt to speed through this bill, the attempt to get it done before the supreme court announces its decision on obamacare. i have yet to explain, have anybody explain to me why we're benefited by moving this before the supreme court rules. if somebody got a concern that there's something in this bill that might be affected by what the supreme court ruling is, would we not be smart to delay this until after the ruling to see if there's some adverse reaction to what we've done? if i thought there was any reason to do that, i'd be on the senate floor pleading with my colleagues today.

but the truth is there's nothing that will come out in the supreme court decision that will affect the user fee relationship between drugs, devices buy logics and generics and the food and drug administration. but somebody wanted to finish it, and they set that as the goal that everybody could see. because of the hard work of my colleagues on both sides of the aisle, the final bill includes new incentives intended to help spur the next generation of lifesaving antibuy i don't -- antibiotics. this is a good thing. unfortunately the strategy for the f.d.a. to submit a strategy and implementation plan that would help ensure greater certainty regard f.d.a.'s work with antibuy 0 -- antibiotics was not included in the final bill. yet we've all watched on tv as a

young lady that was attacked with a virus that's eaten her hands and feet, an infection, what does she need? she needs a breakthrough in antibiotic therapy. this was a real opportunity for us to send a message out there that not only are we committed to do it, we're committed to set up a regulatory structure that allows it to happen. carefully drafted g.a.o. reporting requirements intended to help f.d.a. and congress identify progress against regulatory challenges in this space has also fallen away. this has nothing to do with richard burr or michael bennet. this was the general accounting office. unfortunately, the reporting requirements that remain is nearly as robust as the language passed by the senate earlier this year. these requirements were intended

to help identify and root out the regulatory challenges in this space to ensure that the incentives included in the final bill are as meaningful as possible and ultimately do achieve the goal of the next generation of novel antibiotics reaching patients. i can't think of anything more important than for us to make sure -- i know the president comes from a state where devices are a key part of the economy. another reporting requirement that fell away is one that my colleagues have heard me talk about a lot over the past year. the medical device user fee agreement includes reporting on the total time to decision in calendar days, not f.d.a. days. this sounds a little bit like disney world. what in the heck are f.d.a. days? i know what calendar days are.

tomorrow's going to be one number higher than today and yesterday was one number lower, and every 28 to 31 days we switch and it becomes a new month and we start counting over again. not at the tpafd. and that's -- not at the f.d.a. that's why it was important that calendar days be substituted for what we call f.d.a. days at the f.d.a. patients don't care about f.d.a. days. patients care about how long it takes in calendar days for safe and effective products to reach them. my colleagues may recall that last year the final agricultural appropriations bill included an requirement for f.d.a. to report on calendar days, because knowing the average number of calendar days it's taking for f.d.a. to approve therapies to reach patients, it is important for assuring that we see a full

picture of how well f.d.a.'s working in a metrics that the american people understood. last year when the senate considered the issue of counting calendar days for medical products, dr. paul howard, a senior fellow in the director of the manhattan institute center for medical progress, described the importance of counting calendar days. he wrote -- and i quote -- "the pdufa clock stops when the f.d.a. requests more information from sponsors. so repeated requests for more information from the f.d.a. can significantly draw out the time before a product reaches the market. even if the agency completes its review within the specified pdufa time frame, knowing actual calendar days that elapse from between the time that a sponsor submits an application to the time it's approved should give congress some sense of how efficient, how efficient the review process is. if the f.d.a. is repeatedly asking for more information and

lots of time, it's added to the approval process. it has important implications for patients who wait longer for new therapies and investors who may perceive the regulatory process as arbitrary and time-consuming." here again, another independent analysis of what should be important to the american health care system. and on assessment, the calendar dates are absolutely vital to congress's ability to understand how long does it really take at the f.d.a.? and we're not even the person trying to finance the breakthrough. i appreciate that the final bill will now require more granular reporting with respect to the prescription drug user fee agreement, which is a good thing. but i'm baffled that a reporting requirement congress has supported in the past and which

was included for generic drugs was not included in the final bill. talking about calendar days. how in the world could calendar days be important enough to put in the generic bill part and dropped from everything else? why? because f.d.a. didn't want it. the f.d.a.'s gotten used to that little stop watch that they've got. and when they ask you for a little more information, they reset it so they get to start again. my dear colleague, tom coburn, and i both are disappointed that a provision offered by him and which i supported was removed from the final bill. i've talked about a number of things removed from the final

bill. i'm not sure how the ranking member gave me a number at the beginning that i had interest in 12 things, and i had 11 accepted. i can't count as i'm going through my presentation, but i think i'm on three or four that have been dropped. the medical device user fee agreement includes the requirement for an independent assessment of f.d.a.'s management of devices. unfortunately, the assessment included in the prescription drug user fee agreement and the final bill will look at only one-third of the f.d.a.'s work with drugs. let me say that again. the medical device user fee agreement includes the requirement where an individual assessment of f.d.a.'s management of devices, unfortunately the assessment included in the prescription drug fee agreement and final bill will look at only one-third of the f.d.a.'s work for drugs.

calendar days applying one section generic drugs don't apply and devices, drugs, biologics. now all of a sudden we've got an independent assessment of f.d.a.'s management of the devices industry where we're only applying that to one-third of the area of drug evaluation and not to generics and not to biologics. senator coburn's provision which was first introduced in a bill that senator coburn and i introduced, the patients f.d.a. act, would have ensured an independent assessment of all f.d.a.'s drug work. upon introduction of the patient's f.d.a. act, dr. paul howard wrote that this provision -- and i quote -- "perhaps the most important provision because the outcome of that review may or may not be welcomed by the

f.d.a. but it will force congress to pay attention and highlight the f.d.a.'s importance as the gateway for medical innovation not just in the united states, but the world." paul howard's no relation to me. this is, again, it's an independent doctor who makes a comment on a provision in an obscure bill that was introduced in congress. and he says perhaps the most important provision. yet, it only applies now to one-third of the drug area, and all we wanted to do was to apply it to the whole thing, not including this independent assessment is a missed opportunity for congress, for consumers, and patients to have a complete independent and objective look at f.d.a.'s management of its mission and resources with respect to drugs. i understand that some of my

colleagues are concerned about overreporting, but i would come back to the basic point that you don't know what you don't measure. this is about how congress and the f.d.a. prioritize. and given what's at stake, not including targeted reporting requirements that will help out f.d.a. to better achieve their mission on behalf of patients, is a huge, huge missed opportunity. why? speed over policy. i'd also like to talk about a key provision in the senate's upstream supply chain provisions. it's not included in the final bill. many of my colleagues know the globalization of the drug supply chain presents unique challenges in assuring the safety of the drugs america's patients receive. quite a bit of time has understandably been devoted to this issue. unfortunately, while the bill includes many bipartisan

provisions that will help f.d.a. to better target inspections of drug facilities based on risk, the final bill falls short in addressing end-to-end supply chain security. you know, that's sort of important. i think the american people sort of take for granted that we've got that in place now. in addition to not including bipartisan downstream provisions, the final bill does not include the senate's bipartisan provision to ac accredittate third party auditors to conduct drug safety audits of drug establishments. to be khraoerbgs these third-party -- to be clear, these third-party drug safety audits would not have replaced official f.d.a. inspections, but they would have been an important risk-based tool for the f.d.a. to leverage in taking

steps to ensure a safer global prescription drug supply chain. i actually believe that america thinks we've got that in place right now. who could be opposed to such a commonsense solution? it was a bipartisan initiative. was it the house that kicked it out? was it the f.d.a. that kicked it out? it really doesn't matter. this was smart to have in the bill. the only conclusion i can come to is speed trumps policy, that our quest to get this done quickly meant that we didn't look closely enough at the things that we should have done and could have done, and we didn't do. now, the ranking member talked about my disappointment and his disappointment on the downstream

drug distribution security. i just want to take a brief moment and comment on downstream. i want to thank senator bennet, the other side of the aisle. we worked toge -- together, and because of his hard work and dedication to this issue, i think i can say that we're both disappointed that the final bill does not include bipartisan provisions that we have been working on together for the past few months. my colleagues all know why this is an important issue. it's important for america's patients and consumers. i remain committed to establishing a workable and reasonable traceability system that strengthens the integrity of the pharmaceutical distribution supply chain. it's critical that we replace the current patchwork of inconsistent, inefficient and

costly state laws with a predictable, workable and appropriate federal standard. i'm committed to get this done. as i said to the ranking member and the chair, it's not going to be easy. we knew that when we took this on. we can't do it fast. i didn't know we had a stopwatch on how quickly we could get this bill through the senate and how quickly we could get through conference and how quickly we could get it passed. i reminded my colleagues the current user fee agreement doesn't expire until later this year. it didn't have to be done now. but it was. and for now 45 minutes, i have pointed out things we could have done, should have done and didn't do, and it's embarrassing. this could have been done. this was the right vehicle to put this in. because it was a must-pass piece

of legislation. now, let me, if i could, talk about some of the provisions that senator coburn and i introduced in the patient's f.d.a. act. i'm pleased that we were able to find a bipartisan path forward on some of these provisions which will put in place an unprecedented level of transparency and accountability at the f.d.a. while the f.d.a. should have already done many of the things that will now be explicitly required of them by ensuring we hold f.d.a. accountable to measures and reports on specific requirements, there is a greater chance that they're going to actually get done. there is no certainty without congressional oversight. greater transparency and accountability provisions included in the package today will help to ensure greater

regulatory certainty and timely decisions on behalf of america's patients, which is key to ensuring america maintains its role as a world leader in medical innovation and our patients have access to the most cutting-edge therapies in as timely as possible fashion. f.d.a. will be required to develop a regulatory science strategy, an implementation plan with clear priorities and report on the progress made in achieving these priorities in fiscal year 2014 and fiscal year 2016. the current f.d.a. commissioner has acknowledged that the f.d.a. is relying on 20th century regulatory science to evaluate 21st century medical products. let me read that again. the current f.d.a. commissioner has acknowledged that the f.d.a. is relying on 20th century regulatory science to evaluate 20th century -- to evaluate 21st century medical products.

let's stop. let's get this right. even the commissioner of the f.d.a. is saying you know what? we're not even in the same century in how we do what we're trying to accomplish. in other words, the products that the f.d.a. is required to regulate is advancing faster than the agency's ability to regulate it. i'll be honest, that's a big problem. former f.d.a. commissioner was right when he said that the f.d.a. must be capable of ensuring that its reviewers know just as much about advances in emerging sciences as the creators of the products they regulate. listen, i will be the first to say at the food and drug administration we have some of the best and the brightest. they are some of the most dedicated federal workers. they are some of the smartest folks i've ever seen.

but they process approvals. they're not on a bench doing research and development. they don't understand how medicine and science has changed since they left the bench themselves. there is every reason to believe that people should be required to go back and be innovators and not necessarily make a lifetime of work as a reviewer at the f.d.a. there has been much talk about regulatory science, but it's hard to tell if these efforts are targeted and achieving the desired results of helping the f.d.a. to apply the most cutting-edge scientific tools in their research and their review of medical products. the agency must have clearly defined goals and metrics against which their progress

will be tracked. this is the only way to ensure that the advances in regulatory science are being applied and f.d.a. is prepared to regulate the most novel and cutting-edge medical products ever created. gek has well -- g.a.o. has well documented f.d.a.'s management challenges. the agreement included in the final bill will further increase these challenges by adding more than 1,200 new f.d.a. f.t.e.'s or employees and growing the scope in regulatory mission and responsibilities. the uncertainty at the f.d.a. are symptoms of unaddressed systemic management issues. this is the agency that controls 25 -- they regulate 25 cents of every dollar of our economy. a february, 2010 g.a.o. report found that the f.d.a. does not

fully use established practices for effective strategy planning -- or strategic planning and management. the f.d.a. agreed with the g.a.o. recommendation to take several actions to improve f.d.a.'s strategic planning and management, such as development of a strategic management plan and working to make f.d.a.'s perfornce measures more results oriented. i -- i can't think of a business in america that doesn't do that today. however, two and a half years later, f.d.a. has failed to adopt many of the key recommendations. to address this concern, the final bill requires the f.d.a. to submit the congress' strategic integrated management plan with specific accountability metrics as recommended by the g.a.o. even though the f.d.a. admitted to the g.a.o. based upon their recommendations that they needed to do this and that they would do it two and a half years later, we're now putting it in statute in the user fee bill.

g.a.o. has well documented f.d.a.'s challenges to sufficientlily and successfully utah -- sufficiently and successfully utilize its information technology process. g.a.o. has also noted how these challenges undermine f.d.a.'s ability to use accurate and timely information to augment its regulatory mission. g.a.o. reports in 2009 and 2012 found that the f.d.a. has made mixed progress in establishing the i.t. management capabilities essential to supporting the f.d.a.'s mission. that's the information technology. so an agency that's on the cutting edge of medical approval in this country in 2009, 2012 was found to have made mixed progress in establishing the management capabilities essential through technology to complete their mission.

a comprehensive i.t. strategy plan is vital for guiding and helping to coordinate the f.d.a.'s i.t. activities. a comprehensive i.t. strategy plan, including results-oriented goals and performance measures, is vital for guiding and helping to coordinate the f.d.a.'s i.t. activities, especially since the user fee agreement includes specific i.t. goals. the final bill requires the f.d.a. to report on their progress in developing and implementing the comprehensive i.t. package called for by the g.a.o. to ensure further congressional oversight, g.a.o. will report on the progress f.d.a. makes on meeting the results-oriented goals and performance measures set out in their i.t. plan they submit to congress. enhanced reporting requirements with respect to biosimilars and generic drugs include key

reporting on clearing the backlog of generic applications will also provide important transparency in the f.d.a.'s work and serve as an early warning indicator if the agreements are not being fulfilled. i'm also pleased that we were able to find a path forward on important pro-patient provisions from the patient's f.d.a. act and provisions that will also reduce unnecessary regulatory burdens for innovators. i want to thank my colleague, senators mikulski, alexander and hagan for working with us to ensure that the unnecessary red tape does not get in the way of meeting patients' unique medical device needs. the custom device provision in the bill provides an important path forward toen chewer doctors are able to meet patients' most unique medical device needs in as timely manner as possible. the risk-benefit frame work

included in the user free agreement and codified by the final bill will facilitate the balanced consideration of benefits and the risk of f.d.a.'s drug decisionmaking. as innovators have increasingly turned to global markets and opportunities overseas, f.d.a.'s work with its global pier regulate -- peer regulators has taken on an even greater significance. f.d.a.'s work with its global counterparts to encourage uniform clinical trial standards will optimize global clinical trials to ensure the need to conduct duplicative clinical trials as minimized. while f.d.a. maintaining the gold standard for approval. i want to thank senator paul. i want to thank senator paul for working with me to ensure that we have optimized global clinical trial work and f.d.a.'s work with global peer regulators as much as possible to reduce

unnecessary regulatory hurdles. senator paul was a champion in the committee to say why don't we accept the data that we get from trials in europe for applications that are under review for approval in the united states? and the answer i gave him was in 1997 when we wrote the food and drug administration cosmetic modernization bill, we gave the f.d.a. the authority to do that, and now some 15 years later, it has never, ever, ever been used. as a matter of fact, the f.d.a. won't even consult with a company that says tell us how we need to design our trial in europe so you will accept our data. but you know what? it's got to happen in the future if we can't drugs to be cost-effective so that people can afford them. if we can't innovation to happen here as well as over there.

if innovation and the place where it's ultimately approved is determined by whether you can recover the cost of your investment, i will assure you we're all going to shop somewhere else for our drugs, our devices, our biologics and even our generics. it won't be here unless we learn how to share that data from continent to continent. i want to highlight some specific medical device regulatory improvements. there may be any number of reasons a sponsor wants to conduct certain clinical studies that are not directly related to the classification or approval of medical devices by the f.d.a. however, some sponsors have noted the tendency of the f.d.a. to effectively prejudge the approval of a medical device by basing its decision related to a request to conduct clinical investigations of a device on whether or not the f.d.a. believes the clinical study will be adequate to support the ultimate classification or approval of a device.

if the f.d.a. approves the investigational use of a device, only using the more narrow regulatory standard of device approval or class if i occasion, clinical research in the united states could be unduly restricted. the final bill would return the investigational device exemption approval process to the standard authorized by the statute, which is a good thing for both patients and for innovators. the final bill will also improve regulatory certainty, transparency and accountability with respect to medical devices by requiring f.d.a. to provide a substantive summary of the scientific or regulatory rationale for significant decisions. as many of my colleagues know, section 510-k of the food, drug and cosmetic act requires device manufacturers to notify f.d.a.

of their intent to market a medical device at least 90 days in advance. medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be -- or effectiveness could be affected. such change or modification could relate to the design, material, chemical composition, energy source or manufacturing process. there are legitimate concerns about recent guidance issued by the f.d.a. that could increase the regulatory burden related to the 510-k modification without benefits to patients. it will go a long way to restoring balance to the 510 modification process by making it clear the 1997 guidance remains the standard until f.d.a. issues new guidance with

appropriate input from stakeholders on that subject. while i wish that we could have gone further to strengthen and improve the device third party review and inspection program, the final bill does reauthorize these programs and includes a provision from the patients f.d.a. act to set forth a process for reacred education today -- accreditation and reauthorization of third party reviewers. the other thing we placed in the 1997 act and hopes that we would see academia in america actually be approved as third-party evaluators, not for heart stints or that class of device, but how about things like band-aids? how about those things that we shouldn't waste an f.d.a. reviewer's time on? couldn't they contract a -- company contract with an academic institution to evaluate and reapprove, reaccredit?

f.d.a. has chosen to do that in house. this is the first and important step to enhance the third-party review program. from the least burdensome requirement i appreciate the bill underscores the least burdensome requirement we put in the 1997. it reduces burdens to improve access to medical devices. a central purpose of the modernization act of 197 was to ensure the timely availability of safe, effective new products that will benefit the public and that our nation continues to lead the world in new product innovation and development. the goal was to streamline the regulatory process and reduce burden to improve patient access to breakthrough technologies. this law required f.d.a. to eliminate unnecessary burdens that may delay the marketing of beneficial new products but the

statutory requirements for clearance and approve -- approval remain the staple same. the section of the statute that captures these are referred to as least burdensome. for years the f.d.a. included least burdensome in the guidance documents and letters but towards the end of 2009 the least burdensome language disappeared only to reappear after congress expressed significant concern regarding the f.d.a.'s afailure to apply these in the work of devices. the lack of consistency has added to the regulatory uncertainty and unnecessary regulatory burden in a manner completely inconsistent with the law. it is said that congress needs to reaffirm the provision that's been in law since 1997, but i want to thank senator klobuchar and senator bennet for working with me to underscore the importance of affirming the least burdensome requirement in this final bill.

the final bill restores more appropriate balance to f.d.a.'s conflict of interest rules. this is an issue in which many patient groups have weighed and many members have worked because of its important to patients and overall confidence in the f.d.a. advisory committees. ensure youing f.d.a. has the access to the most qualified experts is vital tony sure f.d.a.'s scientific capabilities and confidence in its regulatory decisions. it is critical that patients have the benefit of the very best expertise when weighing decisions that impact patient imenact to lifesaving products. unfortunately, since 2007 increasingly complex and restrictive conflicts of interest rules have often resulted in the agency being able -- being able to consult with leading experts and difficulty in filling key advisory committee positions. these challenges are

compromising the quality and the timely messness -- timeliness of the f.d.a. decisionmaking. the final bill should help address these concerns and ensure the f.d.a. can draw upon the most knowledgeable experts. lastly, i'd like to highlight the advancing breakthrough therapies for patients act. bipartisan legislation i was pleased to join senator bents and senator hatch in supporting because it will ensure patients have access to targeted, lifesaving therapies as efficiently as possible. as former f.d.a. commissioner von eschenbach has said breakthrough technologies deserve the breakthrough in the way the f.d.a. evaluates them. this is supported by the friends of cancer research and the national venture capital association. an on end by friends of cancer research noted highway the sequencing of the human genome has helped unlock a greater

understanding of disease at the molecule level, helping to make personalized medicine become reality. they noted two main goals of the breakthrough legislation. first, to reduce the total development time and cost of the most promising breakthroughs. and second, to minimize the number of patients that would be given a controlled regime or currently available treatment that doesn't work well. they are right to underscore in order to full tile phil the promise of breakthrough therapies in this legislation, the regulators at f.d.a. must fully engage working with sponsors early, early in the development and review process once a product has received the breakthrough designation. more than 45 organizations representing patients, advocates, physicians, caregivers and researchers and consumers have weighed in to congress urging the advancing breakthroughs therapies for

patients acting included because they recognize employing such and all hands on deck approach for these therapies will ultimately result in the most efficient development program and help ensure the most promising new treatments reach patients as safely and effectively as possible. many would argue that modernization of the acceleration process and fast track pathways have been a long time coming since congress has not significantly updated either pathway since 1997. earlier this year dr. paul howard in writing about breakthrough legislation noted -- and i quote -- "the most important section of the legislation may be the clause that requires the secretary of h.h.s. to commission an independent ent at this time to assess the efficacy and predictability of how f.d.a. has applied the directives in this legislation no later than four years after the bill passes." he goes on to say -- and i quote -- "that may be the best way to

ensure we won't wait another 15 to 20 years to understand how well the f.d.a. is utilizing the authority granted to it by congress. unfortunately, this independent assessment did not make it in the final bill." speed trumps policy. in summation, the f.d.a. faces an unprecedented challenge today, challenges that we couldn't have envisioned a generation ago. yet f.d.a. still regulates a decade ago, based upon the commissioner. the agreement many of the provisions in the final bill be intended to address these challenges. unfortunately, the final bill does not bring to bear all the tools that could have been included to ensure transparency and accountability for patients

and taxpayers. this is a missed opportunity. i ask my colleagues where we be if provisions enacted as part of this bill like the breakthrough therapy provision do not achieve their stated purpose. where will we be if congress does not do our part to ensure accountability on the part of the agency by carrying out consistent congressional oversight? where will america's patients be in five years? will f.d.a.'s regulatory standard be the global gold standard? will america lead the world in innovation? will the world's leading drug and device innovators choose to innovate in america or continue to -- the disturbing trend of exporting great innovation and good jobs overseas and continued face of regulatory uncertainty? there are good provisions in this final bill, but more work remains to be done.

america's patients and innovators are counting on congress to conduct the proper oversight. in the months and years head to ensure these authorities and responsibilities are implemented and fulfilled consistent with the law. they are also counting on congress to complete the unfinished business of doing all we can do to ensure that the f.d.a. fulfills its mission on behalf of america's patients and our nation's global leadership in medical innovation is restored. i commit to my colleagues, constituents and the f.d.a. i intend to complete the unfinished business before us today. in either future legislation or in committee action. mr. president, you have been patient and observant. i thank you for that. at this time i will yield the floor. i see my colleague here, and at his conclusion i will pick back up with the two and a half additional hours that i have

reserved. the presiding officer: the senator from kentucky. mr. paul: mr. president, i'm not a big fan of foreign aid. we have a lot of problems in our country and i just don't see how we can send billions of dollars overseas when we've got bridges that are falling down in our country. two bridges in my state were impassable. one was hit by a boat and has been impassable for six months. we have another bridge that's over 50 years old, was shut down for emergency repairs and traffic stacked up for miles. yet we send billions of dollars overseas when we don't have enough to fix our own bridges. it doesn't make any sense. we borrow a trillion dollars a year from china simply to turn around and send it to some other country. it makes no sense. i'm not a big fan of sending your money overseas. but i'm even less a fan of sending your money to countries who don't seem to be our friends. now, pakistan has worked with us on the war on terror. but recently pakistan has chosen

not to let any of our supplies, our food and military supplies to traverse pakistan. recently pakistan has said we owe them $3 billion. we're giving them $2 billion a year and they say we are back, we owe them $3 billion that's not even included in that. recently pakistan has also said they want to charge us $5,000 per container of food that goes across their land. and for years bin laden lived contentedly right in the middle of pakistan underneath their noses. so what's up with that? we're giving pakistan $2 billion a year and bin laden's just twiddling his thumbs there. they're not letting our supplies go roos, -- across, our demanding a past payment of $3 billion for who knows what, and we continue to pay them. recently it's gotten even are worse. dr. shakil afridi is a doctor who helped us get bin laden. i don't know how his name became

public. somehow his name was leaked. somebody leaked his name. i don't know whoever leaked the name if they were trying to puff themselves up and make them look like they were strongly fighting terrorism, but by leaking his name, he's now in prison for 33 years. dr. shakil afridi is a pakistani who helped us get bin laden. the pakistani government has put him in prison for 33 years. his life has been threatened. if he is released, which i hope he will be released, his life has been threatened and he's in danger because his name is public. how did his name become public? somebody leaked his name. this is inexcusable. if this came from within our government, whoever leaked his name or leaked this information needs to be held accountable. i mean put in prison in our country for leaking state secrets. the thing is that his name is now known in public, and he is threatened. his family is threatened.

not only that, but anyone around the world who wants to help us to stop terrorism around the world who is willing to stand up and say i will help america, they are now threatened. do you think people are going to want to help fuss they know their name is going be the print -- to be printed in "the new york times"? we have things we have to not divulge about people helping us to gatt combath terrorism. dr. afridi is in prison for 33 years and i'm going to do what i can to free him. i'm saying we shouldn't send them any more money. stop immediately. i'm not saying take a small amount next year, don't send them a penny this year or next year, don't send them the $3 billion. one, we don't have it to send to them, we have to borrow it 30 tr from china, but i'm giving them one chance to get out if they'll release dr. afridi, i'll stand down. my bill was blocked. i tried to have a vote on this

last week and the leadership here said no, you won't have that vote. but we have a process where if you get enough signatures from senators, you can ask for a vote an ged -- and get it. that's where we are. i have enough signatures to get a vote. i'm meeting with the pakistani ambassador, with president obama's state department and what i will tell them is what i'm telling you. this is not a secret. if dr. afridi is not successful with his appeal -- which scomg up in the next three weeks -- if he is not released and provided safe passage out of pakistan if he wishes, then i'll have this vote. and i defy anyone in this body to stand up here and vote to send u.s. taxpayer dollars to pakistan when they're treating us this way. so we will have a vote in this body on ending all aid to pakistan immediately if we don't get some results. now, this isn't mean i don't want to have diplomacy with pakistan. pakistan has been a frinld over

many years and i see -- friend over many years and i see in reason to end that. pakistan has many elements who are pro-western and do want to engage in the world. i'm all for that. but you shouldn't have to buy your friends, you shouldn't have to pay a random, you shouldn't have to lavish them with taxpayer dollars. in fact, it discourages respect when you give them so much money. let's make them earn our respect, let's be friends with pakistan, let's have diplomatic ties to pakistan. let's try to help each other. terrorism doesn't help pakistan. they're threatened equally by it. i can list four pakistani leaders who have been assassinated in the last 15 years. why are they assassinated? because of radical elements in their own country. so they should be with us on trying to stop extremism, on trying to stop this radicalism. so my words for the senate today and for the american people are, and that i'm watching out for your money, i realize that we have needs here at home that

must come first, but also that i will force a vote on this and i'm not going to send any more of your money or try not to let the senate send any more of your money to pakistan unless they're willing to cooperate, unless they're willing to be friends with america, unless they're willing to release the man who helped us get bin laden. so i will ask for a vote. it will come in the next few weeks, and i will keep everyone in america up to indicate on this. and i thank the senate -- up to date on this. and i thank the senate for allowing me this time. and i suggest the absence of a quorum. the presiding officer: the clerk will call the roll. quorum call:

the presiding officer: the senator from north carolina. mr. burr: mr. president, i ask the quorum call be vitiated. the presiding officer: without -- without objection. mr. burr: i thank the president. mr. president, i thank senator paul for relinquishing the mike and just for the purposes of members who are planning, i think we'll be about another hour and we'll know shortly and i'll naught word out if, in fact, that's going to be the case. but i intend to make sure that everybody's able to make a 5:00 briefing. and i've spent the first hour

talking about the f.d.a. user fee agreement bill, the history of it, what this bill did and a lot about how this bill came up short. i'd like to jog in a few different directions over the next period of time, if i can, of great interest to me and great interest to a lot of members is the commitment that we owe to our nation's military heroes. over four decades ago at one of the two marine corps bases in america, camp lejeune in jacksonville, north carolina, they experienced serious contamination of its water. that contamination is likely the worst environmental exposure incident on a domestic military installation in the history of the country. both in the magnitude of the

population potentially exposed to volatile organic solvents and the duration of the contamination, estimated to be 30 years or longer. hundreds of thousands of veterans, their families, along with civilian workers cycled through camp lejeune from the busy years of world war ii through the vietnam conflict and into the mid-1980's as we rebuilt our modern military. during these decades, unbeknown to the base residents, the wells feeding the water supply on the base were drawing water from an aquifer contaminated with industrial chemicals that were dumped on the base. like the degreing solvent d.c.e., a known human car sin again. another carcinogen, benzy, from, from underground leaking storage tanks, along with the try and cleaning solvent p.c.e., and a third human carcinogen,

vinylchloride. the navy and marine corps began to test some of the base wells in the 1980's to comply with federal regulations. and apparently to also locate the source of various contaminations. yet it would take several more years and numerous warning signs before the navy finally decided it should shut the wells down in 1985-1987. as we know now, the navy and marines had specific regulations on their own to maintain safe drinking water and test for contaminants. had they adhered to their regulation, the many years of problems at camp lejeune might have been avoided. it's also important to note that the source of those contaminations should never have been in question since lejeune's drinking water was then and is now solely derived from the wells located within the

perimeters of camp lejeune, north carolina. in 1989, the e.p.a. designated camp lejeune a superfund site and in 1991, the c.d.c., via its agency for toxic substances and disease registry, or astdr, began a statutorily mandated study of the contamination. those studies continue to this day, in large part because the navy's records of the contamination were not completely turned over to the afsdr until 1009 and 2010. scientists at the astdr and others involved in the review of the records have stated that the levels of certain contaminants recorded in well samples taken by the navy were at such high levels that they have never been seen before and in many cases they far exceed what we now consider to be safe levels for drinking water.

well, the veterans administration is awarding disability benefits to lejeune veterans on a case-by-case basis today. but that's a slow and unpredictable process while many are suffering without adequate health care. it's my hope that in the coming weeks, we will finally pass critical legislation in this congress to require the v.a. to take care of the veterans and their family members. many of them are ill from exposure-related conditions and have no other means of getting health care. they are rightly looking to the v.a. and to the congress for help. if we can get this legislation passed, it will be a starting point on the road to doing the right thing for those who have sacrificed so much for our nation. i just think it's absolutely a crime that now, some 40 years later, we haven't even completed the studies that we need to, to

understand the severity of the problems that we have. i might add that some of the service members and some of the family members that served at camp lejeune during this time are no longer with us so it's hard to reconstruct exactly why, but i can assure you, when you have some estimate ten times the number of male breast cancer cases from people that lived on that base during that time, one might conclude that it was a hot spot based upon its drinking water. my hope is that this congress will move forward with a very small initial step but also make a commitment to these family members and service members to not quit until we do the right thing. mr. president, this week the supreme court's going to rule on the president's health care law.

you'd have to live under a rock not to realize it's going to happen thursday morning at 10: 10:00. we have waited patiently every time the supreme court has rolled out their announcement for the last three weeks i think of cases that they had decided as the court comes to the end of their summer business. two years ago, then-speaker nancy pelosi told americans -- and i quote -- "we have to pass the bill so that we can find out what's in it." "we have to pass the bill so we can find out what's in it." seems fitting that we stop and take stock of what the american people have learned about the president's health care law over the past two years. the american people have found they can't afford the president's health care law. the medicare chief actuary in

his final estimate of the health care law projected it will increase health care spending across the economy by $31 $311 billion. now, that's a ten-year number. but understand that the president promised that the health care law would reduce costs it wasn't a goal -- reduce costs. it wasn't a goal. he promised it would reduce costs. unfortunately, it's made things worse by increasing health care costs. and i think that the medicare chief actuary is probably a very conservative estimate of an increase of $311 billion. growth in the u.s. health care spending will almost double by 2014 due to the president's new law. now, this is at a time where we already are in eye situation where it's financially unsustainable on the path that we're on.

the predictions of the president's health care law increasing insurance premiums are already being felt by the american people. depending upon where you live, depending upon who your employer is, depending upon whether you buy your own insurance. it depends on how hard you've been hit. but there's nobody in america that has not seen their premium go up since congress passed this health care bill that was supposed to reduce the cost of health care. the congressional budget office estimated that the new law will increase health insurance premiums by 10% to 13%. this means a family purchasing coverage on their loan have to pay $2,100 a year more because of the president's health care law. and, by the way, 10% to 13% is what many splernz felt as -- many americans have felt as an increase on an newt basis.

an annual basis. new taxes. new taxes on lifesaving drugs, devices and health plans. now, think about that with the hour i just finished. i just talked about the fact that congress needs to be focused on the efficiencies of government, how we bring innovative products, devices, pharmaceuticals, guy oh logics, again -- by logics and generics -- biologics and generics into the marketplace. and embedded into obama care are new taxes on drugs, devices and health plans. the american people haven't felt this yet. at a time that we're supposed to be passing legislation to bring down health care costs, not only does the congressional office say this is going to increase the premium cost, not only does the president's actuary, c.m.s., is under the executive side of government.

it's not under congress' authority. he said that health care spending across it is economy, based upon the health care law, is $311 billion. we have yet to kick in the new taxes on the lifesaving drugs, devices and health plans which will drive up consumer cost and additionally drive up premium costs. just after passage of the new law in may 2010, the director of the congressional budget office said rising -- and i quote -- "rising health costs will put tremendous pressure on the federal budget. in c.b.o.'s judgment, the health legislation enacted earlier this year does not support substantially diminish that pressure. the question is: what were we thinking? and now we've got the court to decide whether it is constitutional or not.

c.b.o.'s latest long-term fiscal outlook notes that the spending on health care has been growing faster than the economy for many years. posing challenges for medicare, medicaid, state and local governments and the private sector. you know, sometimes this is missed by members of congress and our constituents. there is a tremendous cost that we shift to the states and to local governments, depending on how they share in the medicaid state obligations for cost-sharing, where states are picking up a tremendous amount of additional costs because of the passage of the president's health care plan, because we're doubling -- through legislation, we're doubling the amount of people who are on medicaid. so now you're going to get hit

by the increase in your insurance premium, you're going to hit hit by the increase in overall health insurance, you're going to get hit by the increase in the price of devices, you're going to get hit in your state taxes because of the increased burden of medicaid beneficiaries who are in part funded by the state and are are going to now require states to find new ways to raise revenue, which is typically through our state taxes. c.b.o.'s -- c.b.o.'s right to conclude that such rates of growth cannot continue indefinitely because total spending on health care would eventually account for all the country's economic output which c.b.o. concludes -- and i quote -- "is an impossible outcome." well, madam president, we need real reform that actually lowers

cost, not increases cost; we need real policy that institutes better outcomes, not rationing of care, and the american people need to look at what the president promised when he created this legislation. he promised that if you like your plan, you get to keep it. unfortunately, the administration has estimated that up to 69% of all the businesses could lose the ability to keep what they have as a result of the administration's grandfathered health plan regulation. the former director of the c.b.o., doug holtz warns that the law "provides strong incentives for employers and their employees to drop employer-sponsored health insurance for as many as 35

million americans." well, if an employer drops their health care coverage, how can the employee cash in on the president's promise to keep what he's got? millions of seniors will lose access to their medicare advantage plans. now, i'm not quite there, but some of my colleagues have reached that magical number. do seniors not deserve choice? is that what it is? do we just want to give them one thing and no choice? and the truth is, we allow -- we didn't create it; the private sector created it. we allowed the private sector to create medicare choice years ago. and for many seniors, they chose to take the private-sector product. why? because we provided more coverage to them. it provided preventive care.

they actually got covered physicals every year. in many cases they didn't have co-payments. in cases their prescriptions were covered, lopping before we covered part -- long before we created part-d medicare. the president's plan tightens requirements on medicare advantage to the point that some seniors who are on it today will lose it because it is no longer an option in the markets they live in. how in the world can you do that and make a promise that if you like it you get to keep it? health plans offered by regalia greated organizations will be -- regalia filliated organizations will be required to offer products that violate the tenets of their faith. and infringes on the religious liberty.

now, that's going into a ground we've never gone into. and i think there is a reason that we've allowed people to hold to the more standards that they felt were important. then-speaker of the house pelosi said the health care law will create 4 million jobs, 400,000 jobs almost immediately. yet the director of the congressional budget office testified that the new law will reyou don't employment over the -- reduce employment over the next decade over 800,000 jobs. think about that. then-speaker pelosi said 4 million jobs, 400,000 just almost immediately and the c.b.o. director testifies we're going to lose 800,000. that's a difference of 4.8

million jobs in america. the president said that he was going to -- that he was not going to touch medicare. we heard that over and over again. he said to seniors, i'm not going to touch commitment of he'd already taken medicare advantage away as a choice, but he wouldn't going to touch chairmen the law took more than $500 billion out of medicare. a health care plan that today is not financially sustainable and the president in his health care legislation shifted $500 billion ousout of medicare not to put medicare on a sustainable path but to fund new government programs the american people could not afford. arbitrary cuts to providers that jeopardize access to care will not put medicare on a

sustainable path for current future retirees. what does that mean? doctor cuts -- we cut the reimbursement to doctors. we cut the reimbursements to hospitals. we've now got doctors who won't see medicare beneficiaries. if you are 65 and move to raleigh, north carolina, the likelihood is you're not going to kind a primary care doctor who will take you if you are on medicare. to that person to that senior, that's rationing. i don't care how you say and the reality is, this bill caused that. the president promised no family making less than $250,000 a year will see any form of tax increase. well, i just covered a second ago the new health care law is riddled with new taxes and penalties that directly failed on the middle class and -- fall on the middle class and will harm small businesses. new taxes on devices, health plans, they're all going to be passed on to consumers. you can't -- it's disingenuous

to say that everybody in the senate system is not going to feel -- in the system is not going to feel the effects. they are on the products that constitute our health care system. we should be advancing policies that help small business to thrive in america, not policies that increase health care costs; policy thanes courage innovators to export innovation and good-paying jobs overseas. we should be advancing policies that focus on helping to get our economy back on track. unfortunately, the president's health care law does just the opposite. according to the u.s. chamber of commerce survey on small business, 74% of small businesses said that the health care spending law makes it harder, harder, for their firms to hire new workers. 30% said they're not hiring due

to the law. there's only one issue in america: how do we get the american people back to work right now? how do we turn this economy around? we can have all the cuts you want to have from a standpoint of spending. but unless we're willing to put americans back to work and get them productive and participating in the revenue collection of this country, we're not going to get on a pathway to financial sustainability. this country wasn't created because people came here and said, let's create a place called america where everything is free. it was created as an area of unlimited opportunity, and that's why millions a year come here: for unlimited opportunity, not for unlimited handouts. when de tocqueville left the united states and talked about the greatest country in the world and he defined it this way, "the capacity of the american people to give of their time and that he their resources

to people who are in need." he never mentioned state or federal government. he talked about a responsibility of the american people to help somebody that was down on their luck, hungry, homeless, and you know what? for those of us that are adults, it is our responsibility to set the example for the next generation to come up and assume the same individual responsibility. but now it seems like all we talk about is legislation that inserts the federal government or the state government or the local government in the place of what historically made this country great, which was our willingness to assume the responsibility ourselves. let me just assure you, we shouldn't be surprised that the results of the assessment of health care, of the government running health care means job

loss, increased costs. we've got to make sure that we provide more choice, not less choice. we've got to get the american people engaged in negotiating their health care costs, not letting the federal government negotiate your health care costs. i came here for the first time 18 1/2 years ago. i worked for a company of 50 employees. i came to the united states house of representatives and chose the same plan in winsto winston-salem, north carolina, wide that same employer. the only difference was that when i got here, the federal government paid he 75%, my employer paid 75%. i paid 25% here. i paid 25% there. i got exactly the same plan, the same coverage, everything was identical. when i left winston-salem to become a member of the united states house of representatives,

my cost of that health care plan was $105. when the federal government got through negotiating my same mechanic plan, it went up to $1606780. i knew on day one, i didn't want the federal government negotiating my health care because it meant higher prices but no change in coverage. my hope and my plea and my prayers are that thursday the supreme court nullifies this bill and this congress is challenged with going back and step by step or in comprehensive fashion we write a health care bill that includes the participation of the american people, puts responsibility on everybody -- everybody in america should have the responsibility to pay something. when they go int in to access. it doesn't matter whether it is private insurance, whether it is medicare, whether it is medicaid. if we want to financially solve the hole we're in in this

country, then we've got to income-test everything that comes out of the federal government. that means people that have more, pay more; it means people that have less pay something. but we've got to be a country of unlimited something, not of unlimited handouts. a february 2012 surray said that 48 push of small business had not hiring because of the potential cost of health care. studies indicate that the law's innovative tax killing on medical devices could cost an additional 43,000 jobs in america. the president's health care law -- bill is the wrong prescription for america. regardless of the supreme court's decision this week, it is clear: we must advance commonsense, sustainable reforms that actually fulfill the promise to lower health care costs. without that, america will --

should be outraged and i believe will be outraged. now, madam president, also in the news in the last several weeks is an issue that is somewhat personal to me as a member of the senate intelligence committee, as a former member of the house intelligence committee, as one who has dealt with the work of the intelligence committee since the year 2000, and as one who lived up close and personal everything that has happened since 9/11. we've seen an incredible spree of security leaks, leaks of classified and sensitive information.

you know, i go home on the weekends and there'll be a news report on something. and my wife will look at me and she'll say, why is this reported? there's no reason for the american people or for anybody in the world to know about thatt long ago that even if the press found out, they'd never print it. today routinely there are leaks of classified and sensitive information. recently there's been a series of articles published that have described in some cases, in extreme detail highly classified unilateral and joint intelligence operations. i'm not talking about suggesting that it might be there or without detail. i'm talking about specifics of what happened. to describe these leaks as troubling and frustrating is an

understatement. they are inexcusable. by whoever. our intelligence professionals are allies, and most importantly, the american people deserve better than what they've seen over the last several weeks. i'm personally sick and tired of reading articles about sensitive operations that -- quote -- "current and former u.s. officials, individuals who were briefed on the discussion. officials speaking on condition of anonymity to discuss the clandestine programs. a senior american officer who received classified intelligence reports. according to participants in the program. according to officials in the room. and individuals who none of would allow their name to be used because the effort remains highly classified and parts are -- of it continue today.

that's the basis. that's the basis that these front-page stories run on. and i'm not confirming or denying that anything in it is accurate or inaccurate. because as a member of the committee, i sign an object tpwaeugs that says -- i sign an obligation that says no covert action wheul i even comment on. any person that holds secret, compartmentalized clearance has an obligation to never acknowledge the existence of a program. i asked not long ago was the drone program still a classified program. the answer i got was "yes," but the white house press secretary for the last three weeks stood at the podium and talked about drone attacks on a program that i technically cannot go out and acknowledge either exists or it

doesn't. our freedom with understanding that politics trumps security has reached a new level. it's got to stop and it's got to stop now. the unauthorized disclosure of classified intelligence at best violates trust and potentially damages vital liaison relationships and at worst gets people killed. clandestine operations were often, as i wrote with senator coats and rubio in "the washington post," highly perishable and they depend on hundreds of hours of painstaking work and the ability to get foreigners to trust our government. i strongly believe that these leakers are also violating the trust of the most important constituency of all: the american people. even more troubling is that there appears to be a pattern that these stories and leaks, they may be designed to make the

administration look good on national security. it used to be that the good stuff was buried by t media and the worst was run. not anymore. the truth be told, rarely have i seen a story that paints this administration in a bad light. then when we're about to, the administration invokes executive privilege. they can do that. that's okay. but there's a big difference between invoke executive privilege or not producing documents for fast and furious and relosing classified -- releasing classified information that puts at risk individuals who are embedded in terrorist organizations who are doing their job to keep america safe. this has crossed the line. i wish this administration was as concerned about preventing leaks of classified information as it is about keeping a lid on the information congress is

asking for. as a member of the senate intelligence committee, i understand firsthand the grave importance of keeping information secure. the unauthorized and reckless disclosure of classified information undermines the hard work of our intelligence officers and puts lives at risk. and it jeopardizes our relationship with overseas partners. congress's intelligence oversight committees will not tolerate nor should the american people. so quite simply, i come to the floor today to deliver a message to those individuals who were briefed on the discussions, who were part of the program, who were in the room, who are speaking on condition of anonymity: stop talking. whatever agenda you have, i can assure that you it's not worth the damage that you're causing and the lives you're putting at risk. we cannot continue to tolerate leaks at any level or branch of

government. now, my colleagues and i are considering every available legislative option to ensure the security of the intelligence community operations and the people who support them. if you have access to classified information and are tempted to leak that information for whatever reason, i ask you to remind yourself that you may be hurting and what trust you're violating. and more importantly, keep your mouth shut. the intelligence committee on both sides of the hill, i think, will take action in their authorization bill to try to address a structure that brings a new level of oversight and hopefully prosecution to those who choose to leak secrets. in the interim, i'm still considering the fact that for any person who openly talks about a program that is secret or compartmentalized that the

day they say one word about that program, they lose their top secret clearance. i'd love to see them lose their pension, but i understand how problematic that is. but at least we can stop the bleeding by taking away their access to the conversations or the meetings that they happen to be a participant in or they happen to -- or happen to be entrusted with the information in a fashion that allows them to go out and publicly talk about that, and jeopardize the lives of americans, the lives of our partners, and more importantly, the security of the american people. madam president, on august 5, 2011, standard & poor's downgraded the credit rating of the united states for the first time in our history and they cited out-of-control debt and

lack of a serious plan to address it as its main reason. nearly a year later the administration's done nothing to remedy this problem. as a matter of fact, sometime at the end of this year we're going to run out of our ability to borrow money. it's called the debt ceiling. and i can't tell you today, because we're not told, whether that's going to happen in october, november, december, or january, but it doesn't go much past the first of the year. and i sort of pity the next president, whoever that is. they're probably going to get inaugurated one day, and the next day they're going to have to come to congress and ask for $3 trillion increase to the national debt. and as difficult as it is for me to say, we're going to have to do it. the country has to have the

capacity and the capability to borrow money to function. but you would think that with this all known, we'd take the opportunity now to begin to change the grotesque spending habits to begin to prioritize the investments that we make, that we would attempt to reform the programs that cost us the most and lead to an unsustainable financial future for the united states. a country that will soon be $17.8 trillion in debt that i won't be here to pay back, but my children and my grandchildren will. and you have to ask yourself as a parent: is that fair? and the answer is it's not. now, instead of doing anything, last year the debt ceiling needed to be increased by $2.1

trillion. and we're about to blow through it. why? because we spent $1 trillion more on an annual basis than what we collect. there is no business, no family, no institution in the world that could spend $1 trillion more than they collect and be in business. nor can this country. and the time is running out. and, by the way, it's hard to put a calculation on $1 trillion. what is $1 trillion? well, it's 100% of the federal investment in k-12 education. it's 100% of the investment in higher education. it's 30% of the v.a. budget. it's 100% of the national institutes of health. it's 100% of the cost of the national science foundation. it's 100% of the federal partnership with states and localities for infrastructure, bridges, roads, sidewalks.

it's 100% of our national defense. it's all branches of the military, active and reserve; all bases of the military, domestic and foreign. it comes up to about $942 billion. you want to balance this year's budget, we've got to cut everything i just talked about and find $60 billion more just to balance this year's budget. well, the take-away from this is we're not going to delete our national security. we're not going to decrease our investment in the national institutes of health, national science foundation. we're going to be a partner in k-12 and higher education. there's a lot of places we can cut and prioritize and we should be doing it. but the take-away is you can't get there unless you're willing to reform entitlements, unless we're willing to look at where the majority of the money is spent. we can't get there. so we've got to do something,

and tilled you it starts -- and i would tell you it starts with addressing the imbalance that we have in spending and collection right now. not next year. madam president, consistent with this is the senate still hasn't passed a budget. in fact, the president's own budget didn't receive a single vote in congress when we voted on it. i shouldn't laugh. we're on track for another year with a $1 trillion deficit. how could -- how could any company run an annual -- run

their company on an annual basis without a budget, without a financial road map as to what they do? but now for over 1,000 days the united states senate has not passed a budget, and the law says we've got to do it. that's incredible. it is absolutely incredible. and over the last three and a half years we've added $5 trillion to the national debt more than in the previous eight years combined and current estimates by the c.b.o. put federal debt at 70% of our gross domestic product by the end of this year. we're reaching irreversible levels of debt as it relates to the size of our economy. it is unsustainable and it is dangerous for the fiscal health of our country. the status quo needs to change. congress needs to address the

impending fiscal cliff or risk another downgrade in the coming months. we can accomplish this by passing a budget that moves us towards balance. we can accomplish this by reforming entitlements and pushing band-aids on -- and not putting band-aids on issues for another time. our debt will begin to decrease when we put the american people back to work and we get policies in place that encourage the investment of capital. how about something novel? why don't we reform our tax code? give me the ability to go to a small business in north carolina and tell them they're going to pay exactly the same thing g.e. pays. it's hard for me to explain how they pay 36% and g.e. paid nothing. and i'm not faulting g.e. don't get me wrong. that's exactly what the tax code

currently says. that doesn't make it right. it doesn't mean we have an obligation to leave it like that in the future. i look at it as an opportunity for us to bring equity. but as we bring equity, why don't we bring everybody's obligation, their rates down? it's time for u -- us to do away with loopholes and deductions, to flatten the rates for everybody, to broaden the participation by more americans. you know what? if we do that, we'll be like a magnet for global capital. what's it take to create jobs in the united states? it takes an investment. reform the tax code, flatten the rates, broaden the base. you'll attract capital that will flee to america and create jobs like we've never seen, at a time where the world continues to try to figure out how to get out of

a hole, we have got an option to do it. i'd like to yield for a second to the -- a senator: unanimous consent? mr. burr: absolutely. mr. harkin: i ask unanimous consent that senator burr have the time until 4:40 p.m., that i be recognized for up to five minutes following the remarks of senator burr. following that after my remarks, all remaining time be yielded back, the motion to concur with an amendment be withdrawn and the senate proceed to vote on adoption of the motion to concur in the house amendment to s. 3187. the presiding officer: is there objection? without objection, so ordered. mr. harkin: i thank the senator. mr. burr: i thank the senator from iowa. so, you know, i just gave us a recipe for solving our financial -- our economic crisis in america. some might say it won't work. well, i don't know. i think it will. i can tell you this, what we're doing is not working. we're not putting anybody back

to work. we're still losing. in my state of north carolina, it's 9.4% unemployment. how far -- how long does it have to continue before we look at it and say this might be a systemic problem? can we recover from this? how many law school graduates can we look at this year where 60% of the class of graduates from may 1 now at the end of year don't have a job? as a parent, i always thought the toughest thing was to make sure that my kids got in school and that they graduated in four years. now the greatest burden on a parent is to make sure when they get out, they get a job that has a paycheck. and maybe that check puts them in a situation where they are self-sustainable. that's not the promise we made to our kids. that ought to be the driving force behind every adult in this country demanding a change,

because most of our kids did exactly the thing we asked them to -- stay in school, make good grades, go to college, get a major. you will be guaranteed a job and an unlimited future. and now the seniors who graduate from college who aren't finding a job, their experience is being questioned by their little brother or sister at home who is struggling to get through high school and wondering why they want to do six more years of education if their older sibling couldn't find a job. it doesn't have to be like this. it doesn't have to be like this. all we have to do is muster up the backbone that we need to pass legislation that creates the atmosphere for capital to be invested in job creation. you know, i'm not rich but i'm getting tired of us dividing america in as many pieces as you can divide it.

we already divide it based upon political boundaries but now we're trying to divide it based on everything we can find. yet, for every politician when they give that big speech on tv, they boil it down to this is about americans. but when you look at the campaign rhetoric that's out there, they slice and dice to try and divide it in as many ways. let me just assure you, we're not going to solve this if america doesn't solve it. it's not going to be solved in the halls of congress unless the american people demand it. it's not just one segment of america. it's all segments of america. i talked about de tocqueville's definition of the greatness of america earlier. he didn't point out some americans that did it good or did it right. he looked at america as one. as a matter of fact, when you look historically at this

country -- and i realize i only have a couple of minutes left, i will be brief. when the capitol dome was torn off and the new construction started, it was because of the wing that we're currently in in the united states senate and an identical wing that was built op the house side. when those wings were added, architecturally the dome that was on top of the capitol was out of proportion, and that dome was called a bull finch dome. in about 1851, 1852, they started building the dome that we see today made of nine million pounds of cast iron. as that dome was about a third finished, abraham lincoln was president, and you could actually watch the civil war battles across the potomac on the other side of the river. then came the end of the war and lincoln was president and had every right to be punitive to

the south because they lost. well, i challenge everybody to go back and read lincoln's speeches after the civil war. remember, the first action was to let every southerner go and keep their gun because he knew they needed to eat. but in every speech that president lincoln gave after the end of that conflict where he could have in those -- in his remarks been punitive to the south, president lincoln talked about one nation, one people. because as the leader of the united states, he understood that his single job was to bring this country back together, and with probably the greatest reason to draw division in america, he refrained from that temptation and he spent all of

his time redefining what makes america great, and that's a united country of people. so in the temptation to win elections and the temptation to show the highlights or successes of one party over the other, i'll conclude with this today. we've got a real opportunity. real opportunity as leaders in this country. to set by example how we go forward. let's quit the political divisions. let's start it with the two presidential candidates. don't slice and dice america to where it's this group and that group against this group and

that group. let's realize if you want to change the direction of this country, somebody has to stand up and bring america together. my belief is that we need to do it now or there may not be another opportunity. i can look at my good friend, senator harkin and myself, and we're at an age where we're not going to drastically change our future. we have made the bed we're going to sleep in, but for our children and our grandchildren, the impact of what we can do can drastically change the opportunities they have got for a lifetime. i'd love to leave this institution believing that we have had an impact that extends prosperity and opportunity for generations to come, but for a majority of the two and a half-plus hours i have taken today, we don't have the backbone to take it on. it's not going to happen. if we don't do it, nobody else

will. let's demand that the leadership that we put in place is willing to show the leadership needed to bring this country back together for a common purpose, and that purpose to be a country of unlimited opportunities where everybody is being treated fairly. i thank the president for her attention. i yield the floor. mr. harkin: madam president? the presiding officer: the senator from iowa. mr. harkin: madam president, we're about to move to a vote on the f.d.a. reauthorization bill, a bill which i said earlier we have spent more than a year working on in committee.

it's had a lot of input from senators on all sides, and industry stakeholders, consumer groups, and this is the result of a -- of a wide collaboration on all these issues. i just wanted to respond to a couple of things that my friend -- and he is my friend from north carolina -- said earlier about the bill and about the amendment that he was concerned about on the track and trace amendment. the senator from north carolina talked about speed. he said that we were rushing this through. well, madam president, the vote in the senate was 96-1. the house vote was unanimous. that doesn't happen if a bill is tried to be rushed through. anybody tries to rush a bill through is not going to get 96 votes in the senate or a unanimous vote in the house. now, again, my friend questioned

how hard i -- questioned how hard we really tried to get the track and trace provision included in the conference report. well, i might turn the question around and question how hard the senator from north carolina and the senator from colorado worked to get this included because we have been working on this bill for over a year. and my friend, a good member of the committee, has been very much involved in many aspects of this bill, he and his staff. so i wonder then why the amendment was dropped on our staff one day before the filing of the bill at the midnight hour. i might also point out that on september 14 of 2011, our committee had a hearing on this issue, on the supply chain issue, and the record will show

that i, the chairman, was the only one to raise the issue of track and trace at that hearing. two weeks before markup, senator burr and senator coburn introduced an f.d.a. bill. our staff -- i don't mean just my staff. senator enzi's staff and my staff worked for two weeks to incorporate elements of this bill into the reauthorization. now, these were elements of the bill introduced two weeks before by the senator from north carolina, senator burr, and senator coburn, so our staff spent two weeks trying to incorporate elements into the bill, and they did, and we did incorporate a lot of elements. i would point out that there was nothing in that bill that mentioned track or trace that was in that bill that was introduced two weeks before. so, again, i just say if this was so important, why wasn't it in that bill -- in their bill? if it was so important, why did it wait until sunday evening at 6:20 p.m. the day before filing

when we get the language? so again, who is trying to rush what? so again, i -- i don't -- i don't -- we did not try to rush anything, but when you get something dropped in your lap at 6:20 p.m. the night before the filing, it's hard to build a consensus, and that's what this bill is. we did go to conference on this, but this issue involves a lot of different players, and we just could not get that consensus. so i say to my friend from north carolina, we are still working on this, we will work on it in good faith, but you have the state of california, you have the pharmaceutical manufacturers, you have drugstores, you have got consumers, you have got a lot of people out there that have something to say about this, and we have to build that coalition in order to get a good track and trace bill through. so, madam president, we are now

about to vote on the critical f.d.a. bill reauthorizing user fees, modernizing f.d.a.'s authority in several meaningful and targeted ways, addressing the drug shortage problems, streamlining the device approval process, enhancing our global drug supply chain authority, all the while maintaining and improving patient safety. because this bill will directly benefit patients in the u.s. biometrics industry, it's critically important to the industry and to patients that we get this done. i urge my colleagues to vote for final passage. pass this bill. that will be done. it's the same bill that the house passed unanimously. once it's done here, we will send it to the president and get it signed and move ahead with a good reauthorization of the federal -- of the federal food and drug administration. the presiding officer: under the previous order, the motion to concur with amendment numbered 2461 is withdrawn and the

question occurs on the motion to concur in the house amendment to s. 3187. is there a sufficient second? there appears to be. there is. the clerk will call the roll. vote:

vote: