Skip to main content

tv   U.S. Senate Takes Up FDA Bill Confirms Ambassadors  CSPAN  August 3, 2017 9:59am-12:00pm EDT

9:59 am
america. i had worked for transportation companies, some of whole background was in transportation. it's nice now to be able to return to a field in which i had worked previously, and it's nice to be back in a department that i'm very familiar. >> watch our interview with elaine chao, secretary of transportation in the trump administration. that's friday at 8:00 a.m. eastern. >> cspan, where history unfolds daily. in 1979, cspan was created as a public service by america's cable television companies. it's brought to today by your cable or satellite provider.
10:00 am
>> the senate is coming in now, working on an fda authorization bill that the regulatory affairs society has an article about. senate majority leader mitch mcconnell has said it is critical to speeding up the drug approval process. without it, the important work of ensuring drugs and devices are safe and effective would come to a screeching halt. last week the fda pushed back its august 1 reauthorization deadline to avoid sending layoff notices to thousands of employees. the house passed its version of the bill on july 12. the chaplain: let us pray. almighty god, who is the same yesterday, today, and forever, we are transient creatures who long for a sense of permanence. help us to find our permanence with a
10:01 am
fixed and abiding faith in you. strengthen our lawmakers for the challenges of these times. keep them in the shadow of your wings, protecting them from seen and unseen dangers. use your powerful arm to guide, protect, and sustain our nation. lord, hasten the day when people everywhere will seek and find you. lord, let the tranquility of your dominion increase in your nation and world. we pray in your sovereign name.
quote
10:02 am
amen. the presiding officer: please join me in reciting the pledge of allegiance i pledge allegiance to the flag of the united states of america, and to the republic for which it stands, one nation under god, indivisible, with liberty and justice for all. the presiding officer: the clerk will read a communication to the senate. the clerk: washington d.c., august 3, 2017. to the senate: under the provisions of rule 1, paragraph 3, of the standing rules of the senate, i hereby appoint the honorable luther strange, a senator from the state of alabama, to perform the duties of the chair. signed: orrin g. hatch, president pro tempore. mr. mcconnell: mr. president? the presiding officer: majority leader. mr. mcconnell: earlier this week, i set out a number of
10:03 am
items for the senate to get done during this work period, both in terms of nominees and legislation. first on nominees, we had to confirm an f.b.i. director. we've done that. we needed to make progress on a number of other nominations that have been held up for entirely too long. slowly but surely we are. we confirmed a well qualified judicial nominee. we confirmed several officials who will be critical to advancing administration policy in the defense department, and yesterday afternoon we confirmed a nominee to the national labor relations board who will help return it after eight years of habitually siding with union bosses over workers to its intended role as an impartial judge that calls balls and strikes in labor dispute. all of this is progress, but we still have nominees to confirm for positions across many agencies in both security and nonsecurity roles and many
10:04 am
cabinet members still await the number two officials for their departments. so we have more to do. the same is true of legislation. we had to pass the veterans choice legislation -- we have. in fact, we passed some additional veterans legislation as well. under the last administration we learned after shocking scandal that spread through veterans affairs facilities across the nation. we all agreed our veterans deserved far better than that. ever since congress has continued to work on a number of initiatives designed to bring more justice to veterans and more reform to the v.a. senator isakson, the chairman of the veterans affairs committee, has been a tireless advocate for our nation's veterans and a driving force on seeing these bills through committee and through the senate. we passed a number of good reforms into law already. we continue to build on that progress today. just a couple of months ago, we
10:05 am
passed important v.a. reform legislation that is now law. the v.a. accountability and whistle-blower protection act is helping to shore up accountability measures, improve transparency, and enhance the v.a.'s ability to remove unsatisfactory employees while also protecting those who speak up about wrongdoing within the v.a. we passed three more veterans bills. one heads back to the house for final passage. the veterans appeals improvement and modernization act will help address the delays that many veterans have experienced by modernizing the v.a.'s antiquated claims appeal process. the other two bills now await the president's signature, the v.a. choice and quality empowerment act we passed earlier this week will provide additional resources to shore up the critical veterans choice program so veterans who face long wait and travel times at v.a. facilities will have the
10:06 am
option of accessing private care instead. and the harry w. comery veterans assistance act we passed yesterday will expand access for veterans, a g.i. bill benefits as they transition back to civilian life. i want to thank the president and his administration for working with congress to improve health care for our nation's veterans. i also want to thank again senator isakson for his unwavering leadership on veterans issues and v.a. reforms. he's never stopped working to strengthen the v.a. system for those who rely on it and to overcome the systemic problems that have left many veterans frustrated and hurting. these veterans bills can make a real impact in the lives of the people we represent. that a -- that's also true of the f.d.a. legislation we need to pass during this work period as well. and i'm hopeful we'll have the
10:07 am
opportunity to do so today. this legislation which was passed by the help committee on a 21-2 bipartisan vote is more important than ever in light of life-saving developments in immunotherapy. it's never been more relevant given that personalized medicine is just over the horizon. passing this legislation will help speed up the drug approval process for patients in need. it will help address the time and cost of bringing life-saving drugs to market. and it will allow the important work of ensuring our drugs and devices are safe and effective to move forward. so i want to recognize the chairman of the help committee, senator alexander, for helping make this critical legislation a top priority and for working with colleagues to move it in a timely manner. so we're making progress this week. for the future of life-saving medicine, for our veterans, for
10:08 am
the leadership of our country's most critical agencies. we know we still have more to do in all these areas, but we're passing critical legislation. we're confirming nominees to important positions, and we're taking steps in the right direction. the presiding officer: under the previous order, the leadership time is reserved. morning business is closed. under the previous order, the senate will resume consideration of the motion to proceed to h.r. 24 for which the clerk will report. the clerk: motion to proceed to the consideration of h.r. 2430 an act to amend the federal food, drug and cosmetic act, to revise and citizens the user fee programs for prescription drugs, medical devrys and biosimilar biological products and for other purposes. the presiding officer: under the previous order, the time until 11:00 a.m. will be equally divided between the two leaders or their designees. mr. durbin: mr. president? the presiding officer: the senator from illinois.
10:09 am
mr. durbin: mr. president, i want to start this morning's presentation on the floor of the senate with a question. what is the most heavily subsidized private business in america, the for-profit business that receives more federal subsidies than any other. is it a defense contractor? no. is it some farming participation? no. the most heavily subsidized for-profit private business in america today are for-profit colleges and universities. why? because the revenue that they receive from the federal government accounts for 85%, 90%, 95% or more of all the revenue they take in. how can that possibly be? how could you run a private for-profit business and have a federal subsidy of 98%?
10:10 am
how is that possible? here is how it works. student graduates from high school. student applies to the for-profit college and university. for-profit college and university accepts the student on the condition that the student sign over pell grants, federal money, and the student's federal government loan. student signs over the pell grant, signs over the loan, enrolled in the school. this for-profit school now is home free. they've admitted the student. they've received all the money from the student. and the student is headed for classes. it works only if the student at the end of the day ends up some value in their education, some experience that helps them go on to get a job to pay off their student loans. it turntionz out -- turns out that in too many instances
10:11 am
for-profit colleges and universities entice these young people into signing up for classes that are worthless, end up not preparing them for any job. notice they're in a terrible fix. if they finish the course, they have a heavy, large student debt and they end up in a position where they can't get a job and pay it off. how often does this happen? think of three numbers. 9% of students graduating from high school today in america go to for-profit colleges and universities. what am i talking for-profit? university of phoenix, devry, rasmussen. the list goes on and on. 9% of high school students go to these schools. 20% or more of federal aid education goes to these schools. why? because the tuition that they charge is so high. but here's the kicker.
10:12 am
35%, one out of three students in america who default on their student loans have teanlded -- have attended these for-profit colleges and universities. so we decided under the previous administration, the obama administration, to start asking some hard questions. how are these for-profit colleges and universities enticing these students in? what are they saying to them to bring them in to sign up for classes and for their student loans? and secondly, if the students finish their degrees at these for-profit colleges and universities, how likely are they to end up with a job that's worth something, a job that allows them to pay back their student loan? those are legitimate questions, aren't they? if you were the parent of a child who said, dad, i just heard about the university of
10:13 am
phoenix. i want to go to school there. you'd obviously say well, what are you interested in taking? is it a good course? how much does it cost? what will be your debt when you're finished? what is your likelihood of finding a job? those are obvious questions. and we put all those questions into something called the gainful employment rule. at the end of graduating from for-profit colleges and universities, will you be gainfully employed as a graduate student into a job that gives you a chance to pay off your student loan and to really keep the promise that that for-profit school made to you? just weeks ago the new secretary of education betsy devos announced that our u.s. department of education was going to rewrite the gainful employment rule. the rule, as i said, was written by the obama administration after years of debate, contenuous debate -- contentious debate with the industry, and it
10:14 am
was designed to ensure that career training programs that receive federal student aid are meeting their statutory obligation to prepare the students for a job. gainful employment. and don't forget, a lot of young people applying for college are in families that have limited college experience. mom and dad may have never gone to college. so when you say devry or university of phoenix, mom and dad may say is it any good, son? is it any good, to your daughter. well, the son or daughter can say, dad, the federal government will loan me the money to go there. it must be a good school. they wouldn't loan me the money to go to a place that's bad. that's a natural reaction. we are in fact condoning, endorsing this industry by saying if you go to these schools, you get tax-payer funded student loans. i don't think it's too much to ask the programs promising to
10:15 am
train students for specific jobs actually lead to students being able to get those jobs and repay their loans. the gainful employment rule cuts off federal student aid, programs where a graduate rate of student debt to earnings is too high during any two years of a three-year period. we look at the jobs of the graduates of the for-profit schools. we look at the income of the students. and they say what is the likelihood that student can make their student loan repayment based on their employment. it is in fact gainful employment? so prior to leaving office, the obama department of education released gainful employment data for the year 2016. it showed that graduates of public undergraduate certificate programs -- now, that's those that go to community colleges; different colleges altogether -- earned'd 9,000 more than those that went to for-profit colleges
10:16 am
and universities. you know what the difference is? if you decide to go a community college in my home state of illinois in my hometown o hometo to lincoln community college, a great community college, like those of those in our state, you are a going to get a good education and it went cost you much. and let me give you the kicker. all of your hours can be transferred to upper-level colleges and universities. but if you make a bad decision and go to a for-profit college, different things happen. you end umwith a real debt -- you end up with a real debt for that first year out of high school. and guess what? virtually none of the credit hours can be transferred to any other college or university. that's the reality of what students face. of the programs that saddle students with too much debt compared to the income that students receive after the program, listen to this -- when
10:17 am
we looked at all of the student debt and all of the jobs of all of the graduates across the united states, it turns out that 98% of the students who couldn't pay off their student loans after graduating went to for-profit colleges and universities. that was the 2016 analysis. that's what led to the gainful employment rule. this is cruel, to take a young person who is doing just what they were told to do -- go to college, get a degree, don't quit with high school -- saddle them with debt, make an empty promise about what's going to happen after they graduate and then they find themselves in a job where they can't pay off their loan student. let me give you a specific example so you understand what we've run into. the digital photography program in schaumburg, illinois -- let
10:18 am
me quickly add, the folks who put this together were pretty smart. we have an outstanding college in chicago called the art institute of illinois. my daughter graduated from there. however, this bunch, the for-profit group, decides to call their operation the illinois institute of art instead of the art institute of chicago. they're owned by a for-profit giant, the education management corporation. they failed the gainful employment raoul in the year 20 -- rule in the year 201. listen to what they wrote on their website for students who wanted to enroll. quote, there is a market for people who constraint find -- constantly find ways to fill the world with their impressions and insights and digital photography can help you make a positive impression when you're ready to match your talents against the competition. from the very start we'll guide your development, creatively and
10:19 am
technically. it's a step-by-step process that's all about preparing you for a future when you can do what you love. that's what's on the website. for the high school student who likes the idea of majoring in digital photography at the illinois institute of art in schaumburg. boy, doesn't that sound good? so let's contrast that with what the gainful employment rule found about that particular program. get ready. you know what the total cost of the digital photography course was at the illinois institute of art, the for-profit school? total cost -- tuition, fees, books and supplies -- to prepare you to be a digital photograph photographer: $88,000. $88,000. it gets better. that's if you live off-campus.
10:20 am
want to live on-campus? the company helps you find an apartment nearby over the four years, an additional $56,000. let's do the quick math here. $144,000 in debt finishing four years, majoring in digital photography at the illinois institute of art. how many students have to borrow money to do that? 84% of the students who went to that school and took digital photography had to borrow the money. 84%. and guess what the typical graduate of the illinois institute of art in schaumburg, illinois, in the digital photography course earns after leaving the program? remember that promise on their website? how much do they earn? average: $20,493.
10:21 am
$20, 493. a quick calculation what. if i'm being paid the minimum wage in america. in illinois it is $9.25 an hour. well, i'd be making right around $18,500 a year in a minimum-wage job. i've gone to the illinois institute of art in schaumburg to take the digital photography course and instead of making $18,500 a year, many a. making $20,493. that's almost $20,00-- that's at $2,000 more a year. i forgot $144,000 in debt that i also have. how many years -- let's do the math. how many years an additional $2,000 to pay off $144,000? only 2 years and you'd -- only 72 years and you'd be able to pay off your student debt. what a ripoff. these people ought to be ashamed of themselves. and we ought to be ashamed of
10:22 am
ourselves that we're supporting this kind of fraudulent activity at the expense of students who are just trying to get a better education. that's why we wrote this gainful employment rule, to say to the illinois institute of art and those just like them, stop it. stop fleecing these kids. stop burying them in debt and incidentally, parents and even grandparents sign on for that debt, too. and you know something else you ought to remember? of all the debts that you can incur in life, there are only a handful of them that can never be discharged in bankruptcy. student loans would happen to be in that category. you know what that means? no matter how bad it gets -- and it can get to the point where you have no income whatsoever, no matter how bad it gets, you can't go to the courts and say, please, turn me free. discharge this debt in bankruptcy. give me a chance to start all over again. you can do it with your home mortgage. you can do it with an auto loan,
10:23 am
you can do it if you have a loan for a boat. but not with student loans. it's with you for a lifetime. we've had cases where a grandma decided to help her granddaughter by cosigning the note at one of these miserable schools. the daughter couldn't pay back the student loan. they went after grandma's social security payments. that's what this is all about. that's how serious this can become. there's no way students leaving that digital photography program at this for-profit college in schaumburg will ever repay their loans making that money. under the gainful employment rule, if the illinois institute of art doesn't change its program or lower its price or help its students get better jobs, we'd stop providing student loans to the students who are engaged in that program. we're not going to be complicit. we shouldn't be -- in this fraud. the rule requires schools to post their gainful employment data online using a new
10:24 am
easy-to-read disclosure. so that students can read, well, what happened to students that took the digital photography course? did they get jobs? how much did they earn? the rule requires schools to provide a warning to students about failing programs so they know before they sign up, they know before they go in debt. think about what these disclosures might have meant to amy. amy went to this notorious institute, the illinois institute of art, the schaumburg, illinois, photography program. she wrote me a letter and told me her story. she moved out of her parents house at age 19 and after a few years realized she couldn't have the life she wanted with the job she was working. she was getting 50 an hour raises every other year. she says, i wanted to pursue a year and i was really serious. i was passionate about it.
10:25 am
she visited this illinois institute of art campus in schaumburg. if he fed me all these success stories. they -- they fed me all these success stories. they said they had an excellent placement program. they told her she would have been making slightly over minimum wage wage after incurring all this debt. what if they had been required to dell amy that employers wouldn't accept her degree and she would never pay off their student loan? well, amy and tens of thousands of students like her across the country would have been spared from hardship that can change their lives. amy says her time at the institute of art, quote, ended up ruining my life. in her 20's she made a decision to go to college, got so deeply in debt and can't pay it back. the program culminated in a portfolio where the students displayed their best work.
10:26 am
you know how many employers after amy finished the course and did her display, do you know how many employers showed up for amy's class portfolio show at the illinois institute of art? none. not one. amy and her family, who took out the loans to help her, now hold more than $100,000 in student loan debt from her tomb at the illinois institute of art. she is stuck with a degree which, as she said, she considered a joke. using the questionable legal authority which she claims she has, the new secretary of education betsy devos has decided to delay for a year the requirement that schools warn students like amy about these failing programs. delayed it for a year. that's another year that for-profit education companies will be able to hide the truth about their miserable results. it means students are going to be defrauded because education
10:27 am
secretary betsy devos has decided to let it happen. it means more students like amy and more federal dollars in the pockets of these greedy for-profit college executives. you wouldn't believe what these people pay themselves who head up these for-profit colleges and universities. take the most successful basketball coach in the united states of america at the college level. take the most successful football coach in a state like alabama. take a look at what they get paid and i'm sure in alabama they would pay them even more if they could. and then compare them to what these c.e.o.'s pay themselves off of these poor students. for thit is time for us in congo speak up. we also know that secretary devos intends to rewrite the gainful employment rule, which she called, quote, a regulatory reset. what does that mean? we hear a lot of speeches on the
10:28 am
floor about too many government regulation. if you were amy schneider or her parents, would you consider a disclosure to students about the real results of their education a disclosure to students about the debt they're going to incur and the income they're likely to earn overregulation by the federal government? we're putting a lot of money on the line. we gave $100,0000,000 at least y to go to school. but she got a promise to pay it back. if she defaults, that money isn't paid back into the treasury. for the good of the taxpayers as well as for her family, she is this have some basic regulations and accountability. secretary devos says the rule is unfair and arbitrary. the even the department of education agreed that it was a good rule in terms of protecting kids and companies. the rule is supported by many
10:29 am
state attorney generals including lisa madigan in my home state. the gainful employer rule has been repeatedly overturned by the courts, says secretary devos. wrong. since it went into effect in 23015, every federal court it has been in front of has upheld the underlying rule. the secretary is just plain wrong. it is time for secretary devos and the trump administration to stop aiding and abetting profit -- for-profit colleges. mr. president, i yield the floor.
quote
10:30 am
mr. schumer: mr. president? the presiding officer: the democratic leader. mr. schumer: mr. president, as the senate wraps up its work this week, i've been in discussions, multiple, with my friend the majority leader about clearing nominations with bipartisan support. and we've made significant progress. now that we've moved past the terrible process used on health care, i hope we can get back to a more normal way of legislating and clearing noncontroversial nominees. the two are tied together.
10:31 am
we can't avoid regular order when you want to and then say democrats should use regular order whatever you want us -- whenever you want us to. but now that health care is done, i think we can tie the two together. normal way of legislating, clearing noncontroversial nominees as we move forward in september. of course, controversial nominees will still require the proper vetting. but i'm committed to help moving noncontroversial, bipartisan nominees forward. i hope the fever is breaking. there's a real desire in this body to move past the acrimony of the health care debate and get to a place where we can work together to advance legislation that helps the american people. and i'm hopeful that the discussions between the republican leader and i will produce a package of nominees we can pass today. now, on taxes, the republican leader has said the next big issue this body will take up is taxes. democrats were excluded from even participating in health care discussions from the very first day of congress. a process that ultimately ended
10:32 am
in failure. so we have made the first overture this time to show our republican friends we're serious about bipartisan process on tax reform. we have sent them a letter outlining three very basic principles. this is a guideline for our republican colleagues to come work with us, and these are very simple principles that i think the vast majority of americans would support. let me say what they are. first, -- well, first, the republican leader has said that he would pursue reconciliation again. a process that purposefully excludes democrats. almost again on the first day when we begin to talk about tax reform. the majority leader brought down the curtain on bipartisan tax reform before a discussion between our two parties could even begin. he said democrats don't want to have a bipartisan discussion. of course we do. we have said it over and over again until we're blue in the
10:33 am
face. but i guess the majority leader somehow didn't like the three principles we laid out, and i'd like him to specifically answer what it was. we know he probably agrees, so which of these three principles does the majority leader disagree with? tell us. which of the three? we know he probably agrees with the third. surely he can't think that a blunt budget tool that excludes 48 members of the senate is a good way to write legislation. he said so many times himself, i quoted him yesterday, he warned the senate about becoming, quote, an assembly line of one party's partisan legislative agenda. those are his words, mitch mcconnell. the senate should not become, quote, an assembly line of one party's partisan legislative agenda. that's what he did on health care. is he doing it again on tax
10:34 am
reform? i hope not. well, we know he probably agrees with the second principle. no increase to the debt and deficit. and we know he agrees because he said so before. the republican leader and members of his party have spent decades assailing the debt and deficit. as recently as may 16, the republican leader told bloomberg tv that tax reform will have to be revenue neutral. so that one doesn't seem to be -- and again, i'd like to hear what he has to say explicitly, explicitly so we can work together. but that doesn't seem to be it. it leaves us with the first principle -- no tax cuts for the top 1%. now, here again, i understand why the majority leader and my friends don't want to come out and say this is the reason they have decided to pursue a tax bill on their own, but it almost
10:35 am
certainly is. tax cuts for the wealthy are extremely unpopular with the american people, and for good reason. the top 1% of this country takes 20% of our income, a greater percentage of its wealth. the wealthy are doing well, god bless them. their incomes are going up at a faster rate than anybody else. but when we're talking about our tax code and rewriting it, we shouldn't be focused on giving the 1% another tax break. while millions of working families struggle to afford the cost of college, prescription drugs, food, and health care. i'm afraid the majority is in the same boat as they are as health care. they don't want to say their real reason for being -- for changing health care. they want to slash medicaid. a good number of courageous members on the other side said we won't do that, but that was the core of the senate bill. they knew it was unpopular with
10:36 am
the american people. so they didn't talk about it, and they entered a process that hid it from the american people. i think, unfortunately, history's repeating itself. they know how popular cutting taxes on the top 1% are, but the special interests, koch brother wing of their party, that's their number-one goal. that's all they talk about is cutting taxes on the wealthy. so they're stuck. well, to my colleagues, have the courage to break free from the koch brothers and the special interests. don't give breaks to the top 1%. everyone knows they don't need it. it's an old discredited idea that has lost its steam except among the hard right koch brother wing of the republican party. most americans, democrats, republicans, and independents don't go for it, so break free. if our republican colleagues hold basis for doing tracks --
10:37 am
if our republican colleagues' whole basis for doing tax reform is not cutting taxes on the top 1%, we'll send that message from one end of america to the other, and their ideas will certainly fail, as they did with health care. on a related point, madam president. i saw this morning president trump has been bragging about the success of the stock market, which, by the way, was going up, went up more points under president obama than under president trump. obama was there longer, but it started going up years ago. it's just continuing. most economists would give president obama at least as much credit as president trump, but that's not the point i wish to make. the stock market is mainly owned by the wealthy. as of 2013, the top 20% own 92% of all stock shares. so when the stock market's going up, it's helping those 1%. the average american is not
10:38 am
looking for stocks to go up, is not looking for corporate profits to hit record levels as much as they are looking at how's my paycheck, how are my expenses? that's why we have a better deal for you, because we want paychecks for average americans to go up. we want expenses for average americans to go down. we want them to have the tools so they can make a better living and their -- than their kids can in the 21st century. the focus on the stock market is the focus on the highest end of people. many will dispute whether president trump deserves credit for it, but it's even -- whether you think so or you don't, i don't, by and large, it's not what the american people are looking for. it's not the basis of bragging about the economy. well, going back to taxes, the american people will rebel against a tax cut for the wealthy, so republicans clearly won't talk about it in their
10:39 am
plan. they will give a crumb to the middle class and try to hide the massive giveaway to the already fortunate. i can see no other reason why they would object to these three very reasonable, very popular principles other than that. and we hope they won't try to sneak it through in the same partisan process. finally, mr. president, a final word on immigration. yesterday, i heard the president railing against migrant workers and wrapping his arms around the cotton-purdue bill. the bill goes after hardworking people who want to play by the rules, contribute to our economy and earn citizenship, while doing nothing to address the unscrupulous practices of employers that abuse our visa programs to outsource jobs and displace american workers. but here's what i'd like to focus on. so the president has this nice announcement, he's cutting back on immigration, but a n month ago, he actually increased the
10:40 am
number of h-1b h-1b visas -- h-1b v.c.r.'s, -- visas, a program the president knows well. many of those h-1b visas work in hotels. i don't know the number, but there are plenty of trump hotels. so when the president actually looks at negligence in his own business, he says we need more immigrants. and he has said when asked before, well, he couldn't get american workers. but when he comes up with his big immigration plan, i think appealing to not the higher instincts of americans, he says slash it. those two are complete contradiction. to hold both those views is to hold hypocritical views. the president wants to talk about immigration because he thinks the politics are to his advantage, but in truth, his immigration policy has a
10:41 am
stunning hypocrisy at the core of it. the president criticizes and seeks to limit almost every immigration program except the one that benefits his own business. i yield the floor. ms. collins: mr. president. the presiding officer: the senator from maine. ms. collins: thank you, mr. president. mr. president, i rise today in support of the food and drug administration reauthorization act that we are now considering. let me begin by commending chairman alexander and ranking member murray of the senate health, education, labor, and
10:42 am
pensions committee for their leadership in bringing this important legislation to the senate floor. this bill is the product of bipartisan, bicameral work, and it is proof that we can make progress when we work together on the areas where we can find agreement. f.d.a. user fees which are reauthorized under this bill are critical to moving the most advanced research from a promise to a cure and ensuring that new treatments reach patients in need. user fees where companies fund a portion of the premarket review of their products account for more than a quarter of all f.d.a. funding, yet the f.d.a.'s authority to collect these fees will expire at the end of next month unless congress acts, and
10:43 am
thus the urgency of getting this bill across the finish line. that is why it is imperative that we advance this bill now and ensure that work on these promising new pharmaceuticals continues uninterrupted. in may, the help committee on which i am pleased to serve overwhelmingly approved bipartisan legislation to extend and reauthorize the f.d.a. fees in order to support the public health of our nation. the bill before us also incorporates many provisions that were advanced by individual committee members. it's a great example of how a committee process should work and was collaborative. we each brought ideas to the table, and during our markup, those ideas were offered as
10:44 am
amendments and in many cases incorporated into the legislation. i want to thank the chairman and the ranking member for including in this important legislation provisions that i authored with senator claire mccaskill. those provisions seek to accelerate the review process for prescription drugs in cases where there is limited or no competition. our purpose is to lower or at least moderate the escalating prescription drug prices that are one of the key cost drivers in our health care system today. during the last congress, our senate aging committee, which i chair and at that time senator mccaskill was the ranking member, had a bipartisan
10:45 am
investigation into the causes, impacts, and potential solutions to the egregious price spikes for certain off-patent drugs, for which there were no generic competitors. let me explain this situation a little more, mr. president. what we found was happening is that in cases where the patent on the original brand name pharmaceutical had expired, there were these companies that were not traditional pharmaceutical companies. they were not firms that had invested hundreds of millions or even a billion dollars in r&d in order to develop a new prescription drug. that's not what we're talking about. we're talking about these pharma
10:46 am
companies, i call them hedge fund companies, wait until it has expired and then buy the pharmaceutical drug and virtually overnight impose egregious price increases. as one of the executives of these companies said when asked why he did so, he answered simply because i can. well, obviously that has a very detrimental impact on patients, on health care providers, on insurers, on federal programs, such as medicaid and medicare. so building on our investigation, senator mccaskill and i sponsored legislation that making pharmaceutical markets more competitive act to foster a more competitive generic marketplace and to improve access for affordable medicines. that's key, mr. president.
10:47 am
if we can have more competition in the prescription drug marketplace, that's what drives down costs. that's what drives down prices. and we know that from our experience when generic drugs come on the market. the bill that we are considering today includes key provisions based on our legislation that were adopted unanimously as an amendment that i sponsored during the committee markup. first, our provisions would require the f.d.a. to prioritize the review of certain generic applications. it would set a clear time frame of no more than eight months for the f.d.a. to act on such applications where there is inadequate generic competition. this would help to resolve situations where there are drug shortages as well as circumstances where there are
10:48 am
not more than three approved competitors on the market. the aging committee's investigation into sudden price spikes found that older drugs with only one manufacturer and no genetic competitor are particularly vulnerable to dramatic and sudden price increases. one company we investigated increased the price of a drug called daraprim, a life-saving drug for serious parasitic -- $13.50 a pill to $750 a pill. an increase of more than 5,000% and they did so literally overnight. now, keep in mind that this
10:49 am
company terring pharmaceuticals had nothing to do with the costly research and development that brought about this life-saving drug known as dir daraprim but after they bought the drug and the patent ebbs paired and saw there was no competitor, they increased the price by 5,000 percent overnight. this price hike for a drug that's remained unchanged since 1953 is unacceptable and underscores the urgent need for legislation to prevent bad actors from taking advantage of a noncompetitive marketplace. second, the bill would improve communications between f.d.a. and the eligible sponsors prior to the submission of an application for the approval of
10:50 am
a generic drug. that would improve the quality of applications from the beginning, increasing the chances of successful approval bid f.d.a. third, new reporting requirements would provide increased transparency into the backlog of applications for drug approvals and pending generic and priority review applications. fourth, this bill would provide the public with accurate information about drugs with limited competition. drug manufacturers would be required to notify and provide rationale when removing a drug from the market, and the f.d.a. would publish a list of the off-patent brand-name drugs that lack generic competitors so that if you're a generic drug company, you would know that this is an opportunity to
10:51 am
develop a competitor drug. i want to give the new f.d.a. commissioner a great deal of credit for incorporating some of our suggestions. he cares deeply about this issue. this bill would streamline the regulatory process to address incidence in which delayed reinspection of manufacturing facilities becomes barriers to generics entering the markplace. by taking these steps, we will enhance regulatory certainty for generic drug companies, help prevent shortages, increase competition to lower prices and prevent ma nonlies and deter practices that can lead to unjustifiable, exorbitant price hikes. i'm pleased that the legislation also includes another bill that
10:52 am
resulted from our aging committee investigation. this provision will help prevent bad actors from receiving unwarranted vouchers under the tropical disease voucher program. this program was intended to incentivize the development of medicines for neglected diseases yet was exploited by the notorious martin shkreli, the founder. after spiking the price of daraprim, he purchased another decades-old drug, one once again without a competitor that is used to treat a life threatening infection that is rare in the united states. mr. shkreli sought to use the tropical disease voucher program to gain exclusivity and hike the price for a drug that is not in fact a new drug. our legislation revises the
10:53 am
program to better ensure it achieves its intent which is spurring the development of therapies that are truly new to treat and cure neglected diseases. mr. president, drug companies should not be able to increase their prices dramatically by thousands of percent overnight without any justification, without the development of modifications of the drug that improve its effectiveness, for example. our legislation will help to foster a much healthier and more competitive generic marketplace as the best defense against such exploitation. and i am pleased that our bipartisan plan will increase generic competition which is so important to american families and particularly our seniors which -- who take a
10:54 am
disproportionate number of the prescription drugs that are prescribed in this country. before closing, let me just briefly mention another important provision in the bill before us, the over-the-counter hearing aid act of 2017. approximately 30 million americans experience age-related hearing loss yet only about 14% of those with hearing loss use assisted hearing technology often because they simply can't afford the price of costly hearing aids. we know from a hearing that we recently held in the aging committee that social isolation among our seniors can be exacerbated by hearing loss that is left untreated. that in turn increases that social isolation, increases the risk of serious mental and
10:55 am
physical health outcomes. by making some types of hearing aids available over the counter just as people buy cheaters to see with over the counter, eyeglasses, these -- this legislation will help increase access to and lower the cost of the products for the consumers who need them. mr. president, the legislation we are considering today will help bring life-saving drugs to the marketplace. it will ensure that the f.d.a. continues to operate smoothly and most important, that promising therapies make it to the american people. again, i want to commend chairman alexander and ranking member murray for their leadership, and i encourage all of our colleagues to join me in supporting this important legislation. thank you, mr. president. i yield the floor.
10:56 am
10:57 am
10:58 am
10:59 am
mr. enzi: mr. president? the presiding officer: the senator from wyoming. mr. enzi: mr. president, i yield back all time. the presiding officer: all time is yielded back. the clerk will report the motion to invoke cloture. the clerk: cloture motion, we the undersigned senators in accordance with the provisions of rule 22 of the standing rules of the senate do hereby move to bring to a close debate on the motion to proceed to calendar number 174, h.r. 2430, an act to amend the federal food, drug and cosmetic act, to revise and extend the user fee programs for prescription drugs, medical devices, generic drugs and bow
11:00 am
crow similar biological products and for other purposes signed by 17 senators. the presiding officer: by unanimous consent, the mandatory quorum call has been waived. the question is, is it the sense of the senate that the debate on h.r. 2430, the f.d.a. reauthorization act of 2017 shall be brought to a close. the yeas and nays are mandatory under the rule. the clerk will call the roll. vote: vote:
11:01 am
11:02 am
11:03 am
11:04 am
11:05 am
11:06 am
11:07 am
11:08 am
11:09 am
11:10 am
11:11 am
11:12 am
11:13 am
11:14 am
11:15 am
vote:
11:16 am
11:17 am
11:18 am
11:19 am
11:20 am
11:21 am
11:22 am
11:23 am
11:24 am
11:25 am
11:26 am
11:27 am
11:28 am
11:29 am
11:30 am
vote:
11:31 am
11:32 am
11:33 am
11:34 am
11:35 am
11:36 am
11:37 am
the presiding officer: on this vote the yeas are 96. the nays are 1. three-fifths of the senators duly chosen and sworn having voted in the affirmative, the motion is agreed to. a senator: mr. president. the presiding officer: the clerk will report. the senator from tennessee. mr. alexander: thank you, mr. president. i ask unanimous consent that after the disposition of the nomination the senate resume consideration of the motion to proceed to h.r. 2430, that all postcloture time be expired and the motion to proceed be agreed to. further, there be no amendments in order to h.r. 2430, that
11:38 am
there be ten minutes of debate equally divided in the usual form and that following the use or yielding back of that time the bill will be read a third time and the senate vote on adoption of the bill with no intervening action or debate. the presiding officer: is there objection? without objection. mr. alexander: mr. president, i ask unanimous consent that the committee on health, education, labor and pensions be discharged from further consideration of s. 581 and the senate proceed to its immediate consideration. the presiding officer: the clerk will report. the clerk: s. 581, a bill to include information concerning a patient's opioid addiction in certain medical records. the presiding officer: is there objection to proceeding to the measure? without objection. the committee is discharged and the senate will proceed. mr. alexander: mr. president, i ask unanimous consent that the manchin substitute amendment be agreed to, the bill as amended
11:39 am
be considered read a third time and passed, and the motions to reconsider be considered made and laid upon the table. that's the manchin-capito substitute -- excuse me -- laid upon the table. the presiding officer: is there objection? without objection. mr. alexander: mr. president, i ask unanimous consent that the committee on health, education, labor, and pensions be discharged from further consideration of s. 1052 and the senate proceed to its immediate consideration. the presiding officer: the clerk will report. the clerk: s. 1052, a bill to strengthen the use of patient experience data within the benefit risk framework for approval of new drugs. the presiding officer: is there objection to proceeding to the measure? without objection, the committee is discharged and the senate will proceed. mr. alexander: i ask unanimous consent that the bill be considered read a third time and passed and that the motion to reconsider be considered made and laid upon the table. the presiding officer: without objection.
11:40 am
the senator from wisconsin. mr. johnson: in five minutes i'm be asking consent to pass the right to try act of 2017. if i could take a few moments to tell the story of how that right to try bill has been passed by 37 states obtained that name. i believe it was probably march of 2014 i met tricket wendler, a young mom with three children who came to washington, d.c. with a group of other individuals advocating for those patients and their families and people suffering from a.l.s., lou gehrig's disease, an incurable and devastating disease. a week before meeting trickett i talked with the goldwater institute who was talking about their right to try legislation,
11:41 am
beginning to pass through state legislators. mentioning the fact that i supported right to try brought tears streaming down trickett's face. unfortunately she lost her battle to a.l.s. in march 2015 but she has inspired something that i think is going to give so many thousands, maybe tens of thousands, maybe millions of americans hope when they face a similar type of disease where there's no hope, where there are no further options other than potentially an experimental drug that has been proven safe according to the f.d.a. in our press conference announcing the introduction of this bill, we had matthew bellina, a naval aviator, lieutenant commander, one of the finest among us also stricken with a.l.s. we had jordan mcglenn, a little boy with duchenne's
11:42 am
muscular dystrophy and his mother laura speaking at that press conference. and remarkably a man also stricken with a.l.s., frank mongiallo and his wife and their children asked to speak. he made such an impression on our gathering that i encapsulated that press conference, particularly his speech, into a little video that i showed to my colleagues which resulted in so many is cosponsorships of this bill. these are real people facing their mortality with no hope. this right to try piece of legislation will give those individuals and their family hope. i want to truly thank my lead cosponsor from across the aisle senator joe done -- joe donnelly in the chamber here today and senator king and senator manchin who decided not to play politics whatsoever and decided to is cosponsor a bill by somebody who is in a tough reelection fight. i want to thank my 43 republican
11:43 am
cosponsors, particularly senator mcconnell. as leader, one of the first cosponsors who helped me get those other 42 cosponsors. i want to particularly thank senator alexander and ranking member murray who worked so cooperatively with me and my staff to make this moment possible. i'd like to thank vice president pence who also met frank m mongiallo and became a real advocate for this. and president trump who after meeting these types of victims, these individuals also supported this piece of legislation. i'd like to thank the gold water institute and darcy olson for their tireless efforts and the 37 states and the 97.7% of the legislators who when given a chance to vote to give people the right to try, the right to hope, voted yes. i'd also like to thank a very special person, dr. dell
11:44 am
poussant. dr. poussaint is an oncologist from houston, texas. he was engaged in an f.d.a. trial with cancer. with 150 patients the drug was working so he petitioned the f.d.a. to allow another 78 patients to participate in the trial. the f.d.a. said no. dr. dell poussaint said yes, putting his career at risk. it's that kind of courage that we want to reward today by passing this right to try bill. but in general, or in conclusion i want to thank the thousands of patients, their families who have taken their wheelchairs, gone to their state capitals, come here to washington, d.c. and advocate for their personal freedom, their personal liberty, for their right to try, for their right to hope and for the right to hope of millions of other americans faced with these incurable diseases.
11:45 am
with that, mr. president, i ask unanimous consent that the johnson-donnelly amendment at the desk be considered agreed toened a the bill as amended be considered read a third time and passed and that the motions to reconsider be considered made and laid upon the table. the presiding officer: the senator from wisconsin. mr. johnson: i ask unanimous consent that the committee on help with discharged from further consideration of s. 204 and the senate proceed to its immediate consideration. the presiding officer: the clerk will report. the clerk: s. 204, a bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with state law and for other purposes. the presiding officer: is there objection to proceeding to the measure? without objection, the committee is discharged and the senate will proceed.
11:46 am
mr. johnson: i ask unanimous consent that the johnson-donnelly amendment at the desk be considered agreed to and the bill be considered read and third time -- a third time and passed and the motion to reconsider be considered made and laid upon the table. the presiding officer: is there objection? without objection. joo thank you, mr. president -- mr. johnson: thank you, mr. president. the presiding officer: the senator from indiana. mr. donnelly: i thank my colleague, the senator from wisconsin, senator johnson, for all he's done to spearhead this effort. this giving folks a shot. it doesn't provide any guarantees, but it allows folks to be able to take their into their own hands, to make
11:47 am
judgments and to decide, i want to take a shot at this. for me, it was a wonderful family from indiana, who, by the way, this morning, mr. chairman, they are at lego land down in florida because our young boy is getting along, but time is ticking. jordan has multiple sclerosis, and his mom said we want a chance to make jordan better. that's what this bill do. to all the families that senator johnson mentioned, we're so proud of you. we're so grateful to you for your advocacy because it was your words, your examples that have helped to get this done and so i went to say to everyone in
11:48 am
indiana and everyone in america how grateful we are that this right tro try is -- right to try is passed and to mr. chairman and ranking member murray, thank you for making this happen. i yield back. the presiding officer: under the previous order, the senate will proceed to executive session to consider the following nomination, which the clerk will report. the clerk: nomination, department of energy, dan r.brulett to be secretary of energy. the presiding officer: there will be 15 minutes of debate equally divided in the usual form. the presiding officer: the senator -- the senator from washington. murmur i -- mrs. murray: i am proud that we are working together on this legislation and this shows how we can solve challenges by putting patients and families
11:49 am
first. this so-called user fee agreements are essential to supporting the f.d.a. operation and mission, they allow the f.d.a. to meet the complex challenges of 21st century technology and they help to ensure that f.d.a. upholds the gold standard of approval while approving new drugs and devices efficiently. passing the f.d.a. reauthorization act is necessary if congress wants to advance safe, effective and innovative medical products for patients and families across the country. i would add, mr. president, when we pass this reauthorization today, more than 5,000 employees at f.d.a. will able to continue their critical work without worry of interruption. they work every day to help advance medical innovations to patients. i am pleased to have worked alongside the chairman of the work committee, the senior senator from tennessee and all of our colleagues on and off the
11:50 am
floor to bring these finalized agreements. they reflect years of negotiations between the f.d.a. and industry and incorporate input from patient and consumer groups and support some of our most urgent priorities. restructuring the biodrug fees, make -- maying sure that patients are considered in the drug and device development and passing these agreements. the f.d.a. reauthorization includes priorities and provisions are from members across the political spectrum. i again thank chairman alexander and all of my colleagues, in particular senators casey, franken and warren on their work to improve medical device safety, senators hassan and young to get better information to providers about opioids, senators mccaskill and collins for their work and senators
11:51 am
bennet and rubio to get benefits to kids with cancer. i want to thank my staff and chairman alexander's staff who worked so well together over months of hard work to get this done. this bill advances several significant bipartisan priorities i'm proud to support. the help committee has a strong tradition of bipartisan success in the user fee agreements and i am very proud to say that we have kept it that way. so i think this bill not only improves f.d.a., but it also shows that when we work together with a common goal we can get things done and make progress. so i thank the chair and yield the floor and thank my partner, senator alexander. the presiding officer: the senator from tennessee. mr. alexander: i see that senators isakson and tester are here and i think they want to make a few remarks before the vote. first i want to say a few words following senator murray and i
11:52 am
will place the rest of my comments in the record. this legislation is -- is very important legislation. last year we passed the 21st century cures act to move these modern medical miracles into medicine cabinets and doctors' offices more rapidly. this is funding that pays for a quarter of the payment for all of the food and drug administration which has a critical role in approving the safety and effectiveness of those drugs, treatments and devices. as with most things in the senate, there are actually important and work well and get a result, a lot of hard work has gone into this. it started two years ago with republicans and democrats, senator murray and i and our staffs, working together with the house of representatives at the same time, working with the manufacturers, the f.d.a., and many others, working out many
11:53 am
differences of opinion so that now we get to a result within a few minutes we're probably going to adopt this by a voice vote almost unanimously, and everyone will say, that must have been easy. it wasn't that easy, but it's how work gets done in the united states senate when we do it well. i want to compliment our colleagues and the staff and the house of representatives for what they've -- for what they've done. we will continue to focus our attention on the 21st century cures act. a piece of legislation is not worth the paper it's printed on unless it's implemented properly. but this legislation says to the men and women who work at the food and drug administration and to their leader, dr. gottlieb, we value what you do. in our act we gave the administrator more authority to hire and pay talented people to
11:54 am
work there and approve the miracles that are coming and we're doing this in a timely way so your work will not be interrupted. i thank senator murray for the work she has done and this is typical for our committee when we work well and we usually do. i ask unanimous consent to place my full remarks in the record. the presiding officer: without objection. mr. alexander: i ask to place my -- my statement in the record, including senator murray's staff, the food and drug administration, the legislative counsel and senator mcconnell's staff. they have all been critical to the success that we're about to have today. the presiding officer: without objection. mr. isakson: mr. president, i rise for a moment to reflect on what was a great night for the
11:55 am
united states senate, the united states government, for the population of our country, but most importantly for those who served us as veterans in the military. last night the senate agreed to significant legislation on three fronts to make the v.a. better and more responsive to our veterans. ranking member tester and i worked to make sure that we dealt with the needs that the v.a. had so that the stories we see on the front pages of papers, stories about people being mistreated or having to wait so long for their appointments. we have given the tools to take care of that. i told the ranking member, this is called the no excuses day. the secretary will have no excuses for any mistakes, any tools that he needs to see that we are responsive to the veterans of america passed in the senate and passed in the house. six major bills in the first seven months of this year, a
11:56 am
remarkable achievement. it is a testimony to teamwork, the staff, and a testament to the leaders of the democrat and republican parties. the majority leader and minority leader made it possible. i'm not going to read all the names of the staff now because i know we're in limited. i ask unanimous consent to enter for the record every staff member that served on the v.a. to make sure it had its best year ever and i ask unanimous consent to make sure it is a part of the record rsm. the presiding officer: without objection. mr. isakson: credit is a lot of times is given to people with titles. senator tester and i have the titles when it comes to the v.a. committee. the reason the v.a. committee was successful in comploishing every -- accomplishing every single goal is because of every rank and file member, we took our name plates off, put our armor on and didn't say no to
11:57 am
problems that looked to hard and said yes to those questions that made sense. the v.a. has better health care, better medical benefits and i'm proud to have been a part of it and i commend senator tester on his effort and contribution and id yield to senator tester at this time. the presiding officer: the senator from montana. mr. tester: i thank chairman isakson for his great work on the v.a. committee. we have gotten a lot of work done this congress. we haven't put up artificial barriers. we sat down and all realized that taking care of veterans is a cost of war. we need to live up to the promises made to those folks when they signed up. we have done some good work. it is not only johnny, it's not only myself, it's also the people who served on that committee, many of whom are in the chairman per and i thank them -- chairman, and i thank
11:58 am
them. it is about work together. it is about talking to folks. it's about compromise and it's about not digging in, but moving together. this is a great country and it was built by people working together. the v.a. committee is a prime example of people working together. we set aside our differences. we listened to the veterans services organization. we let them drive the bus to an extent. we worked with the secretary of the v.a. we have been transparent. we have been honest when wees disagreed. we haven't -- when we disagreed. this is the way it can work when we start with agreement rather than disagreement. what has happened? we have two bills signed into law, the accountability law, which fires bad employees, protects whistle blowers, and the act that reduces
11:59 am
out-of-pocket expense ps for veterans. and we passed bills last night. we are going to expedite this and bring it down from three years to one year. the v.a. is going to do. we will give them the tools to do that. the v.a. choice funding fix so it will allow the private sector to fill in the gaps. it will help recruit and retain more doctors and nurses, critically important, and it expands the capacity in the v.a., which, quite frankly, is important and then the g.i. bill which breaks down educational barriers and helps veterans to transition into civilian life. we have done some good work for this body and for the veterans. we feed to -- we need to continue on that line as we continue to address health care and important issues like tax reform. it's about work together, it's about

52 Views

info Stream Only

Uploaded by TV Archive on