[Congressional Record Volume 163, Number 132 (Thursday, August 3, 2017)]
[Senate]
[Pages S4782-S4787]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




           FDA REAUTHORIZATION ACT OF 2017--MOTION TO PROCEED

  The ACTING PRESIDENT pro tempore. Under the previous order, the 
Senate will resume consideration of the motion to proceed to H.R. 2430, 
which the clerk will report.
  The senior assistant legislative clerk read as follows:

       Motion to proceed to Calendar No. 174, H.R. 2430, a bill 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 biosimilar biological products, 
     and for other purposes.

  The ACTING PRESIDENT pro tempore. Under the previous order, the time 
until 11 a.m. will be equally divided between the two leaders or their 
designees.
  The Senator from Illinois.


                  For-Profit Colleges and Universities

  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 operation? No.
  The most heavily subsidized for-profit, private business in America 
today is for-profit colleges and universities. Why? Because the revenue 
they receive from the Federal Government accounts for 85, 90, 95 
percent or more of all of 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 percent? How is that possible?
  Here is how it works. A student graduates from high school. The 
student applies to a for-profit college or university. The for-profit 
college or university accepts the student on the condition that the 
student sign over Pell grants--Federal money--and the student's Federal 
Government loan. The student signs over the Pell grant, signs over the 
loan, and is enrolled in the school.
  This for-profit school now is home free. They admitted the student. 
They 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 with some value in their education--some experience that helps them 
go on to get a job to pay off their student loans.
  It turns out that, in too many instances, for-profit colleges and 
universities entice these young people into signing up for classes that 
are worthless. They end up not preparing them for any job. Now they are 
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. So 9 percent of 
students graduating from high school today in America go to for-profit 
colleges and universities. What am I talking about--for-profit? There 
is the University of Phoenix, DeVry, Rasmussen, and the list goes on 
and on. So 9 percent of high school students go to these schools, and 
20 percent or more of Federal aid to education goes to these schools. 
Why? Because the tuition they charge is so high. But here is the 
kicker: 35 percent, one out of three students in America who defaults 
on their student loans has attended these for-profit colleges and 
universities.
  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?
  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 is 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 Phoenix, and I want to go to school there, you would 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 are finished? What is 
your likelihood of finding a job? Those are obvious questions. 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 graduated student into a job that 
gives you a chance to pay off your student loan and really keeps the 
promise that the 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 contentious debate with the 
industry. It 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--for gainful employment.
  Don't forget that 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,

[[Page S4783]]

Daughter? 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 is bad. That is a natural 
reaction. We are, in fact, condoning, endorsing this industry by 
saying: If you go to these schools, you get taxpayer-funded student 
loans.

  I don't think it is too much to ask the programs promising to train 
students for specific jobs that actually lead to students being able to 
get those jobs and, in the process, repay their loans.
  The gainful employment rule cuts off Federal student aid if programs 
where graduates' ratio of student debt to earnings is too high during 
any 2 years of a 3-year period. We look at the jobs of the graduate of 
the for-profit schools, we look at the income of the students, and then 
ask: What is the likelihood that student can make their student loan 
repayment based on their employment? Is it, 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 is 
those who go to community colleges, different colleges altogether--earn 
$9,000 more than those who went to for-profit colleges and 
universities. Do you know what the difference is?
  If you decide to go to a community college in my home State of 
Illinois, in my hometown of Springfield, and go to Lincoln Land 
Community College--a great community college like most of those in our 
State--you are going to get an education, a good one, and it will not 
cost you much. 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 up with a real debt for that first year out of high school and 
guess what. Virtually none of the credit hours you take at that for-
profit school can be transferred to any other college or university. 
That is the reality of what students face.
  Of the programs that saddled students with too much debt compared to 
the income students receive after the program--listen to this--when 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, 98 percent 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 is 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 is going to 
happen after they graduate, and then they find themselves in a job they 
can't pay off their student loan. Let me give you a specific example so 
you can really understand what we have run into.
  The digital photography program at the Illinois Institute of Art in 
Schaumburg, IL--now, let 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, decided to call their 
operation the Illinois Institute of Art, instead of the Art Institute 
of Chicago.
  They are owned by a for-profit giant, the Education Management 
Corporation. They failed the gainful employment rule in the year 2016. 
Listen to what it wrote on their website for students who wanted to 
enroll:

       There's a market for people who constantly find innovative 
     ways to fill the world with their ideas, 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, both creatively and 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 is what is 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. Do you know what the total 
cost of the digital photography course was at the Illinois Institute of 
Art, the for-profit school--total cost of tuition, fees, books, and 
supplies to prepare you to be a digital photographer? It is $88,000--
$88,000. It gets better. That is if you live off campus.
  Do you want to live on campus? The company helps you find an 
apartment nearby. Over the 4 years, it is an additional $56,000.
  Let's do the quick math here. That is $144,000 in debt, finishing 4 
years, majoring in digital photography at the Illinois Institute of 
Art. How many students have to borrow money to do that? Eighty four 
percent of the students who went to that school and took digital 
photography had to borrow the money--84 percent.
  Guess what the typical graduate of the Illinois Institute of Art in 
Schaumburg, IL, in the digital photography course earns after leaving 
the program. Do you remember that promise on their website? How much do 
they earn? On average, it is $20,493--$20,493.
  Here is a quick calculation. What if I am being paid the minimum wage 
in America? In Illinois, it is $9.25 an hour. Well, I would be making 
right around $18,500 a year in a minimum-wage job. I have gone to the 
Illinois Institute of Art in Schaumburg to take the digital photography 
course and instead of making $18,500 a year, I am making $20,493. That 
is almost $2,000 more a year. Oh, I forget. I forgot $144,000 in debt 
that I also have. Let's do the math. How many years of an additional 
$2,000 to pay off $144,000? It is only 72 years, and you would be able 
to pay off your student debt. What a rip-off. These people ought to be 
ashamed of themselves, and we ought to be ashamed of ourselves that we 
are supporting this kind of fraudulent activity at the expense of 
students who were just trying to get a better education.
  That is 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. Incidentally, many 
times parents and even grandparents sign on for that debt too.
  You know something else you ought to remember? Of all the debts you 
could 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. Do you know what that means? No matter how bad it gets--and 
it could 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. You can do it if you have a loan for a boat but not with student 
loans. It is with you for a lifetime.
  We have had cases where Grandma decided to help her granddaughter by 
cosigning the note at one of these miserable schools. The granddaughter 
couldn't pay back the student loan, and they went after Grandma's 
Social Security payments. That is what this is all about. That is how 
serious this can become.
  There is 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 would stop providing student loans to 
the students who are engaged in that program. We are 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, easy-to-read 
disclosure so students can read what happened to students who took the 
digital photography course. Did they get jobs? How much did they earn?
  That is also one of the requirements of the gainful employment rule. 
It requires schools to provide warnings to students in advertising and 
marketing materials about failing programs so they know before they 
sign up--they know before they go in debt.
  Think about what these disclosures and warnings might have meant to 
Ami Schneider from Hoffman Estates, IL. Ami went to this notorious art 
institute--the Illinois Institute of Art--

[[Page S4784]]

the Schaumburg digital photography program from 2007 to 2010. She wrote 
me a letter and told me her story.
  Ami said 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-cent-an-hour raises every year. She 
said: I wanted to pursue a career, and I really was serious. I was 
passionate about it. She visited this Illinois Institute of Art campus 
in Schaumburg. ``I went into [the school],'' she wrote me, ``and they 
fed me all these success stories. They told me they had [an] excellent 
placement'' program.
  What do you think would have happened if they would have told Ami 
that at the end of the day, she would have been making slightly more 
than minimum wage after taking all these courses and incurring all this 
debt? What if they had been required to tell Ami that employers 
wouldn't accept her degree and she would never pay off her student 
loan?
  Well, Ami and tens of thousands of students like her across the 
country would have been spared from a hardship that can change their 
lives. Ami says her time at the Illinois Institute of Art ``ended up 
ruining my life.'' In her twenties, 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 show where the students 
displayed their best work. Do you know how many employers--after Ami 
finished the course and did her display--do you know how many employers 
showed up for Ami's class portfolio show at the Illinois Institute of 
Art? None. Not one.
  Ami and her family who took out the loans to help her now hold more 
than $100,000 in student loan debt from her time 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 Ami about these 
failing programs--delayed it for a year. That is 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 Secretary Betsy DeVos has decided to let it happen.
  It means more students like Ami 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 am sure in Alabama they would pay them even more 
if they could--and then compare it to what these CEOs pay themselves 
off these poor students. It is disgraceful. For the sake of the 
students and taxpayers who immediately would benefit from real 
warnings, it is time for us in Congress to speak up.
  We also know Secretary DeVos intends to eventually rewrite the 
gainful employment rule, what she called a ``regulatory reset.'' What 
does that mean?
  We hear a lot of speeches on the floor about too much government 
regulation. If you were Ami 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 are going to 
incur and the income they are likely to earn overregulation by the 
Federal Government?
  We are putting a lot of money on the line to give $100,000, at least, 
of the Federal taxpayers' dollars to Ami to go to school, but she has 
to 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, we should have some basic regulations, some basic 
accountability.
  While Secretary DeVos says the rule is unfair and arbitrary, the 
Department of Education Inspector General agreed with the assertion 
that it was a good rule in terms of protecting kids and protecting 
taxpayers. I am proud to say the rule is supported by many State 
Attorneys General, including Lisa Madigan in my home State of Illinois, 
veterans groups, and student advocates.
  Secretary DeVos said the gainful employment rule has been 
``repeatedly . . . overturned by the courts'' Wrong. In effect, since 
it went into effect in 2015, 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 for-profit colleges that defraud students and bilk 
taxpayers.
  Mr. President, I yield the floor.


                   Recognition of the Minority Leader

  The ACTING PRESIDENT pro tempore. The Democratic leader is 
recognized.


                              Nominations

  Mr. SCHUMER. Mr. President, as the Senate wraps up its work this 
week, I have been in multiple discussions with my friend the majority 
leader about clearing nominations with bipartisan support, and we have 
made significant progress. Now that we have moved past the terrible 
process used on healthcare, I hope we can get back to our normal way of 
legislating and clearing noncontroversial nominees. The two are tied 
together. They can't avoid regular order when they want to and say that 
Democrats should use regular order whenever they want us to.
  Now that healthcare is done, I think we can tie the two together--the 
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 am committed to help move 
noncontroversial, bipartisan nominees forward.
  I hope the fever is breaking. There is a real desire in this body to 
move past the acrimony of the healthcare debate and get to a place 
where we can work together to advance legislation that helps the 
American people. I am hopeful that the discussions between the 
Republican leader and me will produce a package of nominees we can 
confirm today.


                               Tax Reform

  Mr. President, the Republican leader has said that the next big issue 
this body will take up is taxes. Democrats were excluded from even 
participating in healthcare discussions from the very first day of 
Congress, a process that ultimately ended in failure. So we have made 
the first overture this time to show our Republican friends we are 
serious about a bipartisan process on tax reform. We sent them a letter 
outlining three very basic principles. This is a guideline for our 
Republican colleagues to come work with us. These are very simple 
principles that I think the vast majority of Americans would support. 
Let me say what they are.
  First, the Republican leader has said that he would pursue 
reconciliation again, a process that purposefully excludes Democrats 
almost again on the first day 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 says 
that Democrats don't want to have a bipartisan discussion. Of course we 
do. We have said this over and over again until we are blue in the 
face, but I guess the majority leader somehow didn't like the three 
principles we laid out, and I would 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 has said so many times himself. I quoted him 
yesterday.
  He warned the Senate about becoming ``an assembly line for one 
party's partisan legislative agenda.'' Those are Senator McConnell's 
words. The Senate should not become ``an assembly line for one party's 
partisan legislative agenda.'' That is what he did on healthcare. Is he 
doing it again on tax reform? I hope not.
  Well, we know he probably agrees with the second principle: no 
increase to the debt and deficit. We know he agrees because he has 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

[[Page S4785]]

Bloomberg TV that tax reform will have to be revenue-neutral, so that 
one doesn't seem to be it. Again, I would like to hear what he has to 
say explicitly so that we can work together.
  It leaves us with the first principle: no tax cuts for the top 1 
percent. Here again, I understand why the majority leader and my 
Republican friends don't want to come out and say that this is the 
reason they have decided to pursue a tax bill on their own, but it 
almost certainly is.
  Tax cuts for the wealthy are extremely unpopular with the American 
people--and for good reason. The top 1 percent of this country takes 20 
percent of our income, a great percentage of its wealth. The wealthy 
are doing well. God bless them. Their incomes are going up at a faster 
rate than those of anybody else, but when we are talking about our Tax 
Code and rewriting it, we shouldn't be focused on giving the 1 percent 
another tax break while millions of working families struggle to afford 
the cost of college, prescription drugs, food, and healthcare.
  I am afraid the majority is in the same boat as they were with 
healthcare. They don't want to say that their real reason for changing 
healthcare is wanting 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 the American 
people, so they didn't talk about it. They entered into a process that 
hid it from the American people.
  I think, unfortunately, history is repeating itself. They know how 
unpopular cutting taxes on the top 1 percent is, but for the special 
interest, Koch brother wing of their party, that is their No. 1 goal. 
All they talk about is cutting taxes on the wealthy. So they are stuck. 
When will my colleagues have the courage to break free from the Koch 
brothers and special interests?
  Don't give breaks to the top 1 percent. Everyone knows they don't 
need it. It is 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' whole basis for doing tax reform is 
cutting taxes on the top 1 percent, we are going to send that message 
from one end of America to the other, and their ideas will certainly 
fail, as they did with healthcare.
  In a related point, I saw this morning that President Trump has been 
bragging about the success of the stock market, which, by the way, was 
already going up. It went up more points under President Obama than 
under President Trump. It started going up years ago. It is just 
continuing. Most economists would give President Obama at least as much 
credit as President Trump. But that is not the point I wish to make.
  The stock market is mainly owned by the wealthy. As of 2013, the top 
20 percent own 92 percent of all stock shares. So when the stock market 
is going up, it is helping the 1 percent.
  Average Americans are not looking for stocks to go up, not looking 
for corporate profits to hit record levels, as much as they are looking 
at how are their paychecks, how are their expenses. That is why we have 
a better deal for them. We want paychecks for average Americans to go 
up. We want expenses for average Americans to go down. We want them to 
have better tools, so they and their kids can make a better living in 
the 21st century.
  The focus of the stock market is on people at the highest end. Many 
will dispute whether President Trump deserves credit for it, but 
whether you think so or you don't--I don't, by and large--it is not 
what the American people are looking for, and it is not a basis for 
bragging about the economy.
  Well, going back to taxes--the American people will rebel against a 
tax cut for the wealthy, so the Republicans clearly will not talk about 
it in their plan. They will give a crumb to the middle class and try to 
hide a massive giveaway to the already fortunate. I can see no other 
reason why they object to these three very reasonable, very popular 
principles other than that, and we hope they will not try to sneak it 
through in the same partisan process.


                              Immigration

  Finally, Mr. President, a word on immigration: Yesterday, I heard the 
President railing against migrant workers and wrapping his arms around 
the Cotton-Perdue bill. The bill goes after hard-working 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 who abuse our visa programs to outsource jobs and displace 
American workers.
  Here is what I would like to focus on. The President has this nice 
announcement that he is cutting back on immigration, but a month ago he 
actually increased the number of H-2B visas--a program the President 
knows well. Why? A lot of those with H-2B visas work in hotels. I don't 
know how many, but I bet a good number are in Trump Hotels. So when the 
President actually looks at immigration in his own businesses, he says: 
We need more immigrants. When asked before, he has said: Well, we 
couldn't get American workers. But when he comes up with his big 
immigration plan--I think not appealing to the higher instincts of 
Americans--he says: Slash it. Those two are complete contradictions. To 
hold both of 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 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.
  The ACTING PRESIDENT pro tempore. The Senator from Maine.
  Ms. COLLINS. Thank you, Mr. President.
  I rise 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 Pensions Committee for their leadership in bringing this 
important legislation to the Senate floor. This bill is the product of 
bipartisan, bicameral work and is proof that we can make progress when 
we work together on the areas where we can find agreement.
  FDA 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 one-quarter of all FDA funding. Yet the FDA's 
authority to collect these fees will expire at the end of next month 
unless Congress acts, 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 FDA 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 is a great example of how 
a committee process should work. It was collaborative. We each brought 
ideas to the table, and during our markup, those ideas were offered as 
amendments and in many cases incorporated into the legislation.
  I 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 
healthcare 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 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.
  Now, let me explain this situation a little more.
  What we found was happening is that in cases in which the patent on 
the

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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 in R&D in order to 
develop a new prescription drug. That is not what we are talking about. 
We are talking about these pharma companies--I call them hedge fund 
pharmas--that wait until the patent has expired, then buy the 
pharmaceutical drug and virtually overnight impose egregious price 
increases. One of the executives of these companies, when asked why he 
did so, answered simply ``because I can.''
  Obviously, that has a very detrimental impact on patients, on 
healthcare providers, on insurers, and on Federal programs such as 
Medicaid and Medicare.
  So building on our investigation, Senator McCaskill and I sponsored 
legislation, called the Making Pharmaceutical Markets More Competitive 
Act, to foster a more competitive generic marketplace and to improve 
access for affordable medicines. That is key. If we can have more 
competition in the prescription drug marketplace, that is what drives 
down costs, and that is what drives down prices. We know that from our 
experience when generic drugs come on the market.
  The bill that we are considering today that is based on our 
legislation includes key provisions which were adopted unanimously as 
an amendment that I sponsored during the committee markup.
  First, our provisions would require the FDA to prioritize the review 
of certain generic applications. It would set a clear timeframe of no 
more than 8 months for the FDA to act on such applications where there 
is inadequate generic competition. This would help to resolve 
situations in which there are drug shortages, as well as circumstances 
in which there are 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 generic competitor 
are particularly vulnerable to dramatic and sudden price increases.
  One company that we investigated, Turing Pharmaceuticals, increased 
the price of a drug called Daraprim, which is a lifesaving drug for 
serious parasitic infections, from $13.50 a pill to $750 a pill--an 
increase of more than 5,000 percent--and they did so literally 
overnight. Now, keep in mind that this company, Turing Pharmaceuticals, 
had nothing to do with the costly research and development that brought 
about this lifesaving drug, known as Daraprim, but after they bought 
the drug--after the patent had expired and they saw that there was no 
generic competitor--they increased the price overnight by 5,000 
percent. This price hike for a drug that has 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 the FDA and the 
eligible sponsors prior to the submission of an application for the 
approval of a generic drug. That would improve the quality of 
applications from the beginning, increasing the chances of successful 
approval by the FDA.
  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 FDA would publish a list of off-patent brand name drugs 
that lack generic competitors, so that if you were a generic drug 
company, you would know that this would be an opportunity to develop a 
competitor drug.
  I give the new FDA Commissioner a great deal of credit for his 
incorporating some of our provisions. He cares deeply about this issue.
  Finally, this bill would streamline the regulatory process to address 
incidents in which the delayed re-inspection of manufacturing 
facilities becomes a barrier to generics entering the marketplace.
  By taking these steps, we will enhance regulatory certainty for 
generic drug companies, help to prevent shortages, increase competition 
to lower prices and prevent monopolies, and deter practices that can 
lead to unjustifiable, exorbitant price hikes.
  I am pleased that the legislation also includes another bill that 
resulted from our Aging Committee's investigation. This provision will 
help to 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 of Turing. 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 program to better ensure that it achieves 
its intent, which is to spur the development of therapies that are 
truly new in order to treat and cure neglected diseases.
  Drug companies should not be able to increase their prices 
dramatically by thousands of a percent overnight without any 
justification--without the development of modifications in 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. I am pleased that our bipartisan plan will increase 
generic competition, which is so important for American families and 
our seniors, particularly, who take a disproportionate number of the 
prescription drugs that are prescribed in this country.
  Before closing, let me 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 percent of those with hearing loss use assistive 
hearing technology, often because they simply cannot 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 and increases the risk of serious mental and physical health 
outcomes. By making some types of hearing aids available over the 
counter, just as people buy readers to see with, which are over-the-
counter eyeglasses, this legislation will help increase access to and 
lower the cost of the products for the consumers who need them.
  The legislation we are considering today will help to bring 
lifesaving drugs to the marketplace and will ensure that the FDA 
continues to operate smoothly and, most importantly, that promising 
therapies make it to the American people.
  Again, I 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.
  I yield the floor.
  Mr. ENZI. Mr. President, I wish to express concern with section 709 
of H.R. 2430, concerning over-the-counter, OTC, hearing aids.
  I have a daughter who has worn hearing aids since she was a toddler. 
I have firsthand experience with the kind of expertise needed by 
providers to ensure that those who require a hearing aid have their 
specific and unique medical needs met.
  I believe that everyone on all sides of this issue desire the same 
thing, and I appreciate Chairman Alexander working with me to get a 
study relating to this matter. I believe that we are all working, in 
sincerity, towards a goal of providing those who would benefit from 
hearing aids with access to safe and effective products that will help 
them live the kinds of lives which they choose and desire. That being 
said, I am concerned about a policy which will create a division 
between a healthcare provider and a patient who needs that provider's 
expertise.
  Thank you.
  The ACTING PRESIDENT pro tempore. The Senator from Wyoming.

[[Page S4787]]

  

  Mr. ENZI. Mr. President, I yield back all time.
  The ACTING PRESIDENT pro tempore. All time is yielded back.


                             Cloture Motion

  Pursuant to rule XXII, the Chair lays before the Senate the pending 
cloture motion, which the clerk will state.
  The senior assistant legislative clerk read as follows:

                             Cloture Motion

       We, the undersigned Senators, in accordance with the 
     provisions of rule XXII of the Standing Rules of the Senate, 
     do hereby move to bring to a close debate on the motion to 
     proceed to Calendar No. 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 biosimilar biological products, and for 
     other purposes.
         Mitch McConnell, Steve Daines, Mike Crapo, James M. 
           Inhofe, Lamar Alexander, Pat Roberts, Thom Tillis, 
           Orrin G. Hatch, John Cornyn, Cory Gardner, Roy Blunt, 
           James E. Risch, Roger F. Wicker, Tim Scott, John Thune, 
           Mike Rounds, John Hoeven.

  The ACTING PRESIDENT pro tempore. By unanimous consent, the mandatory 
quorum call has been waived.
  The question is, Is it the sense of the Senate that debate on H.R. 
2430, the FDA 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.
  The legislative clerk called the roll.
  Mr. CORNYN. The following Senators are necessarily absent: the 
Senator from North Carolina (Mr. Burr), the Senator from Oklahoma (Mr. 
Inhofe), and the Senator from Arizona (Mr. McCain).
  The PRESIDING OFFICER (Mr. Sullivan). Are there any other Senators in 
the Chamber desiring to vote?
  The yeas and nays resulted--yeas 96, nays 1, as follows:

                      [Rollcall Vote No. 185 Leg.]

                                YEAS--96

     Alexander
     Baldwin
     Barrasso
     Bennet
     Blumenthal
     Blunt
     Booker
     Boozman
     Brown
     Cantwell
     Capito
     Cardin
     Carper
     Casey
     Cassidy
     Cochran
     Collins
     Coons
     Corker
     Cornyn
     Cortez Masto
     Cotton
     Crapo
     Cruz
     Daines
     Donnelly
     Duckworth
     Durbin
     Enzi
     Ernst
     Feinstein
     Fischer
     Flake
     Franken
     Gardner
     Gillibrand
     Graham
     Grassley
     Harris
     Hassan
     Hatch
     Heinrich
     Heitkamp
     Heller
     Hirono
     Hoeven
     Isakson
     Johnson
     Kaine
     Kennedy
     King
     Klobuchar
     Lankford
     Leahy
     Lee
     Manchin
     Markey
     McCaskill
     McConnell
     Menendez
     Merkley
     Moran
     Murkowski
     Murphy
     Murray
     Nelson
     Paul
     Perdue
     Peters
     Portman
     Reed
     Risch
     Roberts
     Rounds
     Rubio
     Sasse
     Schatz
     Schumer
     Scott
     Shaheen
     Shelby
     Stabenow
     Strange
     Sullivan
     Tester
     Thune
     Tillis
     Toomey
     Udall
     Van Hollen
     Warner
     Warren
     Whitehouse
     Wicker
     Wyden
     Young

                                NAYS--1

       
     Sanders
       

                             NOT VOTING--3

     Burr
     Inhofe
     McCain
  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.
  The Senator from Tennessee.


                           Order of Procedure

  Mr. ALEXANDER. Mr. President, I ask unanimous consent that after the 
disposition of the Brouillette 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, that there be no amendments in order to H.R. 2430, that there 
be 10 minutes of debate equally divided in the usual form, and that 
following the use or yielding back of that time, the bill be read a 
third time and the Senate vote on passage of the bill with no 
intervening action or debate.
  The PRESIDING OFFICER. Is there objection?
  Without objection, it is so ordered.

                          ____________________