[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
[[Page S4786]]
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.
____________________