[Congressional Record Volume 163, Number 28 (Thursday, February 16, 2017)]
[Senate]
[Pages S1240-S1242]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]



                        Prescription Drug Prices

  Mr. COTTON. Mr. President, I recently read a story in the Wall Street 
Journal that I thought was so alarming it demanded action. Here is the 
headline: ``Marathon Pharmaceuticals to Charge $89,000 for Muscular 
Dystrophy Drug After 70-Fold Increase.''
  Yes, that is $89,000 a year, and, yes, that is a 70-fold increase--
70-fold, as in 7,000 percent.
  For those of you who have not read the article, here is the story. 
There is a rare disease called Duchenne muscular dystrophy. It affects 
about 12,000 young men in the United States. Most of them, 
unfortunately, end up dying in their twenties and thirties because of 
it.
  We don't have a cure yet for Duchenne. Until recently, there was not 
even a treatment with FDA approval. So, for many years, patients and 
parents have been importing a drug called deflazacort, a steroid, from 
other countries. Even though it is not a cure, it at least helps treat 
symptoms and has been a welcome relief to many families.
  Well, technically it is illegal to import a drug that doesn't have 
FDA approval. But there is a catch. The FDA does not quite enforce the 
ban against all unapproved drugs. In fact, it has issued regulatory 
guidance saying that you can get an exemption and buy an unapproved 
drug from overseas if you meet five conditions. First, you have to have 
a serious illness for which there is no other treatment available. 
Second, you can't sell the drug. Third, you can't pose an unreasonable 
risk to your health. Fourth, it has to be for you and you alone. Fifth, 
you can't buy more than a 3-month supply.
  All of that sounds fair enough. But if someone comes along and gets 
FDA approval for their version of the exact same drug, the exact same 
chemical composition of the drug that is being imported, then you 
cannot buy it overseas anymore. That is exactly what happened here.
  This was not a new drug. This was not a medical breakthrough. This 
was not a scientific advance. This was, plain and simple, an arbitrage 
opportunity. Other people had already gone to the trouble of making a 
drug that worked, but if you paid the expenses of getting FDA approval, 
you would essentially buy for yourself monopoly pricing power. That is 
what other companies missed, and now, to cover the costs of going 
through that approval process, Marathon is increasing the price from 
roughly $1,500 a year to $89,000 a year.
  I don't think it is an overstatement to say that this turn of events 
is nothing short of outrageous. It defeats the very purposes of our FDA 
laws. The reason we offer people the chance to create a monopoly is to 
encourage innovation and medical breakthroughs, to generate new drugs 
that are going to solve diseases or illnesses.
  What we are saying is, if you go to the pain and expense of 
developing a new treatment, we will give you the sole rights to sell it 
for a number of years so you can recover your costs, and, therefore, we 
will encourage more medical breakthroughs to alleviate the pain and 
suffering of the American people. In other words, monopoly rights are 
not merit badges. They are not a reward for business smarts. They are 
supposed to serve the interests of patients. They are supposed to 
expand access to treatment. But in this case, what we see in our system 
is, in fact, restricting access and driving up the price for that 
coverage.
  I understand that many people with Duchenne are happy that Marathon 
has done this because now that the drug has FDA approval, insurance 
companies will likely cover it--unlike before when people had to pay 
out of pocket, meaning that poor kids didn't get access to deflazacort, 
whereas upper middle-class and rich kids typically did.
  I also know that Marathon has promised to increase spending on 
research on a new drug and to help people of limited means afford that 
treatment. That, too, is all to the good.
  I am not casting aspersions on anyone's motives here, but let's be 
real. Someone has to pay the full price of this drug at $89,000 a year. 
We have a drug that used to be available for $1,500 a year, and now it 
is $89,000 a year. Whatever happened, that is a systemwide failure. We 
as a Congress have to address it.
  There is simply no getting around the fact that this story should 
never have been written in the first place because it should have never 
happened in the first place. We should be channeling peoples' ambition 
and entrepreneurial spirit into finding cures, not finding new and 
clever ways to make a profit. That is what our food and drug laws are 
designed to do. That is what they have clearly failed to do in this 
instance.
  I just want to say that I am not going to let this story disappear. I 
am going to work with my colleagues to find a legislative solution to 
this mess and promote affordable, high-quality healthcare for all, for 
all families whose young children suffer from Duchenne and for every 
other orphan disease that has drugs that can be used for treatment and 
right now are being blocked from the market or for which we are paying 
way too much money as a society.
  I yield the floor.
  I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Ms. CANTWELL. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Ms. CANTWELL. Mr. President, for the last 47 years, the EPA has 
enforced science-based environmental policies that have resulted in 
cleaner air and water, the cleanup of some of our Nation's most 
contaminated lands and waters, and has improved our understanding of 
our changing climate. All of this has led to a healthier America.
  Bipartisan Administrators of the Environmental Protection Agency--
everybody from the great Washingtonian Bill Ruckelshaus to most 
recently Gina McCarthy--took on the role and responsibility as EPA 
Administrator, knowing that it was their responsibility to protect 
existing environmental law and to let science be the guide on research 
and new policies. They took the EPA mission to heart, and they fought 
to protect human health and the environment.
  I have questions about whether the nominee, Mr. Pruitt, follows those 
same values, and I come to the floor to oppose his nomination to be the 
Administrator of the EPA.
  Mr. Pruitt has repeatedly attacked needed EPA regulations, and he 
supports polluters at the expense of the environment and health laws. 
He doesn't believe the scientifically proven causes of climate change 
are real.

[[Page S1241]]

  Less than a year ago, then-Oklahoma attorney general Scott Pruitt, 
working in their State, wrote: ``Scientists continue to disagree about 
the degree and extent of global warming and its connection to the 
actions of mankind.'' That was written in the Tulsa World.
  When questioned by my colleagues during the hearing process, he said: 
``The climate is changing, and human activity contributes to that in 
some manner'' but the degree of that contribution is ``subject to more 
debate.''
  The reason I raised these issues is that this issue of climate and 
climate impact is so real in the State of Washington. It is already 
happening, and it is already affecting our industries.
  As EPA Administrator, Mr. Pruitt would have the responsibility for 
setting the Agency's agenda, including how to respond to climate 
change, yet the fact that he doesn't support the existing climate 
change science puts him in a role where I think he would not protect 
the economic interests of our State.
  We cannot have a lackadaisical attitude about these issues. It is not 
a hypothesis. It is here. It is happening.
  In the Pacific Northwest, it is altering our region's water cycle, 
putting Washington's farming jobs and our $51 billion agriculture 
economy at risk. Wildfire seasons are longer and more severe than ever 
before. It is costing our Nation billions of dollars.
  Warmer water temperatures in our streams and rivers have degraded 
salmon spawning habitat, led to massive die-offs, and certainly our 
shellfish industry has been very challenged.
  With 25 percent of carbon dioxide emissions being absorbed by our 
oceans, it is raising the acidity level, and that is impacting the 
chemistry of Puget Sound. Oceans and their absorption of carbon dioxide 
emissions and these acidic conditions are making it hard for our 
shellfish industry to do the type of seeding that needs to take place. 
It is severely impacting the Pacific Northwest's $278 million shellfish 
industry. Ocean acidification has been found to dissolve the shells of 
important prey species, and the ocean acidification effects then carry 
up the food chain, if they are not addressed.
  If we have an EPA Administrator who isn't going to work to cut down 
on carbon emissions and thinks that it is only part of the impact, 
aren't there a lot of Northwest jobs at stake? For example, our 
maritime economy alone is worth $30 billion, so I would say there is a 
lot at stake.
  In looking at the record of Oklahoma attorney general Scott Pruitt, 
he fought EPA regulations that protect public health, including the 
cross-state air pollution rule, the regional haze rule, the clean air 
standards for oil and gas production sites, and the clean water rule.
  Despite this issue of repeatedly suing the EPA, he recently told 
Congress: ``I do not expect any previous lawsuits to adversely affect 
my performance as EPA Administrator.''
  Well, I have serious concerns about how Mr. Pruitt's past lawsuits 
will influence his aggressive attitude as EPA Administrator in not 
fighting for the things that are going to protect the jobs and economy 
in Washington State that count so much on a pristine environment.
  A letter was sent by 773 former EPA employees who served under 
Democratic and Republican administrations, stating: ``Mr. Pruitt's 
record and public statements strongly suggest that he does not share 
the vision or agree with the underlying principles of our environmental 
statutes.''
  His record does not give me the confidence that he is the right 
person to lead this Agency at this point in time.
  But there are other issues. During his time as Oklahoma attorney 
general, Scott Pruitt planned the Summit on Federalism and the Future 
of Fossil Fuels. This summit brought together energy industry 
executives with attorneys general to strategize against EPA, and they 
specifically discussed EPA's overreach, as they put it, regarding a 
very important issue called the Pebble Mine.
  The Pebble Mine is an attempt by some who want to actually establish 
a gold mine in the very place of one of the most successful salmon 
habitats in the entire world: Bristol Bay, AK.
  The EPA followed the letter of the law in their multiyear, science-
based assessment of Bristol Bay. They basically made sure that 
everybody understood what was at risk: that Pebble Mine would destroy 
up to 94 miles of salmon spawning streams; it would devastate anywhere 
from 1,300 to 5,350 acres of wetlands; and it would create 10 billion 
tons of toxic mine waste, which is nearly enough to bury Seattle. And 
all of this would occur in the headwaters of the greatest salmon 
fishery on Earth, where half of the sockeye salmon on the planet spawn.
  So the notion that this is how this nominee would spend his time--as 
I said, the mine itself is a direct threat to the $1.5 billion salmon 
industry in Bristol Bay. That is 14,000 jobs just in the Pacific 
Northwest. The importance of making sure that the mine is not located 
there is of the utmost importance, I say, to the salmon fisheries of 
the entire Pacific Northwest.
  I want to make sure we are putting someone in place who is going to 
fight for the laws that are on the books and to show leadership, not 
spend time trying to undermine the Agency, the organization, and its 
existing authority.
  If Scott Pruitt allowed Bristol Bay to go forward, it would be 
devastating to our State. It would be voting in favor of these 
polluters instead of making sure that we are protecting science and 
environmental law.
  I have very serious concerns, and that is why I am opposing this 
nominee. I hope my colleagues on the other side of the aisle will 
realize that these economies--the ones that depend on clean air and 
clean water, safe salmon spawning grounds--are dependent on our doing 
the right thing to protect what is really our stewardship of this 
planet that we are on only for a very short period of time. I hope my 
colleagues will consider all of this and oppose this nominee.
  Mr. President, I yield the floor.
  The PRESIDING OFFICER. The Senator from Florida.
  Mr. NELSON. Mr. President, I want to speak about this nomination from 
the standpoint of our State, our State of Florida, because we are 
famous for sugar-white beaches, fertile fishing grounds, and unique 
environmental treasures, such as the Florida Everglades. These precious 
natural resources need our protection and our stewardship. In fact, 
Florida's multibillion-dollar tourism industry is driven by the fact 
that people come to our State to enjoy these kinds of environmental 
treasures.
  I have just come from a meeting with the American Hotel & Lodging 
Association. With multibillions of dollars of investments all over 
Florida, what happens if the guests don't come? That is a major 
investment that is lost.
  And, oh, by the way, a few years ago during the BP oil spill--when 
the oil got only as far east from Louisiana as Pensacola Beach, and 
some oil was in Choctawhatchee Bay and Destin and some tar balls were 
as far east as Panama City Beach, but not any further--the visitors 
didn't come because they thought the beaches were covered with oil.
  Well, right now Florida's unique environment is threatened by several 
environmental challenges, from the threat of fracking in this honeycomb 
of limestone filled with freshwater that supports the peninsula of 
Florida to algal blooms that have plagued much of Florida's Treasure 
Coast this last year, to the red tide in the Tampa Bay area, and to 
Burmese pythons in the Everglades. And that is just a little bitty 
partialness of the plagues. To deal with these challenges, States such 
as ours depend on the EPA as a backstop.
  I am here to express my concerns about the President's pick to lead 
this agency. It has been well documented that the President's pick is a 
friend of the oil industry. There is nothing wrong with that. But this 
is an industry that has invested hundreds of thousands of dollars in 
political contributions to Mr. Pruitt and the PACs supporting him over 
the years.
  Ever since I was a young Congressman, I have been fighting to keep 
oil rigs off the coast of Florida. In the first place, there is not a 
lot of oil out there, but Florida's unique environment--from what I 
just told you about, the BP oil spill--its tourism-driven economy, and, 
oh, by the way, the largest testing and training area for the U.S. 
military in the world, the Gulf of Mexico off of Florida, as well as 
all of the testing ranges on the east coast, and how about the rockets 
coming out of the

[[Page S1242]]

Cape Canaveral Air Force Station and the rockets coming out of the 
Kennedy Space Center--because of all of those, you can't have oil rigs 
down there. For all of those reasons, it makes Florida incompatible 
with offshore oil drilling. An EPA Administrator with such close ties 
to the oil industry is deeply concerning for the people of Florida.

  But Mr. Pruitt's ties to Big Oil aren't the only concern that we have 
in Florida. During his confirmation hearing, Mr. Pruitt said that he 
believes that his views on climate change are ``immaterial'' to the job 
of the EPA Administrator.
  Whoa, the EPA Administrator is directly involved in things that 
involve climate change. I can't think of a more relevant issue for our 
EPA Administrator to be concerned with because Florida is ground zero 
when it comes to the effects of sea level rise.
  These are not projections, not forecasts. These are measurements over 
the last 40 years in South Florida. The sea has risen 5 to 8 inches.
  By the way, where is three-quarters of the population of Florida? It 
is along the coast. We are already seeing regular flooding at the mean 
high tide in the streets of Miami Beach, and they are spending millions 
on infrastructure in order to get those pumps working to get the water 
off the streets and raising the level of the streets.
  We are seeing the saltwater, which is heavier than freshwater, seep 
into the ground where there is a honeycomb of limestone filled with 
freshwater, and the seawater is seeping into the freshwater. So cities 
are having to move their city well fields further to the west because 
of the saltwater intrusion, and it only gets worse.
  The threat Floridians face every day is a result of this sea level 
rise that is very real. It is critical that we have an EPA 
Administrator that understands that there are things that are happening 
because of climate change. It is not immaterial to the job of the EPA 
Administrator; it is very relevant.
  There is Mr. Pruitt's history of questioning science, especially when 
the facts conflict with his friends, whom he surrounds himself with, 
about the effects of science. So whether it is protecting Florida's 
livestock from deadly parasites or protecting the air we breathe, 
science informs policy decisions that affect all of us--clean water, 
clean air. It affects public health, national security, and the 
environment.
  Yet we continue to see troubling reports about scientists being 
muzzled from the State level all the way up to the Federal level in the 
EPA. So it just seems that this is unacceptable. Our scientists should 
be free to publish scientific data and not be muzzled. They should be 
able to publish their reports without fear of losing their jobs or 
being censored for using phrases like ``climate change.''
  That is why I recently sponsored legislation to protect our 
scientists from political interference. The Scientific Integrity Act 
would ensure that Federal scientists can communicate their findings 
with the public. It requires Federal agencies to implement and enforce 
scientific integrity policies and ensure that procedures are in place 
so that if those policies are violated, it is known and there is a 
procedure to deal with that.
  I conclude by stating that Floridians and the State of Florida cannot 
risk the health of our environment or our economy on an EPA 
Administrator who pals around with folks that do all of what I am 
talking about--they question our scientists, denying the true threat we 
face from sea level rise and climate change. Floridians can't afford 
such a risk, and they shouldn't be forced to take this risk. Therefore, 
I will vote no on Mr. Pruitt's nomination to be EPA Administrator.
  Mr. President, I yield the remainder of my postcloture debate time to 
Senator Carper.
  The PRESIDING OFFICER. The Senator has that right.
  Mr. NELSON. I yield the floor.
  The PRESIDING OFFICER. The Senator from North Dakota.
  Ms. HEITKAMP. Mr. President, I join my colleagues today to recognize 
that the environment is critically important. One of the true issues 
States face is getting back to the promises of the Clean Air Act and 
Clean Water Act to make sure States enjoy primacy, and I think that is 
a critical component that is not being discussed today as we look at 
guaranteed clean water and clean air--making sure that those closest to 
those issues have the ability to have the input that was anticipated by 
almost every environmental statute. So I would remind my colleagues 
that when we focus many times on Federal issues and Federal 
appointments, one of the most important things that we can do is focus 
on the fact that these Federal agency heads need to work cooperatively 
with State organizations.
  Scott Pruitt, who is a soon-to-be former attorney general, 
understands the State role, and I think that is a critical 
qualification and an important distinction to make.