[Congressional Record Volume 165, Number 43 (Monday, March 11, 2019)]
[Senate]
[Pages S1751-S1754]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]



                               Socialism

  Mr. CORNYN. Mr. President, in thinking about some of the debates 
swirling about here in Washington, DC, as to whether capitalism or 
socialism should be a preferred economic model, I recall a story that 
involves Boris Yeltsin, who went on to become the Russian President, 
who happened to be in Houston, TX, in 1989, visiting the Johnson Space 
Center--a very important part of NASA in Houston--when he decided to 
visit a grocery store in Clear Lake, TX. Though it sounds like it could 
be, this isn't the beginning of a Wes Anderson film.
  It was nearly 20 years ago, in 1989, when the Soviet Union had not 
yet imploded and when the Berlin Wall was still standing. It would be 2 
years before Yeltsin would be forced to take steps to begin to 
transform the Soviet

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economy. As I said, he was in the Houston area, finishing a tour of the 
Johnson Space Center, when he made an unscheduled stop at a Randalls 
grocery store before he headed to Miami.
  The Houston Chronicle reported at the time that Yeltsin gawked at the 
abundant produce, the selection of fresh fish, the checkout aisle, and 
especially the frozen pudding pops. He roamed the aisles, according to 
the story, stared at the frozen food section, and took advantage of the 
free samples of cheese. He actually talked to some of the customers 
there and asked questions about what they were buying and how much it 
cost them. He was stunned--absolutely stunned--as this was a far cry 
from the grocery stores in the Soviet Union. Yeltsin said: ``Even the 
Politburo doesn't have this kind of choice, not even Mr. Gorbachev.''
  That day, Boris Yeltsin learned something that the overwhelming 
majority of people in our country already know--that socialism cannot 
provide the bounty, the prosperity, or the choices that capitalism can.
  Leon Aron, who wrote Yeltsin's biography, quoted one of his 
associates.
  He said:

       For a long time, on the plane to Miami, he sat motionless, 
     his head in his hands. ``What have they done to our poor 
     people?'' he said, after a long silence.

  He told his fellow countrymen who were traveling with him that if 
their people were to see the conditions in American supermarkets, 
``there would be a revolution.''
  Make no mistake about it. If the most radical Democrats in our 
country today get their way on the outlandish socialist policies they 
are pushing, the American people will be calling for a revolution.
  The Green New Deal, Medicare for All, and economic security for those 
who are able-bodied yet who are unwilling to work are policies that are 
not going to raise up the most economically disadvantaged people in our 
country. They are going to pull everyone else down. Socialism promises 
not prosperity for all but what Winston Churchill called the equal 
sharing of miseries.
  Though these self-proclaimed democratic socialists make big promises 
on how their policies will deliver fairness and equality for all 
Americans, that could not be further from the truth. The first thing 
these policies would do is to bankrupt our country. These unworkable 
economic policies will kill jobs and outlaw our most reliable, 
affordable energy sources. ``Medicare for All'' will turn into 
``Medicare for none'' when the entire system crashes and when those who 
are unwilling to work will lose any incentive to even try. It would 
subsidize a nation of slackers.
  This threat of the seductive embrace of socialism isn't an 
exaggeration. Some of our friends across the aisle are actually 
critical of the equal opportunity, ``pulling yourself up by your 
bootstraps,'' hard-working economic system that has made our country 
the envy of the world. They say: You didn't create your success; the 
government did--what a bunch of hooey.
  Over the weekend, one Democratic Member of the House who was speaking 
at South by Southwest in Austin, my hometown, referred to capitalism as 
``irredeemable'' and tried to blame capitalism for every problem that 
exists in our society. I admit that we are not perfect, but capitalism 
isn't the cause of every problem that exists in our society. Of all 
places to complain about the perils of capitalism, there is more than a 
little irony in her having chosen Texas--the most successful, free-
enterprise economy in our Nation.
  Instead of talking about this socialist, Big Government approach that 
we all know will fail, let's look at how the Texas model has led my 
State to become an economic powerhouse and the envy of the Nation.
  We keep taxes low, government spending restrained, and regulations at 
a rational minimum to give people and the small businesses that provide 
jobs the freedom to pursue their dreams and to prosper. I must say that 
it is obvious that it is working. The unemployment rate in Texas is 4 
percent, which is among the lowest in the Nation. In Midland--in the 
Permian Basin, the heart of the energy boom in my State--unemployment 
is 2.1 percent. You are hard-pressed to find anybody to take the jobs 
that do exist because, essentially, everybody who is willing to work is 
fully employed. The biggest problem that job creators have is getting 
the workers they need. Yet there is a silver lining for the workers. 
This pushes wages higher as businesses compete for their labor.
  Last week, the U.S. Census Bureau and the U.S. Bureau of Economic 
Analysis released international trade data that showed Texas, for the 
17th year in a row, as the top State for exports. We make stuff, and we 
sell stuff. We grow things. We raise cattle and agricultural products, 
and we sell them. We are the top State for exports. In fact, our 
exports account for nearly 20 percent of the exports of the entire 
Nation. In 2018, that totaled more than $315 billion of exports--more 
than double that of California's, which is the second highest exporter. 
These earnings not only fuel the economy of our State, but they boost 
the entire Nation.
  Our export dominance is only part of the reason Texas is thriving. 
Together, with lower taxes and less burdensome regulation, businesses 
and dream seekers are drawn to our State, which creates opportunities 
for everyone who is willing to work. Instead of growing government and 
increasing the tax burden, we allow businesses--small, medium, and 
large--to invest in their workforces, in our communities, and in our 
way of life.
  In Texas, we believe that less government is more. We don't try to 
centralize power in the statehouse. We give businesses, entrepreneurs, 
and hard-working Texans of all backgrounds, ethnicities, and races the 
freedom by which they can create their own opportunities. We know that 
the more you tax, the more there are government controls and that the 
more you regulate, the greater the burden is on new ideas, investment, 
and opportunity.
  The socialist policies being espoused by some members of the 
Democratic Party are not going to make our businesses and our economy 
stronger or more competitive. Indeed, history has shown that these are 
failed policies that will stifle innovation, discourage hard work, and 
make us look more like that 1980s Soviet grocery store.
  Instead of our grocery stores being filled with a selection of 
beautiful produce, fresh meat, your favorite snack foods, they will be 
stocked with whatever the government says it wants you to have. Instead 
of making an appointment with your doctor when you are sick, you will 
wait for Lord knows how long to get an appointment with a government-
run clinic and have few, if any, options. Instead of forcing ourselves 
out of bed in the morning to go to work, people who are able but who 
don't want to work will stay in bed, knowing they can receive food and 
medical care that will be subsidized by your labor and your hard-earned 
tax dollars.
  That is what these old--but now, somehow, dressed up as something 
new--failed ideas that have been proposed by our Democratic colleagues 
would do. Forget government ``of the people, by the people, and for the 
people.'' They want a country by the government, for the government--
the people be damned.
  In his autobiography, Yeltsin wrote: ``When I saw those shelves 
crammed with hundreds, thousands of cans, cartons and goods of every 
possible sort, for the first time I felt quite frankly sick with 
despair for the Soviet people . . . that such a potentially super-rich 
country as ours has been brought to a state of such poverty.''
  I pray that our country never sees that day when it is brought to 
ruin because of these 21st century socialists.
  I yield the floor.
  I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The bill clerk proceeded to call the roll.
  Ms. COLLINS. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                                 S. 659

  Ms. COLLINS. Mr. President, I rise today to discuss Senate bill, S. 
659, the Biologic Patent Transparency Act. This bill would help 
encourage competition in the prescription drug marketplace and begin to 
put an end to the harmful patent strategies that block new drugs from 
coming to market. I am pleased to be sponsoring this legislation with 
my friend and colleague

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from Virginia, Senator Tim Kaine, as well as with Senators Portman, 
Shaheen, Braun, and Stabenow, all of whom have joined us as original 
cosponsors.
  Prescription drugs are vital to the health and well-being of 
Americans, especially our Nation's seniors, 90 percent of whom take at 
least one prescription drug in any given month. Developing these 
medicines is a lengthy, expensive, and uncertain process. It often 
takes more than a decade and can cost billions of dollars to bring a 
new drug from the laboratory to the patient. Most drugs fail during the 
clinical trials. If we want new medicines to reach consumers who need 
them, the companies that invest in this research and development and 
take the risks necessary must see a fair return on their investment.
  To encourage such investments, Congress grants inventors limited 
periods of patent protection during which their products are legally 
shielded from competition. Rewarding these investments has proven to be 
beneficial to many Americans. The past century could be termed the 
``Age of Miracle Drugs,'' with discoveries such as insulin and 
penicillin, and treatments for cancer, heart disease, HIV, and other 
serious medical conditions. Today, however, we might well define a 
``miracle drug'' as one that has not doubled in price since the last 
refill.
  Although our country leads the world in prescription drug innovation, 
we also lead the world in drug spending. According to one estimate, 
U.S. spending on prescription drugs will reach between $580 billion and 
$610 billion by the year 2021. In 2017, Americans spent more than $330 
billion on retail prescription drugs, and nearly one-quarter of 
individuals surveyed reported difficulties paying for the cost of their 
prescription medications.
  How well I remember standing in the pharmacy line several months ago 
behind a couple who were informed by the pharmacist that their copay 
would be $111. The husband turned to his wife and said: ``Honey, we 
just can't afford that.'' They then turned around, left their 
prescription on the counter, and left the pharmacy. I asked the 
pharmacist how often that happens, and he told me, ``Every day.'' That 
is the kind of onerous burden too many Americans are facing, and it's 
causing them to forgo fulfilling a prescription, to stretch out doses, 
or simply to choose to buy the medicine and short themselves on food or 
be late in paying their rent or mortgage.
  Among the most expensive drugs on the market today are biologics. 
These are incredibly promising drugs for the health and well-being of 
many Americans. They have revolutionized treatment for many serious and 
life-threatening conditions, from diabetes and rheumatoid arthritis to 
cancer and multiple sclerosis.
  Today, fewer than 2 percent of Americans use biologics, yet biologics 
account for nearly 40 percent of total spending on prescription drugs. 
Last year, the Senate Aging Committee, which I chair and which the 
Presiding Officer is a member of, held a hearing to examine the price 
increases for one of these groundbreaking treatments. HUMIRA, the 
world's best-selling prescription drug, is a biologic that was first 
approved for the treatment of rheumatoid arthritis by the Food and Drug 
Administration, the FDA, in 2002. In 2017, U.S. sales of this product 
generated an astonishing $12.3 billion in revenue for the drug's 
manufacturer.
  Now, HUMIRA is truly a miracle drug for many patients. It is used to 
treat a variety of conditions, ranging from rheumatoid arthritis to 
Crohn's disease to ulcerative colitis and plaque psoriasis. So a wide 
range of diseases and conditions are responsive to HUMIRA. According to 
various reports, more than 200 patent applications have been filed for 
HUMIRA, with nearly 90 percent of those filed after HUMIRA was first 
approved by the FDA in 2002.
  According to the manufacturer's CEO, more than 130 patents are 
included in HUMIRA's patent portfolio today. Protections provided by 
these patents can block competition and extend the drug's market 
monopoly until the year 2034. Keep in mind that this is for a drug that 
was first approved in 2002. We're talking about extending the patents 
until 2034.
  HUMIRA has increased in price yet again this year, and although 
biosimilars have been approved by the FDA, patent litigation is blamed 
for keeping these lower cost alternatives from reaching the market. And 
HUMIRA is not the only biologic to be protected by such an extensive 
portfolio of patents--what we call a ``patent thicket.''

  Enabling the creation, approval, and marketing of competitive 
biological products must be among our top priorities when we consider 
ways to reduce the healthcare costs of Americans.
  The Biologic Patent Transparency Act is an important step Congress 
can take to shine light on the patent thickets that protect these 
biologics and to stop some of the gaming that has prevented consumers 
from accessing lower cost, FDA-approved products.
  So what will our bill do? It has three major components. First, our 
bill would require manufacturers to disclose to the FDA the web of 
patents that protect their approved biologics from competition by 
biosimilar manufacturers--a process that we already know works. It has 
worked remarkably well for the small molecule drugs that are governed 
by the Hatch-Waxman Act of 1984. Although generics accounted for only 
13 percent of U.S. prescriptions immediately before the Hatch-Waxman 
Act was passed, today they make up 90 percent. These generics often 
cost 70 to 90 percent less than the branded product. They have 
significantly reduced costs and expanded access to necessary treatments 
for Americans. According to one estimate, generics have saved consumers 
more than $1.6 trillion in drug costs over the last decade.
  Second, our bill would tackle the patent strategies that are 
intentionally designed to block competition by limiting the 
enforceability of late-filed patents against biosimilar manufacturers 
that have already filed applications with the FDA.
  According to one estimate, over 70 of the patents covering HUMIRA 
were applied for and granted within three years prior to the expiration 
of the initial patents.
  So here's what is happening. A manufacturer of a wildly successful 
drug sees that its patents are about to expire and that a competitor--a 
biosimilar manufacturer--is on the way to getting approval by the FDA 
for its product. So what that original brand manufacturer does is make 
small alterations, frequently, in the product. It doesn't change the 
product in a dramatic way. It doesn't come up with a brand new 
medicine, but it changes it ever so slightly or decides to patent an 
aspect of it that was not previously patented. The whole purpose is to 
prevent that biosimilar manufacturer from bringing to market a more 
affordable product that consumers could access. That is just wrong. 
That is not what patents are intended for. And as I made clear earlier 
in my statement, I support a limited period of exclusivity for the 
innovator manufacturer. I think we should reward that investment in 
research and development and clinical trials, which is often very 
expensive. But it is not right for the patent system to be gamed this 
way, for it to be exploited and for last-minute patents to be filed for 
the sole purpose of precluding a competitor from coming to market with 
a less expensive, equivalent drug.
  Restricting the enforcement of these late-filed patents that are 
filed after the application by the biosimilar manufacturer has been 
filed with the FDA will still protect the important investments made by 
the manufacturers, while encouraging the biosimilar manufacturers to 
bring important innovations to consumers sooner and at a lower cost.
  Finally, the third part of our bill would require the FDA to 
regularly publish specific information related to approved biologic 
products, making it easier for prospective competitors to evaluate and 
plan for the development and introduction of biosimilars.
  In addition to the name and patent information for all approved 
biological products, our bill would require the FDA to publish 
information including the drug's marketing status, applicable reference 
products, periods of exclusivity, biosimilar or interchangeable 
products, and approved indications for usage. The FDA will be required 
to regularly update this information as well, so that it is readily 
available and up-to-date. So what this will do is allow

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the biosimilar manufacturer to go to what is known as the ``Purple 
Book'' at the FDA, take a look at the drug it wishes to compete with, 
and learn what existing patents are there, how long they are going to 
be in effect, and plan accordingly.
  America's system of protecting innovation has provided our citizens 
with tremendous benefits, especially in the area of pharmaceuticals. Of 
that there can be no doubt. We must provide pharmaceutical 
manufacturers with the ability to recoup their investments, but at the 
same time, we cannot be blind to the costs of these drugs, nor to cases 
where patent laws are manipulated to preserve monopolies and prevent 
lower cost, equivalent drugs from coming to market. Passing the 
Biologic Patent Transparency Act is a major step we can take to put a 
stop to the patent-gaming that blocks consumers from accessing lower 
cost drugs. I encourage my colleagues to support this crucial 
legislation.
  Thank you.
  I yield the floor.
  Seeing no one seeking recognition, I suggest the absence of a quorum.
  The PRESIDING OFFICER (Mr. Boozman). The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Mr. INHOFE. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.