February 27, 2019 - Issue: Vol. 165, No. 36 — Daily Edition116th Congress (2019 - 2020) - 1st Session

[Pages S1501-S1502]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]



                        Prescription Drug Costs

  Mr. President, I come to the floor this morning to give the first of 
what may turn out to be many speeches on a subject that affects every 
single American. The question is the rising cost of prescription drugs 
in this country.
  The first drug that I wanted to address, I wanted to choose carefully 
because I wanted to choose a drug that really is important to the 
largest number of Americans. So I thought to myself, what is the most 
commonly used life-or-death drug in America today? There is some debate 
about it, but I am going to suggest that it is insulin.
  In 1923--almost 100 years ago--researchers were awarded the Nobel 
Prize for the groundbreaking discovery of insulin to treat diabetes--
1923.
  The chief scientist in the discovery was Dr. Frederick Banting. He 
believed that insulin should be accessible to everyone. His team sold 
the patent to the University of Toronto for $1 so that ``no one could 
secure a profitable monopoly'' on the production of insulin. That might 
seem hard to believe today, with the price of insulin having increased 
more than 600 percent over the past two decades.
  Take a look at the chart, which maps the increases in price. Eli 
Lilly's blockbuster insulin drug, Humalog, was introduced in 1996 at a 
cost of $21. By 2019, the cost went up to $329.
  Sanofi's Lantus was $35 when it came to the market in 2001. It now 
costs $270. The insulin drug, NovoLog, cost $40 in 2001. By 2018, it 
went up to $289--for insulin.
  How many Americans are affected by this? There are 30 million 
Americans who live with type 1 or type 2 diabetes--almost 10 percent of 
our population. Approximately 7.5 million of them rely on insulin to 
manage their blood sugar levels. It is a matter of life and death. Yet 
patients are suffering because of these dramatic price spikes.
  A recent study found that one-quarter of patients who rely on insulin 
have been forced to ration their doses due to cost, basically in 
contravention of the advice of their doctors.
  This is a story that many of us have heard here. Last year, we heard 
from the mother of Alec Raeshawn Smith. He went off his mom's health 
insurance. Under the Affordable Care Act, he could remain covered until 
he reached the age of 26. He had diabetes. He had coverage for his 
insulin until he reached the age of 26. Then he couldn't afford to buy 
health insurance. So when he went off of that insurance, he was faced 
with the monthly cost of his insulin out of pocket. That monthly cost 
was $1,000.
  He managed a little restaurant, and he couldn't come up with $1,000. 
So he decided that he would ration his insulin and not take as much as 
was required by his doctor, trying to make it last between paychecks. 
Alec died as a result of that decision.
  How is it that in the richest country on Earth, patients are having 
to ration their insulin or start GoFundMe websites just to survive?
  Insulin was a cure found in the 20th century that patients now cannot 
afford in the 21st century. Pharma's war on patients with diabetes must 
come to an end.
  Yesterday, there was a hearing, widely televised, where seven or 
eight of the CEOs of major pharmaceutical companies faced the music 
before the Senate Finance Committee. Senator Grassley, Senator Wyden, 
and many others asked questions about the issue I am raising today: 
What is going on? Why are you raising prices so high? There were no 
good answers coming from these executives.
  Today, I am going to start highlighting on the floor of the Senate 
the egregious cases of pharmaceutical greed in the United States.
  Years ago, there was a Senator from Wisconsin named William Proxmire. 
He was an unusual man. He was far different than most Senators today. 
He was the type of fellow who would show up at the University of 
Wisconsin games, passing out cards. That was his style of campaigning. 
He didn't spend a lot of money on television and radio.
  He really was a grassroots politician, and he was a tenacious fellow. 
He started something called the Golden Fleece Award--Proxmire of 
Wisconsin's Golden Fleece Award. Once a month or more, he would come to 
the floor and talk about waste--taxpayer waste--in our Federal 
Government. It developed a national reputation.
  In deference to Senator Proxmire, whom I had a chance to meet when I 
was a college student, I am going to try to follow in his tradition by 
pointing out egregious examples of greed by the pharmaceutical industry 
in the United States on a regular basis with the Pharma Fleece Award.
  My first Pharma Fleece Award is for the pharmaceutical industry's 
extortion of 7.5 million diabetic patients in America who depend on 
insulin. This is a lifesaving product that has been around for almost a 
century.
  How can the most common life-and-death drug be so expensive? First, 
the United States is an outlier. The same companies I am talking about 
sell exactly the same drug in other countries around the world for a 
fraction of the cost.
  The United States represents only 15 percent of all of the global 
insulin market; yet we generate more than half--more than 50 percent--
of Pharma's revenue for this drug.
  How can Lantus cost $372 in the United States? The exact same drug 
made by the same company costs $46 in France and $67 in Canada. Why? 
Why are we paying five, six, and seven times more in the United States 
for exactly the same drug? It is because the governments of France and 
Canada care about the cost, and they say to the company Sanofi, in this 
case, that makes Lantus: If you want to sell Lantus in Canada, we are 
not going to let you hike the prices and raise them to the high 
heavens. We are going to keep the prices reasonable so that the people 
of Canada can afford this lifesaving drug. What do we do in the United 
States? Nothing. We let them charge whatever they wish.
  How can Lantus cost $372 for Americans, while the same, exact drug 
for the French is $46, and just across the border, in Canada, it is 
$67?
  Our problem is that our system doesn't function as a free market. 
There is virtually no competition. Three companies control the insulin 
supply in America: Eli Lilly, Sanofi, and Novo Nordisk.
  Typically, in a free market, three competitors would lower the 
prices, wouldn't they? But in America, these three charge as much as 
they can and get away with it because they are protected by government-
granted monopolies.
  We should reward innovation, we should promote research, and we 
should ensure that companies do make a profit for their good work, but 
abusive manufacturers should not be protected from competition by our 
government.
  Lantus has been on the market since the year 2000. Sanofi has 
received 49 secondary patents on insulin. What does that mean? They 
have created a fortress around this lucrative drug for a 37-year 
monopoly in offering this drug for sale in America.
  Unfortunately, there is no effective deterrent today against Big 
Pharma's greed and price gouging on these and so many other drugs. That 
is why, earlier this month, I introduced a bill called

[[Page S1502]]

the Forcing Limits on Abusive and Tumultuous Prices Act, or FLAT Prices 
Act. This legislation will discourage and deter the pharmaceutical 
industry from raising prices by reducing the government monopoly 
periods when they do.
  You see, companies are awarded monopoly periods from 5 to 12 years by 
the Food and Drug Administration for drug approval beyond the patent 
protection. My FLAT Prices Act would reduce this FDA-granted 
exclusivity period for a drug whose price increases more than 10 
percent a year, bringing generic competitors into the marketplace, 
creating real competition, and trying to lower prices for Americans.
  That brings us to another issue. Today, there remains no generic, no 
biosimilar insulin that can be substituted in a pharmacy. Think about 
it. Almost a century after the discovery of human insulin and even half 
a century after the discovery of synthetic and analog insulin, we still 
don't have a generic insulin for sale in America that is affordable.
  I will acknowledge that these changes in insulin have improved the 
quality of life for patients. They have made them safer, more 
effective, and more convenient, but these changes have delayed the 
development of generic substitutes.
  There are other reasons the FDA has regulated insulin as a drug 
rather than as a biologic, placing insulin under a framework with a 
much higher bar than generics to prove they are substitutes. Thanks to 
the Affordable Care Act--ObamaCare--the Food and Drug Administration is 
supposed to be shifting its regulatory process for insulin to enable 
copycat versions, known as biosimilars, to be approved quickly. 
Unfortunately, FDA's plan to implement this law will not bring relief 
to patients any time soon.
  I do believe that the Food and Drug Administration Commissioner, Dr. 
Gottlieb, truly wants to lower costs and spur competition. I wasn't 
convinced when his nomination came up for a vote, but I have had 
subsequent conversations with him, and I think he is genuine. I think 
he wants to see the prices come down.
  However, the Food and Drug Administration's current plan will 
effectively freeze the approval process for lower cost insulin and 
force generic insulin makers who are under review to resubmit their new 
applications each year.
  This creates a 2-year lockup where it is unlikely that any new 
insulin competitors will come to market. America's diabetic patients 
cannot wait.
  That is why Senator Cramer, a Republican from North Dakota, and I are 
sending a letter urging the Food and Drug Administration to revise and 
bring flexibility to this process so we can get the lower cost insulin 
on the market approved sooner.
  Two weeks ago, I received a little note from a constituent in Mount 
Vernon, IL. That is downstate, near where my father was born. He wrote 
that both he and his daughter had been diagnosed with type 1 diabetes 
in 1997. At that time, their Humalog insulin cost $10. Today, he writes 
that the cost is $300 a bottle, and he needs six bottles a month.
  His monthly costs have risen from $600 to $1,800. Here is what he 
said in this letter:

       At some point, drug companies must be held to account for 
     the actions they are taking. These cost increases are costing 
     American citizens to choose between insulin and eating in 
     many cases. I'm tired of listening to all the excuses. . . . 
     what is it going to take for Congress to do its job?

  I agree with my constituent. Congress needs to step up and demand 
real change. The sky-high cost of life-or-death insulin is literally 
killing Americans.
  My work with Senator Cramer to speed FDA approval of lower cost 
insulin and my bill to shorten monopolies for abusive pharma companies 
are a start. This pharma fleecing of insulin patients across America 
must end.
  I yield the floor.
  The PRESIDING OFFICER (Mr. Sasse). The Senator from Iowa.