Remedy Act

Floor Speech

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Mr. DURBIN. Mr. President, if you watched ``60 Minutes'' on Sunday, you would not have been surprised that there was a segment relating to prescription drug pricing. Everywhere we turn, somebody is raising the question about why we are paying so much for prescription drugs and why the cost of these drugs has gone through the roof.

We want to encourage research. We want to encourage innovation. We understand that these are profit-making companies, so we understand we will pay for that. But what we are seeing in terms of the pricing of drugs across America now is inconsistent with any of the history that we have had. It seems as if pharma believes that if they own a drug, they can charge whatever they can charge, and no one will question them.

It makes a difference. Blue Cross Blue Shield, the largest health insurer in my State of Illinois, analyzed the cost of care in our State and nearby and asked: What is driving the increase in health insurance premiums? The cost of prescription drugs, even more than the cost of inpatient hospital care.

Look at all of those big hospitals and all of the important work they are doing and expensive procedures they are involved in. All of that cost does not equal the rising cost of prescription drugs. That is why our health insurance premiums are going up, so it is understandable that more and more of us are talking about this and trying to find practical ways to approach it that might make things better.

Can you consider one policy that might have the support of Democrats and Republicans, the American Association of Retired Persons, the American Medical Association, the American Hospital Association, 88 percent of Americans, and the Trump administration? What in the world could that be? Here it is: a measure I introduced in 2017 to require pharmaceutical companies to disclose the prices with new prescription drug advertising.

Last year, Senator Chuck Grassley, Republican of Iowa, and I teamed up to pass a measure in the Senate to require pricetags on the television ads. We were stopped in conference by a single House Republican.

Think about those television ads. What do they tell us in those ads? For 60 seconds, as fast as they can talk, they tell us everything under the sun. If you are allergic to XARELTO, do not take XARELTO. Certain negative things may happen if you take this drug or the other drug. On they go for 60 seconds without stopping. Yet they never disclose the price of the drug.

After Senator Grassley and I put our bill in last year, I got a call from the Secretary of Health and Human Services, Alex Azar. He decided he wanted to pick up on our effort and join us. Think about that for a minute--a Republican Senator, a Democratic Senator, and the Trump administration agreeing on something. It turns out, he thinks it is a good idea, and I do too.

If we had price disclosure on these ads on television, it might open the eyes of a lot of people as to what it costs. What is the most heavily advertised drug on television today? HUMIRA. Why was HUMIRA invented or discovered? To treat arthritis, particularly psoriatic arthritis. Guess what they discovered. It also had a side benefit they didn't anticipate. You know the little red patch on your elbow-- psoriasis? If you take HUMIRA, all of a sudden, that little red patch goes away. So if you are watching the ads on television, some of them are about arthritis, but some of them show ladies sitting by swimming pools with flawless skin because they are taking HUMIRA. It is very interesting.

There is one thing they leave out. Do you know what HUMIRA costs? It costs $5,500 a month. This red patch on my elbow may trouble me when it comes to the swimsuit competition, but I am not going to spend $5,500 to deal with it. I think they ought to have to disclose the price of the drug. We take their prices; we do not make up the price. The price they declare as pharmaceutical manufacturers--we believe that is the one that should be advertised.

On Monday, Senator Grassley and I introduced the bill to codify this rule that the Trump administration is pushing for price disclosure and to ensure its long-term implementation. We are happy to have on board with us Senator Lamar Alexander, Republican of Tennessee, and Senator King, Independent Democrat from Maine. Disclosing prices in drug ads is a simple step to give patients a break at the pharmacy. We have to do a lot more. I think this is a good starting point, though.

American patients and taxpayers pay the highest prices in the world for most medications. Eli Lilly, out of Indianapolis, IN--they make a drug called Humalog. It is for diabetes. It is an insulin drug that can cost up to $329 per dose here in the United States. Humalog, insulin, diabetes--the cost is $329.

What does the same vial of the same drug made by the same company cost in Canada? It costs $38. It is $329 here and $38 there.

In 2017, Canadians could purchase AbbVie's HUMIRA, which I mentioned earlier, for $20,000; for Americans, $40,000. The worst part of this price disparity is that American taxpayers are the ones paying to develop these drugs in the first place. Our tax dollars at the National Institutes of Health provide the clues and the direction for these companies to take our federally funded research and turn it into a valuable drug, a valuable medical device, and then charge us more than any other place in the world.

All 210 drugs approved by the Food and Drug Administration between the years 2010 and 2016 received funding from the National Institutes of Health, supported by nearly $40 billion by U.S. taxpayers each year. I am all for that, incidentally--funding the NIH and leading to this research. But make no mistake, these breakthrough drugs start at the National Institutes of Health at taxpayers' expense. So American taxpayers get hit twice. We pay for the initial research, which leads to the drug, and then we, of course, pay for the drugs at the highest levels.

The heart of the problem is that our system does not function as a free market. There are too many forces at work when it comes to prescription drugs that limit competition. Often Big Pharma charges as much as they can get away with because they manipulate the patent system to avoid competition.

The theory used to be that if you discovered the drug, you could sell it exclusively for, say, 20 years, and then everybody could take your formula, make generic drugs, and there would be open competition so that the price would go down. That is not how it works.

The core issue is that roughly 10 percent of brand name, patent- protected drugs account for 80 percent of spending in America. The overwhelming prescriptions are for generic drugs, which are affordable drugs, but it turns out that even though 90 percent of the prescriptions are for generic drugs, they account for only 20 percent of all the spending. It is that 10 percent of brand name drugs that account for 80 percent of all prescription drug spending because they are so expensive.

In what other industry does the price of the consumer product increase year after year after being introduced on the market? Maybe a collector of artwork or baseball cards but certainly not when it comes to something that is a life-and-death commodity like a drug.

The point is, I don't believe our Founding Fathers envisioned a scheme where Sanofi's Lantus, insulin that was approved in the year 2000, would receive 45 additional patents after it was approved by the FDA, providing a massive 37-year monopoly by Sanofi on this insulin product. During that time, the price of insulin has increased from $35 to more than $270 because Sanofi has successfully bought lower cost generic competitors, and it is not just Lantus or insulin.

Celgene's cancer drug, REVLIMID, has been awarded 96 patents, many of which were awarded after the initial FDA approval. As a result, REVLIMID, effectively, has gone 40 years without competition.

The same goes for Pfizer's nerve pain drug, Lyrica. You have seen that one advertised on TV. I have. That entered the market in 2004. Lyrica has received 68 patents, including filing more than 2 dozen after initial FDA approval. They are gaming the system to avoid competition to keep their prices high.

In fact, the top 12 best-selling drugs in America each have an average of 71 patents. Why do they get a new patent? Because they have decided that instead of a 150-mg tablet, there will be a 75-mg tablet, and they get a new patent. Or they put a new coating on the outside of the pill or they have a new manufacturing technique. They get the patent. They have exclusivity in the market for another extended period of time.

The top 12 best-selling drugs in America each have an average of 71 patents, and 74 percent of all new drug patents are for drugs that are already on the market. They are gaming the system.

We can and we should reward innovative research so that companies can earn a profit for good work and big ideas. But an abusive manufacturer should not be allowed to game the government patent system while being shielded from competition.

This month I am going to give what I call my Pharma Fleece Award. I made a special sign here so that pharma would know what we are talking about. This month we are going to give this Pharma Fleece Award to Celgene, Pfizer, and Sanofi for stacking excessive secondary patents to block generic competition. The net result, of course, is that American consumers pay more for their products.

To address this, I introduced legislation last month with Senator Cassidy, Republican from Louisiana and a medical doctor, called the REMEDY Act. Our bipartisan bill reduces incentives for Big Pharma to ``evergreen,'' which is a technical term in this application. It is an effort to amass endless quantities of follow-on patents that shield blockbuster drugs from competition from generics. You see, under an act, a law known as the Hatch-Waxman Act, when a generic drug manufacturer seeks approval from the FDA, they are routinely blocked by a maze of patents held by the brand name company.

The generic company has the option to say whether they think the patents covering the brand name drug are not valid or relevant. If so, that can trigger a patent infringement lawsuit. When this happens, the FDA issues a 30-month freeze on the generic company's application to hash out the issue. The problem with this 30-month freeze is it extends the monopoly period for the drug again, and it incentivizes the filing of secondary follow-on patents that may not add to the safety or efficacy of the drug.

This automatic 30-month freeze on competition encourages pharma to amass large numbers of secondary patents and block generic companies from putting on the market a drug that would be in competition with their brand name drug. No matter how weak the patent is, how peripheral it may be--like the coating on a pill that I mentioned earlier--it works. For 30 months, there is another delay before there is competition.

The REMEDY Act, which Senator Cassidy and I introduced, would restrict this 30-month freeze of FDA approval so that it applies only to primary substance patents. This removes an incentive for brand name manufacturers to continue to game the system by filing excessive follow-on patents, and it makes it easier for low-cost generic competitors to come to market.

Big Pharma is gaming the system at the expense of American patients, at the expense of the American health system, and at our expense when it comes to health insurance premiums. What are we going to do about it? Well, it turns out, we happen to be working in a place which makes laws, the U.S. Senate. We are supposed to take a challenge like this and do something about it--not just lament the fact that prescription drug pricing is out of control, but actually do something.

Lucky me, I serve on the Senate Judiciary Committee, which has authority over many of these issues, particularly when it comes to patent law. There are things we can do as members of the committee to bring down prescription drug pricing.

Honestly, if you follow the U.S. Senate, we can do something other than a nomination, which is all we have done around here for a long, long time. I am sure the American voters are happy to see us work on nominations, but they would be much happier if we worked on the high cost of prescription drugs. We have done little or nothing on this subject, other than talk about it for the last few months.

Senator McConnell, the Republican leader, has decided not to bring legislation to the floor of the Senate anymore. That is just from the days of yesteryear when we actually debated a bill, offered amendments, had votes. People showed up on the floor because we were doing something.

Look at it now.

American patients need help from the high drug prices, not more unqualified, divisive nominees but actual legislation to help American families. What a break it would be if the U.S. Senate became the U.S. Senate again.

I hope Senator McConnell will allow us to put a bill on the floor of the Senate. It would be a great celebration here in the Senate. I think Republicans and Democrats would enjoy the opportunity to actually come to the floor, have a debate, and pass a bill that may become a law that ends up helping Americans. For many of us, that is the reason we ran for office, and I hope we can return to that very soon. nominations

Once again, this week the Republican Leader has scheduled no legislation for votes on the Senate floor.

Instead, our Republican colleagues are spending another week rubber stamping President Trump's nominees.

This week, the Republican majority scheduled votes on three Trump judicial nominees. Each of these nominees has expressed views that are ideological and extreme.

First there was Michael Truncale, nominated to the District Court for the Northern District of Texas. Mr. Truncale gave a speech in 2011 where he outrageously called President Obama ``an un-American imposter.''

He described the Supreme Court's decision in Shelby County that gutted the Voting Rights Act as ``a victory.'' He has called for defunding Planned Parenthood and said that he opposes the bipartisan DREAM Act.

He has called the Environmental Protection Agency a ``job killer'' and called for eliminating the Departments of Education and Energy.

Mr. Truncale also gave a radio interview in 2012 thanking the Tea Party movement ``for what it has meant to our country and to our Republican party.''

Despite all this, only one Republican Senator, Senator Romney, voted against Mr. Truncale.

Then there's Ninth Circuit nominee Kenneth Lee of California, who has been advanced by Republicans over the objection of both home State Senators. That never happened before until this year, but this is now the fifth time we have seen a nominee advance with no blue slip.

Mr. Lee initially failed to provide dozens of his controversial writings to the Senate Judiciary Committee.

I remember when President Obama's Ninth Circuit nominee Goodwin Liu initially failed to fully disclose articles he had written to the Judiciary Committee. Republican members of the Committee said it was ``potentially disqualifying'' and said it showed either incompetence or an attempt to hide his writings.

Senate Republicans ended up filibustering Goodwin Liu's nomination. Yet every Republican member of the Judiciary Committee voted for Mr. Lee's nomination. The double standard is obvious.

When we were finally able to review Mr. Lee's writings, we saw he routinely expressed extreme views. Here are just a few examples:

He wrote: ``Charges of sexism often amount to nothing but irrelevant pouting.''

He said: ``homosexuals generally are more promiscuous than heterosexuals, and thus their risk factor [for AIDS] increases exponentially.''

He called affirmative action ``liberals' most sacred shibboleth.''

And he called multiculturalism a ``malodorous sickness.''

Then there is Wendy Vitter, nominated to the District Court for the Eastern District of Louisiana.

Like Mr. Lee, Ms. Vitter also initially failed to disclose more than 100 speeches and documents to the Judiciary Committee.

The matters she failed to disclose included a panel she moderated in 2013 at a Louisiana Right to Life conference. At this panel, she told the audience to urge their doctors to put in their waiting rooms a brochure entitled ``The Pill Kills.'' This is a brochure about how birth control pills supposedly kill women.

Ms. Vitter also claimed in a 2009 speech that we are ``throwing out our Constitution'' by counting the full population in the national census.

All three of these judicial nominees have expressed extreme ideological views that raise serious questions about their judgment. Yet Republicans are rubber stamping all three of them to lifetime appointments on the federal bench.

Then there is President Trump's nominee for Deputy Attorney General, Jeffrey Rosen. Mr. Rosen simply does not have the right qualifications for this important job.

The Deputy Attorney General runs the day-to-day operations of the Justice Department and oversees its law enforcement components.

At this critical moment, we need a Deputy Attorney General who is familiar with the Justice Department, who has experience in overseeing criminal investigations and prosecutions, and who is committed to the Department's role of enforcing the law independently without fear or favor.

Mr. Rosen has no experience working in the Justice Department or handling criminal cases. When I questioned him about core DOJ functions and agencies he will oversee if confirmed, he wasn't familiar with them and said he would have to get up to speed.

For example, when I met with him and asked him about the landmark First Step Act, he said he had ``begun getting informed about it.''

When I asked him about the Deputy Attorney General's role in overseeing the Federal Bureau of Prisons and addressing their critical staffing shortages, he said he wasn't familiar and couldn't comment.

When I asked him about voting rights and voter suppression, he said he hadn't had occasion to study the issue.

When I asked him about the DEA's role in setting opioid production quotas, which he will oversee, he didn't know about it.

When I asked him about DOJ's role in immigration matters, including his priorities for the immigration courts he will oversee, he said he looked forward to learning more about it.

Mr. Rosen was a longtime colleague of Attorney General Barr at a law firm, and he has held positions in other government agencies like the Department of Transportation. But that does not make him qualified to be the Deputy Attorney General.

Because my Republican colleagues used the nuclear option to change the Senate rules, there is now less time for the Senate to debate controversial nominees like Mr. Truncale, Ms. Vitter, and Mr. Rosen.

But the American people see what is going on. They see the rush by President Trump and Senate Republicans to confirm nominees who are ideological or who lack the right qualifications for the job.

I oppose these nominees. And I regret that the Senate's advice and consent process has become an exercise in Republican rubber stamping. This institution can, and should, do better.

I see that my colleague from Texas is here on the floor, and I don't want to take any more time.

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