Stop Stalling Act and Creates Act

Floor Speech

Date: May 15, 2019
Location: Washington, DC

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Mr. KAINE. Madam President, I rise with my colleagues to just tell stories I am hearing from Virginians. Having completed a campaign last November, I was out doing a lot of listening and have continued to do a lot of listening since then. In your own mind, you kind of categorize the stories, and, first, above all else, are stories about healthcare. I hear stories about a lot of things, but I hear stories about healthcare probably as much as all other areas combined. In the area of healthcare, the issue of the price of prescription drugs is No. 1.

Hundreds of Virginians have reached out to me to let me know about the high cost of prescription drugs and how that affects not only their health but even their ability to put food on their table or a roof over their heads. Today I want to share some stories from Virginians and then talk about some commonsense legislation and a present opportunity to bring drug prices down.

Andrew from Great Falls shared this story with me. His father was being treated for CML, which is a leukemia that is effectively curable, and he was prescribed the drug Gleevec. Now, this story goes back a little bit, and here is what Andrew said:

In the United States, Gleevec costs approximately $159 to manufacture for a year's dose.

That is the manufactured cost.

In India, a generic version of this drug costs about $400 a year to purchase for use. In Canada, the price is around $8,800 a year for a generic of the drug, and $38,000 a year for the branded drug. In the United States, there is no available generic, and the brand name drug's marketing cost is $146,000 a year. This is not a drug that consumers can simply choose to take or not take--to be blunt, they will . . . literally die of cancer if they don't take it.

Now, since Andrew wrote me the letter, a generic has been approved in the United States that has provided him and other families relief, but for a long period of time, $146,000 in the United States for a drug that costs $159 to manufacture, and the price to patients in other countries is dramatically less.

Daniel from Martinsville in Southern Virginia wrote to me about the high price of insulin, which is a common theme, I know, for all of us here with constituents.

He writes:

I paid $505.00 for 3 bottles of Humalog Insulin . . . at Walgreens. This is a three month supply, but another Eli Lilly insulin is required by my wife in order for her to avoid death [and that is hundreds of dollars more].

Laurie from Norfolk wrote to me to share her story. Laurie has rheumatoid arthritis, and she lives on Social Security. She writes:

The drug company wants $65,000 for the drug. With my Medicare part D, they only want $8,000--[that is good, but that is] over 1/3 of my annual income [as a senior on Social Security for one drug]. I have applied for the drug companies patient assistance program [because] the pain is too great. I can't use my hand without the drug. The drug companies are getting away with robbery. We need Medicare to have the authority to negotiate drug prices.

Ron from Arlington, just across the Potomac, wrote me after he went to renew a prescription he had been taking for more than a year.

That is an outrageous increase of 100 percent or $100 more out of my pocket for exactly the same thing [every time I buy it]. I am a retired federal employee on a limited income and I am locked into this insurance plan for the rest of the year. So I have to take $100 more out of my pocket to obtain the exact same thing.

Every time he buys it, 100 percent increase in the price.

Marie from Virginia Beach wrote me about a drug that costs $375,000 a year. She writes:

Without the drug I most likely will be bedridden. I cannot afford the exorbitant price. . . . I recognize the recovery cost of research is the main expense, since manufacturing cost is extremely cheap, but when the sufferers cannot afford your drug, then what have you gained?

Medicare is prohibited from negotiating the price of prescription drugs. Medicare Part D enrolls over 43 million seniors nationwide, giving the program incredible bargaining power if it could only be used for their benefit.

Many seniors are on fixed incomes. The average senior gets Social Security. Their median income is $28,000, so an $8,000 drug cost is one-third to a quarter of their income. In the wealthiest Nation in the world, seniors should not have to choose between paying for their medication and putting food on the table or heating their home. So many of these seniors tell me about getting medication and then thinking: If I cut the pill in half and just take half a dose, maybe I can save some money--but that then comes at an incredible reduction in the efficacy of the prescription you are taking to control your healthcare condition.

This is why I joined with Senator Klobuchar, and I appreciate her organizing this group of us on the floor today, to introduce the Empowering Medicare Seniors to Negotiate Drug Prices Act, which allows Medicare to negotiate drug prices. This is simple, basic, best business practice. Everybody will negotiate prices. Why should we bar the Medicare Part D Program that provides a prescription drug benefit to 43 million people--why should we bar them from negotiating for drug prices?

According to a recent analysis, Medicare would have saved $14.4 billion. That is billion with a ``b.'' Medicare would have saved $14.4 billion on just 50 drugs in 2016 if the program had paid the same prices as the Department of Veterans Affairs, which is allowed to negotiate. That is a whole separate level of absurdity. Why would we, as Congress, allow the Department of Veterans Affairs, as they buy these same drugs from the same manufacturers, to negotiate and get a volume discount but tell the Medicare Program they can't? We actually know how much money we would save because of allowing the Veterans Affairs Department to negotiate, which they should be able to, but why would we then handcuff Medicare Part D and not allow them?

If Medicare would have saved $14.4 billion just in those 50 drugs in 1 year, that is $14.4 billion that could be used for better healthcare, the deficit reduction, tax relief, Pell grants, education expenses. There is also a savings not just to Medicare but to patients that would also be in the billions.

Every corner pharmacy negotiates the price of prescription drugs. Every Walmart does. When they are buying prescription drugs to sell in their pharmacy, they negotiate based on volume. It makes no sense that the Federal Government is not allowed to do the same thing.

Another area is biologic medicines. They represent a new and very promising area of treatment. I do want to stop here and say I am not one of these people who use a big broad brush and say pharmaceutical companies are bad. Why are we living longer? Why is the average age going up and up and up? It is going up and up and up because of better medical care, and much of that medical care and improvement is innovation in the pharmaceutical industry, so I am not on a campaign to say pharmaceutical companies are bad. They are producing lifesaving prescriptions that are easing suffering and prolonging life. It is just that the price Americans pay for those drugs is so far out of whack with what other nations do, and one of the things that is innovative, that is great is biologic medicines.

When competing products--they are called biosimilars--attempt to enter the market, they often find it impossible to navigate the thicket of patent laws that protect the branded product because they lack access to readily accessible information. So when biosimilar manufacturers are able to uncover the web of patents, expensive litigation too often results in patents being found to be invalid or unenforceable.

That is why I joined with Senator Collins from Maine on a second bill to introduce the Biologic Patent Transparency Act. Our bill promotes patent transparency by requiring manufacturers of approved products to disclose and list patents covering their products with the FDA in what we call the FDA Purple Book. The legislation encourages manufacturers to apply for patents sooner, allow prospective biosimilar manufacturers to challenge weaker or invalid patents earlier in the product development process to eliminate waste, and the legislation will help us bring needed biosimilar treatments to patients faster and ultimately help lower drug prices.

Finally, a word about insulin. Over 30 million people--that is like the combined population of about 19 or 20 States--live with diabetics in the United States, and insulin is a critical and life-sustaining daily treatment for 7\1/2\ million of those people. Yet, between 2012 and 2016, spending on insulin nearly doubled, even while there was little change in the actual use of insulin. So what explains that?

The price hikes we have experienced have caused Virginians who need these drugs, whose stories I have indicated, to endure severe financial hardship, ration their supplies, or even skip the needed medication.

In February, I joined all my Democratic colleagues on the Health, Education, Labor, and Pensions Committee, where I sit with Senator Smith, who preceded me, and we sent a letter to three insulin manufacturers requesting information about recent price increases, how the revenue contributes to research and development, and what companies are doing to help patients access affordable insulin.

In closing, I said there are not only good ideas in Senator Klobuchar's bill and in others, but there is also a good time. In the Health, Education, Labor, and Pensions Committee, our Chair, Senator Alexander, and our ranking member, Senator Murray, have indicated that one of the bills we want to work on this year is a bill of single-shot strategies to reduce medical costs. It is not going to be the rewrite of the healthcare system. Senator Alexander and Senator Murray were heard to describe that if we can do a bill with a series of singles, that would be a very good thing. So we will work together as colleagues to come up with a series of strategies that could bring healthcare costs down, and we have an opportunity in this bill to have some of those provisions deal with provisions just like those I have described that can reduce the cost of prescription drugs.

I am proud to join my colleagues to share stories of Virginians. It is probably the single-most frequent complaint I hear, and it is a complaint we can do something about.

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