Mr. President, I rise today to bring attention to an urgent issue affecting all Americans. Actually, the number one thing that I heard about when I was home - and especially at our state fair, which by the way, is the biggest state fair in the country because we don't count Texas because they're open for a month. 2 million people, record crowd, 1.9 million people to be exact. I went out there most of the days, and I was able to talk to folks right where they were. And the issue that they're talking about is the high cost of prescription drugs in our country.
The price of insulin has tripled in the last decade. The price of the infectious disease drug Daraprim increased 5,000 percent overnight. The antibiotic Doxycycline went from $20 a bottle to nearly $2,000 a bottle in just six months. And, of course, the price for an EpiPen, which got so much attention over the last few weeks, which is used to treat life-threatening allergies – my daughter carries one everywhere she goes - that shot up by nearly 500 percent since 2007.
It seems every week we hear another disturbing report of drug companies focused on profits.
According to a 2016 Reuters’ report, prices for four of the nation's top 10 drugs increased more than 100 percent since 2011. The report also shows that sales for those 10 drugs went up 44 percent between 2011 and 2014, even though they were prescribed 22 percent less.
I continue to hear from people across my state and the nation about the burdensome cost of prescription drugs. There are heartbreaking stories about huge price tags that are stretching families’ budgets to a breaking point.
This is just an example. I brought these home with me from the state fair and brought them to Washington. Just a few days at our state fair booth, where people just came up and filled out cards about their stories on increasing drug prices. Just a few of the emails from just since August 25th that we've gotten. Calls into our office every single day.
Take for example the Dwyer family from Cambridge, Minnesota. At eleven years-old Abby was diagnosed with a rare form of Leukemia. A few years later her older brother Aaron was diagnosed with stage three Lymphoma. Thankfully both Abby and Aaron are doing much better, but the family faced astronomical out-of-pocket expenses during their treatment. Abby is on a drug with an average wholesale price in the U.S. of $367 per day, which is double the average price in other countries.
Or the example of a family from Elk River, Minnesota. Due to their son's allergies, they must buy four EpiPens a year – two for home, one for school, and one for daycare. Now, that's not overdoing it. I can tell you having had a child with allergies since she was four years-old, that you don't just buy one. You have to buy one for school. And then you also have to buy one maybe for grandma's house. And then one gets lost. So you end up not just buying one EpiPen. In reality, most families are buying four to six, which is two-packs, three-packs, sometimes even four-packs. So, this family from Elk River, Minnesota, buys four EpiPens a year-- two for home, one for school, and one for daycare. This year the family paid $533 for a two-pack, even after using Mylan’s coupon. They shouldn't be forced to spend over $1,000 each year just to make sure that their son is safe every single day.
I recently heard from a family in Lakeville, Minnesota, whose daughter was diagnosed with Type 1 diabetes. She needs insulin on a daily basis. This means paying $108 a month for Humalog, which is a fast-acting form of insulin. This significant financial burden is on top of all the other costs they must pay for their daughter’s diabetes - test strips, insulin pump, and a glucose monitor.
Unfortunately, these families are not alone. A recent study showed that one out of four Americans whose prescription drug costs went up said they were unable to pay their bills. One out of five were forced to skip doses of their medication. Seven percent of people even missed a mortgage payment due to rising prescription drug costs. That’s just not right, and our country must do better.
And I think one of the most frustrating things about it, having heard from the EpiPen - because my role with this all during the last few weeks - I got screenshots of photos of this exact same product in Australia for $150 from someone that saw it online. In Great Britain - I was on a show broadcast out of Europe - and there the host had it right there on the screen at 150 bucks. Out of Canada - in fact, the Canadian prices - us in Minnesota being so close to Canada - are 50 percent, on average, of American drugs across the board.
The burden extends beyond patients, of course, to states and the federal government. Programs such as Medicare, Medicaid, and the Children’s Health Insurance Program, or S-CHIP, paid roughly 41 percent of the nation’s prescription drug costs. So, when drug prices increase with abandon, American taxpayers are left footing the bill.
So, people who think, well I don't need those EpiPens - they're paying for it because Medicaid's buying them, because S-CHIP is buying them, because Medicare is buying them.
We learned just last week that the company that manufactures EpiPen – and perhaps other companies – have found ways to make taxpayers pay even more. Mylan marketed EpiPen like a brand-name drug, right? We heard about this this week, becaue they just and we appreciate that, introduced a generic version. It controled, however - their other version, their marketed version - controlled at least 85 percent of the market, and they would claim they were having innovations and that's how they justified that enormous price0 increase from $100 to about $600 from 2009 to present.
However, through the Medicaid Program - so remember they're marketing it not as a generic. Everyone knew that because they just introduced the generic. Well, in the Medicaid Drug Rebate Program, they wrongly classified we found out this week when I had sent a letter along with Senator Grassley and Senator Blumenthal. We found out that they wrongly classified EpiPen as a generic drug to the government. So, to the government they claimed it was a generic drug. And this misclassification means that Mylan has been paying lower rebates to Medicaid, increasing the burden on American taxpayers.
So you think, okay, misclassification. What does that mean? Well, I can tell you what that means.
In Minnesota alone - because I specifically asked about Minnesota - in one year, my state overpaid an estimated $4.3 million. Why don't we multiply that out by all the states in the union and all the years where its been happening.
At this point, we do not know the total amount taxpayers have overpaid on EpiPen or how many other drugs from other companies are misclassified. That’s why I’ve called on the Department of Health and Human Services (HHS) to conduct a nationwide investigation to determine how much the misclassification, of first of all EpiPen, has cost states and the federal government and to identify other misclassified drugs from other companies.
Take these examples from the Canadian International Pharmacy Association: In the U.S., a 90-day supply of Abilify, a drug used to treat depression and other mental health disorders, costs $2,621 dollars. In Canada, a 90-day supply of the exact same drug is only $467 dollars, which is over 80 percent cheaper. So, you see these examples of these high-price drugs, and I think one of the things we need to do - I don't know how those are classified - but is to see how are these being classified for Medicaid purposes.
Working with the Department of Justice, HHS should use all the tools it has to recover any overpayments. As I mentioned, in 2009 - so we've asked specifically about EpiPen - well, Mylan paid almost $120 million - I don't think this has been that very well known - back in 2000 to correct a misclassification of drugs. That was in 2009. Now we found out with EpiPen, which is about 10 percent of their profit, that this has been misclassified for years and years and years.
Misclassification is just one way the government – and, as a result, taxpayers – are paying more than necessary for prescription drugs.
One thing is absolutely clear: we must act now to make the cost of prescription drugs more affordable for all Americans. There is not one silver bullet that will fix the problem across the board, but there are some commonsense solutions to address this problem. Today I'm going to offer four such solutions – any one of which would provide real relief. But the best way is to do all of them.
Okay, the first is, I mentioned Canada a few times. In fact, I just mentioned some of the Canadian prices for the drugs. Canada - in Minnesota, we can actually see Canada from our porch – well, they spend a lot less money than we do on prescription drugs. As I mentioned, last year, average prescription drug prices in Canada were less than half as expensive as they were in the United States – a price gap that has expanded significantly over the last 10 years.
I mentioned a few of them with Abilify. You've got Celebrex, anti-inflammatory drug, costs $884 dollars in the United States for a 90-day supply. Canada: $180 dollars. That is nearly 80 percent less.
I mentioned EpiPen. At $623 - of course now we're going to get the rebate and the generic introduced after public outcry, which is not the way this should be working. A two pack in Canada costs 62 percent less – that was $237.
These staggering differences are why I introduced bipartisan legislation with Republican Senator John McCain to allow Americans to safely import prescription drugs from Canada. The Safe and Affordable Drugs from Canada Act would require the Food and Drug Administration to establish a personal importation program that would allow Americans to import a 90-day supply of prescription drugs from an approved Canadian pharmacy.
Now, there may be other safe drug suppliers in other countries. I think we know that. But we thought, in order to kind of get the noise down, focus on one country that's our neighbor. One of our best trading partners. And why not we just go with the friendly people of Canada for an experiment to see how this works to allow some competition by allowing drugs in from Canada.
To provide needed safeguards, the FDA would publish an online list of approved Canadian pharmacies so people know where they can purchase safe drugs. These approved pharmacies would need to have both a brick-and-mortar and online presence and must have been in business for at least five years.
Also, these pharmacies would not be permitted to resell products purchased outside of Canada. The drugs from Canada would need to be dispensed by a licensed pharmacist and would be required to have the same active ingredient, route of administration, and dosage form and strength as an FDA-approved drug.
There would also be safeguards to ensure the personal importation program is not subject to abuse. Patients must have a valid prescription from a doctor, and certain types of drugs including controlled substances would not be permitted.
This is a safe and commonsense step that would save families real money and inject greater competition. We are about competition in this country. That is how we bring prices down. We have a friendly neighbor to the north that clearly has lower priced drugs than ours. And that's why Senator McCain and I have joined along with Senator Susan Collins and Angus King of Maine and many others to say, let's do this. That's one solution.
Second solution: pay-for-delay. It's kind of one of those things when I told our citizens in Minnesota about this at the state fair, they could not believe it.
Beyond the drug importation legislation, we should also crack down on illegal “pay-for-delay” deals that prevent less expensive generic drugs from entering the market.
Pay-for-delay agreements occur when a brand-name drug company - so you've got a pharmaceutical company pays a generic drug competitor not to sell its products. This is going on in the United States of America. My booth at the state fair is next to Bob's Snake Zoo, which sometimes people come out yelling and screaming because they get a little scared from the snakes. This is scarier than that. In fact, pharma companies are paying generic companies to keep their products out of the marketplace.
That is why I've introduced the Preserve Access to Affordable Generics Act with Republican Senator Chuck Grassley of Iowa. This gives the Federal Trade Commission greater ability to block these anti-competitive agreements.
By allowing generic drugs to enter the market more quickly, the government would save money through the purchase of lower cost generic substitutes. That’s why it is estimated that limiting these sweetheart deals would generate over $2.9 billion in budget savings over 10 years and save American consumers billions on their prescription drug costs.
Who can be against this? You literally have two competitors - one accepting money, one paying them off to keep their products off the market. The Supreme Court had a case which made some difference. The FTC has a bunch of open cases. But it has been agreed in hearing after hearing that Senator Grassley and I have held that this would be a smart thing to do. Remember $2.9 billion is what it would save, but it would save more. The government saves that much but it also saves the consumers.
Third good idea: Allowing Medicare to negotiate prices. This is another thing where Minnesotans and Americans cannot believe this is the case, but in fact, the combined and incredible market power of the seniors of America has not been unleashed in terms of getting good deals for the seniors of America.
Under current law, prescription drugs for Medicare beneficiaries are provided through private prescription drug plans. The plans are responsible for crafting benefit packages and negotiating with pharmaceutical companies for prices and discounts.
The Department of Veterans Affairs and Medicaid can currently negotiate drug prices with pharmaceutical companies, but the law bans Medicare from doing so. This makes no sense, and it’s a bad deal not just for our seniors but for all taxpayers.
That’s why I introduced the Medicare Prescription Drug Price Negotiation Act. This legislation would allow Medicare to directly negotiate with drug companies for price discounts. The federal government should leverage its large market share to negotiate better prices for more than 39 million seniors - that is market power - covered under Medicare Part D.
Last and finally, the CREATES Act. I've worked on this bill with Senator Patrick Leahy, Senator Grassley, and Senator Mike Lee – to introduce the bipartisan Creating and Restoring Equal Access to Equivalent Samples Act (CREATES Act). That is a mouthful, but what it would do would put an end to strategies that delay generic competition and cost American consumers billions of dollars.
To receive approval from the Food and Drug Administration, a generic must test its product against the brand-name product to establish equivalence. You would want that. Without access to brand-name samples, there can be no generic product.
For a long time, generic companies would simply buy these samples from a wholesaler. Now, some brand-name companies prevent generic companies from obtaining samples. Or the brand-name company simply refuses to negotiate safety protocols with the generic company. In either case, the longer the brand-name company can delay the generic company’s approval, the longer the brand maintains its monopoly.
The CREATES Act would allow a generic drug manufacturer facing one of these delay tactics to bring an action in federal court in order to obtain the needed samples or stop a branded company from dragging its heels on negotiating safety protocols. The bill would also allow a federal judge to award damages in order to deter future delaying conduct.
The Congressional Budget Office estimates that this bill would save the government $2.9 billion over 10 years. The savings to consumers and private insurance companies would likely be far greater.
So, let's review this as my colleagues come to the floor. Number one solution: Allow for safe drugs from Canada, would bring down the prices, would bring in competition. A bipartisan bill - Democrats and Republicans that I have with Senator John McCain.
Number two soultion: Allow for more generic compeititon by passing the CREATES Act that I just mentioned. The bill with Senator Leahy, Grassley, and Senator Lee, and myself. A bipartisan bill that allows for samples to go quickly to the generic companies, so that they can actually create the drugs that will compete and bring the prices down.
Solution number three: Stop those pay-for-delay deals that are unbelieveable, that would bring in CBO estimate $2.9 billion over 10 years by saying to the generics and the pharma companies, 'You can't pay each other to stop competition.' Competition helps consumers.
And the final solution, which I think is the biggest idea: Negotiation under Medicare Part D, which would finally take the kind of negotiation that we see at the veterans administration, which have brought down the prices for veterans of America and harnessed that bargaining power of 39 million seniors so that we get better prices.
Four ideas. Three of them have Democratic and Republican co-sponsors. I want a vote on these proposals because I believe, based on what I saw at our state fair booth - again, just a few days of the cards that we received - that these anticompetitive practices have to stop and we need to bring down the price of prescription drugs for the hardworking Americans in this country.
Thank you, Mr. President. I yield the floor.