The Presiding Officer. The Senator from Louisiana.

Floor Speech

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Ms. KLOBUCHAR. Mr. President, I thank the Senator from Indiana for his words.

We both are from States that have a lot of jobs involved in medical devices, and, in fact, this bill is something we worked on very hard. I am the cochair of the medical device caucus in the Senate. This has been our top priority, to try to move those FDA rules along, and this bill does that. It is an agreement--a rare agreement--between government and industry, which is something both parties want. We would like to move those approvals along for the patients, long-suffering patients who should have access to medical devices, and then also for the industry, where we have seen way too much venture capital money go to places such as Europe simply because that process moves faster. So this is a very good bill, and I am so pleased we have bipartisan support.

I see that the Senator from Wyoming, Mr. Enzi, has come into the Chamber, and both he and Senator Harkin deserve a lot of praise.

I wish to focus today on one piece of this bill, something I have worked very hard on, and it really came out of things I heard in my State, things I heard from pharmacists literally 2 years ago, things I have heard from patients. I got together with our staff. I see that our legislative director, Rose Baumann, and Andrew Hu, who did a lot of work on this bill, are here today. We went and talked to all kinds of people involved. We talked to pharmaceutical companies to try to figure out what was going wrong with drug shortages; we talked to the people who were suffering the most--the patients; we talked to the pharmacists, and we said: What would work here? And the FDA told us that, in fact, when they did get early notification from pharmaceutical companies that there was going to be some kind of shortage, it helped. They were able to avert that shortage. They have done it successfully over 100 times, and they have done it many times with some key drugs. And the earlier notice they have, the better it is for everyone because they can, in fact, then avert the drug shortage, and that is what this is about.

I will tell you that, for me, this whole bill and this whole provision really comes down to a little boy named Axel Zirbes, a young boy with bright eyes and a big smile. Because of leukemia, this little boy, when I saw him, had no hair on his head. He and his family were thrown into a panic about 1 year ago when they learned that an essential drug--cytarabine--was in short supply and might not be available for their son, who they had just found out was diagnosed with leukemia and was supposed to start treatment, and the doctor says: You know
what, we don't know if you should start it--you should start it immediately, but we don't have this critical cancer drug, this critical leukemia drug.

They decided they would take Axel to Canada, where the drug was readily available, and just when they were making those plans to go there, they found out that some of the drug had been located and that Axel could come in for his treatments. Well, that should never have happened, not in the United States of America, not to a family of a little 4-year-old boy, both parents working hard to make sure their child could have health care and then this happens. It makes no sense.

There is the story of Mary McHugh Morrison, who joined me at a forum I held on this topic in Edina, MN. Mary is a woman whose cancer had, unfortunately, returned after a shortage of Doxil. That is a chemotherapy drug that had kept her ovarian cancer at bay. In fact, this shortage interrupted her chemotherapy regimen. Mary struggled to find remaining vials of Doxil and then struggled with the ethical dilemmas of using the drug she found when others would not be able to use it. She literally talked at the forum about how she had personally called people, used connections, tried to find those vials, and she realized that when she got those drugs, other people wouldn't have them.

Again, this shouldn't be happening in the United States of America. She shared her experience with us. And because of a few delays in treatment, Mary's doctor told her that her tumor had, unfortunately, returned and that she was then no longer responding to that drug. This past February, CT scans, unfortunately, showed that Mary's tumor size had doubled. She was immediately accepted into a clinical trial at the Mayo Clinic and began treatment. Fortunately, she is so far responding well and her health is improving.

These shortages are happening all over this country. Every single Senator in this Chamber has heard about one of them. You heard Senator Coats from Indiana talking about what he had heard. So the fact that we heard this first in Minnesota I don't think is any surprise. We have an active State. We have people who believe you can still make a difference. We have pharmacists who are on the front line every day, and they came to us to get this bill introduced.

We heard from emergency medical responders, who have told me that shortages have made it difficult to stock lifesaving drugs in their ambulances. I have listened to stories from parents whose children rely on drugs to help maintain their focus at school. I have seen firsthand how doctors and pharmacists have had to struggle to keep their patients alive as they look for these drugs.

These shortages have had significant impact on these patients' quality of life, oftentimes forcing them to pay hundreds more for expensive alternatives or risking their professional careers to adjust for their diseases and spending hours and days just trying to find a way to fill a prescription.

When we are dealing with so many costs and resource issues with health care, the last we want is for doctors and nurses and pharmacists to be wasting away hours trying to find drugs and then ultimately, in most cases, finding them, but this is no way to run a railroad. Across the country, hospitals, physicians, and pharmacists are confronting unprecedented shortages of these drugs.

So those are the stories, but here are the numbers.

The number of drug shortages has more than tripled over the last 6 years, jumping from 61 drug products--remember, there are thousands of shortages, but this is 61 different drug products in 2005 to more than 200 drug product shortages in 2011.

A survey by the American Hospital Association found that virtually every hospital in the United States has experienced shortages of critical drugs in the past 6 months. More than 80 percent reported delays in patient treatment due to shortages.

For some of these drugs, no substitutes are available or, if they are, they are less effective and may involve greater risk of adverse side effects. The chance of medical errors also rises as providers are forced to use second- or third-tier drugs that they are less familiar with using.

A survey conducted by the American Hospital Association showed that nearly 100 percent of their hospitals experienced a shortage--100 percent. Another survey conducted by Premier Health System showed that 89 percent of its hospitals and pharmacists experienced shortages that may have caused a medication safety issue or an error in patient care.

It is clear that there are a large number of overlapping factors that have resulted in these unprecedented shortages. Experts cite a number of factors: market consolidation, poor business incentives, manufacturing problems, production delays, unexpected increases in demand for a drug, inability to procure raw materials, and even the influence of the gray market. Literally, people are trying to make money off of this now. They hear there is a shortage, and they buy up the supply and then sell it at a higher price. Financial decisions in the pharmaceutical industry are also a major factor. Many of these medications are in short supply because the companies have simply stopped production. They decided it didn't work for their profits to keep producing them. Mergers in the drug industry have narrowed the focus of product lines. As a result, some products are discontinued or production is moved to different sites, leading to delays. When drugs are made by only a few companies, a decision by any one drug company can have a large impact. That would make sense.

To help correct a poor market environment or to prevent gray market drugs from contaminating our medication supply chain, we must address the drug shortage problem at its root. Last year I introduced the Preserving Access to Life-Saving Medications Act with Senator Bob Casey. We also have the support of Senator Collins and others. This is a bipartisan bill that would require drug manufacturers to provide early notification to the FDA whenever there is a factor that may lead to a shortage. We also had support from the Presiding Officer, as well as Senator Blumenthal of Connecticut and many other people from across the Senate.

This bill will help the FDA take the lead in working with pharmacy groups, drug manufacturers, and health care providers to better prepare for impending shortages, more effectively manage shortages when they occur, and minimize their impact on patient care. And that is why I am pleased that the early notification provision from my bill is included in the Food and Drug Administration Safety and Innovation Act, the one that Senator Coats and I were just discussing and that we are debating today.

I thank Senator Harkin and Senator Enzi for their leadership on the HELP Committee in bringing this legislation forward and including my provision. In a bipartisan manner, the HELP Committee brought together several working groups to address a wide range of issues, from medical device innovation to drug shortages. In the drug shortage working group, we spoke with experts from patient groups, providers, drug manufacturers, and the FDA to try to find an appropriate solution.

Ultimately, the legislation now includes many policies that I believe will help address shortages. In addition to the early-notification requirement, again, the FDA is going to be able to look in our own country, and if they can't find something in our own country they can look at safe locations overseas. You simply can't keep these patients waiting for their treatment.

In addition, the bill directs the FDA to improve communications inside and outside its walls, requires more robust record-keeping and reporting, and asks for studies on how pricing factors impact drug shortages.

I believe this bill represents a step forward in our ability to prevent these shortages--a strong step forward. With manufacturers providing early notification, the FDA's drug shortage team can then appropriately use their tools to prevent shortages from happening. As I mentioned, in the last 2 years, the FDA, with more information, has successfully prevented nearly 200 drug shortages. Imagine the hundreds of thousands and millions of patients that has helped. So we need to extend it. That is what this bill does.

One such example is the recent shortage of methotrexate. This is a very common drug used in chemotherapy to treat cancers such as leukemia. For me, the most devastating part about the shortage is that I heard about it from the Zirbes family--the family of this little 4-year-old boy who had to suffer through the shortage of cytarabine earlier. Only this time, the FDA took quick action once it learned of this potential shortage and worked with other manufacturers to boost production and helped stop the bleeding before this became a major crisis. That is an example of what can happen with early notification. They are allowed to then go to other manufacturers and find the people who can make the drug to get it to the hospitals, to get it to the patients. And today, with strong cooperation between the FDA and pharmaceutical manufacturers, methotrexate is available for patients who rely on it just like that little 4-year-old boy Axel Zirbes.

Together with Senator Casey, we were able to work with the HELP Committee and in a bipartisan manner come up with a solution that would give the FDA more tools to prevent drug shortages and ensure patients such as Axel or Mary have the drugs they need when they need them. Recent announcements by the FDA have proven that early notification and cooperation with manufacturers have helped reduce the number of drug shortages by over half. There have been 42 newly scarce drugs so far this year, compared to 90 in the same period last year. That is progress.

While I applaud the FDA in their efforts to address this crisis, 42 drugs in shortage is still 42 too many for me. That is why it is so important to pass this provision and give the FDA the tools it needs to get the number down to zero.

I understand that early notification requirements may be a short-term solution to a long-term problem. That is why I will continue to work with my Senate colleagues to come up with a broad permanent solution, one that includes methods to address the root causes of drug shortages.

It has been a long road to get to this point. Nearly 2 years ago I began hearing about this drug shortage issue, and when I first talked about it some of the doctors said: Really? I haven't heard about it. Now, 2 years later, they have all heard about it. That is why we introduced the Preserving Access to Lifesaving Medication Act. That is why we came together to get an agreement in this legislation. That is why the President issued an Executive order that pushed for more voluntary notifications from manufacturers, and the FDA released an interim final rule that broadened the scope of the current notification requirement. That is why it is so important that we pass this legislation.

Patients such as Axel or Mary should not have to be burdened with the added stress and worry about whether they are going to have enough medication to get through their next treatment. They have enough on their minds. Let's get this done. It is a great example of people working across the aisle. When they heard something from their constituents, they were willing to listen and to put this bill together. Me, I would like to have gotten it done 2 years ago, but later is better than never. We can get it done this week.

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