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 that we worked on very hard. I'm the co-chair of the Medical Device Caucus in the United States Senate; this has been our top priority to try to move those FDA rules along, and this bill does that. It's an agreement, a rare agreement between government and industry, which is something that both parties want.

We would like to move those approvals along for the long-suffering patients who should have access to medical devices and also for the industry where we've seen way too much venture capital money go to places like Europe, simply because that process moves faster. And so this is a very good bill, and I'm so pleased we have bipartisan support. I see the Senator from Wyoming, Senator Enzi, has come into the chamber, and both he and Senator Harkin deserve a lot of praise.

Now, I wanted to focus today, Mr. President, on one piece of this bill, something I've worked very hard on, and it really came out of things I heard in my state, things I heard from pharmacists literally two years ago, things I heard from patients, and I got together with our staff -- I see Rose Baumann and Andrew Hu are here today -- and we went and talked to all kinds of people involved in this, pharmaceutical companies, we tried 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 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 those shortages. In fact, they've done it successfully over a hundred times, and they have done it many, many times with some key drugs. And the earlier notice that they have, the better it is for everyone, because they can, in fact, then avert the drug shortage, and that's 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, with a big smile and because of leukemia, this boy, when I saw him, had no hair on his head. He and his family were thrown into a panic when they learned an essential drug was in short supply and might not be available for their son, diagnosed with leukemia, was supposed to start treatment, and the doctor said he should start immediately but we don't have this critical cancer drug, this leukemia drug. They took Axel to Canada where the drug was readily available and just when they were ready to go there, they found out some of the drug had been located and Axel could come in for his treatments.

That should never happen, not in the United States of America, not for a family of a 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.

Or the story of Mary McHugh Morrison, who joined a forum I held in Medina, Minnesota. Mary's cancer had, unfortunately, returned after a shortage of a chemotherapy drug that kept her ovarian cancer at bay and, in fact, this shortage interrupted her regimen.

Mary struggled to independently find remaining vials and struggled with the ethical dilemmas of using the drug she found when others would not be able to find it. She talked about how she had used connections, tried to find those vials and realized when she got those drugs, other people didn't get the drug. 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 she was 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.

But these shortages, Mr. President, are happening all over this country. Every single Senator in this chamber has heard about one of them. You heard Senator Coats from Indiana just talking about what he'd heard. And 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 that believe that you can still make a difference. We have pharmacists that 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 ambulance.

I've listened to stories from parents whose children rely on drugs to help maintain their focus at school.

I've 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 impacts 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.

You know, when we are dealing with so many costs and resource issues with health care, the last thing we want is for our 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 shortage 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 six years, jumping from 61 drug products -- remember, there's thousands and 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 six months. More than 80% reported delays in patient treatment due to shortages.

For some of these drugs, no substitute drugs are available. Or if they are, they're 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're less familiar with using.

A survey conducted by the American Hospital Association showed that nearly 100% of their hospitals experienced a shortage. 100%. Another survey conducted by Premier Health System showed that 89% 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 the drug, inability to procure raw materials, and even the influence of a “gray market.” Literally, people are trying to make money off of this now. They hear there's a shortage, 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 fair 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, Mr. President, 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 Lifesaving Medications Act with Senator Bob Casey. We also had the support of Senator Collins and others. This was 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 you, Mr. President, as well as from 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'm 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 want to 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 and find an appropriate solution. Ultimately, the legislation now includes many policies that I believe will help direct 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. So in addition to that, 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 that 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.  In the last two years, the FDA, with early notification and more information, has successfully prevented nearly 200 drug shortages. Imagine the hundreds of thousands and millions of patients that that has helped. So we need to extend it. That's what this bill does.

One such example is a recent shortage of Methotrexate. This is a very common drug used in chemotherapy to treat cancers like 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 four-year-old boy that had to suffer through the shortage of cyterabine 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 help stop the bleeding before this became a major crisis. That is an example of what can happen with early notification. They're allowed to then go to other manufacturers and find the people that 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 them, just like that little four-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 like Axel and Mary have the drugs that they need when they need them.

Recent announcements by the FDA have proven that cooperation with manufacturers have helped reduce the number of drug shortages by over a half. There have been 42 newly scarce drugs so far this year compared to 90 in the same period last year. That's progress.

While I applaud the FDA. And 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 FDA the tools that 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's 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, Mr. President, to get to this point. Nearly two years ago I began hearing about this drug shortage issue, and when I first talked about it, some of the other doctors said, “Really? I haven't heard about it.” Now they have all heard about it.

That's why we introduced the Preserving Access to Lifesaving Medications Act. That's why we came together to get agreement.

That's why the president issued an executive order that pushed for more voluntary notifications for manufacturers and the FDA released an interim final rule that broaden the scope of the current notification requirement. That why, Mr. President, it is so important that we pass this legislation.

Patients such as Axel or Mary shouldn't have to be burdened with the added stress or worry about whether or not they will have enough medication to get through their next treatment. They have enough on their minds.

So 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 put a bill together. Me, I'd like to have gotten it done two years ago. But later is better than never. We can get it done this week. Thank you very much, Mr. President, I yield the floor.