I rise today to talk about a serious public health crisis facing our nation and to highlight some of the important progress that we have made today.
We are currently confronting shortages of critical medications. These drug shortages impact people across our country forcing some patients to delay their lifesaving treatments or use unproven, less effective alternatives. In some cases drug shortages have resulted in patients not being able to get the kind of treatment that they've gotten and getting left behind.
I've been working to address this problem for over a year since I first heard from hospitals, pharmacists and patients in Minnesota that they were facing shortages of essential medications, particularly chemotherapy drugs. Their urgency led me to send a letter to FDA Commissioner Hamburg to take actions to address this public crisis. Over the next few months I continued to receive calls and visits from constituents asking help to find medications in short supply. I worked with manufacturers, stakeholders and the FDA to try to find an appropriate solution to ensure that patients continued to receive the care that they deserve and they need.
I would also add that while in several cases the crisis was averted, this took hours and hours of individual pharmacists' time, of individuals doctors' time. And at a time when we are trying to be as efficient as possible in our health care system, the last thing we need is to have a doctor or a nurse or a pharmacist spending half a day just looking for medication because there is a shortage.
In February, I introduced the Preserving Access to Lifesaving Medications Act with Senator Casey. This legislation, which has bipartisan support and a total of 17 cosponsors, would give the food and drug administration the ability to require early notification from pharmaceutical companies when a factor arises that may result in a shortage.
And today the president issued an executive order that adopts this framework for an early notification system. The executive order will do this. It will push drug companies to notify the FDA of any impending shortage of certain prescription drugs. It will expand the FDA's efforts to expedite review of new manufacturing sites, drug suppliers and manufacturing changes. And it will direct the FDA to work with the Department of Justice to examine whether drug companies responded to potential drug shortages or other third parties have engaged in hoarding medications or raising prices to gouge consumers. This action will help further reduce and prevent drug shortages, protect consumers, and prevent price gouging. This step enhances actions that have already been taken by the FDA and it puts in place additional tools to address drug shortages.
Mr. President, this is something you probably didn't even hear about a few years ago, but this year we've learned that drug shortages are having a direct toll on families across America. Just a couple of months ago i met a young boy named Axle Zirbes. He is a cute four-year-old boy from the Twin Cities with a big smile. He happens to have no hair on his head because Axle is being treated for leukemia. When he was slated to start chemotherapy, his parents learned a potential drug might not be available for their son. They are thrown into a panic and desperately looked for any alternatives. They even prepared to take Axel to Canada where Cytariben is still readily available. Imagine you're parents to a four-year-old, find out he has leukemia, can't get a drug which is commonplace and you're starting to prepare to fly Canada because our own country has not kept up with the supply of this drug.
Fortunately he never had to go to Canada. At the last minute the hospital was able to secure the medication from a pharmacy that still had a supply. But Axel and his parents sadly are not alone.
There were 178 drug shortages reported in 2010. Keep in mind, Mr. President, these are not individual stories like Axel's. These are actual drugs, 178 different drugs across the country basically affecting millions of patients, that had drug shortages in 2010. That is a dramatic increase from just five years ago. 55 shortages just five years ago. Think of that increase. For some of these drugs, no substitute drugs are available. Or if they are, they are less effective and they may involve greater risks of adverse side effects.
The chance of medical errors also rises as providers are forced to use drugs they are not familiar with. A survey conducted by the American hospital association showed that nearly 100% of their hospitals experienced a shortage in the past year. Another survey conducted by Premier Health System showed that 89% of its hospitals and pharmacists experience shortages that have caused medication safety issue or an error in patient care. We want to be doing the opposite, Mr. President. We want to be reducing errors. We want to be getting patients the help that they need.
It is clear that there are a large number of overlapping factors that are resulting in unprecedented shortages. Experts cite a number of factors that are responsible. These include market consolidation, manufacturing problems and production delays, unexpected increases in demand for a drug, inability to procure raw materials and even the influence of the gray market, where people are basically hoarding these drugs when they find out that there could be a shortage and then upping the prices as if things weren't bad enough.
Financial decisions in the pharmaceutical industry are also a major factor. Many of these medications are in short supply because companies have simply stopped production. They decided it wasn't profitable enough to keep producing them. Instead of the lower-priced and lower-profit generic drugs, companies are looking at more expensive brand name drugs. Mergers in the drug industry 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 one drug company can have a huge impact on the market. 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.
The early notification system that would be established under the Preserving Access to Lifesaving Medications Act and the President's executive order that is advanced today will help the FDA take the lead in working with pharmacy groups, drug manufacturers, and health care providers to better manage for impending shortages more effectively manage shortages when they occur and minimize the impact on patient care.
What does this really mean? Just so you know, the FDA already does this with orphan drugs when there is just one drug and the drug manufacturer thinks that they're going to run out of the drug. They do tell the FDA so the FDA can step in and maybe look internationally for another drug. We saw that happen with the H1N1 virus. They are allowed to do that now but manufacturers are not required to do that in some of the situations where we're encountering the 178 drug shortage.
That's what our amendment does. It says if you see a drug shortage coming down the pike, you have to let the FDA now. You have to work with the FDA because they have successfully averted dozens of drug shortages this year. So we don't pretend this is going to solve everything, Mr. President, but it's at least something we can do right now which will give the FDA the power to go in there and work with the drug manufacturers and try to find other sources so the parent of a four-year-old kid with leukemia or a pharmacist who is trying to serve customers at his pharmacy or a doctor who is trying to treat patients and she has to get on the phone and call a bunch of hospitals to try to find a drug. This simply doesn't make any sense at all. This is a national problem, not a problem for a 4-year-old boy.
Our legislation would also direct the FDA to provide up to date public notification of any actual shortage situations to develop an evidence-based list of drugs vulnerable to shortages and to work with the manufacturers to come up with a continuity of operations plan to address potential problems that may result in a shortage, and the bill would also direct the FDA to establish an expedited inspection process for manufacturers of a product in shortage. This would allow them to get inspected sooner so we could get the drugs to market. With manufacturers providing early notification, the FDA's drug shortage team which already exists can then appropriately use their tools to prevent shortages from happening.
As I mentioned, in the last two years, the FDA, with early notification and more information has successfully prevented 137 drug shortages, so this is something that actually works. While the President's executive order takes steps toward advancing these goals, he has made clear that we must pass this bill in order to protect patients and ensure consumers that they have access to the life-saving medications that they need and deserve. So the executive order helps, but we still need to pass this bill.
I understand that this may be a short-term solution to a long-term problem. That's why I have also been working with several of my colleagues on a bipartisan basis to come up with a broad, permanent solution, one that includes methods to address the root causes of drug shortages. This includes Senator McCain and Senator Corker, and it includes Senator Burr, and I also see Senator Blumenthal here who has been working on this issue. We have basically Senators including Senator Casey and others working with the Health Committee who have been working to get this done.
At the urging of this bipartisan working group, the FDA held a public workshop in September that brought together patient advocates, consumer groups, health care professionals and researchers to discuss the causes and the impact of drug shortages and possible strategies for preventing or mitigating future shortages.
In addition to the work group, I have been speaking with a broad range of stakeholders to try to discover why we have seen such a large number of drug shortages that we have not seen in the past. The facts don't lie, the numbers don't lie. There has been an enormous increase in the number of drug shortages. This current explosion of shortages appears to be a consequence of a lack of supply of certain products to keep up with a substantial expansion in the scope and demand for these products.
Due to the complex nature of these drug shortages, there is no single or simple solution that will solve all problems. A solution will require everyone involved to play a role in mitigating future drug shortages. We must ensure that we have the manufacturing capabilities to keep up with demand.
One solution may be to provide tax incentives to incentivize manufacturers to continue to make drugs that are on the shortage list or to provide other market incentives such as including exclusivity pricing similar to those that we give to manufacturers who make orphan drugs. In addition, I have urged the FDA to improve their communication with patients and providers. This will ensure that patients and doctors are not the last to know when there is a shortage.
I also favor permanent reimportation of drugs from safe countries like Canada. Not everyone involved in this issue thinks that is a good idea, but I can tell you if we were to allow that, that little 4-year-old boy wouldn't have had to start looking at flights to Canada.
One thing is clear -- this is a national public health crisis that must be addressed. The President's actions today will provide additional tools to address drug shortages, but more must be done. I will continue to work with my colleagues in the bipartisan working group for a broad, permanent solution. I will also continue to work with Senator Casey, with you, Mr. President, and with all of the other senators involved in this including Senator Susan Collins to get our legislation passed.
It is common sense, it is not over the top, it simply takes a tool that's used now to avert drug shortages for orphan drugs and expands it so that other drug manufacturers when they have drugs that are going to experience a shortage are required to notify the FDA, and it just gives the FDA a little extra time, whether it's one month, whether it's six months, whether it's a year, to look for the drug in other locations. And I think it also would give us some insight into what actually is going on here so we can fix this. Thank you very much, Mr. President. I yield the floor.