Chairman Harkin, Ranking Member Enzi, and my fellow colleagues on the HELP Committee – I am glad that this hearing is being held today to discuss causes and solutions to the drug shortage crisis.  And I appreciate the opportunity to join you all and briefly share my thoughts and experiences after having worked on this issue for the past year.

The country is facing what experts are calling a "crisis" with "unprecedented" shortages for a record number of essential drugs.  Drug shortages have impacted individuals all across the country – forcing some patients to delay their life-saving treatments or use unproven, less-effective alternatives.  In some cases, drug shortages have even resulted in patient deaths.

Over a year ago, I heard from hospitals, pharmacists, and patients from Minnesota that they were facing shortages in essential medications - specifically to chemotherapy drugs.  Their urgency caused me to send a letter to FDA Commissioner Hamburg urging the FDA to take actions to address this public health crisis.

Over the next few months, I continued to receive calls from constituents asking for help in finding 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 they needed and deserved.

And just a few months ago, I met a young boy named Axel Zirbes.  Axel Zirbes is a cute four-year-old boy from the Twin Cities with bright eyes and a big smile.  He also happens to have no hair on his head.  That's because Axel is being treated for leukemia.

When he was scheduled to start chemotherapy earlier this year, Axel's parents learned that an essential drug, cytarabine (sye-TARE-a-been), was in short supply and might not be available for their son.  Understandably, they were thrown into a panic and desperately looked for any available alternatives.  They even prepared to take Axel to Canada, where cytarabine (sye-TARE-a-been) was still readily available. 

Fortunately, it didn't come to that.  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 are not alone. 

As you know, there were 178 drug shortages reported in 2010 and already 231 reported as of this November - a dramatic increase from 55 just five years ago.

For some of these drugs, no substitutes are available.  Or, if they are, they're less effective and may involve greater risks 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.

A survey conducted by the American Hospital Association showed that nearly 100 percent of their hospitals experienced a shortage.  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 error in patient care. 

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 for the shortages.  These include market consolidation and poor business incentives, 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".

However, when drugs are made by only a few companies, a decision by any one drugmaker can have a large impact.

Therefore, 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.

Earlier this year, I introduced the Preserving Access to Life-Saving Medications Act with Senator Bob Casey of Pennsylvania. The bill would require drug manufactures to provide early notification to the FDA whenever there is a factor that may lead to a shortage.

This will help 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.

The legislation would also direct the FDA to provide up-to-date public notification of any actual shortage situation and the actions the agency would take to address them. 

Additionally, the bill requires the FDA 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 and add redundancies to protect against potential shortages.

And the bill would also direct the FDA to establish an expedited reinspection process for manufacturers of a product in shortage.

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 137 drug shortages.

And while the President's Executive Order took steps toward advancing these goals, he has made clear that Congress must act in order to protect patients and ensure consumers have access to the life-saving medications that they need and deserve.

I understand that this may be a short-term solution to a long-term problem.  That's why I have been working with several of my colleagues on this Committee to come up with a broad, permanent solution – one that includes methods to address the root causes of drug shortages.

At the urging of this bipartisan working group, the FDA held a public workshop in September that brought together patient advocates, industry, consumer groups, health care professionals, and researchers to discuss the causes and impact of drug shortages and possible strategies for preventing or mitigating future shortages.

In addition to the workshop, I have been speaking with a broad range of stakeholders to try to discover why we have seen such a large number of shortages over the past few years. 

And I have also urged 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. 

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 those 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 all stakeholders to play a role in mitigating future drug shortages.

That includes increased and transparent coordination between the offices in the FDA responsible for drug shortages, compliance, and new drug applications. 

That includes better record keeping and communication between the drug manufacturers and the FDA.

And it must include methods to ensure that we have the manufacturing capabilities to keep up with demand.  One solution may be to provide tax credits to incentivize manufacturers to upgrade their production capabilities or to remain in or join the market.

But one thing is clear:  This is a national public health crisis that must be addressed.  I will continue to work with my colleagues in the Committee and in the Senate to try to develop a broad and permanent solution and urge my colleagues to support this legislation that will help ensure access of needed medications for our nation's patients. 

Thank you.