[Congressional Record (Bound Edition), Volume 158 (2012), Part 1]
[Senate]
[Pages 361-363]
[From the U.S. Government Publishing Office, www.gpo.gov]




                          DRUG SHORTAGE CRISIS

  Ms. KLOBUCHAR. Mr. President, I rise today to talk about the drug 
shortage crisis that is continuing to spread across the country. I am 
proud to stand here today with my friend and colleague, Senator Susan 
Collins of Maine, who has been a leader on this issue and who shares my 
concern for so many patients who are struggling to find much needed 
medication. This is a crisis that has grown to such proportion that 
current drug shortages have impacted individuals all across the 
country, forcing some patients to delay their lifesaving treatments or 
use unproven, less effective alternatives. In some cases, drug 
shortages have even resulted in patient deaths. Enough is enough. We 
can no longer just simply talk about this issue and have meetings. We 
need to act.
  Here is one story. A few months ago, I met a young boy named Axel 
Zirbes. Axel has bright eyes and a big smile. He also happens to have 
no hair on his head because he has childhood leukemia. When his parents 
found he had leukemia, and he was scheduled to start chemotherapy 
treatment last year, they learned that an essential drug--Cytarabine--
was in short supply and might not be available for their son. 
Understandably, they were thrown into a panic, desperately looking for 
any available alternatives. They even prepared and made plans to take 
Axel to Canada, where the drug was still readily available. 
Fortunately, it didn't come to that.
  But Axel and his parents are not alone. Earlier this month, I held a 
forum in Edina, MN, where a woman by the name of Mary McHugh Morrison 
shared her story of how she struggled with the shortage of the 
chemotherapy drug Doxil. When Doxil went into shortage last year, Mary 
was in the middle of her chemotherapy regimen and was shocked when her 
doctor told her they had actually run out of the drug necessary to 
continue her treatment. This is in Minnesota, where we have excellent 
health care, as you know, Mr. President. Literally, they ran out of the 
drug in the middle of a chemotherapy treatment.
  While trying to get herself added to a wait list, Mary was able to 
call around to other hospitals and clinics in her area in search of any 
available Doxil and was able to find extra treatments four separate 
times. She actually talked to the forum about how she grappled with the 
ethics of the fact that because she knew people and was

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able to call around and get this, that she was taking this limited drug 
out of supply for herself and not for other patients.
  However, because of a few delays in the treatment, Mary's doctor told 
her that her tumor had, unfortunately, returned and that she was no 
longer responding to Doxil. She is now going without treatment and, 
depending on her health condition, could be placed on a clinical trial 
at the Mayo Clinic in March.
  But these shortages aren't just affecting cancer patients. There are 
also shortages in drugs that help people improve their quality of life. 
Just this week, the Minneapolis Star Tribune reported that hundreds of 
patients in the Minnesota Sleep Disorder Center at Hennepin County 
Medical Center have suffered a shortage of Ritalin, Adderall, and their 
generic equivalents. These shortages have had significant impacts on 
these patients' quality of life, oftentimes forcing them to pay 
hundreds more dollars for expensive alternatives or professionals 
risking their careers to adjust to their diseases and spending extra 
hours and days of time trying to find ways to fill their prescriptions 
or their pharmacists doing that or their doctors doing that or their 
nurses doing that. We know how difficult this health care system is 
anyway, and now we are putting patients in this position and wasting 
the time of medical professionals to find drugs that should be readily 
available.
  These are just a few examples of real people who are just trying to 
deal with their disease, and there are many more like them.
  Across the country, hospitals, physicians, and pharmacists are 
confronting unprecedented shortages. Many of these are generic drug 
products that have been widely used for years and are proven effective. 
Many of them are for cancer. The number of drug shortages has more than 
tripled over the last 6 years--and if you don't believe my stories, 
listen to this--jumping from 61 drug products that were in shortage in 
2005 to more than 200 last year. That is not 200 instances, that is 200 
different kinds of drugs that affect hundreds of thousands and millions 
of patients across this country. A survey by the American Hospital 
Association found that virtually every single hospital in the United 
States of America has experienced shortages of critical drugs in the 
past 6 months. More than 80 percent reported delays in patient 
treatment due to a shortage. These aren't just a few stories that come 
into our office anymore, these are the facts.
  For some of these drugs, no substitutes are available or, if they 
are, they may be 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 with which they are less 
familiar.
  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. These include market consolidation and 
poor business incentives, manufacturing problems, production delays, 
unexpected increases in demand for a drug, inability to procure raw 
materials, and even--and this is a new phenomenon--the influence of a 
``gray market,'' where middlemen are literally hoarding the drugs 
because they have heard there is going to be a shortage.
  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. Mergers in the drug industry have 
narrowed the focus of production lines. As a result, some products are 
discontinued or production has moved to different sites, leading to 
delays. When drugs are made by only a few companies, a decision by any 
one drugmaker can have a large impact.
  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 to address this 
issue. With the support and leadership of Senator Collins, Senator Bob 
Casey, and others, this bipartisan bill would require drug 
manufacturers to provide early notification to the FDA whenever there 
is a factor that may lead to a shortage. This will help the FDA take 
the lead in working with pharmacy groups, drug manufacturers, and 
health care providers to better manage and prepare for impending 
shortages, more effectively manage those shortages when they occur, and 
minimize--and that is what we want to do--their impact on patient care. 
The legislation would also direct the FDA to provide up-to-date public 
information of a 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 that may result in a shortage. 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--and they do 
now have a drug shortage team--can then appropriately use their tools 
to prevent shortages from happening.
  If you think this wouldn't work, in the last 2 years the FDA, with 
more information, has successfully prevented nearly 200 drug shortages. 
So it does work when they get the information. But nothing requires 
them to get the information, and that is what we are trying to do 
today. It is not the end-all, be-all solution for the long term, but at 
least in the short term, when these patients are experiencing these 
drug shortages that can impact their treatment, that can impact their 
lives, it gives the FDA that extra tool to look for alternative drugs. 
If they can't find them in this country, maybe they can find them in 
Canada. But it puts the patient first, not the drug companies.
  At the urging of the bipartisan work group I have been involved in, 
the FDA held a public workshop last September that brought together 
patient advocates, industry, 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 workshop, we 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. This current explosion of 
shortages appears to be a consequence of a lack of supply of certain 
products to keep up with the substantial expansion in the scope and 
demand for these products. We must ensure we have the manufacturing 
capabilities to keep up with the demand.
  There are a lot of ideas for incentives and pricing, but we also know 
that those will take a long time to take effect on the immediate 
shortage problem. That is why we want to get this bill passed--and 
passed very soon.
  The President has issued an Executive order, which is helpful, but it 
still doesn't get at the very serious problem of the kinds of drug 
shortages we are seeing. The Executive order pushes drug companies to 
notify the FDA of impending shortages, expands the FDA's current 
efforts, and instructs the FDA to work with the Department of Justice. 
But there is still much more work to be done. Patients such as Axel or 
Mary shouldn't have to be burdened with the added stress and worry 
about whether they have enough medicine. It is time for action. I urge 
my colleagues to pass our bill.
  I now turn it over to my friend and colleague from Maine, Senator 
Susan Collins.
  The PRESIDING OFFICER. The Senator from Maine.

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  Ms. COLLINS. Mr. President, let me first begin my remarks by 
commending my friend and colleague from Minnesota for leading the way 
on this very important bill.
  There are so many issues that divide us in this Chamber. Surely, this 
is an issue that should unite us. It is not a Democratic issue. It is 
not a Republican issue. It is an issue of serious consequence to the 
American people and to our health care system. I would hope--and the 
reason Senator Klobuchar and I have come to the floor today--that we 
can act immediately to pass our bill, get it through the House, and 
send it to the President.
  Physicians, pharmacists, and patients throughout the country are 
struggling to cope with the surge in shortages of needed drugs which is 
causing significant disruption in health care and putting patients at 
risk. I share with my colleague from Minnesota her concern about this 
critically important problem.
  According to the U.S. Food and Drug Administration, the number of 
drug shortages has nearly quadrupled over the last 6 years, jumping 
from 61 products in 2005 to a record 231 by the end of November of last 
year. And there appears to be no end in sight.
  Many of the drugs in short supply are vital. They are used in 
hospitals and cancer centers for anesthesia, for chemotherapy, and for 
the treatment of infections. There are also continuing shortages of 
drugs used in emergency rooms and in intensive care units.
  I have met with several doctors and other medical professionals and 
pharmacists in Maine who are extremely concerned about this issue. They 
have told me that these shortages are causing serious problems around 
our State and across our Nation, including forcing some medical centers 
to ration drugs or postpone elective surgeries. Even more tragic, 
oncologists have told me of situations where they have been forced to 
change a patient's chemotherapy regime midcourse because they suddenly 
encountered a shortage of a particular drug. Moreover, for some drugs, 
such as the leukemia drug Cytarabine, which Senator Klobuchar mentioned 
as well, there are no effective substitutes.
  This crisis is widespread. In a survey by the American Hospital 
Association, more than 80 percent of our hospitals reported that they 
have had to delay treatment due to the shortages. Just think what that 
is like for a patient who has received the diagnosis of cancer and has 
started treatment and then finds out the lifesaving drug they need is 
not available. It is hard enough to cope with the devastating 
diagnosis. To add to that the fact that the drug you need isn't 
available is just too much to bear. More than half of our hospitals 
have said they could not provide some of their patients with the 
recommended therapy.
  Drug shortages are also adding to the cost of care. Hospital 
pharmacists are having to spend additional time--some 8 to 12 hours per 
week--dealing with shortages, increasing labor costs by an estimated 
$216 million a year.
  That is why I joined with my colleague from Minnesota in cosponsoring 
the Preserving Access to Life-Saving Medications Act. Our bill will 
provide the FDA with better tools to better manage and, we hope, 
prevent shortages of lifesaving medications.
  First and foremost, it takes the very commonsense step of requiring 
pharmaceutical manufacturers to notify the FDA of the discontinuance, 
interruption, or other adjustment in the manufacture of a drug that 
would likely lead to a shortage. Providing early warning when a drug 
will not be available will help both physicians and their patients. It 
builds on its successful model--the FDA's Drug Shortage Program--which 
encourages manufacturers to report potential or existing shortages so 
that the problems can be addressed or other manufacturers can ramp up 
their production. Through this voluntary approach, the FDA was able to 
avert 195 shortages last year.
  Our bill also directs the FDA to provide up-to-date public 
notification of any shortages, and it directs the FDA to work with 
manufacturers to establish contingency plans to address drug shortages 
due to manufacturing problems, such as the shortage of raw materials or 
reduction in production capabilities.
  Our legislation would give the FDA the information and the tools it 
needs to help address and prevent drug shortages. This, in turn, will 
help to ensure that our hospitals and health care professionals are 
able to provide the best care medical science allows. Most important, 
it will help ensure that patients have access to the medications they 
need when they need them most.
  I am proud to join with my colleague from Minnesota in sponsoring 
such an important initiative. I urge our colleagues on the HELP 
Committee to act quickly to report this bill and the full Senate to act 
without delay to approve it as well. Surely, this is an issue that 
should bring this Chamber together and that we should act on 
immediately.
  The PRESIDING OFFICER. The Senator from Minnesota.
  Ms. KLOBUCHAR. Mr. President, I ask to speak as in morning business.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Ms. KLOBUCHAR. Mr. President, I thank Senator Collins for her great 
leadership. This bill is moving. This bill is picking up support across 
the Nation. Again, we need to get it done. We cannot wait. These 
patients cannot wait.

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