[Congressional Record (Bound Edition), Volume 157 (2011), Part 11]
[Senate]
[Pages 16272-16273]
[From the U.S. Government Publishing Office, www.gpo.gov]




                             DRUG SHORTAGES

  Ms. KLOBUCHAR. Mr. President, I rise today to talk about a serious 
public health crisis facing our Nation and to highlight some of the 
important progress we have made to date. We are currently confronting 
unprecedented shortages of critical medications. These drug shortages 
have impacted 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 getting the kind of treatment they had gotten or being slow in 
getting their treatment and being left behind. I have 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, 
urging the FDA to take action to address this public health 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 continue to receive the 
care they deserve and they need.
  I would add, while in several cases the crisis was averted, this took 
hours and hours of individual pharmacists' time, individual doctors' 
time. 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 
nurse or pharmacist spend half a day to look for medication because 
there is a shortage.
  In February I introduced the Preserving Access to Life-Saving 
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. 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 current 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 have responded to potential drug shortages by illegally 
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.
  This is something we probably didn't hear about a few years ago, but 
this year we have learned that drug shortages are having a direct toll 
on families across America. A couple of months ago I met a young boy 
named Axel Zirbes. Axel Zirbes is a cute 4-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 is 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, was in short supply 
and might not be available for their son. Understandably they were 
thrown into a panic and desperately looked into any available 
alternatives. They even prepared to take Axel to Canada, where 
cytarabine is still readily available.
  Imagine this. You are parents of a 4-year-old, you find out he has 
life-threatening leukemia, and you cannot get medication which is 
actually quite commonplace in the treatment of this disease, and you 
are starting to fly to Canada because our own country somehow 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, these are not 
individual stories such as Axel's. These are actually drugs, 178 
different drugs across the country, basically affecting millions of 
patients, that had drug shortages in 2010. That is a dramatic increase 
from 5 years ago. There were 55 shortages 5 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 percent of their 
hospitals experienced a shortage in the past year. Another survey, 
conducted by Premier Health System, showed that 89 percent of its 
hospitals and pharmacists experienced shortages that have caused a 
medication safety issue or an error in patient care.
  We want to be doing the opposite. We want to be reducing errors. We 
want to be giving patients the help they need. It is clear there are a 
large number of overlapping factors resulting in unprecedented 
shortages. Experts cite a number of factors that are responsible for 
the shortages. These include 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 markets, where people are basically 
hoarding these drugs when they find out there could be a shortage and 
then upping the prices, as if things were not 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 was not profitable 
enough to keep producing them.
  Instead of low price, and lower profit, generic drugs, companies are 
looking at more expensive brandname drugs. 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

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made by only a few companies, 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 Life-Saving 
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 prepare for 
impending shortages, more effectively manage shortages when they occur, 
and minimize their impact on patient care.
  Just so you know, the FDA already does this with orphan drugs. When 
there is only one drug and the drug manufacturer thinks they are 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. You saw that happen with 
the H1N1 virus. When we had a short supply they went to other 
countries. They are allowed to do that now, but manufacturers are not 
required to do it in some of the situations we are encountering now 
with those 178 drug shortages. That is what our bill does. It basically 
says if you see a drug shortage coming down the pipe because one or a 
number of these factors is present, you have to let the FDA now know. 
You have to work with the FDA because they have successfully averted 
dozens of drug shortages this year.
  We do not pretend this is going to solve everything, but at least it 
is 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 person who is doing that is not the parent of a 4-year-
old kid with leukemia or a pharmacist who is trying to serve customers 
at his pharmacy, or a doctor trying to treat patients and she has to 
get on the phone and call a bunch of hospitals to try to find a drug. 
It simply does not 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 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. This 
would allow them to get inspected sooner so we can 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 2 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 it clear we must pass this bill in order to 
protect patients and ensure consumers they have access to the 
lifesaving medications they need and deserve. So the Executive order 
helps, but we still need to pass this bill.
  I understand this may be a short-term solution to a long-term 
problem. That is 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, Senator Corker, and Senator 
Burr. I also see Senator Blumenthal here, who has been working on this 
issue. We have Senators--including Senator Casey and others--working 
with the HELP 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 working 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, and 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 would solve all problems. A solution will 
require everyone involved to play a role in mitigating future drug 
shortages. We must ensure we have the manufacturing capabilities to 
keep up with demand. One solution may be to provide tax incentives to 
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 that which we give to manufacturers that make orphan 
drugs. In addition, I have urged the FDA to improve its communication 
with patients and providers. This will ensure patients and doctors are 
not the last to know when there is a shortage. I also favor permanent 
reimportation of drugs from safe countries, such as 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 would 
not have to look 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 the Presiding Officer, 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 is 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. It 
gives the FDA that little extra time, whether it is 1 month, 6 months, 
or 1 year, to look for the drug in other locations. I think it would 
give us some insight into what is actually going on here so we can fix 
this.
  I yield the floor.
  The PRESIDING OFFICER (Mr. Blumenthal). The Senator from Nebraska.

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