[Congressional Record (Bound Edition), Volume 153 (2007), Part 8]
[Senate]
[Pages 11354-11356]
[From the U.S. Government Publishing Office, www.gpo.gov]




             HATCH AMENDMENT ON ANTIBIOTICS AND ENANTIOMERS

  Mr. HATCH. Mr. President, I would like to discuss the amendment which 
deals with antibiotics and enantiomers, which is included in the 
managers' package we are adopting today.
  I offered this amendment at the HELP Committee markup, but withdrew 
it with assurances that we would work it out prior to floor action. 
There have been constructive discussions among all interested parties 
and I believe we have worked language out that is acceptable.
  There is a great urgency to this situation, and I want to make 
certain my colleagues understand it fully.
  The Infectious Diseases Society of America, the Alliance for Aging 
Research, the Institute of Medicine, the Resources for the Future, the 
Centers for Disease Control, and many others have been sounding the 
alarm about the growing threat from resistant microorganisms and the 
need for innovation in the area of antibiotics.
  Congress must listen.
  Nobel Laureate Joshua Lederberg said it well:

       We are running out of bullets for dealing with a number of 
     (bacterial) infections. Patients are dying because we no 
     longer in many cases have antibiotics that work.

  The Hatch amendment is intended to be an initial step in the fight 
against these resistant strains of bacteria by increasing incentives 
and innovation.
  Additionally, the language in the amendment requests FDA to work with 
companies to apply the Orphan Drug Act to antibiotics wherever 
possible. Hand-in-hand with this, it reauthorizes the Orphan Drug Act 
grant and contracts from fiscal years 2008 through 2012. As many of my 
colleagues know, this act has resulted in important medicines for rare 
diseases.
  The Hatch amendment also ensures that currently existing incentives 
for new drugs are available for new single enantiomers in new 
therapeutic areas such as Alzheimer's, cancer, and type II diabetes 
among others. In 1997, FDA issued a Federal Register notice 
acknowledging that the policy needed clarification and this amendment 
would do that.
  Let me start with the issue of antibiotics and the need for new 
antibiotics to fight drug-resistant infections. Many of us have become 
more and more concerned that there is an alarming increase in the 
number of drug-resistant infections--many of them serious--and we are 
running out of treatment options.
  My first chart is based on data from the Centers for Disease Control 
and Prevention and shows how resistant strains of infections have 
spread rapidly from 1980 to 2000. My colleagues, this is a very 
alarming trend and sadly, for all of us, the problem of resistance 
continues to grow.
  A report many of us are familiar with, Bad Bugs, No Drugs, from the 
Infectious Diseases Society of America, IDSA, highlights the lack of 
R&D for new antibiotics.
  Antibiotics are not profitable compared to medications that treat 
chronic conditions and lifestyle issues. Also, antibiotics are taken 
for short periods of time--unlike medications for chronic disease which 
may be taken daily.
  And, when a new antibiotic comes on the market, it is discouraged 
from use to avoid the development of resistance. As a result, it is 
fair to say that major pharmaceutical companies have not been making 
significant investments in antibiotics.
  Given that there are few, if any, antibiotics in the drug development 
pipeline, if Congress fails to act, we walk blindly into a future where 
we must fear basic infections we have long taken for granted are not a 
problem.
  Medicine changed dramatically when penicillin was discovered and 
physicians had a tool to treat deadly infections.
  Can any of my colleagues imagine life without penicillin? I am sorry 
to inform you, we are about there.
  Over the years, many infections became resistant to penicillin, but 
we were OK--we moved on to the next antibiotic. We had methicillin--and 
now serious infections are resistant to that.

[[Page 11355]]

  We should consider what the health professionals are telling us. Will 
we listen? We are taking antibiotics and our ability to treat bacterial 
infections for granted.
  Infectious disease doctors from all over the country have been 
writing to their Senators to express their support for my amendment. 
They tell heart-wrenching stories.
  Dr. Helen Boucher, a physician at Tufts Medical Center in Boston, MA, 
wrote to tell Congress that patients are routinely lost ``to infections 
caused by resistant bacteria for which we have few to no options. 
[They] recently lost two bone marrow transplant recipients who survived 
all the chemo but died of multiply-resistant gram negative infections. 
In both cases, [physicians] pulled an old antibiotic off the shelf and 
gave it as a last resort, knowing how toxic it was but having NO other 
options for these young people. . . .''
  She wrote:

       As a doc and an American, it's horrifying to know that few 
     to no companies are investing even in discovery of new 
     antibiotics for these infections . . . just this week [she] 
     was presented a case of a previously completely healthy 33 
     year-old lady who presented to the hospital in Boston with 
     pneumonia and died within 6 hours from community-acquired 
     MRSA. Her story and so many others that we see ALL the time, 
     make the need for new and powerful options to treat these 
     infections critical.

  Community-acquired MRSA is an infection that was historically 
acquired while in the hospital, but now is impacting young, healthy 
people. We have heard stories of high school, college and professional 
athletes losing their lives or careers as a result of these infections. 
Sadly, this infection has become far too common, difficult to treat and 
has few options to fight it. It can leave individuals disfigured, if 
they survive.
  In my own State of Utah, the number of children with MRSA infections 
at the Primary Children's Medical Center in Salt Lake City has 
dramatically increased since 1989.
  Dr. Andy Pavia of Salt Lake City told me that he ``cared for a 2 
month old girl who developed MRSA pneumonia and almost died as a 
complication of an otherwise mild respiratory infection. She survived 
and will be going home to her parents, but only after 2 weeks of the 
most sophisticated intensive care and an additional 4 weeks of 
intravenous antibiotics.''
  Dr. Pavia went on to explain that the Primary Children's Medical 
Center sees the impact of resistant bacteria almost every day.
  In fact, he wrote:

       Last week a two year old girl [who] was weeks away from 
     being cured of Burkitt's lymphoma developed shock due to a 
     bloodstream infection with a highly resistant strain of a 
     gram-negative bacteria. Fortunately, the bacteria was 
     sensitive to one remaining antibiotic. If it had been 
     resistant, she would not have left the Pediatric ICU alive.

  The doctor related that MRSA is an aggressive, difficult to treat, 
form of staph that has spread rapidly within communities. Half of the 
children he sees with severe MRSA infections acquired their infection 
at home.
  This is a picture of Bryce, whose family tells a similar story. He 
had his first cold 2 days before Christmas. Before then, 14-month-old 
Bryce Smith had never been sick. At 2 a.m. on New Year's Day, his 
parents took him to the emergency room, where the seriousness of their 
son's condition became immediately apparent.
  An X-ray showed that Bryce had pneumonia. A CT scan showed that his 
right lung was filled with fluid. Four hours after arriving at the ER, 
Bryce was scheduled for surgery. Doctors found that a methicillin-
resistant staph infection had eaten a hole through his lung.
  For the first 12 days that Bryce was in the hospital, the doctors 
didn't know whether he would live. Doctors battled to force air into 
the child's lungs, but as they told his mom, it was like trying to pump 
air into a brick.
  Doctors prescribed high levels of antibiotics, including vancomycin, 
in a desperate battle to fight the infections. For 6 weeks, the child 
did not wake up. During Bryce's stay in the hospital, he has suffered 
from several additional infections. Bryce is doing much better now, he 
was released from the hospital, but he still must relearn how to walk. 
His recovery could take several months. As of April 2007, the Smiths' 
total bill for Bryce's care is just under $1 million.
  Fortunately, the family's insurance does not have a ceiling on 
payments; otherwise, the Smiths say they would be in financial ruin. 
Bryce's ongoing care needs are decreasing, but he still has regular 
visits with the pulmonologist, nephrologist, and his pediatrician. He 
still tires out easily with exertion.
  The fact that children acquire this infection at home is significant 
because we used to only worry about it in the hospital.
  Last month, there were numerous articles about CDC's concern that 
cases of resistant gonorrhea have dramatically increased and respond to 
only one antibiotic.
  There has been much concern over the past couple months related to 
extensively-drug resistant--XDR-TB. Right now, there is a man in 
Phoenix, AZ, whom authorities took action to isolate in order to avoid 
the spread of the deadly XDR-TB infection he had contracted while out 
of the country.
  This comes in addition to the numerous reports of our soldiers coming 
home from Iraq with Acinetobactor--a resistant infection that is 
especially difficult to treat and the only option is a very toxic 
antibiotic.
  One doctor we have heard from, in a local community, indicated he has 
seen two patients just this month with infections resistant to every 
antibiotic currently available.
  That is becoming a common occurrence.
  Infectious disease specialists can do little more than provide 
supportive care for those unfortunate patients. Without any new 
antibiotics in the pharmaceutical pipeline, there is no promise of a 
treatment for years to come.
  Whatever we do to begin to address this serious concern, we can't 
hope to realize the benefit for more than a decade. Drug development 
takes time and money. Yet few companies are willing to invest either in 
the area of antibiotics.
  I believe this chart shows that is the case. As you can see from this 
chart, the number of new antibacterial agents that have actually been 
approved is minimal. The market forces don't work well for antibiotics. 
When we cannot rely on the market, government has an obligation to step 
in.
  The Hatch amendment focuses on incentives for research and 
development of antibiotics. Specifically, my amendment: Provides 
equitable treatment for so-called ``old'' antibiotics; promotes 
communication and education of current law orphan drug incentives by 
directing FDA to convene a public meeting to clarify what ``bad bugs'' 
may qualify for orphan designation; reauthorizes the Orphan Drug grants 
and contracts program which expired September 30, and requires FDA to 
establish, update and make publicly available information on antibiotic 
breakpoints. This is important to assure that the antibiotics we and 
our children take are effective against bacterial infections and 
minimize the progression of resistance.
  Antimicrobial resistance is a public health crisis. In many ways, it 
is even bigger than drug safety, a point our colleague, Dr. Coburn, 
made at the HELP mark up.
  This is an issue that touches not just the old or the young, but all 
Americans throughout every walk of life. Antibiotics are as precious a 
natural resource as water is to a vibrant and healthy community and, 
guess what, the creek is drying up. The Hatch amendment only takes the 
first steps to address these issues.
  If we cannot work together on these more minor provisions, how will 
we truly combat antimicrobial resistance? What will we say to the 
children, soldiers, athletes, elderly and so many others that contract 
these deadly diseases which only years before were successfully treated 
with antibiotics? Are we really willing to walk away and leave nothing 
in our arsenal to fight these bad bugs?
  I would like to turn my attention now to a provision in the Hatch 
amendment which encourages innovation in

[[Page 11356]]

another area. This provision provides for 5-year exclusivity for 
enantiomers of previously approved racemic drugs in different 
therapeutic areas based on new data.
  Enantiomers are mirror images of the same drug. You can think of them 
as left-handed and right-handed molecules. We now understand that, in 
some cases, these enantiomers have very different activity and safety 
profiles.
  In simplest terms, imagine the biological target is a glove that fits 
one hand better than the other. When Hatch-Waxman was passed 
originally, we didn't contemplate the isolation of one enantiomer from 
an approved drug made up of a mixture of enantiomers and its 
development for a new use based on all new data.
  But today that is exactly what is happening. Sponsors are finding new 
important uses for enantiomers of drugs previously approved as a 
mixture of enantiomers.
  Where FDA is requiring all new data for approval of these single 
enantiomers and will not allow a company to rely on any of the data 
submitted in the original application for the mixture of enantiomers, 
these single enantiomers are effectively new chemical entities and 
should be entitled to 5-year exclusivity.
  In 1997, in a Federal Register notice, FDA laid out the issue, 
acknowledging the lack of clarity in the law regarding 5-year 
exclusivity for enantiomers and the need to incentivize this type of 
development. FDA requested comments but never finalized a policy.
  The Hatch amendment makes it clear that development of an enantiomer 
for new use in a new therapeutic area based on new data would qualify 
for 5-year exclusivity. However, in order to address the potential for 
abuse the revised provision limits 5-year exclusivity to approvals in a 
new therapeutic class.
  As this chart states, innovation and development of enantiomers may 
provide treatments in cancer, Alzheimer's disease, type II diabetes. 
When it comes to FDA, we need to get it right.
  I feel we have done a lot of good with this bill, and I voted for it 
in committee with the understanding the issues I raised on antibiotics 
and enantiomers would be addressed before we reached final passage. I 
am glad that, as of yesterday afternoon, we have worked out all 
remaining concerns and I believe the chairman's commitment at the 
markup has been honored.
  I know that some were concerned about this amendment, specifically 
because its incentives provisions were fueled by exclusivity. With all 
due respect, I understand the importance of the generic drug industry. 
We spoke earlier about the need to get it right for follow-on 
biologics.
  But we should listen to the public health associations, who 
understand the need to support innovation. Indeed, the Alliance for 
Aging Research, Infectious Diseases Society of America, National 
Organization of Rare Disorders, and Immune Deficiency Foundation are 
dedicated to advocating for patients and doctors and improving public 
health in this country, and they fully support this amendment in its 
entirety.
  The Infectious Diseases Society of America represents doctors that 
see the threat of resistant bugs every day. They recognize the need for 
innovation in their therapeutic area.
  This isn't different than 10 years ago when the American Academy of 
Pediatrics argued passionately for the need for innovation in pediatric 
research. Some may not remember that the generic drug industry opposed 
that provision saying that innovation was not necessary.
  In contrast, I am pleased that we have achieved an agreement today 
that recognizes the need for this innovation in research involving 
antibiotics and enantiomers.
  Ten years ago, Congress passed the last major piece of FDA 
legislation, the Food and Drug Administration Modernization Act, or 
FDAMA.
  Those of us who were here then recall ever-so-vividly the infamous 
chart of the feet displayed with great effectiveness by our colleague 
Senator Kennedy.
  I hasten to say many have had recurring nightmares about the horror 
of these feet. The Senator and his very bright staff were ever-so-
clever in their effective use of this chart. Today, I hope to have the 
same effect, although I do not wish to spawn a new generation of 
nightmares.
  I submit to my colleagues, that if we had adequate antibiotics in 
development, we never would have had to look at these diseased feet. 
With passage of my amendment today, perhaps this chart can be relegated 
to the Russell attic forever.
  In closing, I thank my colleagues for recognizing that antimicrobial 
resistance is not a brand issue or a generic issue. Effective treatment 
for Alzheimer's, cancer, or type II diabetes is not a brand issue or a 
generic issue. These are public health issues.
  I urge my colleagues to take these issues seriously and appreciate 
that we have joined together and not let these serious concerns fall 
subject to politics as usual. These are growing problems and require 
attention before it is too late.
  We need to make sure that innovation is encouraged in these areas and 
high scientific standards are maintained and the Hatch amendment does 
just that.
  The PRESIDING OFFICER (Mr. Webb). The Senator from Ohio is 
recognized.

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