[Congressional Record Volume 154, Number 154 (Friday, September 26, 2008)]
[Senate]
[Page S9638]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]


[[Page S9638]]
                    ANTIBIOTIC RESISTANT INFECTIONS

  Mr. BURR Mr. President, I rise today to speak about legislation 
passed by the Senate yesterday, S. 3560. Antibiotic resistant 
infections are a serious and growing threat to public health in the 
United States, and I am pleased that S. 3560 contains a provision to 
address this threat.
  The Institute of Medicine and the Infectious Disease Society of 
America, among others, have been warning us about antibiotic resistance 
for decades. We all know the therapeutics that work today against 
infections will be less effective over time as bacteria mutate into new 
resistant strains--and the pipeline of new antibiotics is nearly empty. 
My colleagues and I in Congress have been talking about the importance 
of developing new antibiotics for years, yet little has been done to 
create incentives to bring these anti-infectives to market.
  In 2000, Senator Kennedy stated on the Senate floor, ``We are in a 
race against time to find new antibiotics before microbes become 
resistant to those already in use.'' He could not have been more 
correct. That year, the Centers for Disease Control and Prevention 
estimated that methicillin-resistant Staphylococcus aureus, MRSA, was 
the cause of 126,000 hospitalizations in the United States. Today, that 
rate has tripled to nearly 400,000 hospitalizations per year and MRSA 
is the cause of an estimated 19,000 deaths every year.
  The number of MRSA infections in hospitals has increased 10-fold 
since 1993. The University of North Carolina hospital systems reported 
earlier this year that 55 percent of patients with skin infections had 
a resistant strain.
  Perhaps more frightening than hospital-acquired infections are those 
infections acquired in the community, including our elementary schools, 
athletic teams, and offices.
  These numbers are more than statistics. Every Senator in Congress has 
constituents who have been impacted by MRSA. These super bugs are 
attacking and in several cases, killing healthy children and adults.
  Earlier this year, six otherwise healthy high school football players 
at East Forsyth High School in Winston-Salem were diagnosed with MRSA. 
As the father of two boys who grew up in Winston-Salem and a former 
football player myself, this story hits close to home. Unfortunately, 
this outbreak was far from isolated.
  According to the National Institute for Allergy and Infectious 
Diseases, antimicrobial resistance is driving up health care costs, 
contributing to the severity of disease, and increasing death rates 
from certain infections. In 2003, the economic burden for staph aureus 
associated hospital stays in the United States was $14.5 billion.
  As you may know, many pharmaceutical companies are abandoning or 
scaling back antibiotic research and development in favor of more 
profitable drugs that treat chronic conditions. This is a regrettable, 
but understandable, development as market forces that would lead 
companies to consider investing in new antibiotic development are weak. 
Because antibiotics work so well and quickly in most cases, they are 
prescribed for only one or two weeks. That means antibiotics do not 
have as large a market as drugs that patients take for years. Bottom 
line--increasing the number of safe and effective antibiotics available 
in the United States is crucial to protecting the public health.
  Section 4 of S. 3560, entitled ``Incentives for the Development of 
and Access to Certain Antibiotics,'' is an important step forward to 
help spur research on new antibiotics and provide incentives for the 
creation of additional generic antibiotics.
  In the Food and Drug Administration Modernization Act of 1997, FDAMA, 
legislation I sponsored in the House, Congress moved antibiotics from 
section 507 to section 505 of the Food, Drug and Cosmetic Act because 
it did not make sense to have antibiotics separate from other drugs in 
the statue. Congress added language in FDAMA to ensure that antibiotics 
approved under section 507 would not be able to double dip on Hatch-
Waxman benefits due to their new status under section 505. Those 
benefits include 3-year and 5-year data exclusivity and patent term 
extension for drugs. The FDAMA language said that any application for 
an antibiotic that was submitted to the Secretary could not ``double 
dip.'' As a result, companies have no access to Hatch-Waxman incentives 
to develop drugs based on active ingredients of the old 507 antibiotics 
submitted to, but not approved by, the Food and Drug Administration, 
FDA.
  Equally important, the FDAMA language also negatively impacted 
generic drug companies' ability to gain approval of and market generic 
equivalents of antibiotics approved under section 507.
  Section 4 of S. 3560 says that any antibiotic that was the subject of 
an application submitted to the FDA, but not approved before FDAMA, can 
get the 3 year and/or 5 year Hatch-Waxman exclusivity or a patent term 
extension. According to the FDA, approximately 10 antibiotics fit this 
category of submitted but not approved and about half of those could 
never be approved because of issues with the active ingredients. 
According to a Congressional Research Service legal expert, the Patent 
Act would apply to this language, and it would be legally confusing if 
it did not mention the available Hatch-Waxman patent term extensions. 
For that reason, the provision authors added language providing the 
option of data exclusivity or a patent term extension.
  This provision also addresses the negative consequences of the FDAMA 
language on generic drugs. Section 4 of S. 3560 includes language 
clarifying the ability of generic drug companies to gain approval of 
and market generic equivalents of antibiotics approved under section 
507.
  This provision was included in Senate-passed S. 1082, the Food and 
Drug Administration Revitalization Act, and was agreed upon in Senate-
House conference negotiations. Due to a lack of funding in H.R. 3580, 
the Food and Drug Administration Amendments Act, the House pulled this 
provision before passage of H.R. 3580, Public Law 110-85.
  I commend Senators Baucus, Grassley, Kennedy, Enzi, and Brown for 
making antibiotic incentives a priority at this time. It is important 
to encourage more treatments for the increasing number of resistant 
microbes we face.

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