Clinical and Regulatory Development of Antibiofilm Drugs: The Need, the Potential, and the Challenges - Antibiofilm Agents: From Diagnosis to Treatment and Prevention - page 461

David Livermore, the director of antibiotic resistance monitoring at the UK's
Health Protection Agency stated:
“So much of modern medicine —from gut surgery to cancer treatment to transplants—
depends on our ability to treat infection. If resistance destroys that ability then the whole
edifice of modern medicine crumbles.” (Stovall 2011 )

Also in 2011, the European Commission recognized the urgent need for a “new
business model” for the development of new antibiotics. This new model would
benefit from an unprecedented and collaborative effort between the government and
companies developing new antibiotics to combat antibiotic-resistant infections
(European Commission 2011 ).
In 2012, the US Congress reauthorized the Food and Drug Administration Safety
and Innovation Act (FDASIA) that contains new legislation entitled “Generating
Antibiotic Incentives Now” (GAIN) in its Title VIII (United States Senate Bill
S.3187 2012 ). This legislation provides new pathways to improve the speed of the
regulatory review process for new antibiotics with the potential to overcome
antibiotic-resistant infections and provides incentives to companies for their devel-
opment such as extending the period of market exclusivity within the USA.
Congress, by establishing the GAIN Act, has clearly demonstrated that develop-
ment of new antibiotic drugs to address antibiotic resistance is a critical priority.
A letter from the Infectious Disease Society of America (IDSA) written in
support of the GAIN Act (Infectious Disease Society of America 2011 ) stated that:
Antibiotic-resistant infections significantly increase both health care and societal costs and
hospital stays as demonstrated by an analysis of antibiotic-resistant infection data from a
study conducted at Chicago Cook County Hospital (Roberts et al. 2009 ). Extrapolating that
analysis nationwide, the authors concluded antibiotic-resistant infections cost the
U.S. health care system in excess of $20 billion annually, $35 billion in societal costs,
and more than 8 million additional days spent in the hospital. The cost to society of
antimicrobial resistant infections in terms of lives lost and the economy will only rise as
antimicrobial resistance continues to spread.
The urgent calls to action, as well as the global infectious crisis itself, have
continued to grow more desperate during 2013. The United Kingdom's Chief
Medical Officer, Dame Sally Davies, recommended that antibiotic-resistant bacte-
ria be “ ranked alongside terrorism and climate change on the list of critical risks

to the nation” (McCarthy 2013 ).
In September of 2013, the CDC announced in a 114-page report entitled
Antibiotic Resistance Threats in the United States, 2013 (CDC 2013 ) that in the
USA alone, over two million people become infected with antibiotic-resistant
bacteria each year and that at least 23,000 people die as a direct result of those
infections annually. The CDC stated that these estimates are “minimum estimates.”
While there are many unmet needs in health care today, there are none with more
far-reaching, potentially catastrophic consequences on a global

...

level, than

antibiotic-resistant infectious disease.
In light of so many urgent calls for (a) new mechanisms of action, (b) new
targets, and (c) new strategies to overcome infectious diseases, it is of great concern