Trends and Considerations in Global Infectious Disease Drug Dev | Page 7

These FDA guidelines have been the cornerstone of controversy
between the FDA, the industry and Congress, slowing the development
of antimicrobial drugs. Congress has placed into the last two renewals
of the User Fee legislation the requirement that the FDA provide a
certain number of guidances, and mandated that the FDA provide a
new guidance for specific pathogens by July 2013. With these challenges
and a dearth of final, clear clinical trial guidelines for antimicrobials,

According to the Infections Disease
Society of America (ISDA), only

two new antibiotics
have been approved in the
US since

2009

investment in this therapeutic area has been viewed as too risky.
Industry and the Infectious Disease Society of America (IDSA)
have lobbied Congress to force the FDA to change its ways.
Resistant Bacteria
In contrast to other therapeutic areas, bacteria and other microbes
develop resistance to drugs. While antibiotics have saved the lives of
millions of people, the very use of potent antibiotics creates newer
resistant strains and fosters their spread. With ever-increasing multidrug resistance posing significant development challenges, there is a
major unmet medical need for new antibiotics without safety concerns
that target the microbe, not the disease. Through Congressional and
medical group pressure, the FDA and EMA are responding appropriately.

Figure 6. Challenges

to Successful Development:
Additional Costs of Antibiotic Resistant Bacteria 6

Worldwide, antimicrobial resistance is most evident in diarrheal
diseases, respiratory tract infections, meningitis, sexually transmitted
infections, and hospital- and healthcare-acquired infections.8 The
incidence of infection with multidrug resistant (MDR) gram-negative
bacteria is on the rise, particularly among patients in healthcare settings.
These infections are extremely difficult to treat, leading to increased
morbidity and mortality.8 Drug resistance is reaching crisis proportions
in the US and globally, challenging sponsors to continuously develop new
approaches to the treatment of infections. In the US, antibiotic resistance
costs an estimated $20 billion a year in excess healthcare costs, $35
million in other societal costs, and more than eight million additional
days that patients spend in the hospital.6
Resistant Viruses
In the US, four antiviral drugs are FDA-approved for use against influenza: amantadine & rimantadine, both approved for influenza A and zanamivir (Relenza®) and oseltamivir (Tamiflu®), approved for both influenza
A and influenza B. Resistance of influenza A viruses to antiviral drugs can
occur spontaneously or emerge during the course of antiviral treatment.
Most influenza viruses tested during 2011-2012 were susceptible to the
neuraminidase inhibitor antiviral drugs, but H1N1 and H3N2 resistance
to the adamantanes class of antiviral drugs remains widespread.9

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