Biomedical Engineering Reference
In-Depth Information
numbers of patients will have unmet medical needs related to effective antibacterial drug
therapy. Therefore, it is important for the public health that new antibacterial drugs be
developed while also considering how best to ensure appropriate use.
To foster development of new antibacterial therapies for the treatment of serious bacterial
diseases, we are exploring approaches that may help streamline development programs for
antibacterial drugs, especially for drugs that could address an unmet medical need. As
recognized in FDA regulations for the evaluation of drugs intended to treat life-threatening
and severely debilitating illnesses.
“The Food and Drug Administration (FDA) has determined that it is appropriate to exercise
the broadest flexibility in applying the statutory standards, while preserving appropriate
guarantees for safety and effectiveness. These procedures reflect the recognition that
physicians and patients are generally willing to accept greater risks or side effects from
drugs that treat life-threatening and severely-debilitating illnesses, than they would accept
from drugs that treat less serious illnesses. These procedures also reflect the recognition that
the benefits of the drug need to be evaluated in the light of the severity of the disease being
treated” (ibid).
Despite the FDA's efforts to “exercise the broadest flexibility in applying the
statutory standards,” a regulatory pathway that specifically enables and facilitates
antibiofilm drug development remains to be defined.
5 Current Regulatory Path for Antibiofilm Agents
and Challenges for Development of an Antibiofilm-
Specific FDA Guidance
There are two types of categories of antibiofilm agents: (1) those with both
conventional antibacterial activity against planktonic bacteria and antibiofilm activ-
ity and (2) those with antibiofilm activity, but without potent conventional antimi-
crobial activity, an example of which may be certain biofilm dispersants. Under
current FDA guidances the two categories of agents are likely to face very different
regulatory hurdles (Figs.
1
and
2
). As of October 2013, the FDA has not yet granted
a label claim
related specifically to activity against biofilms
for either category of
agent, despite the fact that some antibacterial FDA-approved drugs have been
demonstrated in nonclinical studies to have antibiofilm activity and also indirectly
to be effective against infections related to biofilms (Bjarnsholt
2013
).
Importantly, agents in the first category (those that can achieve FDA approval
based on conventional antimicrobial activity) have a current, viable path to regu-
latory approval, as outlined in existing FDA guidances. This path is feasible
because in vitro, in vivo, and clinical antimicrobial efficacies can be evaluated
using a substantial body of existing standardized methodologies that are acceptable
and well known to the FDA. It can therefore be expected to result in the availability
of new drugs with antibiofilm activity to treat patients who are in dire need of new
treatment strategies. Thus while these new, innovative drugs can be granted label
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