Clinical and Regulatory Development of Antibiofilm Drugs: The Need, the Potential, and the Challenges - Antibiofilm Agents: From Diagnosis to Treatment and Prevention - page 466

In 2014, the Center for Biofilm Engineering at Montana State University is
taking the initiative to create the first opportunity to bring key industry, academic,
and regulatory stakeholders together. Together with FDA, they co-sponsored a
conference, “Biofilms, Medical Devices, and Anti-biofilm Technology: Challenges
and Opportunities” in the Washington, DC, area to create an opportunity for FDA
scientists and administrators to engage in dialog with members of the pharmaceu-
tical, industrial, and academic community. FDA's co-sponsorship of the conference
is a clear indication of the agency's increasing awareness of the need for engage-
ment, communication, and collaboration to solve the challenges of developing
standardized test methods and a regulatory path for antibiofilm agents.
Moving forward, the challenge for government agencies such as NIH, CDC, and
the scientific and medical communities at large will be the commitment of substan-
tial resources to the development of standardized evaluation procedures relevant to
(a) the role of biofilms in infections, (b) diagnosis of biofilm infections in patients,
and (c) evaluation of antibiofilm drug activity both clinically and in vitro. Such
methodology development will allow for a more clinically equivalent and efficient
comparison of diagnosis and treatment outcomes. It can be anticipated due to the
heterogeneous and obscure nature of biofilms that many new methods and pro-
cedures will be required.
7 Potentially Expedited Paths for Antibiofilm Agents
That Have Conventional Antimicrobial Activity
Professional organizations such as the Infectious Diseases Society of America
(IDSA) are actively lobbying Congress for the development of exceptions to
existing regulatory pathways to rapidly facilitate the development of drugs to
treat patients with severe and life-threatening infections. The IDSA is encouraging
the development of legislation providing for a new Limited Population
Antibacterial Drug (LPAD) approval mechanism and is further encouraging the
FDA, even in the absence of such legislation, to enact the LPAD mechanism under
its current statutory authority. From the perspective of the IDSA,
FDA has an essential role to play in ensuring that Americans have access to safe and
effective drugs. But, in so doing, the agency must ensure that the risks associated with
approving new products are appropriately balanced with the need to provide patients in
desperate need with access to beneficial products. To date, when it comes to antibiotics, and
particularly antibiotics needed to treat patients with the most serious bacterial infections,
FDA's benefit-risk equation has been out of balance.
LPAD will rebalance the benefit/risk equation and provide an important new approval
pathway option for companies interested in and able to develop antibacterial drugs that treat
the most serious infections where insufficient satisfactory therapeutic options currently
exist. At least 15 companies and 24 medical and public health organizations including the
American Medical Association (AMA) have lined up with IDSA in support of LPAD's
creation.