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Regulatory Focus™ > News Articles > Fear of Disease's Deadly Potential Leads to Regulatory Science Initiative

Fear of Disease's Deadly Potential Leads to Regulatory Science Initiative

Posted 07 November 2012 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) plans to hold a meeting on the regulatory science issues surrounding the development of antibiotics to treat Burkholderia pseudomallei -a dangerous gram-negative bacterial pathogen capable of killing a high percentage of those it infects.

FDA is holding the workshop with a number of other agencies-most of which are military-related-in the hopes of developing classes of products known generally as medical countermeasures (MCMs). Such development is usually not done in response to a current threat, but rather in advance of one occurring or under the expectation that one might occur.

What makes Burkholderia pseudomallei so dangerous, regulators write, is that it is often deadly, highly contagious, requires lengthy courses of antibiotics to rid the body of the bacteria and has a relatively high (6%) rate of recurrence during the year after antibiotic treatment.

"In addition to the public health threat posed by naturally occurring infections, B. pseudomallei has been determined to pose a material threat sufficient to affect the United States' national security," added regulators. "Because of the lengthy antibiotic therapy required to treat melioidosis and glanders and the suboptimal clinical outcomes, lack of vaccines, possible biothreat applications, and public health implications, there is significant interest in developing new MCMs as well as improved animal models to evaluate candidate MCMs for these diseases."

Similar development programs have already been used to develop treatments for anthrax, and FDA is in the process of developing treatments of mass casualty burn events and scenarios to plan for the protection of the US' blood supply during an emergency.

But, as with other recent initiatives, FDA's actions are focused more generally on regulatory science.

The meeting's general purpose is to build, "On information presented at previous meetings and identifying future areas of research needed to advance animal model development and to advance candidate medical countermeasures (MCMs) for approval, licensure, or clearance."

Like FDA's models to develop anthrax vaccines, the agency said it will consider the availability of relevant animal models to show safety and efficacy, the ability of agencies to stockpile MCMs or diagnostic tests, and the regulatory considerations of development and approval.

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