Antibiotic Development Incentive Menu: Options Getting Longer
This article was originally published in RPM Report
Congress continues to look at ways to stimulate more research on anti-infectives. The list of potential incentives gets longer each time another drug category wins a new form of incentive. None of the ideas has succeeded yet in coalescing a political consensus; but potential legislative vehicles are out there.
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The bill focuses on particularly virulent, resistant pathogens and also includes priority review designations and review of FDA guidelines.
FDA’s effort to create a clearer path for antibiotic development has produced a series of new guidance documents. Those guidances are making some products in development look well-positioned for regulatory review, and rekindling the interest on Wall Street in specialty antibiotic firms.
FDA got a chance to show off its ability to stimulate antibiotic development during an advisory committee review of a new cephalosporin from Forest Labs. In the past, the agency has been faulted for failing to set clear targets for anti-infective trials; with ceftaroline, the agency went to the other extreme, stepping in to support an application with key re-analyses of data.