Antibiotic Incentive Bill Reintroduced: Industry Hopes for 2012 Enactment
This article was originally published in RPM Report
The bill focuses on particularly virulent, resistant pathogens and also includes priority review designations and review of FDA guidelines.
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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.
An effort to identify early biomarkers of antibiotic efficacy is turning toward patient assessments of drug activity. FDA and industry scientists are both participating in the biomarker effort. The attention to patient observations reflects a growing interest at FDA.
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.