This article was originally published in RPM Report
The drug safety/user fee bill working its way through Congress has some surprising benefits for antibiotic drug developers, and a voucher scheme to let companies developing drugs for tropical diseases earn the right to faster FDA reviews for more commercially attractive products.
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The bill focuses on particularly virulent, resistant pathogens and also includes priority review designations and review of FDA guidelines.
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.
Starting in September, pharmaceutical companies will have the opportunity to buy the right to a faster FDA review on the open market. If it works, the priority review voucher program could revolutionize development of drugs for neglected diseases, while increasing the value of more traditional commercial products in the US.