Comment on antibiotic development incentives to fight superbugs

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In yesterday’s Dispatch, we discussed the introduction of a bill called Generating Antibiotic Incentives Now, which seeks to provide financial and other incentives for pharmaceutical companies to invest in the development of new antibiotics to combat drug-resistant bacteria (superbugs). National Institute of Statistical Sciences Assistant Director of Bioinformatics and ACSH Advisor Stan Young, Ph.D., MES, commented on the regulatory hurdles that have hindered the antibiotic development process:

FDA is actively making it harder to clear a new antibiotic. New antibiotics have to beat a marketed drug, not just a placebo. I listened in disbelief at an FDA presentation in Shanghai. I pressed the point with the speaker, and she stood by her statement.


ACSH's Dr. Josh Bloom, who co-invented the antibiotic Tygacil, agrees based on his own antibiotic research experience. “Dr. Young is correct. Tygacil almost didn't get approved because Wyeth had to show it was BETTER than Vancomycin. It was better or equal in a few selected infections, so the FDA approved it, but the approval process had to be dropped and restarted several times. Such overly precautionary policies are what discourages drug companies from even trying to develop new drugs that won’t be used for long-term therapy.”