Antibiotics: Leveraging Off-Label Efficacy Data Needed To Drive Appropriate Use, Reimbursement

 
• By Sue Sutter
  
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Clinicians and sponsors want the US FDA to open up antibacterial labeling to include more data on efficacy against resistant pathogens and in other body sites, but regulatory restrictions may require a workaround in the form of rapid, peer-to-peer communications about the data on new products.

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Infectious disease specialists want more data in antibacterial product labeling about efficacy against resistant pathogens. • Source: Shutterstock

Clinicians and product sponsors want to be able to leverage off-label efficacy data for antibacterial drugs. However, the answer may lie not so much in broadening the label’s scope but, rather, in the development of rapid, peer-to-peer critiques of such data to help guide clinical use, stakeholders suggested at a recent US Food and Drug Administration workshop on antibacterial drug development.

At a meeting cosponsored by the Infectious Diseases Society of America, National Institutes of Health and Pew Charitable Trusts, clinicians...

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