Antibiotic Susceptibilty Re-labeling Increases FDA Susceptibility To New Political Challenges!
This article was originally published in RPM Report
Executive Summary
The FDA faces a difficult, legislatively-mandated requirement in the anti-infective area. It is charged with updating antibioitic susceptibility charts in labeling for all approved anti-infectives. That is a huge task -- almost equivalent to re-reviewing the large cadre of existing antibiotic drugs. To try to achieve the task, the agency has proposed trusting an outside standards group for help. That sounds like a practical solution; but Capitol Hill has political problems.