The thorniest regulatory problem in antibiotic drug development isn’t necessarily that the approval bar at the Food & Drug Administration is getting higher, but the fact that FDA has yet to establish formal guidelines on the process. The resulting "catch-as-catch can" regulation, executives say, makes it exceedingly difficult to develop new drugs.
FDA has been developing a series of antibiotic guidance documents for at least five years. Since November 2002, five documents on various topics have been near completion: resistant pathogens; bacterial...