FDA's superior attitude

An application by Oscient Pharmaceuticals Corp. to market Factive gemifloxacin for the treatment of acute bacterial sinusitis has become the battleground for a long-simmering debate within FDA and the infectious disease community about the acceptability of non-inferiority trials for the indication.

At last week's meeting of the Anti-Infective Advisory Committee, FDA officials pressed the case for superiority trials. They said sponsors and the medical community have known for almost three years that a demonstration of superiority is required to gain approval of an ABS indication...