Pharma Blog Watch

Superiority Trials for Antibiotics? (Eye on FDA)
In his blog, Mark Senak discusses an approvable letter sent last week by the FDA to Replidyne and Forest Labs for faropenem asking the companies to demonstrate the superiority, rather than non-inferiority, of the antibiotic. "In other words, the FDA was asking that the sponsors demonstrate that the new compound was better than the standard of treatment rather than equivalent. Safety issues were apparently not raised."

"Wouldn't it be unethical to take people with infections and give them a placebo? Remember Tuskegee? When you know people are infected, you treat them," he writes. "Did this signal a change in policy on the part of the agency? … Usually that kind of policy change involves at least an advisory committee meeting to discuss the matter."