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."
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