FDA under pressure to relax drug rules

Industry says antibiotic pipeline is being blocked by overly stringent clinical-trial requirements for new treatments.

Nature: December 04, 2012

The latest skirmish in the battle between human and microbe played out on 29 November in a hotel conference room in Silver Spring, Maryland. There, an assembly of scientists and clinicians debated the merits of an experimental antibiotic. For some, the coveted prize was not just an endorsement of the drug itself, but a sign that the US Food and Drug Administration (FDA) is finally ready to rethink its clinical-trial requirements for antibiotics — requirements that the drug industry says are unrealistic.

The number of FDA approvals of new antibiotics has dropped even as multi-drug-resistant strains of bacteria have proliferated. FDA advisers at last week’s meeting did recommend approval of telavancin (Vibativ) — a derivative of vanco mycin — for the treatment of hospital-acquired pneumonia when alternative drugs are not suitable. But that vote came nearly two years after the FDA had rejected the drug for a second time because clinical data did not measure up to the agency’s guidelines. Read more