FDA Antibiotic Legislation Should Focus On Criteria, Not Bacteria, Woodcock Says

Congress should allow the agency to determine which drug-resistant bacteria sponsors should target in order to earn incentives for antibiotic development, rather than list specific pathogens, CDER Director Janet Woodcock suggested to a House panel March 8. The window to change the GAIN Act appears to be closing, though.

FDA wants to select the pathogens for drug developers to target in order to receive incentives for developing antibiotics to treat drug-resistant bacteria.

“Because antibiotic resistance evolves rapidly in this dynamic field” and many organisms are involved, CDER Director Janet Woodcock suggested to a House panel March 8 that Congress “set up some general criteria and then have FDA designate

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