There is a consensus among the U.S. government, industry and the medical community that the failure of antibiotic development to keep pace with the evolution of bacterial pathogens constitutes a public health crisis, and that new regulatory policies and economic incentives are needed to create a continuous stream of new antibacterial products.

The Generating Antibiotics Incentives Now (GAIN) Act, which came into effect on Oct. 1, is a building block for creating some of the changes that will be needed to get antibiotic drug development back on track. And political changes have allowed FDA to begin shifting its risk-benefit calculus.