Published on
Monday, November 19, 2012
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.