All Pain, No GAIN: Need for Prudent Antimicrobial Use Provisions to Complement the GAIN Act

Abstract

Once every five years, Congress re-authorizes funding for the FDA under PDUFA. In the current PDUFA legislation, Congress also addressed issues relating to antimicrobial resistance in the Generating Antibiotic Incentives Now (GAIN) Act. This short article critiques the absence of antimicrobial stewardship incentives in the GAIN Act, which is a serious error in the long-term struggle with pathogenic microbes.

Keywords: new antibiotics, Prescription Drug User Fee Act V, PDUFA V, The Generating Antibiotic Incentives Now Act, GAIN Act, antimicrobial resistance, antimicrobial stewardship incentives

JEL Classification: I18, I19, K32