Incentivizing Antibiotic Development: Why Isn’t the Generating Antibiotic Incentives Now (GAIN) Act Working?

The GAIN Act of 2012, designed to incentivize antibiotic development through 5 years of additional nonpatent exclusivity, has produced disappointing results because its eligibility criteria lack sufficient targeting to unmet clinical needs and disproportionately reward modifications to existing drugs over new treatments. The authors recommend narrowing QIDP eligibility criteria to a more targeted list of pathogens, greater use of animal data in eligibility determination, and conditioning benefits on companion diagnostic availability to improve the program’s effectiveness.