Incentivizing Antibiotic Development: Why Isn't the Generating Antibiotic Incentives Now (GAIN) Act Working?
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Updated: Dec 29, 2025

Antibiotic Dereplication Using the Antibiotic Resistance Platform
Published on: October 17, 2019
Jonathan J Darrow1, Aaron S Kesselheim1
1Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Abstract:
Antimicrobial resistance is of increasing global concern. To incentivize the creation of new treatments, the US Congress enacted the Generating Antibiotic Incentives Now Act (GAIN Act) of 2012, which provides benefits to manufacturers of Qualified Infectious Disease Products (QIDPs) including 5 years of additional nonpatent exclusivity. The results of this program have so far been disappointing, largely because QIDP eligibility criteria were not sufficiently targeted to unmet need. The time value of money also means that QIDP exclusivity disproportionately rewards modifications to existing drugs rather than the creation of new drugs. To improve the outlook, GAIN Act criteria should be limited to a more narrowly tailored list of qualifying pathogens to ensure that QIDPs offer clinical value not available from existing treatments. Additional options for improvement include greater reliance on animal data when determining QIDP eligibility and conditioning GAIN Act benefits on the availability of companion diagnostics.
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