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# Change Antibiotic Development Incentives: Study
- URL: https://www.fdaweb.com/change-antibiotic-development-incentives-study/
- Published: 2022-12-13T12:00:00.000Z
- Updated: 2026-09-14T18:09:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153388

Harvard Medical School researchers say policymakers should consider new incentives for developing new antibiotics since many new antibiotics developed in the last five years lacked efficacy evidence on clinical endpoints. Writing in an open-source *BMJ* article, the researchers [say](https://bmjmedicine.bmj.com/content/1/1/e000227?ref=fdaweb.com) most antibiotics introduced in the U.S. between 2016 and 2019 were approved by FDA based on trials with a non-inferiority design that evaluated changes in surrogate outcome measures. “These new antibiotics were often found to be non-inferior and more costly than the older effective comparator drugs,” the researchers write.

They say policymakers should take these trends into account when considering new incentives for developing antibiotics. “Incentives for the development of antibiotics should balance the need for a strong antibiotic development pipeline with ensuring that new drugs show added value for patients by, for example, improving patient outcomes in patients with antimicrobial-resistant infections,” the researchers conclude.