FDAnews Drug Daily Bulletin

FDA Urges Congress to Re-Evaluate GAIN Act to Address Unmet Antibacterial Needs

Feb. 12, 2018

The FDA urged lawmakers to revisit the Generating Antibiotic Incentives Now (GAIN) Act of 2012 and promote antibacterial drug development, in a report submitted to Congress.

The report, required under the Food and Drug Administration Safety and Innovation Act, recommended Congress consider altering the law to increase its focus on promoting development of novel antibacterial and antifungal drugs.

GAIN’s effect on the unmet need for antibacterial and antifungal drugs remains unclear, according to the report. Numerous qualified infectious disease product designations have been granted in the past five

years, suggesting the program is often used by antibacterial sponsors, but it is too early to determine whether products taking advantage of GAIN also address unmet patient needs, the agency said.

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