House and Senate members announced a bipartisan agreement on the Food and Drug Administration Safety and Innovation Act earlier this week, including language to address the dry antibiotic research and development pipeline and bring new antibiotics to the U.S. market, according to a news release from the Infectious Diseases Society of America.
The FDA Safety and Innovation Act includes several provisions, including tax credits for research and development for antibiotics (which will bring these drugs into parity with orphan drugs), public-private collaborations, and the "limited population antibacterial drug" mechanism to streamline FDA approval. The act also calls for a review of antimicrobial stewardship programs, which are critical to protect antibiotics against the rapid development of resistance.
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The FDA Safety and Innovation Act includes several provisions, including tax credits for research and development for antibiotics (which will bring these drugs into parity with orphan drugs), public-private collaborations, and the "limited population antibacterial drug" mechanism to streamline FDA approval. The act also calls for a review of antimicrobial stewardship programs, which are critical to protect antibiotics against the rapid development of resistance.
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