Duke-Margolis Center for Health Policy Webinar: “Improving Regulatory Practices to Sustain Antibiotic Innovation”

Thought leaders from the U.S. government, the healthcare sector, and the investment community joined in a discussion that outlined the regulatory hurdles which compound issues facing antimicrobial drug developers already navigating poor underlying marketplace fundamentals. The regulatory approval process has led to a status quo that encourages an overreliance on older, broad-spectrum antibiotics, when newer options may be more appropriate; these circumstances contribute to antimicrobial resistance. Among the key recommendations, panelists suggested that efforts to achieve regulatory harmonization be guided by patient safety and global access, encouraged drug and diagnostic companies to interact with regulators during development phases to agree on expectations and preempt common challenges, and advised prioritizing antibiotics for pediatric patients—a population that sees a 5- to 10-year lag behind initial adult approvals.

Read a policy summary and watch the webinar here. 




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