Council pushes rapid diagnostics, diagnostic stewardship and stronger incentives to revive antibiotic pipeline
June 24, 2026 | Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS), Executive, Federal
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Council debate on Goals 3 and 4 centered on rapid diagnostics, diagnostic stewardship, and the economics of antibiotic research and manufacturing.
Dr. Robin Patel argued that the most useful diagnostics are those that quickly tell clinicians whether a patient needs an antibiotic and which agent to use; she urged HHS to support regulatory pathways, implementation‑science studies and appropriate reimbursement for high‑value diagnostic tests. "The question we should be answering for them is, do they need an antibiotic? And if they need an antibiotic, which antibiotic," she said.
Members also championed AI and genomic tools to integrate surveillance and electronic medical record data so clinicians receive context‑specific, rapid guidance at the point of care. Dr. Julia Szymczak and others emphasized that implementation science is needed after approval so new tests are used effectively and do not generate misleading signals.
On therapeutics, Dr. Lynn Marks and several members urged whole‑of‑government action to address economic barriers that have hollowed the antibiotic pipeline. Henry Skinner (AMR Action Fund) described how underinvestment, thin clinical development and manufacturing constraints have reduced pipeline quality and warned that incentive mechanisms such as the PASTEUR Act will be essential to sustain R&D and equitable access. Speakers called for workforce investments to keep chemists, microbiologists and clinical specialists needed for drug and diagnostic development.
Members asked agencies to align post‑approval requirements, reduce duplicative burden where feasible and consider models to strengthen domestic manufacturing resilience while maintaining affordability.
Dr. Robin Patel argued that the most useful diagnostics are those that quickly tell clinicians whether a patient needs an antibiotic and which agent to use; she urged HHS to support regulatory pathways, implementation‑science studies and appropriate reimbursement for high‑value diagnostic tests. "The question we should be answering for them is, do they need an antibiotic? And if they need an antibiotic, which antibiotic," she said.
Members also championed AI and genomic tools to integrate surveillance and electronic medical record data so clinicians receive context‑specific, rapid guidance at the point of care. Dr. Julia Szymczak and others emphasized that implementation science is needed after approval so new tests are used effectively and do not generate misleading signals.
On therapeutics, Dr. Lynn Marks and several members urged whole‑of‑government action to address economic barriers that have hollowed the antibiotic pipeline. Henry Skinner (AMR Action Fund) described how underinvestment, thin clinical development and manufacturing constraints have reduced pipeline quality and warned that incentive mechanisms such as the PASTEUR Act will be essential to sustain R&D and equitable access. Speakers called for workforce investments to keep chemists, microbiologists and clinical specialists needed for drug and diagnostic development.
Members asked agencies to align post‑approval requirements, reduce duplicative burden where feasible and consider models to strengthen domestic manufacturing resilience while maintaining affordability.
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