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September 2016
POLICY AND ADVOCACY
Advocacy for New Antibiotics and Policies to Combat AMR Continues
In addition to the historic United Nations meeting this month, IDSA participated in numerous other meetings and events to advocate for sound public policy on antimicrobial resistance. 
 
Improving Regulatory Climate for Antibiotic R&D 

IDSA held a meeting with Janet Woodcock, Director of the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), to discuss next steps for advancing policies to make it more feasible to conduct clinical trials for new antibiotics that address unmet medical needs. The meeting was a follow-up to an FDA workshop in July entitled: “Facilitating Antibacterial Drug Development for Patients with Unmet Need and Developing Antibacterial Drugs that Target a Single Species.” Discussion covered the scientific challenges pertaining to such development programs, including enrollment challenges, clinical trial designs and trial population. Also in September, the FDA, European Medicines Agency (EMA) and Pharmaceuticals and Medical Devices Agency-Japan (PMDA) issued a promising tripartite agreement regarding regulatory approaches for the evaluation of new antibiotics, which stressed the appropriateness of accepting greater degrees of uncertainty (i.e., smaller clinical trials) for new antibiotics that address an unmet need, the usefulness of other types of supplemental data in addition to clinical trials, and the importance of establishing clinical trials networks. 
 
IDSA Congressional Briefing 
 
IDSA co-hosted a congressional briefing in September with the Antimicrobials Working Group (AWG), a coalition of small pharmaceutical companies, to educate congressional staff about the need for new antibiotics, economic incentives, and feasible regulatory policies. IDSA board member Chip Chambers, MD, FIDSA, gave the clinician’s perspective on these issues, joining a panel featuring a sepsis patient, the CEO of Melinta Therapeutics, and an economist from the Duke-Margolis Center for Health Policy. 

Presidential Advisory Council Meeting 
 
The Presidential Advisory Council on Combating Antibiotic Resistant Bacteria (PACCARB) held a public meeting (PDF) also in September focused on antibiotic stewardship and infection prevention. IDSA Treasurer Helen Boucher, MD, FIDSA, and IDSA Diagnostics Task Force Chair Angela Caliendo, MD, FIDSA, serve on the PACCARB. The PACCARB, at the request of Health and Human Services Secretary Sylvia Burwell, will consider recommendations regarding prioritizing resources to combat antibiotic resistance. IDSA staff provided public comments at the meeting about the importance of a One Health multi-pronged approach to resistance that includes stewardship, infection control and prevention, surveillance and data collection, research, and innovation.


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