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November 2016
Year End Policy Forecast

LPAD: Congressional leaders recently announced a bipartisan deal to pursue enactment of the 21st Century Cures Act this year. This legislation includes the Limited Population Antibacterial Drug (LPAD) approval pathway. LPAD would provide an important new approval pathway for antibacterial drugs that treat patients with serious infections and where there exists an urgent unmet medical need. The bill also includes IDSA-championed provisions to speed the updating of antimicrobial susceptibility breakpoints and to support the next generation of biomedical researchers, including ID physician-scientists. Votes in the House and Senate are expected this week, and IDSA is urging all Members of Congress to support.

Federal Funding: IDSA is urging Congress to pass final funding bills for Fiscal Year (FY) 2017 during this calendar year, which provides the best opportunity to secure the strongest funding levels possible for ID priorities. Some congressional Republicans are advocating for a continuing resolution to level fund the government through March 2017.

Public Health Emergency Fund: IDSA continues to advocate for bipartisan legislation to establish a public health emergency fund to allow for a rapid response to emergencies, such as outbreaks of infectious diseases like Zika or Ebola, without the immediate need for congressional action. It is unclear whether this legislation will be able to advance this Congress, and further advocacy in 2017 and beyond may be needed.

Antimicrobial Susceptibility Test (AST) Devices: IDSA recently expressed support for a new draft FDA guidance encouraging the coordinated development of new antimicrobial drugs and AST devices. IDSA also offered additional policy recommendations to speed the availability of AST devices.

Global AMR: Following the United Nations (UN) high level meeting on antimicrobial resistance (AMR) in September, IDSA remains at the forefront of global AMR efforts. Theoklis Zaoutis, MD, represented IDSA on a World Health Organization (WHO) panel to highlight World Antibiotics Awareness Week, November 14-20.

Drug Shortages: Several IDSA members have expressed deep concerns with persisting anti-infective drug shortages at their institutions. IDSA asked the Emerging Infections Network (EIN) to conduct a survey to quantify the scope of this problem. The survey found that despite congressional and FDA action since 2012, drug shortages persist and are negatively impacting patient care—including causing many ID physicians to prescribe broader spectrum antibiotics than would be optimal. IDSA is sharing these data with policymakers and stakeholders and exploring potential policy solutions. IDSA will continue advocating for new policies to address this serious issue.

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