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December 2014
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Progress Continues on Several Antimicrobial Resistance Advocacy Fronts

Senate Introduces PATH Act

IDSA’s 10-year effort to spur the development of new antibiotics took another step forward this month when Sens. Michael Bennet (D-CO) and Orrin Hatch (R-UT) introduced the Promise for Antibiotics and Therapeutics for Health (PATH) Act in the U.S. Senate. The bill would establish the Limited Population Antibacterial Drug (LPAD) approval mechanism for drugs to treat serious or life-threatening infections where there is an unmet medical need. IDSA supports this important bill, as well companion legislation in the House. Many IDSA members have been extremely helpful to the Society over the years in developing and advocating for the LPAD concept.  

IDSA Leads Stakeholders In Support of Stewardship as a Condition of Participation in Medicare


In a letter to the Centers for Medicare & Medicaid Services (CMS), IDSA’s U.S. Stakeholder Forum on Antimicrobial Resistance (S-FAR), and other organizations advocated that hospitals and long-term care facilities be required to implement an antibiotic stewardship program as a condition of participation in Medicare and Medicaid.  CMS is known to be actively considering the proposal.  The recommendation was also made by the President's Council of Advisors on Science and Technology (PCAST) in their recent report on combatting antibiotic-resistant bacteria.

IDSA Participates in Two-Day FDA Meeting on Antibiotics


The U.S. Food and Drug Administration (FDA) recently held a two-day meeting of the Anti-Infective Drugs Advisory Committee (AIDAC) to discuss streamlined clinical trial designs for anti-bacterial products meeting an unmet medical need and to consider recommending approval of ceftazidime-avibactam for the indication of complicated intra-abdominal infections and complicated urinary tract infections.

Jason Newland, MD, member of the IDSA Antimicrobial Resistance Committee (ARC) presented to the committee on behalf of IDSA and PIDS. His presentation outlined IDSA priorities for antibacterial product development policies and included his own patient stories. The committee also considered a series of questions posed by FDA relating to streamlined trial designs. The committee’s input will be used to inform finalization of the FDA’s draft guidance on streamlined development programs and clinical trial designs, including for pathogen-specific antibacterials. In general, the panel supported the concept of streamlined trials for these drugs and understood the reasons why trials for multi-drug resistance organism (MDRO) indications are a particular challenge. Panel members stressed, however, that the FDA must retain significant flexibility to tailor trial requirements based on the severity of medical need.

IDSA staff Amanda Jezek presented to the committee during the December 5 open public comment section on the urgent need for new antibiotics.  The committee subsequently voted in favor of two indications for ceftazidime-avibactam; for complicated intra-abdominal infections (CIAI, 11-1) and for complicated urinary tract infections (CUTI, 9-3).  However, the committee rejected the idea of approving the drug for other indications (including hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia and bacteremia) when limited or no alternative treatments are available, citing the fact that the drug sponsor Cerexa did not submit human data for these indications. The committee also raised concerns about labeling, particularly for patients with renal impairment.



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