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IDSA Proposes New Pathway For Antibiotic Approval
Date:3/8/2012

WASHINGTON, March 8, 2012 /PRNewswire-USNewswire/ -- Congress will consider a new drug approval pathway to encourage development of critically needed, lifesaving antibiotics as part of a strategy to address the public health crisis of antibiotic resistance. The Infectious Diseases Society of America (IDSA) proposed the new pathway, the "Special Population Limited Medical Use (SPLMU)" mechanism, to provide an important new approval option for companies interested in developing drugs to treat patients with serious infections where few or no treatment options exist.

IDSA submitted the proposal to the House Energy and Commerce Committee Subcommittee on Health today during a hearing on the U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) reauthorization legislation. During the hearing, lawmakers will consider whether to incorporate within PDUFA pending legislation known as the Generating Antibiotic Incentives Now (GAIN) Act, which proposes incentives to address the dry antibiotic research and development (R&D) pipeline. PDUFA is considered one of the few must-pass bills this year in Congress.

"Antimicrobial resistance is unequivocally one of the world's greatest public health threats, and we've been sounding the alarm about it – and the lack of new antibiotics in development – for years," said Brad Spellberg, MD, co-chair of IDSA's Antimicrobial Availability Task Force. "This new mechanism provides the opportunity to address this public health crisis while there is still time to fix it."

The SPLMU mechanism streamlines the approval pathway and enab
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SOURCE Infectious Diseases Society of America (IDSA)
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