New drug approval pathway to encourage development of critically needed, lifesaving antibiotics

 "Special Population Limited Medical Use" mechanism provides drug development incentives

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 enables pharmaceutical companies to study SPLMU drugs in far fewer patients than currently is required, more rapidly, and at significantly less cost – because they are intended for more targeted use within a special population of patients who lack other treatment options. SPLMU designation reserves a drug for use in specific populations in which the benefits outweigh the risks, and encourages prudent use of the drug to slow the rate of resistance.

"The proposed SPLMU drug approval mechanism will bring critically needed innovation to the anti-infective pipeline, encouraging antibiotic development and lowering the hurdles to getting these critically needed drugs to patients who desperately need them," said Robert Guidos, vice president of public policy and government relations at IDSA. "In addition, we've designed it to foster antimicrobial stewardship, so these drugs will be used only when appropriate, extending their lifesaving power."

SOURCE Infectious Diseases Society of America (IDSA)