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 cautious use of the drug to slow the rate of resistance.
IDSA submitted the proposal to the House Energy and Commerce Committee Subcommittee on Health during a March 8 hearing on the U.S. Food and Drug Administration Prescription Drug User Fee Act reauthorization legislation.
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