IDSA Proposes New Pathway for Antibiotic Approval
The Infectious Diseases Society of America proposed the new pathway, called the "Special Population Limited Medical Use" mechanism, to provide a new approval option for companies interested in developing drugs to treat patients with serious infections where few or no treatment options exist.
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.
Related Articles on Antibiotics:
© Copyright ASC COMMUNICATIONS 2012. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.
To receive the latest hospital and health system business and legal news and analysis from Becker's Hospital Review, sign-up for the free Becker's Hospital Review E-weekly by clicking here.
New From Becker's Infection Control & Clinical Quality