A new antibiotic approval pathway proposed by IDSA earlier this month has strong potential to be a game changer in antibiotic research and development (R&D), by providing an important new approval option for companies interested in developing drugs for serious infections with few or no existing treatment options. Interest on Capitol Hill is growing, and IDSA members can make a critical difference in the next few weeks by urging their representatives in Congress to support enactment of the proposal. (Email your senators and representatives now.)
IDSA submitted the new concept, the Special Population Limited Medical Use (SPLMU)* drug development pathway, in testimony to a U.S. House Energy and Commerce Health Subcommittee hearing on the Prescription Drug User Fee Act (PDUFA) reauthorization on March 8. Using the SPLMU mechanism, the drug's safety and effectiveness would be studied in substantially smaller, more rapid, and less expensive clinical trials than traditionally required. In return, the drug would be narrowly indicated for use in a small, specific population of patients for whom the benefits of the drug have been shown to outweigh the risks.
The designation, a special logo, a description of the population in which the drug is indicated, and the rationale for limiting use to that population would appear in the drug's labeling. The SPLMU mechanism would foster prudent use of anti-infective drugs to slow the rate at which resistance to the drugs develops. The proposal has received considerable media coverage, including from Reuters and outlets covering Capitol Hill.
On March 30, IDSA and Trust for America’s Health (TFAH) will hold a briefing in Washington, D.C., for congressional staff on the proposal and why it is so critical that it be included in legislation reauthorizing PDUFA. Speakers will include Janet Woodcock, MD, director of Center for Drug Evaluation and Research at the Food and Drug Administration; Brad Spellberg, MD, FIDSA, co-chair of IDSA’s Antimicrobial Availability Task Force; and Jeff Levi, PhD, TFAH’s executive director.
* Editor's Note (04/05/2012): The proposed new drug approval pathway is now known as the Limited Population Antibacterial Drug (LPAD) approval mechanism.
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