Briefing: Developing an Approval Pathway for Limited-Population Antibacterial Drugs
On July 28th, The Pew Charitable Trusts, the Infectious Diseases Society of America, and Trust for America’s Health co-sponsored a briefing with a panel of antibacterial drug experts and stakeholders to discuss the development of a limited-population antibacterial drug (LPAD) approval pathway. Bipartisan legislation has been approved by the House of Representatives and introduced in the Senate: the Promise for Antibiotics and Therapeutics for Health (PATH) Act, S. 185.
The LPAD pathway would enable the approval of new antibiotics that target serious or life-threatening drug-resistant infections in patients who have few or no suitable treatment options. LPAD could help bring critical new drugs to such patients, limiting their use to targeted populations while maintaining safety and efficacy standards and requiring post-market surveillance.
The briefing included presentations, discussion, and an interactive question-and-answer session.
- Janet Woodcock, MD, Director, FDA’s Center for Drug Evaluation and Research
- Helen Boucher, MD, Associate Professor, Tufts University School of Medicine; Member, IDSA Antimicrobial Resistance Committee
- Prabhavathi Fernandes, PhD, President and Chief Executive Officer, Cempra Pharmaceuticals
- Allan Coukell, Senior Director for Health Programs, the Pew Charitable Trusts (moderator)
- “The Need for New Antibiotics,” Helen Boucher, MD, FACP, FIDSA
- “How the PATH Act Can Rejuvenate Antibiotic R & D,” Prabhavathi Fernandes, PhD