Incentives for Change: Addressing the Challenges in Antibacterial Drug Development

As part of an ongoing cooperative agreement with the U.S. Food and Drug Administration (FDA), the Engelberg Center for Health Care Reform at Brookings has formed the Brookings Council on Antibacterial Drug Development (BCADD) to identify steps to address the major technical, regulatory, and financial barriers impeding antibacterial drug development. At the first meeting of the BCADD, stakeholders emphasized the importance of concentrating on discrete policy and program areas to revitalize the antibacterial drug development enterprise.

BCADD convened a diverse group of stakeholders, including FDA officials, industry and biotech representatives, payers, providers, clinicians, and academic researchers Wednesday, February 27, 2013, to discuss two of the economic challenges facing antibacterial drug development:

• Better understanding the potential role of incentives in drug discovery and development; and
• Identifying potential reimbursement models that can support both stewardship and expanded investment for antibacterial drug products.

Antibacterial development has moved slower than other therapeutic areas in part due to the challenges of achieving a return on investment under the current reimbursement system. New models are needed to incentivize research and development of antibacterial products and to separate reimbursement from unit sales in order to help preserve the effectiveness of existing and new antibacterial drugs. The workshop’s objectives are to support the development of pragmatic proposals for the larger stakeholder community to consider.