FDA proposes subscription model to prod antibiotic development

FDA Commissioner Scott Gottlieb, MD, recently unveiled the agency's 5-year initiative to fight drug-resistant bacteria, including a hospital "drug subscription" plan that seeks to reduce the costs and risks of developing new antimicrobials by pharmaceutical companies.

FDA Commissioner Scott Gottlieb, MD, recently unveiled the agency's 5-year initiative to fight drug-resistant bacteria, including a hospital "drug subscription" plan that seeks to reduce the costs and risks of developing new antimicrobials by pharmaceutical companies. The plan also entails promoting antimicrobial stewardship, enhancing antimicrobial resistance surveillance, and improving regulatory science. Speaking at a meeting at the Pew Charitable Trusts in Washington, DC, Gottlieb said sustaining "a strong antibiotic drug pipeline" is vital to combating antibiotic resistance, but antibiotic development is not profitable for most pharmaceutical companies. Part of the issue is drugs that treat multidrug-resistant pathogens are typically saved for times when less expensive first-line drugs are ineffective. Reimbursement reforms could potentially include milestone payments and licensing fees for companies that develop FDA-approved products with high economic and clinical value and efficacy against multidrug-resistant organisms. Other reimbursement approaches could include new technology add-on payments for certain new antibacterial medications that fill key patient and public health needs. FDA is working with agencies including CMS on these and other reimbursement approaches. FDA also released draft guidance this summer regarding the Limited Population Pathway for Antibacterial and Antifungal Drugs, which seeks to accelerate the development and approval of antibacterial medications to treat serious or potentially fatal infections in patient populations with unmet medical needs. "We're encouraged that we've already seen meaningful, early interest by innovators in potentially developing drugs under this new framework," Gottlieb said.