Antibiotic Development: ‘Wildcard Exclusivity’ Proposal Returns
Economic ‘pull’ incentives that don’t require direct government spending draw support from industry and academic stakeholders.
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As HHS develops strategic framework to combat antibiotic resistance, post-market financial incentives may not be included, despite prominent government panels recommending the idea years ago and GAO urging the department to do so in a just-released report. Stakeholders told that GAO reimbursement reform won't be enough to spur a strong antibiotic pipeline.
It's too early to say whether program is working, FDA tell Congress; agency has awarded 147 QIDP designations, but none of 12 approved antibacterals have new mechanism of action.
The Pink Sheet spoke with CEOs of antibiotic firm Zavante and antifungal specialist Amplyx as well as a BARDA official during a roundtable discussion at the recent BIO convention about what's needed to boost antimicrobial drug development, including "push" and "pull" incentives for drug makers.