Antibiotic Development: HHS Not Yet Sold On ‘Pull’ Incentives
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.
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A study of drug approvals over more than three decades shows antimicrobials, including antibacterials, had consistently shorter development and review times than other types of products. While antibacterials were less likely to participate in special US FDA programs designed to help along review, experts said reimbursement reform, not new regulatory flexibility, is needed to help address the crisis of drug-resistant infections.
US House looks to give BARDA more money for antibiotic development in next coronavirus relief bill, while Medicare broadens the types of antibiotics eligible for additional payments to include drugs approved under FDA's limited population antibiotic development pathway. But it's unclear whether the House funding can make it through the Senate and how meaningful the Medicare provision will be given few LPAD approvals.
Upcoming White House report on antibiotic incentives will provide a strong endorsement of one-time payments to reward successful development of new therapeutics. That is a mixed blessing for advocates for legislative action for incentives who are focusing on 'wildcard' patents.