USA – GAO: Pathway for antimicrobial drug development leads to few approvals

A regulatory pathway to encourage development of drugs to combat antimicrobial resistant infections – the limited population pathway for antibacterial and antifungal drugs (LPAD) – has resulted in just two drug approvals by the US Food and Drug Administration (FDA) since 2016, according to a new report from the Government Accountability Office (GAO).

The GAO report, released on 19 November 2021, suggested that the LPAD pathway does not address the underlying economic challenges in developing antimicrobial drugs for limited populations, namely that the sales revenue is insufficient to cover the drug development costs.

GAO reiterated its recommendation from a March 2020 report that HHS develop a strategy to spur the development of new treatments for antibiotic-resistant infections by using postmarket financial incentives that include rewards for market entry or reimbursement reform. HHS did not agree with the recommendation at the time, noting that it was conducting its own analysis for an upcoming strategic framework.

“We maintain that it is important that HHS not delay the development of such a strategic framework, which would be the initial step toward the creation of these incentives. As of June 2021, the agency indicated that it was still examining the issue and this recommendation had not been implemented,” GAO officials wrote…