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GAO Finds That Pathway for Approving Antibacterial and Antifungal Drugs is Infrequently Used

Antibiotic- and antifungal-resistant infections pose a serious public health issue. Yet there may not be a sufficient number of drugs in development to meet this threat.

It is estimated that at least 2.8 million antibacterial and antifungal-resistant infections occur each year in the United States, and more than 35,000 people die as a result, according to the Centers for Disease Control and Prevention. 

The development of new antibacterial and antifungal treatments is one strategy to address the threat of antimicrobial resistance. The Food and Drug Administration (FDA) can use its limited population pathway process for antibacterial and antifungal drugs (LPAD) to approve antibacterial and antifungal drugs for rare, serious or life-threatening infections. It doesn’t change FDA’s approval process, but does offer tools to help FDA accept greater risk and uncertainty when approving such drugs with potential benefits to treat resistant infections. FDA has approved two drugs this way since 2016, including one that treats highly drug-resistant tuberculosis.

During a Government Accountability Office (GAO) review, FDA and stakeholders agreed that LPAD’s effect on the drug pipeline could be limited because the pathway does not address the economic challenges facing the development of these products. For example, according to stakeholders, given the limited market for such drugs, sales revenue can be insufficient to cover development costs, making it difficult for companies to survive in the antibacterial and antifungal drug market. 

In March 2020, GAO reported on similar challenges and recommended that the Department of Health and Human Services (HHS) develop a strategy to further incentivize the development of new treatments for antibiotic-resistant infections, including the use of post-market financial incentives, which could include rewards for market entry or reimbursement reform. HHS did not concur with this recommendation, and as of June 2021, the agency indicated that it was still examining the issue and this recommendation had not been implemented.

Read the full report at GAO

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