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August 1, 2018

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IDSA Urges Strong Implementation of LPAD Pathway

FDA has issued draft guidance for implementing the Limited Population Antibacterial and Antifungal Drug (LPAD) Pathway, which is well aligned with the legislation enacted in 2016, spearheaded by IDSA, to establish this new pathway. IDSA has provided recommendations to FDA to optimize its use.

The limited population pathway is essential to strengthening our antibiotic pipeline because many of the deadliest infections with the fewest treatment options now occur in relatively smaller numbers of people, which makes traditional, large-scale clinical trials infeasible. Further, new antibiotics effective against the most difficult to treat pathogens should be used only in the patients who truly need them to protect their utility against the development of resistance. The limited population pathway addresses both challenges and, if utilized, can help bring to market some of the most urgently needed new antibiotics and promote their appropriate use.

IDSA is raising the following key issues with FDA to strengthen the ability of the limited population pathway to bring new antibiotics to market with urgently needed indications.

Flexible trial designs: Given the many complex challenges inherent in studying new antibiotics for use against multidrug resistant pathogens, flexible trial designs will be critically important.

Labeling and monitoring: LPAD offers important opportunities to promote and monitor appropriate antibiotic use via the statutory labeling and monitoring requirements. By approving a new antibiotic for a traditional indication and not a limited population indication, the FDA may essentially forfeit these important stewardship opportunities.

Package Insert Language: FDA should consider offering more flexibility in the package insert language for drugs and studies meeting the LPAD criteria but not necessarily meeting FDA indications for approval in that disease syndrome. Package insert language informs clinical decision making and governs a company’s communications regarding its products. Even if a company cannot achieve a limited population indication for a new antibiotic, IDSA recommends the company still be able to share its study data from use of the new drug in patients with resistant infections. Given our extremely limited antibiotic arsenal, additional data that could inform how a new antibiotic may perform in a patient with a difficult to treat infection would be very useful.

IDSA will continue working with FDA and other federal agencies and Congress to spur antibiotic research and development, promote ID physician-led stewardship, and advance additional strategies to combat antimicrobial resistance.

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