The FDA has moved forward with its guidance on developing drugs for treating diabetic foot infections, finalizing it last week with no revisions despite a number of notable comments from stakeholders.

The 20-page guidance takes a straightforward approach, providing both general drug development considerations and advice for phase 3 efficacy trials, the latter of which covers significant ground, including trial design, population, eligibility criteria, randomization and blinding, among many other topics.

The guidance, however, is notably devoid of diversity considerations for specific ethnicities, such as Hispanic, Indigenous and Black patients, despite public comments cautioning the agency on this area, merely recommending that trial populations include patients with diabetes mellitus and a bacterial foot infection “located at or distal to the malleoli.”

Hispanics and Indigenous patients, for instance, are more likely to experience wound ulcerations, while Black patients are more likely to undergo amputation as a result of diabetic foot infection, the National Center for Health Research (NHCR) claimed in its feedback to the FDA.

“Together, these data reflect discrepancies in treatment response, prognosis, and definitive management among diabetic patients with foot infections,” the center said. “NCHR strongly recommends that the FDA include diversity as part of its drug development population criteria. It is imperative that novel antibiotic medications are tested across a heterogeneous diabetic patient population to fully understand the applications and limitations of their use across the entire diabetic population.

The group also challenged the agency’s decision to recommend noninferiority trials, contending that novel antibiotics should have to show superiority to standard antibiotic treatment to ensure clinical benefit and avoid building public antimicrobial resistance.

Access the final guidance here.

Access the public comments here.