Organizations Call on FDA To Help Address Recurrent C Difficile Burdens

A coalition of 9 health care organizations, including the Peggy Lillis Foundation and the Infectious Disease Society of America (IDSA), recently penned an open letter to the US Food and Drug Administration (FDA) urging the agency’s increased involvement in the development of necessary recurrent Clostridioides difficile infection (rCDI) treatments and preventatives for the at-need US patient population.

The letter included on FDA commissioner Robert M. Califf, MD, and his team to additionally become more engaged with the rCDI patient community, noting that “current standard of care treatment does not meet the needs of patients with C diff and worsen rCDI.”

“No new treatment options have been approved for C diff since 2011,” the letter continued. “And no first-line treatment has been approved to specifically address the significant unmet need for the approximately 100,000 Americans who battle a recurrent C diff infection each year.”

In an interview with HCPLive regarding the letter, Christian Lillis, executive director of the Peggy Lillis Foundation for C. Diff Education & Advocacy, discussed how federal agencies including the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) have increasingly prioritized C difficile antimicrobial treatment development and stewardship—while the FDA has been seen as a “missing piece.”

“We’ve seen what they could do during COVID-19,” Lillis said. “If they want to prioritize developing drugs for particular things, then they can put that out there, grease the wheels, so to speak.”

Conversely, patients with rCDI have struggled during the pandemic to access their physicians and receive fecal microbe transplant (FMT) care in lieu of dwindling antibiotic therapy options. “But really the key point of it is we want the FDA to engage with this community—with survivors, with family members—because that’s not something they’ve done historically,” Lillis said.

Lilli additionally discussed the 2 currently available options for rCDI: antimicrobials and FMT—a pair of options limited by development. He expressed hope for developing microbiome therapies, of which 2 agents will likely be decided upon by the FDA for marketing later this year.

“I hope that more than 1 (is approved), because we’ll find one works better in certain populations than others,” Lillis said. “But in both cases, we have antimicrobials, which are not a profitable part of health care, and so it’s very difficult to get companies to invest in the development.”