On April 28, 2022, the Peggy Lillis Foundation for C. diff Education and Advocacy sent an open letter, cosigned by Alliance for Aging Research, the Amputee Coalition, the Antibiotic Resistance Action Center, the Infectious Disease Society of America, NTM Info & Research, OpenBiome, the Partnership to Fight Infectious Disease, and the Sepsis Alliance to the Food and Drug Administration (FDA). The letter requests consideration by the agency for several critical aspects of the patient experience in order to improve processes for approving novel treatments for C. difficile infections (CDIs) that adequately address patient needs.
No new treatments for CDI have been approved since 2011. FDA has approved fecal microbiota transplants (FMTs) through enforcement discretion (a designation allowing physicians to prescribe the procedure at their discretion after acquiring informed consent), but access is still severely limited both in terms of insurance coverage and the availability of stool donors and facilities or providers to administer FMTs. Furthermore, endpoints in clinical trials of new CDI treatments do not often accurately or comprehensively reflect patient needs or the scope of CDI or rCDI.
In our letter, we have asked FDA to consider these key questions in their regulatory actions:
- What are the best endpoints for trials of treatments for CDI and rCDI?
- What are the socio-emotional impacts of rCDI?
- What are the societal implications of using broad-spectrum antibiotics where narrow-spectrum ones are available? How do we “cost” that in a consumer-based healthcare system?
As advocates for those who have suffered as a result of C. diff, it is our belief that FDA guidance and policy paradigms should be shifted to address both the unmet needs of CDI patients and the needs of the population at large in the face of antimicrobial resistance.
Read the full letter here.