To: US Food and Drug Administration, Blood, Vaccines and Other Biologics Advisory Committee, Rep. Ander Crenshaw, Co-Chair, Crohn's and Colitis Caucus, and Rep. Jim Moran, Co-Chair, Crohn's and Colitis Caucus

FDA: Give IBD Patients Access to FMT

Please urge the FDA to approve fecal microbial transplantation (FMT) for patients with inflammatory bowel diseases like Crohn's disease and ulcerative colitis. These painful, debilitating diseases can be safely and effectively treated with FMT.

Why is this important?

Inflammatory bowel diseases (IBD) such as Crohn's disease and ulcerative colitis are painful, often debilitating diseases that can seriously impact patients' quality of life, and IBD affects 1.4 million Americans. IBD can also be very difficult to treat. There are few medication options, and those medications can cause side effects from headaches and hair loss to dangerously low white and red blood cell counts, liver toxicity, lymphoma, and even death. Even on these potent drugs, many patients can't achieve remission.

Fecal microbial transplant (FMT) is a treatment option with very few side effects, and numerous studies have demonstrated its effectiveness in treating IBD. Unfortunately, the FDA recently classified fecal matter as a drug and a biologic agent. Now IBD patients can only get FMT through clinical trials, which most patients don't have access to.

IBD patients need access to FMT, a safe and effective treatment that could drastically improve many lives. Please urge the FDA to allow IBD patients access to FMT.