The FDA is holding a public hearing on the use of fecal microbiota transfer (FMT) to treat a bacterial infection. Are they paving the way to hand FMT to Big Pharma? Action Alert!
The FDA announced a public meeting for November 4 of this year. The stated purpose of the meeting is to gather scientific information regarding the use of FMT to treat Clostridium difficile (C. diff) infections that are resistant to standard therapies. This follows the recent death of an immune-compromised patient who received FMT contaminated with drug-resistant E. coli. We fear that the FDA will use this tragedy to turn FMT into a drug, turning an inexpensive treatment into a pharmaceutical money maker.
We previously reported that the FDA is in the process of deciding how to regulate FMT. The agency can decide either to treat FMT as a drug, or more along the lines of donated organs or blood, which are covered under the Public Health Service Act (PHS). We argued that, as long as the safety of FMT can be ensured by regulation solely under PHS, this is the path the FDA must pursue to ensure that consumers can continue to access this treatment affordably.
It seems reasonable to assume that basic screening of fecal samples can ensure the safety of FMT. Donated blood, for example, is screened for a variety of infectious disease pathogens before it can be used by patients. A similar regimen should be devised for FMT to ensure that contaminated samples are not given to sick patients.
Given the FDA’s history, however, we fear that the agency will use this recent death to turn FMT into a drug. There are precedents for this: the agency has allowed a number of natural medicines, like CBD oil and l-glutamine, to be turned into expensive drugs.
The FDA acted similarly in its approach towards compounding pharmacies. Recall that Congress passed a law in 2013 after dozens of patients were killed by contaminated medicines from one compounding facility (to which the FDA had sent several warning letters but never followed up). The FDA took this opportunity to go beyond Congressional intent in an attempt to regulate compounding pharmacies out of existence. To justify these actions, the FDA has said that the safety and quality of compounded medicines cannot be guaranteed because they aren’t FDA approved.
Our fear is that the FDA will use similar logic to turn FMT into a drug. They will argue that the safety and efficacy of FMT can only be guaranteed through FDA drug approval, thus turning human poop into an expensive drug—never mind the fact that FDA approved drugs kill about 128,000 people a year and cause 1.9 million hospitalizations.
C.diff sickens 50,000 Americans each year and kills 30,000. FMT has an 80% success rate treating C. diff, with some patients requiring just a single dose. Beyond C. diff, there are vast applications for using FMT to treat illness. It is being studied for a wide variety of indications, including ulcerative colitis, Crohn’s Disease, Parkinson’s disease, multiple sclerosis, childhood regressive autism, metabolic disorders, diabetes, and others. FMT could lead to the next generation of medicines that utilize the trillions of microbes living within us to heal.
To protect FMT, we must tell the FDA not to turn it into a drug.
Action Alert! Write to the FDA, with a copy to Congress, urging the agency not to treat FMT like a drug. Please send your message immediately.