FDA grapples with oversight of fecal transplants
“With so few providers available, proponents of stool transplantation have come up with innovative solutions. One big hurdle is the high cost of screening a stool sample, which can run up to $1,500 per sample. Insurance typically doesn’t cover testing the stool sample because donors are usually healthy without signs of sickness.
Since October 2013, a Boston-based “stool bank” has managed to bring costs down to about $250 per treatment by screening samples in bulk. To date, OpenBiome has shipped over 300 stool samples in ready-to-use frozen preparations to 39 hospitals.
But in March, the FDA released an updated proposal for regulating fecal transplants, saying doctors should only use stool from a donor who is “known” to either the patient or their physician. Some doctors and patients worried the proposal, if finalized, would shutter OpenBiome and a handful of other stool banks, which use anonymous donors and ship to providers hundreds of miles away.
But OpenBiome founder, Mark Smith, says his group continues operating after having several productive discussions with the FDA. Smith says regulators have encouraged him to set up a formal study in which hospitals that work with OpenBiome will contribute data on the safety and effectiveness of fecal transplants.”