FDA to ponder the fecal transplant

Are fecal microbiome transplants safe and effective? That’s been thrown into question, as news of the first reported patient death from the procedure was reported just this week.

But that very issue is up for debate in an FDA meeting this coming Monday — in which regulators will hear new evidence about the procedure and weigh its merits. Such therapies, after all, are inching closer to market, STAT’s Kate Sheridan writes — so issues of how donors are screened, and how drugs made with fecal microbiota are regulated, will likely be discussed. The recently reported patient death, however, didn't make the agenda.