The FDA would like to hear your thoughts on poop transplants
The Food and Drug Administration will be reexamining its approach for fecal microbiome transplants — again. The agency said yesterday that it will hold its second public workshop about the transplants.
The announcement comes less than three months after the FDA announced someone died due to drug-resistant bacteria thought to have been included in a fecal transplant. At the time, the agency also recommended new screening procedures for would-be donors.
Technically, just one indication, recurrent C. difficile infection, will be discussed at the workshop, which is happening on Nov. 4. But among the questions the FDA hopes to answer is how FMTs’ availability may affect the development of drugs targeting the same infection — an issue that the field has been considering for a long time.
The announcement comes less than three months after the FDA announced someone died due to drug-resistant bacteria thought to have been included in a fecal transplant. At the time, the agency also recommended new screening procedures for would-be donors.
Technically, just one indication, recurrent C. difficile infection, will be discussed at the workshop, which is happening on Nov. 4. But among the questions the FDA hopes to answer is how FMTs’ availability may affect the development of drugs targeting the same infection — an issue that the field has been considering for a long time.
If you’re planning to go to the meeting, STAT’s Kate Sheridan would love to know.
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