Opinion

FDA faces backlash over decision to regulate poop as a drug

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Beltway Confidential,Opinion,Health,FDA,Charles Hoskinson,Government Regulation

Last year, the Food and Drug Administration did something that's sparking a backlash in the medical community -- the agency decided to regulate human feces as a drug.

You heard that right: Poop is now a drug.

The rule was pushed out because of the growing promise — and use — of fecal transplants to fight dangerous bacterial infections in the intestine. Research indicates the procedure may have promise in treating other intestinal conditions such as Crohn's disease.

In the current issue of the journal Nature, researchers from the Massachusetts Institute of Technology and Brown University argue in a widely redistributed op-ed that the FDA's policy is complicating research into promising new uses for fecal transplants because of the time-consuming paperwork requirements needed for approval of new drug treatments.

"Reclassifying stool as a tissue product or giving it its own classification, as the FDA does for blood, would keep patients safe, ensure broad access and facilitate research," they write.

The FDA's drug approval process has been controversial for years, and has come under fire for being too slow and cumbersome, especially for over-the-counter products. It's probably not a good idea to allow something that every human body produces to get backed up by the same bureaucratic constipation when it's being used to save lives.

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