乌鸦传媒

The FDA has to a company it says is selling fecal microbiota transplants (FMTs) in various forms -- including "capsules, enemas, and infusions" -- against agency regulations.

FDA sent the letter to Michael Harrop, founder of Human Microbes, saying that claims made on the company's website indicate that its products should be classified as drugs and biological products. Therefore, it would need an approved biologics license application (BLA) to market its treatments to patients, or would need an investigational new drug (IND) application to conduct research.

Particularly, FDA took issue with the fact that the site says that in addition to treating Clostridium difficile, FMT "has shown promising results in clinical trials" for other conditions including irritable bowel syndrome, inflammatory bowel disease, Parkinson's, fibromyalgia, chronic fatigue syndrome, multiple sclerosis, autism, diabetes, and mental health disorders.

It goes on to say FMT "may also have potential applications ... in obesity, autoimmunity, cardiovascular disease, cancer, and more," and that it also can "attenuate adverse effects" of antibiotics, according to the FDA's warning letter.

FDA also cites a titled, "We want your poop," which promotes FMT as a potential treatment for a long list of conditions, and refers to a patient who "cured her bipolar disorder" after an FMT.

Human Microbes offers products directly to patients and gives instructions for self-administering treatments, the warning letter stated, adding that its products "raise potential significant safety concerns due to inadequate donor screening."

A "donor results spreadsheet" available on the site reports adverse events including increased intestinal pain, nausea, sweating, and loss of appetite, FDA stated.

But Harrop takes issue with allegations about product quality. "We are by far the highest quality source of stool donors, and I have a long history of pushing for better donor standards," he told 乌鸦传媒 in an email.

In two on the Human Microbes website, Harrop wrote that he has "been getting extremely burned out screening so many people who don't qualify. It makes this feel like an incredibly useless endeavor."

The blog states that he has been "writing to hundreds of research groups" about donor quality, and expressed concern that no companies are willing to invest in finding a "super-donor."

Human Microbes has received more than a million applicants and still hasn't found one ideal donor, he wrote.

"Out of all the hundreds of FMT clinical trials in recent years, I only recall one or two that went out of their way to try to find a highly effective donor," he added.

Harrop wrote that regulating FMT under an IND "seems poorly applicable to stool."

"Poop is not a drug and I am not developing a drug," he wrote. "I'm searching for people healthy enough to be stool donors. Researchers, doctors, clinical trials, etc., can then purchase stool from our donors."

He added in an email to 乌鸦传媒 that the company has "no limitations on who can purchase stool from our donors, nor for what purpose they can purchase for."

Harrop said he responded to FDA's warning letter, which was dated February 9, and that he hasn't yet heard back from the agency.

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