FDA clenches down on fecal transplants

An effective cure for a brutal bacterial infection is gaining popularity, but there is a price to recognition: the FDA is clamping down on the procedure while researching it as an "investigational new drug." Now that doctors have to do a mountain of paperwork, will it result in a black market for backstreet blendastools?


  1. As often as they take it in the butt from big pharma, I’m surprised they can still clench at all.

  2. OK, first let’s point out exactly how this transfer takes place:

    “…followed by bowel lavage and subsequent infusion of a solution of donor feces through a nasoduodenal tube.” That’s through the nose, my friends – through the nose.

    And if that isn’t enough to put you off your kibble, the FDA clampdown will inevitably lead to the illegal international smuggling of foreign substitutes… that’s right, I’m talking about alien feces. Alien feces!

    1.  I imagine someone suffering from the gastrointestinal difficulties this is a cure for would find a poop tube down the nose the happier option.

  3. I don’t think there can be any question that this is a new drug requiring filing an Investigative New Drug Application and going through the usual process. 

    Yes, it’s not produced in a lab (let’s not get into the details of where the, er, material is produced), but as a biologic intended for the use in the mitigation or control of a disease, it’s a drug under the applicable statutory definitions. 

    The FDA’s process, including classifications as investigational new drugs, is intended to ensure that drugs are safe and effective. The linked article gives reasons why this is important. When patients are given fecal transplants that have not been properly screened for communicable diseases, that’s a safety issue. When there are some who “tout fecal transplants as a solution for everything from irritable bowel syndrome to obesity, despite a lack of supporting evidence,” that is an efficacy issue.

    The FDA isn’t issuing special regulations to make it more difficult to get fecal transplants approved–it is, instead, refusing to waive the existing regulations and requirements. Anyhow who expected the FDA to do otherwise were fooling themselves.

    1.  “touting fecal transplants as a solution” may be the FDAs business. but your claim is wrong – there CAN be question that it’s not a new drug. it’s not new, and it’s not a drug.

      1. Sorry, Jon, but under the legal structures of the Food, Drug, and Cosmetics Act (FDCA) and the Public Health Service Act, as well as under various FDA regulations, it’s a drug. Under the statutes, it’s also an unapproved new drug. The Investigational New Drug Application (IND) process is designed to give the FDA the data needed to determine if a drug is safe and effective. INDs are required for clinical trials and to allow the material to be legally shipped to doctors/hospitals.

        There is a procedure where INDs can be given to patients outside of clinical trials, but as the linked article says, the majority of C. diff cases are not emergencies and so the emergency use provision of the FDCA does not apply. There are other exceptions, such as a §561(b) Individual Patient IND or a Compassionate Use IND, but these do require paperwork the docs in the linked article are complaining about.

        If you’ll forgive the expression and the puns, you can’t just talk out of your ass when it comes to these sort of things. There is a legal and regulatory structure that goes beyond gut instinct and dictionary definitions. If you disagree with me, you’ll have to go beyond just saying that it’s not new and not a drug and explain how it is not a biologic regulated as a drug by the FDCA and PHSA.

    2. This is incorrect. The article specifically states that the FDA deliberately classified fecal transplants as a drug; if they had not done so, it would not have run afoul of any regulations or requirements. Thus the FDA has, in fact, issued a special regulation specifically to make it more difficult to get a fecal transplant.

      If a fecal transplant is a new drug, what is its chemical and biological makeup? Oh, right, that differs for every person and changes over time across a range that covers a vast array of foods and (at least) thousands of different bacteria. The FDA process might be *intended* to ensure that drugs are safe and effective, but it doesn’t work out that way. Not only does the FDA routinely let drugs slip through that are out-and-out dangerous (Vioxx, anyone?), but the FDA’s process usually makes the drug or procedure far more expensive and harder to get while the patients who need the procedure suffer and sometimes die.

      1. Sigh. Had you read the source material by following the links from the article to the American Gastroenterological Association’s (AGA) site to the FDA letter they link to, you’ll note that the FDA took a position that fecal microbiota were a drug under §201 of the FDCA and a biologic product under 351(i) of the Public Health Service Act. See http://highroadsolution.com/file_upload_2/files/fda+response+letter+to+fmt+inquiry.pdf
        The FDA did not issue any new regulations, instead, upon request from doctors from the AGA, they issued an interpretation of where fecal transplants falls into the existing statutes.

        Your complaint about the FDA processes is logically inconsistent. One can either complain that the process is too difficult or that the process is too lax, but it is absurd to claim both with the same sentence.

        Yes, sometimes dangerous drugs get through the system. And yes, the present system for drugs is difficult and expensive. But one can either make the system more difficult and expensive to try to lessen the risks of dangerous drugs getting through or one can loosen the costs and speed drugs through the process at the cost of more deaths and injuries from unsafe drugs. You don’t get to have it both ways.

        It takes about eight and a half years for a drug to get from conception to the shelf. About 1 in a thousand drugs make it to the human testing stage and of those, only about 1 in 5 make it to shelves. The general process goes from (1) discovery or conception of a drug; to (2) non-clinical animal testing to determine if the chemical has the intended effect, determine the toxic level, calculate what a safe human dosage might be, and figure out how the drug is metabolized and excreted by the body. The FDA only becomes involved at and after step 3: clinical trials with consenting subjects (well, consenting under most circumstances-I won’t go into exceptions here). Human testing requires approval from the FDA and usually some sort of institutional review as well. The first round of human testing is on healthy volunteers. The next round, if it makes it past the first, is testing on small groups of controlled patients. The last round is on large groups of patients not necessarily controlled in the environment in which the drug will be used.

        Should a drug make it to the final round, generally the FDA will require at least two adequate and well-controlled clinical studies that demonstrate efficacy and safety. Note that safety requires a risk/benefit analysis. Some drugs carry strong risks, but the risk of not using the drugs is higher.

        Even given the lengthy time it takes for a drug to get to market, once a drug is in the investigative new drug state (AKA past the animal testing and into human clinical trials, as I stated earlier, there are ways patients in need can get access to these drugs. First, in the event of a serious or immediately life-threatening condition, drugs in the clinical trial stage may be available with an emergency application to the FDA. Second, the FDA may give the okay to treat a patient if a drug in clinical trials has no comparable or satisfactory treatment. Third, early access may be made available if the drug’s sponsor is currently actively pursuing pre-market approval from the FDA (the last step to getting a drug on the shelf is pre-market approval).

        This isn’t meant to be the definitive word on the subject by any means, despite the length of my post, this is a mere primer, an introduction to the basic process. There are plenty of other aspects of the statutes and regulations to consider in the NDA and IND process.

        The tl;dr is (1) that the FDA did not issue any special regulations related to fecal transplants and merely issued interpretive guidance that under the existing statutes, fecal microbiota are drugs. (2) The system is not perfect, but you don’t to argue that the system needs to be made safer AND faster. You have to pick one. (3) The clinical test stages are important, but in the end, some dangers and side effects only become known once a drug is in use in the general population. Testing on large groups of patients not necessarily controlled in the environment in which the drugs will be used is the best final stage testing available, but it is not a perfect analogue to widespread general use and it cannot catch every danger or effect.

      1. The FDCA and related statutes is based on classifications and definitions. Some things fit into multiple definitions based on their nature, other things can fit into one or more definitions based on claims made by the manufacturer.

        Here, the product is an article “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.” That is the definition of a drug under §201(g)(1)(B) of the FDCA. It’s a broad definition, yes, but the FDCA is a broad statute. Hell, things like tongue depressors, patient gowns, bedpans, and the like fall under the definition of a medical device under the FDCA and are regulated as Class I medical devices.

        Boing Boing’s headline is misleading. The FDA didn’t clench down on fecal transplants, the FDA was asked a question: are fecal transplants drugs, and the FDA answered with the only reasonable response under existing statutes: yes.

  4. There is already a DIY culture that surrounds this practice. Especially for folks with C Dif, who can’t seem to get better. 

  5. Poop transplants are going to become a real shitstorm when they become more mainstream and less regulated. FDA does not have the legal authority to regulate the practice of the medicine, and the physician may prescribe a drug off-label – the FDA can only control advertising claims.

    I expect to soon see “celebrity poop” being marketed – either poop from celebrities or from people who have become celebrities because their poop is claimed to have superior healing power.

    1. > I expect to soon see “celebrity poop” being marketed

      A possible way forward for Lance Armstrong.  Isn’t life funny .. when one orifice closes, another one opens.

  6. So, if they classify poop as a drug, does that mean they can arrest anyone who’s holding? Meaning: anyone with intestines?

  7. Having had C. Diff and was seriously considering having this done, it seems similar in concept to a bone marrow transplant. From my cursory research, you have a better chance of having a successful transplant if it comes from a relative. If you go to doctors who know what they’re doing, the donor goes through a battery of tests to determine if they have any diseases that could potentially be passed on. So yes it needs to be regulated. Does it need to be classified as a drug rather than a transplant procedure? I don’t know how they classify things, so maybe it was the only way they could do it. Technically you’re not receiving human tissue but bacteria and fungi that live in the human gut. I would hate to think that someone who is already in a compromised immune situation receiving  a donation from a random person who hasn’t been screened. However, given the research and documentation of success and any side effects from the ones that have been done, they could get proper guidelines and procedures in place quickly. 

  8. Doctors were looking at this many decades ago…you’ll find an amusing anecdote about it in the book “The Making of a Surgeon” by William Nolan if my mind isn’t failing me.

    Should help show “prior art” if someone tries to patent it too.

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