By Deborah Cho
Last summer, the FDA reversed its previous decision that required researchers to file INDs for fecal transplants to treat Clostridium difficile. This decision came without much official explanation as to the reasoning behind the reversal, but can be understood as a result of the unusually high success rates of fecal transplants in treating the deadly infection and the impracticality of applying IND requirements to the procedure. As the FDA guidance notes, however, the agency’s “exercise of discretion regarding the IND requirements” affects only the use of fecal transplant to treat C. difficile and does not apply to the treatment of other diseases or conditions.
Despite the peculiarity of this type of treatment, researchers and patients alike seem to have embraced it for its ability to cure more than just life-threatening infections that have few other viable options. In fact, a physician in Seattle studied the effects of fecal transplants on inflammatory bowel disease. And, as it goes with many drugs, there even seem to be clinics claiming to use fecal transplants to treat weight loss.
These other uses of fecal transplants will undoubtedly lead to the manufacture of pills containing essential microbes that accomplish what fecal transplants are able to accomplish, but with better results. As the makers of these new drugs are developing them through FDA-approved studies, the resulting drugs will likely be willingly classified and regulated as biologics. Because of this, it will be difficult for the FDA to continue to allow unregulated fecal transplanting to continue, particularly once such drugs are also developed for the treatment of C. difficile, even if it is for the sake of saving lives. It will be hard to justify disparate treatment of the same product in different forms, and traditional fecal transplants will likely be driven out of the market if they do not show the same efficacy as the manufactured products.
The FDA will then be left in the position of forcing patients to accept highly costly but effective treatment for something that was once probably a fraction of the cost. Though this prospect leaves behind a sour taste, we run into similar justifications for the drug manufacturers that exist for the patent system – namely that beneficial innovation should be incentivized even if it comes at some cost. Regardless, if the FDA steps in and regulates fecal transplants, there will likely be backlash from the medical community as there was last summer because of the lifesaving ability of the treatment. This time, however, the FDA will likely be required to adhere to the appropriate definition and regulation of biologics.