Should Fecal Microbiota Transplants (FMT) be regulated as drugs or tissue donation? This question has stirred a lengthy discussion over the past years. Ever since the FDA has had challenges is deciding whether to regulate the FMT as a drug or an organ donation (4). FMT is used to treat Clostridium difficile infections, which causes diarrhea or life-threatening inflammation of the colon. Regulating FMT either as a drug or tissue donor has a significant impact in terms on both the patients and those that can benefit from its use (3). FMT should be regulated as a tissue donation with appropriate access for patients, and more information is collected to make its use more effective and safe.
Regulating FMT as a tissue donor will make it cheaper for patients to obtain the treatment. If FMT is regulated as a drug, pharmaceutical companies will be required to come up with proposals of their products and submit them for quality and safety assessment (3). This process costs millions of money, meaning that the patients will have to dig deeper into their pockets to obtain the drug. On the other hand, treating FMT as a tissue donation will make it cheaper for the patients to get treatment. Public stool banks such as the nonprofit OpenBiome perform screenings and other test procedure before supplying the FMT product to a medical provider (2). The cost of preparing FMT in public stool banks is less as compared in the pharmaceutical industry where other people would want to benefit themselves.
Delegate your assignment to our experts and they will do the rest.
There is also fear that regulating FMT as a drug may give some companies exclusive rights to produce medications for an extended period. FDA may likely grant proprietary rights to a company which has successfully tested the alternatives to raw stool transplants (5). By doing so, the move may hinder the development of the treatment. They may also have the monopoly of the market, meaning that they would be the ones to control the market and demand. Therefore, patients may not get easy access to the treatment that they need. It is expected that the prices of FMT will rise exponentially if the FDA grant market exclusivity to one company.
However, there are those who believe that regulating FMT as a drug will help improve the efficiency and safe administration of the treatment. Currently, the benefits and side effects of the therapy have not been fully explored. The situation is made worse by several cases of deaths of patients who underwent the transplants(6).Regulating FMT as a drug will indeed enable pharmaceutical companies to explore other options to raw fecal treatment and improve the drug's efficacy (5). However, should the FDA regulate FMT as a drug, it should come up with a way to control the prices of the medicines in the market so that those who want to profit off from the drug do not take advantage of the patients' situations.
While coming up with regulatory policy, the FDA should consider the availability of the treatment and patients’ access to quality treatment. To do this, the FDA can regulate FMT as both a drug and tissue donation (1). The public stool bank can be established and regulated accordingly as a way of controlling the prices of pharmaceutical drugs. This move will not only make the price for the treatment cheaper, but also the patient's access to the treatment will be guaranteed. It will also give the patient an alternative option to choose from.
The FDA should consider regulating FMT as a tissue donation. To begin with, the poop is like a living tissue since it contains the microbiome where the FMT is obtained from (5). Therefore, public stool banks should be regulated the same way as tissue banks. To ensure the efficacy of the efficacy, the public stool banks can be funded to ensure that studies are carried out to improve the treatment. Regulating FMT as a drug will likely cause the cost of treatment to exponentially go high, and thus, patients seeking the treatment will suffer more financially.
References
Food and Drug Administration. (2016). Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies. July 2013.
Hoffmann, D. E., Palumbo, F. B., Ravel, J., Rowthorn, V., & von Rosenvinge, E. (2017). A proposed definition of microbiota transplantation for regulatory purposes. Journal of Gut microbes 8: 208-213.
Hoffmann, D., Palumbo, F., Ravel, J., Roghmann, M. C., Rowthorn, V., & von Rosenvinge, E. (2017). Improving regulation of microbiota transplants. Journal of Science 358 :1390-1391.
Jacobs, A. (2019, March 4). Drug Companies and Doctors Battle Over the Future of Fecal Transplants. Retrieved June 10, 2019, from https://www.nytimes.com/2019/03/03/health/fecal-transplants-fda-microbiome.html
Khoruts, A. (2017). Fecal microbiota transplantation–early steps on a long journey ahead. Journal of Gut Microbes 8:199-204.
Grady, D. (2019, June 14). Fecal Transplant Is Linked to a Patient's Death, the F.D.A. Warns. Retrieved June 15, 2019, from https://www.nytimes.com/2019/06/13/health/fecal-transplant-fda.html
