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FROM SCIENCE
Researchers are proposing a three-track regulatory framework to help ensure that using fecal microbiota transplantations (FMTs) to treat recurring Clostridium difficile infection (CDI) can be done in a more safe and effective manner.
The need for better regulation is arising because, although FMT is considered by many to be the standard of care, samples are inconsistently screened for infectious pathogens.
“The use of prescreened stool obtained from a stool bank and shipped to a physician is increasing, but the stool banks are not regulated,” Diane Hoffmann, the Jacob A. France Professor of Health Care Law at the University of Maryland, Baltimore, and her colleagues wrote in Science.
The authors noted that the Food and Drug Administration has struggled with regulating FMT; so far, it has tried to use the drug approval pathway as a tool to oversee FMT.
However, the authors note that the transplanted material “is not a ‘typical’ drug, and thus may not be appropriate for the drug regulatory pathway.” To that end, Ms. Hoffmann and her colleagues offered three paths that the FDA could implement to regulate FMT.
The first track would cover instances in which a physician obtains the stool from a donor the patient or physician already know. In this case, “FMT would be regulated as the ‘practice of medicine’ subject primarily to state regulation,” the authors proposed. “Physicians performing FMT for CDI would be able to do so based on their scope of practice using clinical judgment and the relevant standard of care.” In this track, the investigational new drug (IND) pathway would be applied when FMT is used for any indication other than CDI unless the use meets clinical innovation requirements.
The second track covers stool obtained from stool banks. In this scenario, it would be “regulated in the same manner as human cell-tissue establishments with some additional oversight,” Ms. Hoffmann and her colleagues wrote. “This would include registering annually with the FDA and complying with rules for donor screening and testing and ‘good manufacturing processes.’ ” Physicians using stool from these banks would be required to report back any adverse events stemming from stool supplied by the banks, and the banks would submit that data to the FDA. Unless operating under an IND, stool banks would only be able to provide samples to treat CDI.
The third track deals with “modified stool-based products” (stool processed in such a way that the original relevant characteristics of the transferred community of microorganisms have been altered). “These products would be regulated as biological products or drugs with some alteration of IND requirements (i.e., elimination of some phase I IND requirements and modification of characterization specifications),” the authors wrote.
“Our proposal improves on the FDA’s current and proposed regulatory scheme as it allows stool banks to continue to provide stool but only under an approved regulatory framework,” Ms. Hoffmann and her colleagues wrote.
They believe that implementation of this three-track structure would not be difficult: “FDA would need to change its position and determine that microbiota derived from stool is a tissue, not a drug or biological product. The framework could be implemented through new guidance or by issuing formal regulations and no statutory changes would be required. The scheme would serve as a useful starting point for regulation of other types of [microbiota transplants].”
gtwachtman@frontlinemedcom.com
FROM SCIENCE
Researchers are proposing a three-track regulatory framework to help ensure that using fecal microbiota transplantations (FMTs) to treat recurring Clostridium difficile infection (CDI) can be done in a more safe and effective manner.
The need for better regulation is arising because, although FMT is considered by many to be the standard of care, samples are inconsistently screened for infectious pathogens.
“The use of prescreened stool obtained from a stool bank and shipped to a physician is increasing, but the stool banks are not regulated,” Diane Hoffmann, the Jacob A. France Professor of Health Care Law at the University of Maryland, Baltimore, and her colleagues wrote in Science.
The authors noted that the Food and Drug Administration has struggled with regulating FMT; so far, it has tried to use the drug approval pathway as a tool to oversee FMT.
However, the authors note that the transplanted material “is not a ‘typical’ drug, and thus may not be appropriate for the drug regulatory pathway.” To that end, Ms. Hoffmann and her colleagues offered three paths that the FDA could implement to regulate FMT.
The first track would cover instances in which a physician obtains the stool from a donor the patient or physician already know. In this case, “FMT would be regulated as the ‘practice of medicine’ subject primarily to state regulation,” the authors proposed. “Physicians performing FMT for CDI would be able to do so based on their scope of practice using clinical judgment and the relevant standard of care.” In this track, the investigational new drug (IND) pathway would be applied when FMT is used for any indication other than CDI unless the use meets clinical innovation requirements.
The second track covers stool obtained from stool banks. In this scenario, it would be “regulated in the same manner as human cell-tissue establishments with some additional oversight,” Ms. Hoffmann and her colleagues wrote. “This would include registering annually with the FDA and complying with rules for donor screening and testing and ‘good manufacturing processes.’ ” Physicians using stool from these banks would be required to report back any adverse events stemming from stool supplied by the banks, and the banks would submit that data to the FDA. Unless operating under an IND, stool banks would only be able to provide samples to treat CDI.
The third track deals with “modified stool-based products” (stool processed in such a way that the original relevant characteristics of the transferred community of microorganisms have been altered). “These products would be regulated as biological products or drugs with some alteration of IND requirements (i.e., elimination of some phase I IND requirements and modification of characterization specifications),” the authors wrote.
“Our proposal improves on the FDA’s current and proposed regulatory scheme as it allows stool banks to continue to provide stool but only under an approved regulatory framework,” Ms. Hoffmann and her colleagues wrote.
They believe that implementation of this three-track structure would not be difficult: “FDA would need to change its position and determine that microbiota derived from stool is a tissue, not a drug or biological product. The framework could be implemented through new guidance or by issuing formal regulations and no statutory changes would be required. The scheme would serve as a useful starting point for regulation of other types of [microbiota transplants].”
gtwachtman@frontlinemedcom.com
FROM SCIENCE
Researchers are proposing a three-track regulatory framework to help ensure that using fecal microbiota transplantations (FMTs) to treat recurring Clostridium difficile infection (CDI) can be done in a more safe and effective manner.
The need for better regulation is arising because, although FMT is considered by many to be the standard of care, samples are inconsistently screened for infectious pathogens.
“The use of prescreened stool obtained from a stool bank and shipped to a physician is increasing, but the stool banks are not regulated,” Diane Hoffmann, the Jacob A. France Professor of Health Care Law at the University of Maryland, Baltimore, and her colleagues wrote in Science.
The authors noted that the Food and Drug Administration has struggled with regulating FMT; so far, it has tried to use the drug approval pathway as a tool to oversee FMT.
However, the authors note that the transplanted material “is not a ‘typical’ drug, and thus may not be appropriate for the drug regulatory pathway.” To that end, Ms. Hoffmann and her colleagues offered three paths that the FDA could implement to regulate FMT.
The first track would cover instances in which a physician obtains the stool from a donor the patient or physician already know. In this case, “FMT would be regulated as the ‘practice of medicine’ subject primarily to state regulation,” the authors proposed. “Physicians performing FMT for CDI would be able to do so based on their scope of practice using clinical judgment and the relevant standard of care.” In this track, the investigational new drug (IND) pathway would be applied when FMT is used for any indication other than CDI unless the use meets clinical innovation requirements.
The second track covers stool obtained from stool banks. In this scenario, it would be “regulated in the same manner as human cell-tissue establishments with some additional oversight,” Ms. Hoffmann and her colleagues wrote. “This would include registering annually with the FDA and complying with rules for donor screening and testing and ‘good manufacturing processes.’ ” Physicians using stool from these banks would be required to report back any adverse events stemming from stool supplied by the banks, and the banks would submit that data to the FDA. Unless operating under an IND, stool banks would only be able to provide samples to treat CDI.
The third track deals with “modified stool-based products” (stool processed in such a way that the original relevant characteristics of the transferred community of microorganisms have been altered). “These products would be regulated as biological products or drugs with some alteration of IND requirements (i.e., elimination of some phase I IND requirements and modification of characterization specifications),” the authors wrote.
“Our proposal improves on the FDA’s current and proposed regulatory scheme as it allows stool banks to continue to provide stool but only under an approved regulatory framework,” Ms. Hoffmann and her colleagues wrote.
They believe that implementation of this three-track structure would not be difficult: “FDA would need to change its position and determine that microbiota derived from stool is a tissue, not a drug or biological product. The framework could be implemented through new guidance or by issuing formal regulations and no statutory changes would be required. The scheme would serve as a useful starting point for regulation of other types of [microbiota transplants].”
gtwachtman@frontlinemedcom.com