Through the strength of its collective membership, MTIG promotes regulatory policies and legislation that support innovation in the microbiome arena. Currently MTIG is focused on advancing the following policy initiatives:
- Streamlining the regulatory process to increase clarity and decrease the amount of time needed for new microbiome therapeutics to reach the market.
- Key areas include: regulatory clarity on clinical trial design, endpoint selection and biomarker selection, use of expedited review pathways, and product nomenclature.
- Educating policymakers, clinicians, patients and the public about the role of the microbiome in human health, and opportunities with products that augment and modulate the microbiome to address unmet medical needs.
- Working with clinical leaders, patient advocates, and other stakeholders to support FDA regulation of microbiome-based drugs and encourage FDA to finalize its draft guidance “Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies” issued in March 2016.
- MTIG supports continuing access to physician prepared FMT with donor controls and patient informed consent, as described in the FDA guidance. However, MTIG believes these standards should not be applied to unregulated commercial-scale FMT that have not established safety and efficacy under FDA regulated clinical trials.
- MTIG believes FDA regulation is necessary to ensure that commercial scale FMT products implement and adhere to the rigorous controls and testing necessary to ensure the quality of the drug product meets regulatory requirements.