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24/04/2025

EMIH Statement on FDA Commissioner Dr. Marty Makary’s Remarks Highlighting the Gut Microbiome’s Role in Health


EMIH is pleased to see Dr. Marty Makary, newly appointed FDA Commissioner, highlight the role of the gut microbiome in human health during his recent interview. His emphasis on the microbiome’s influence aligns strongly with EMIH’s mission to accelerate the availability of microbiome innovations in the market, addressing critical medical needs and enhancing the quality of life and treatment for patients.

1. Role of the Microbiome in Vaginal Birth: Dr. Makary’s recognition of the microbiome’s role during vaginal birth underscores the critical importance of early microbial colonization. At EMIH, we support research from our members currently evaluating single strains approaches in this context.

2. Overuse of Traditional Antibiotics: Antibiotics save lives. However, the overuse of antibiotics alters microbiome which is known to modulate clinical outcome. This reinforces the need for safe and efficient diagnostics for responsible antibiotic use and the development of microbiome-restoring solutions—areas where EMIH’s members have strong expertise.

3. Impact of Foods and Diet in Preventing Diseases: we support Dr. Makary’s advocacy for initiatives such as healthier school lunches and his focus on diet’s role in microbiome health. As he notes, addressing chronic inflammation and diseases like the rise in colon cancer in young people requires looking beyond treatment to the root causes and looking at what is disrupting the gut microbiome and driving general body inflammation.

4. Microbiome Research at the National Institutes of Health (NIH): Research initiatives at NIH are crucial in advancing our understanding of the gut microbiome. This highlights the need to foster collaboration between private and public players. EMIH is committed, in line with its objectives, to playing an active role in Europe in building consortiums driving by the science and delivering microbiome-innovation to patients.

5. Role of the Microbiome in the Gut-Brain Axis: Growing research around the microbiome’s connection to mental health through the gut-brain axis is promising. At EMIH, we support our members advancing clinical evaluation that could improve mental health outcomes and overall well-being.

Unity is strength! EMIH, an independent coalition, looks forward to partnering with key stakeholders to open a new era of microbiome-driven therapies and is committed to ensuring that policymakers and regulators in Europe prioritize the microbiome as a promising sector for global health. We are ready to play a central role in making that a reality.

If you want to see the full interview, click here.

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