An Unclear Path for Microbiome-Based Products at FDA


Gail H. Javitt, Member of the Firm in the Health Care & Life Sciences practice, in the Washington, DC, office, authored an article in Law360, titled “An Unclear Path for Microbiome-Based Products at FDA.” (Read the full version – subscription required.)

Following is an excerpt:

The more than 1 trillion microbes that populate our bodies (collectively, the “microbiome”) play a crucial role in human health. With the advent of sophisticated gene sequencing and software analytics technologies, scientists are increasingly able to characterize the composition and function of the microbiome.

Recent findings shed light on the role of the skin microbiome in regulating immune function and inflammatory response. The microbiome also plays a critical role in protecting us from dangerous pathogens such as C. difficile. Changes in gut microbiota have been associated with a wide range of conditions including cardiovascular disease, obesity, diabetes, cancer and neuropsychiatric disorders.

A diverse set of stakeholders comprising the food, dietary supplement, pharmaceutical and diagnostics industries are exploring how to harness the microbiome to develop new approaches for diagnosing and treating disease and promoting health and wellness. In particular, interest has focused on approaches that modulate the microbiome through the use of “probiotics,” which are live microorganisms with the capacity to confer a health benefit when ingested in adequate amounts.

The biological impact of probiotics derives not from the microbes themselves, but rather, from the chemicals — e.g., acids and enzymes — that they produce. Thus, characterizing and classifying these products and their physiological effect is paramount to the identification and development of microbiome-affecting products.