Realizing the Therapeutic Potential of Probiotics: The Role of FDA

Natural Products Insider

Gail H. Javitt, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, authored an article in Natural Products Insider, titled “Realizing the Therapeutic Potential of Probiotics: The Role of FDA.”

Following is an excerpt:

The Human Microbiome Project (HMP) has vastly increased our knowledge about the diversity of microbiota in the human body. Although significant research remains to be done to understand the role of these bacterial communities in human health and disease, the HMP has increased focus on the potential value of probiotics to provide novel, safe and low-cost therapeutic approaches to pressing public health problems.

The public’s enthusiasm for probiotics has resulted in a worldwide market in excess of $35 billion. However, the plethora of untested probiotics currently in the marketplace and the lack of evidence from randomized controlled trials have led some scientists to question the benefit of the entire category. Some companies that do invest in careful classification of bacterial species and their biological effects may be deterred from promoting their findings by the perception that such promotion would automatically trigger the requirement to submit an application for new drug approval to FDA. On the whole, the industry appears not to be pursuing opportunities to develop therapeutic probiotics because of the perception that making medical claims will require outlays of funds equivalent to drug development.

Realizing the therapeutic potential of probiotics will require a clear and appropriately tailored regulatory path. While FDA’s current regulatory regime is likely more flexible and nuanced than some probiotics manufacturers may appreciate, the absence of clear agency guidance itself can deter the development of new, validated therapeutic probiotics. Furthermore, to the extent FDA’s current interpretation of its regulatory authority creates barriers to market entry, FDA should consider the applicability and appropriateness of such interpretation to all probiotics. The case of C. diff, described below, underscores the potential public health benefits of probiotics and the importance of a clear regulatory path for realizing this potential.