Important projects like the MetaHIT project in Europe or the Human Microbiome Project supported by the NIH (National Institutes of Health) in the US are now producing more and more data on the importance of such complex communities of microorganisms in the human homeostasis.
In addition positive relationships have been shown between the modification of the composition of such communities and some human pathology. As a consequence, it is now commonly accepted that some strains may have a therapeutic potential and may also represent a new therapeutic pathway for some pathologies associated with dysbiosis and for which few treatments are commonly available.
Regulator lag
As usual science and industry go faster than the regulator and the probiotics industry is currently facing a regulatory challenge in Europe as well as in the US. In order to give a simple example, neither FDA (Food and Drug Administration) in the US or EFSA (European Food Safety Authority (EFSA) and EMA (European Medicines Agency) in Europe have a definition for probiotics.
As very well stated by Hoffman et al in their last publication, the FDA guidance published in 2010 refers to ‘Live Biotherapeutic Products’ (LBP) without using the word ‘probiotics’ when it appears to incorporate these products into this category. In addition as highlighted by these authors, “the requirements [in this guidance] are not entirely relevant for probiotics” so they propose two modifications to the regulatory framework that could improve how probiotics are addresses by the FDA: 1. Abbreviated application process 2. Regulated claims
But then we are reminded of the European regulatory framework for food supplements and food additives and the 2007 nutrition and health claims regulation (NHCR).
Under the NHCR there is a clear difference between a health claim, related to a health benefit in the general population of healthy consumers, and medical claims dedicated to a population of patients and in theory restricted to drug products.
Therefore it is of high importance for regulators in the US and in Europe to work on probiotic specificities on each of these two aspects: food supplements on one side and drugs on the other.
One would think that Europe would be better prepared for such a dual evaluation with its system of dual agencies (one for the food (EFSA) and one for drugs (EMA). And one would expect the pharmaceutical side to have worked on this issue. However, as opposed to FDA, neither EMA or any national agency ever produced any specific guidance for what is called in the US ‘Live Biotherapeutic Products’ and what we call ‘pharmabiotics’ in Europe.
In the case of medical claims in the US there is no doubt that such products should be considered as Investigational New Drugs (IND) and would then fall in the first modification described by Hoffman et al. In addition their proposal of an abbreviated application process makes a lot of sense for strains with a long history of safe use in humans.
Registration
My organisation, PRI, is working on the possibility of registering medicinal probiotics as drug products. The PRI works on probiotic specificities when it comes to the European pharmaceutical framework and supports its members in the development and submission of dossiers. This is the opportunity for PRI members and its members to directly interact with EMA and to share with the experts their important need for a specific regulatory framework when it comes to pharmabiotics or medicinal probiotics.
However, work still needs to be done since part of the probiotics industry may need to learn more about the pharmaceutical world as well as the health authorities may need to learn more about the products themselves in order to regulate accordingly.
Since the pharmaceutical regulatory framework is one of the most harmonised in the developed world, and since we are at the beginning of an era for medicinal probiotics, it may be the best time for the industry and the regulators around the world to work together in order to develop the relevant regulatory framework and then allow patients all over the world access to these new products and therapeutic pathways.