The Queens’ Secret Annamese Fertility Herb Resolves an Unmet Medical Need – on track for FDA Botanical Drug Approval

This particular presentation was one of the last of the whole conference; an unenviable place to be as most delegates have left/are leaving. However, this session was unusually well attended and for good reason; botanicals, herbal medicines, supplements and vitamins are a growing industry.

Sue McKinney, the Director of Crinum Health Ltd, gave an interesting insight into the FDA’s stance towards Botanical Drugs, and talked about the growing trend of self-care in consumers. She pointed out that:

• 1 in 2 consumers pursues self-care methods to prolong their good health.
• Over the last nine years, the proportion of the general population thinking that vitamins and minerals or herbal medicines are very effective has increased dramatically (increases of 60% and 55 % respectively) compared with prescription drugs (decrease of 24%).
• Daily use of supplements has also increased globally over a similar timeframe.
• The younger the population, the more likely they are to increase their use of herbal medicine.

This trend towards perceiving supplements/herbal medicines based on more “natural” components as being healthier than chemically developed drugs may enhance the acceptance of botanical drugs. Since the first FDA approval of a botanical in 2006, there are now > 700 investigational New Drugs (INDs) in the pipeline today in the US.

Vietnam, with its long history of medical education (its first medical school was established in 1070 in Hanoi) also has an abundance of plant species, with over 4000 of them said to have medicinal properties.

Sue McKinney has lived in Vietnam for 25 years. Sue, an ex-US Lawyer, partnered with a pharmacist highly renowned for her study of Vietnamese medicine, Dr Nguyer Thi Ngoc Tram, to discover the science behind the ancient Folklore of a “Royal Herb” said to have amazing healing properties. After some time, this rare herb or Crinum latifolium lily was identified amongst at least 12 other species of crinum, and a botanically authenticated source of supply was cultivated and patented by Dr Tram. And so Crila Products were born. In Vietnam of course, there was abundant (if not rigorously controlled) data regarding the efficacy of this herb, but the aim is to launch in the US, where it becomes a little risky for botanical drug developers.

If a botanical product is submitted for FDA approval and then rejected, it is not possible to seek “supplement” status later. However, if a product seeks supplement status first, then FDA approval is applied for and then rejected, the product can still be marketed and sold as a supplement. Developers are therefore better advised to enter the US with their products labelled as supplements initially then apply for Botanical Drug approval.  As for Crila® ? The studies so far indicate that initial benefits in women’s and men’s health are promising.  Watch this space.