Friday, January 29, 2010

Neutraceutical - How close to Pharmaceutical FDA Rigor?

Recently, I was asked to review with FDA rigor and "investor" interest and due diligence, several NCEs for various therapeutic indications, all in areas of unmet medical needs, inhalation devices, state of the art and several neutraceutical products.

For this blog, lets focus on neutraceuticals -

Interesting enough, FDA is closing in on neutraceuticals. These are products that are generating revenue on the market, manufactured by top pharma manufacturing facilities, formulated and contain active substances which in addition to the primary product "marketed" claim - lowers cholesterol, while building muscle and correcting hormonal balance - as well demonstrates efficacy or benefits in other areas, for example CNS - demonstrates a sense of well being in patients diagnosed with bipolar, schizoaffective, psychosis, etc. These are products that have not traveled the clinical and regulatory pathway with FDA rigor.

At some point in life cycle of the neutraceutical and because of the "apparent" medical benefit of the neutraceutical, FDA will step in and demand that the formulation, the product, become quality-controlled and assured and regulated. FDA will want the neutraceutical company to submit a clinical and regulatory submission and product filing.

It will happen - it is just a matter of time. In the last two years, across my desk, four neutraceutical companies in business for at least 10+ years have been contacted by FDA to provide a clinical development and submission plan for filing.

If you are a neutraceutical company, stay tuned - it will happen to you. If it does, FDA will want to see in a realistic time frame, your intent to comply with their request for FDA rigor. I will speak about how to comply and the components of the filing in the next several blogs. I will as well, provide a brief checklist on due diligence from an investor's point of view as well.

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