This weekend was spent attending the Natural Products ExpoWest convention in Anaheim on behalf of a few of our clients. This was our first time attending this conference. Aside from the great food in Hallway E, we spent our time representing our clients and learning a lot. Our impressions:
1. There is an increasing demand for alternatives to prescription medications. Savvy companies are using the power of internet marketing to “promote” their products online directly to consumers and/or their caregivers.
2. Many of these dietary supplements and homeopathic medicines retail at $5-10 more than a branded Rx co-pay. So their monthly costs are not unreasonable if efficacy can be achieved without Rx-associated side effects.
3. There is no shortage of companies attempting to satisfy this demand. An amazing number of companies with full GMP manufacturing and analytical capabilities are in the US (primarily in the NY/NJ area and Utah). These companies can manufacture and number of dietary supplements and homeopathic medicines…and capture a margin along the way.
4. “Claims” are verboten. While the Rx world strives to make clinical claims, the nutraceutical/dietary supplement world runs away from claims. Now interestingly, some of these companies and products are supported by clinical data. However, as claims cannot be made without a full IND/NDA process, these companies simply avoid claims entirely. Instead, they tend to say things like “for respiratory health.” An understaffed FDA will likely make it difficult to catch companies making wild, unsubstantiated claims.
5. Having said this, there is no shortage of companies looking to perform low-cost clinical trials abroad. In some cases, companies are performing head-to-head clinical trials against established Rx products.
The dietary supplement/homeopathic/functional food world is a very different one from the the Rx/OTC/brand/generic world. The lack of field force promotion to physicians will likely limit the market penetration for many of these products. However, solid data combined with an efficient, Internet-based marketing approach may result in successful products that will catch the attention of Rx companies and the FDA.