This blog post was written by Deniz Temelli, Business Analyst at TechAlliance.
Late last fall genetics testing company 23andMe was ordered to stop marketing and selling their Personal Genome Service by the FDA (recap in my last blog post here). The company soon complied and limited their services to providing only ancestry related information. However, since then, a couple of notable things have happened.
First, a consumer from California who had purchased the $99 genetic test filed a class action law suit against 23andMe for at least $5 million in damages claiming that the marketing was misleading and not supported by scientific evidence. Despite the public outcry against the FDA, this law suit shows there are those that support the FDA ruling.
Second, at the end of January, 23andMe published a study that identified 11 genetic markers associated with asthma-with-hay fever. 23andMe stated in their initial response to the FDA letter that despite halting sales and marketing of their service, they will continue with R&D using their existing genetic database. This investment shows the company is confident in the genetic testing industry and hopes to offer their service in the future with expanded scientific evidence.
There will likely be more to come in the story of 23andMe and the FDA, but at this point there are a few lessons that any biotech start-up can learn from this case:
1. Know the classification and regulatory path for your product/service as early as possible
This is likely the first question any investor will ask as it shows how thorough your commercialization plan is. The classification will also heavily dictate your commercialization plan in terms of time and investment required.
Knowing this early in your product development cycle will also allow you to strategically alter features and functions that may change the classification of the product. This enables you to launch a simpler version of your product faster, and then roll out more complicated features in version 2. The easiest way to determine your product classification is through the Health Canada or FDA classification rules or to contact them directly.
2. Seek out a regulatory expert to help you through the process
Navigating the regulatory pathway can be tricky even for a seasoned individual, so for any start-up founder, regulatory can be especially overwhelming. Since regulatory approval is such an integral part of a company’s success, I would suggest working with a regulatory consultant or hiring expertise onto your team. You will likely pay a premium for this service, however it will ensure everything is done right the first time and will allow you to focus on other areas of the business. In the long run, this type of investment upfront will likely be worth it.
3. Engage with the appropriate regulatory body continuously and early on
Although they may be difficult to find, there are people at Health Canada and the FDA whose role is to help companies through the process. At the very beginning, tell them about your product and ask what classification it is, then before doing any clinical or validation studies, keep them in the loop and ask for feedback. It’s much easier and cheaper to change a study before it has started to make sure you’re getting the right data as opposed to doing a whole new study after the fact.
Regulatory approvals are just a fact of doing business within the biotech space. Being strategic and anticipating regulatory hurdles in advance will only help your company be more successful. As a result, you hopefully won’t have to spend the time and money required to deal with a cease and desist letter from the FDA.
