Consumers and life science startup companies alike are reacting strongly to the recent decision by the FDA to restrict the genetic testing company, 23andMe, from marketing its genetic testing service. In our day-to-day work, we are frequently approached with a gamut of regulatory questions from both large and small life science companies navigating the intersection of the changing regulatory and technology environments like this. This convergence is the most difficult part of blending creativity with business practicality—the place we like to dive in headfirst.
With the recent increase in remote medical monitoring activities and devices and the increasing importance of emerging genetic information technologies, it is unlikely that this will be the last that we hear of regulation and innovation not being fully aligned. So, naturally, the 23andMe story is very interesting to us.
In a recent letter to the Google-backed startup 23andMe, the FDA expressed concern about the company’s inability to provide adequate scientific evidence that the tests provide accurate genetic results, and that the unsubstantiated genetic information provided by the tests could cause consumers to make unnecessary or potentially dangerous decisions regarding their health. The FDA cited examples of how information from the tests related to breast cancer risk or susceptibility to drug side effects could be used dangerously if not considered with appropriate medical guidance.
Many comments by the public on online social media channels such as Facebook, Twitter, and blogs suggest that the FDA decision to restrict the sales of the genetic test offered through the 23andMe website is an example of government restricting the rights of consumers to access information about their genetic background and to understand their susceptibility or likelihood of developing certain diseases.
While the overwhelming public perception of the FDA decision seems to be supportive of the company and critical of the government regulating agency, some of us are left wondering if there is more to this story. Could it be that FDA is not trying to simply keep information from the public, but rather ensure, as much as possible, that the information we get is reliable – especially when that information could have a dramatic impact on important, potentially life-changing healthcare decisions we make?
23andMe’s genetic testing kit, the Personal Genome Service (PGS), was marketed up until last week with claims that many of the test results offered a “first step in prevention” that enables users to “take steps toward mitigating serious diseases”. By definition, these claims classify the PGS as a medical device under the federal Food, Drug & Cosmetic Act, and as such it is subject to FDA regulation including the requirement for FDA approval or clearance prior to marketing. However, 23andMe has never been granted such approval.
FDA’s main concern around use of the PGS is that consumers will make important and risky health decisions based on the test results. Some have offered that FDA concern is unreasonable, as the agency has not provided one example of an individual having made a harmful decision based on information obtained from 23andMe. The fact is, there is no way to know whether this has or has not happened; but the FDA’s remit is to protect the public health and they believe the risk of an individual making a harmful decision based on test results from the PGS is high enough to warrant enforcement of the regulations.
Communication between FDA and 23andMe can be found on FDA’s website going back to 2010, documenting FDA’s view that the PGS falls within the category of a regulated medical device requiring approval. Their recent Warning Letter cites “more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications…providing specific feedback on requirements..and regulatory pathways [for approval/clearance]”. Most of this communication is not available to the public, so it is impossible to know the details of why 23andMe has not been able to secure FDA approval to date. Is the FDA being unreasonable with their requirements? Is 23andMe actually making meaningful efforts to comply? At this point, we simply don’t know. But FDA’s considerable time and resource spent working with 23andMe could be a sign of their desire to not only make personal genetic information available, but also of their commitment to ensuring that such sensitive, valuable information is accurate and reliable before people act on it.
It’s easy to assume that a large, bureaucratic government agency like FDA is in the business of putting up roadblocks to progress, and that is what they are doing in this instance. FDA’s sole job is to protect the health and safety of the public. Consider, for a moment, that that is precisely what they are trying to do.
[Editor’s Note: This piece was co-authored by Emily Welsch of Halloran Consulting Group. Halloran and its consultants haven’t done business with 23andMe or its competitors.]
