Genetic Engineering and Biotechnology News have just published the first survey conducted by their Science Advisory Board, a project called SciPulse Perspectives which aims “to take the “pulse” of scientific minds all over the world”. The survey asked 500 US members “ to share their views on the direct-to-consumer (DTC) testing industry, specifically in the context of the FDA’s warning letter to 23andMe back in November of 2013.”
You can read the results of the poll, yourself, and I won’t bother to comment on them. What concerns me is the way the poll has been framed suggests a fundamental misunderstanding of the FDA’s action. The poll infographic states that the FDA’s position is that “there is a potential for harm when genetic testing results are presented without the counsel of a physician” and that the FDA decided “to stop 23andme from providing genetic interpretations directly to individuals without involving an intermediary physician for counsel.” This is a serious misrepresentation of the FDA’s action, which, as I stated in a previous post, is more concerned with the failure of 23andme to provide the Agency with data about the safety and effectiveness of their test, the traditional standard to which FDA holds medical devices. Anyone who reads the FDA’s warning letter to 23andme carefully cannot be in any doubt as to the FDA’s concerns.
To recap, way back in 2012 23andme submitted for FDA approval for portions of the clinical service they provide. The FDA’s 2013 letter revealed that the company has subsequently been in discussion with the Agency about
1) which regulatory pathway they have to take (whether they could get approval via the less onerous 510(k) route or instead have to undertake the more stringent process for Pre Market Approval (PMA), and
2) the types of clinical evidence which the FDA requires in order to approve 23andme’s test.
Let me reproduce the relevant parts of the letter in full:
“we provided ample detailed feedback to 23andMe regarding the types of data it needs to submit for the intended uses of the PGS. As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies. As discussed above, FDA is concerned about the public health consequences of inaccurate results from the PGS device; the main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work.
However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions. In your letter dated January 9, 2013, you stated that the firm is “completing the additional analytical and clinical validations for the tests that have been submitted” and is “planning extensive labeling studies that will take several months to complete.” Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now eleven months later, and you have yet to provide FDA with any new information about these tests. You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA.”
So, to be clear: the FDA took action not because it wants to stop companies like 23andme selling tests direct-to-consumer, but because 23andme had failed to comply with the FDA’s requirement to provide data on the analytic and clinical validity of their test. So if you are going to run a poll on the FDA’s actions, then the question you should ask is this: do you believe that DTC genetics companies should have to comply with the FDCA and provide evidence to the FDA that gives reasonable assurance of the safety and effectiveness of their tests?