The FDA has ordered a shutdown of the internet-based genome testing company 23andMe, in a move which I believe will help discourage inappropriate uses of gene testing.
While an article elsewhere on this site puts the case that this is a bad thing, based on the argument that a mega-scale database of genetic information would be a valuable tool for further research. In this, I would not disagree. I think the issue with 23andMe however is that the FDA has serious concerns about the way this data is being generated.
23andMe operates by advertising a simple DNA collection kit which is obtained by mail order over the internet. The kit is returned to their lab, which runs an analysis and notifies the testee of their results via the internet. The database thus obtained is available in de-identified manner for researchers to access using information collected by customers of 23andMe.
The concerns listed by the FDA are not trivial. They relate in detail to the claims by 23andMe to be able to give detailed advice about the risk of a customer developing various illnesses, or how they may respond to certain drugs. The FDA letter notes that:
Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions.
In other words, whether or not 23andMe have devised an excellent test for these claimed uses, they have repeatedly failed to meet their legal obligations to have their medical device assessed by the FDA as fit for purpose. They may have created the future of medicine as we know it, but they are not above the law.
This alone means that the data they have collected is likely unethically collected, as they should not have been marketing their tests to consumers if the testing device was not properly approved by the FDA. Using the information gathered by potentially illegal means for research is unethical. The FDA letter goes on to detail several very concerning potential situations that could arise from 23andMe customers making health and medical decisions based on testing that has not been shown to be fit for purpose. The 23andMe website carries a statement about the letter which seems a masterpiece of understatement.
We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.
The FDA letter is more blunt.
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.
As an outside observer, I find it odd that the FDA is being accused of picking unjustly on 23andMe. It seems clear they have bent over backwards to accommodate a company which is not behaving like a good corporate citizen should. The company is valued at $126 million so they should be able to afford to comply with reasonable legal safeguards that ensure their product is fit for purpose and the data can be ethically collected and relied upon for clinical care.