Never, ever, mess with the big guns.
The FDA has issued a cease and desist letter to 23andMe and ordered the firm to stop selling their DNA tests based on concerns of accuracy, failure to comply with FDA requirements and the fact that they are providing “specific health recommendations” to their clients.
Here is the actual letter.
“The Food and Drug Administration (FDA) is sending you this letter because you are marketing the 23andMe Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act.
Therefore, 23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device.”
Normally, the DTC (direct to consumer) test concerns voiced are about people misinterpreting their results, or being frightened by them, without the involvement of a physician. In other words, the move until now has been to force you to visit a doctor to obtain a prescription for this type of test. Of course, the underlying assumption is that the physician will then be available and have expertise in all of the areas that the test covers. That, of course, would mean another follow-up visit, and if all you really wanted was the genealogically relevant results, this would in effect kill that part of their business. In fact, it would probably kill the business entirely, at least under the current marketing model.
The FDA says that the product that 23andMe sells is a medical device, especially since it involves important medical information such as the detection of the BRCA-related breast cancer gene and sensitivity to the blood-thinner, warfarin.
Again from the FDA to 23andMe letter:
“Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these.”
The FDA wants 23andMe to show that these tests are accurate. They are concerned, for example, that the BRCA test provided by 23andMe might provide either a false positive or, even worse, a false negative. A false positive would, of course, provide an individual with a great deal of angst, but they would certainly immediately visit a physician who would prescribe industry-standard follow-up testing where the “false positive” would be caught. A false negative, on the other hand, might mask a deadly situation, delaying detection until too late.
The FDA states that they have been working with 23and Me who has failed to provide the necessary proof. From the looks of this letter, and understanding there are two sides to every story, it looks like 23and Me has not taken the FDA seriously.
“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.”
I do believe the FDA has their undivided attention now.
“Therefore, 23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device.”
23andMe has 15 days to reply and if they don’t, it could get even uglier.
“Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific actions you have taken to address all issues noted above. Include documentation of the corrective actions you have taken. If your actions will occur over time, please include a timetable for implementation of those actions. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the actions will be completed. Failure to take adequate corrective action may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.”
Yep, never mess with the big guns.
In 2010, five different companies, including 23andMe, were served with warning letters when Pathway Genomics announced it would sell its DNA testing product at Walgreen, a plan that never came to fruition after the warning letter. However, this is the first letter of this type to be served on a genomics testing company.
What’s next? We just don’t know. 23andMe has yet to comment, but it looks from this letter like they have limited choices at the moment.
Stay tuned for the next episode of the Wild West in DTC Testing.