This is a guest post by Law and Biosciences Professor Hank Greely. It was originally published on his Stanford University blog.
On Friday, November 22, the Food and Drug Administration (FDA) sent a nastygram to 23andMe, the only remaining substantial pillar of the “direct to consumer” genomic testing industry. The letter, available here, is well worth reading in its entirety, but, in brief, it told 23andMe, in no uncertain terms, to stop marketing its “Saliva Collection Kit and Personal Genome Service” (the PGS) on the ground that it was an unapproved and uncleared “device” under the Federal Food, Drug, and Cosmetics Act.
Related: Read our in-depth analysis on why the FDA is targeting 23andMe.
It noted that the PGS, because of its lack of approval or clearance, was both adulterated and misbranded under the Act; the distribution of adulterated or misbranded devices is a federal crime.
23andMe’s initial response, click here, through an unnamed press spokesperson on its blog, was, at least on its face, conciliatory.
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.
What’s going on — and what does it mean in the long run?
There has long been controversy over whether and how the FDA should, or can, regulate genetic tests, whether delivered, as 23andMe does, direct-to-consumer or through a medical professional. These issues simmer below the surface of the cease and desist letter, but it is not clear that, at anything other than the deepest level, they are immediately relevant.
It appears that, for whatever reason, 23andMe chose to ignore the FDA — and the FDA chose not to take it anymore. The FDA letter says:
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.
Note particularly the sentence I bolded.
This sounds as though 23andMe started down the FDA path but, six months ago, not only stopped communicating with the agency but started new and bigger marketing efforts. That suggests that 23andMe did not just ignore the FDA, but, while walking briskly past it, quickly turned and spat in its face.
Now, I have no inside information on this dispute. I have the (scathing) FDA letter and the (timid) 23andMe initial response. Undoubtedly, something was going on other than lost messages at the 23andMe side. I don’t know whether that something was a plan to fight the FDA’s jurisdiction on statutory / novel constitutional grounds, or a hope that the FDA would back down, or something else entirely. But if you ignore the FDA for six months, it is not surprising that the agency is going to be unhappy with you.
So this may just be a slap down of an insubordinate, or royally disorganized, regulated firm. But does it say anything more about the future of FDA regulation of genetic tests?
Well, it does suggest that the FDA thinks it can and should regulate those tests. The letter lays out its reasons: “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.” The letter gives examples, from BRCA 1 and 2 to pharmacogenomic tests where the accuracy, and the patient’s actions on, the 23andMe tests have potentially serious health implications.
Some have argued that the FDA does not have jurisdiction over these direct-to-consumer tests, and they include some very smart colleagues and friends of mine. How can a plastic tube for collecting saliva be a regulated device? Welcome to FDA law. The federal statute defines “devices” (“medical” doesn’t appear in the law) as, among other things,
an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, . . which is–
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals
As the FDA’s letter points out, 23andMe markets its genetic tests as,
“providing “health reports on 254 diseases and conditions,” including categories such as “carrier status,” “health risks,” and “drug response,” and specifically as a “first step in prevention” that enables users to “take steps toward mitigating serious diseases” such as diabetes, coronary heart disease, and breast cancer. Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act.”
A plastic tube for collecting spit doesn’t look much like an MRI machine or an implantable left ventricular assist device, but it is an “article” that, from its marketing information, 23andMe “intend[s] for [medical] use.”
Of course, the decision about jurisdiction (if 23andMe actually dares make it) will ultimately be one of statutory interpretation for the courts, informed by and giving appropriate deference to reasonable interpretations by the agency charged with implementing the statute — the FDA. One never knows about courts, but I think the 23andMe jurisdictional argument is a loser. And, a reality of regulated industries, especially those regulated by the FDA, is that fighting your regulator may well, in the long run, be a very bad idea.
23andMe is a DNA analysis service providing information and tools for individuals to learn about and explore their DNA. We use the Illumina OmniExpress Plus Genotyping BeadChip (shown here). In addition to the variants already included... read more »
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