23andMe FDA letter: Premarket approval requirement could kill at-home genetic testing industry.
The FDA Is Poised to Kill the Personal Genetics Testing Industry
The citizen’s guide to the future.
Nov. 26 2013 12:39 PM

The FDA Could Set Personal Genetics Rights Back Decades

Its letter to 23andMe is foolish and paternalistic.


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The Food and Drug Administration’s recent directive to the company 23andMe to stop marketing its genetic tests directly to consumers is a shortsighted, heavy-handed, double-standard act of paternalism. This is the last shoe to drop in the FDA’s effort to wipe out the right of consumers to discover their own genetic information, some of the most important, private, useful, and interesting information about our own health and well-being. We should have a right to access that data about ourselves, but the practical impact of the FDA’s action will be to put most of that data out of reach for the foreseeable future.

23andMe is the “last man standing” in the once crowded and rapidly expanding direct-to-consumer genetic test field. All the other major competitors were put out of business or stopped selling directly to consumers after the FDA sent threatening letters to all the companies in the industry a couple years ago. 23andMe tried to play ball with the FDA by starting to submit so-called 510(k) applications for some of its tests based on the tests being “substantially similar” to medical devices already on the market. Now, in the letter sent to 23andMe on Friday, the FDA indicates (correctly in my view) that the 510(k) mechanism is not appropriate, because there are no substantially similar approved tests (called “predicate devices”) already on the market.

But then the FDA goes off the deep end and asserts that 23andMe must instead seek premarket approval (PMA) or de novo classification of its tests. The problem is that these regulatory approval pathways generally require clinical testing that takes several years to complete and costs millions of dollars. 23andMe or any other entrant into this field would have to pursue such approval for each test it offers—and 23andMe offers tests for more than 250 diseases and conditions. Moreover, because of rapid advances in the field of genetics, any such test would likely be outdated, replaced by a more precise and advanced test, before the clinical testing and regulatory approval could be completed for the initial test. In other words, the PMA regulatory pathway is infeasible and impracticable for these types of tests, and the FDA’s insistence on such a step is a death sentence for direct-to-consumer genetic testing.


To some extent, the FDA is trapped by an outdated statutory regime that only provides the “nuclear option” of a PMA to approve DNA tests, a technology that was not envisioned when the statute was written. But the FDA was not required to take this heavy-handed and drastic action. We know this because many of the exact same genetic tests are already being provided to consumers through their physicians, without any FDA approval. There are approximately 3,000 genetic tests now commercially available through your doctor, of which only a handful have received FDA approval. So it is apparently now unlawful for 23andMe to sell you a genetic test but OK for your physician to order the exact same test, at a much higher cost to the consumer. This is an unjustified and unwarranted double standard.

There are important reasons why at-home genetic testing may be preferable to consumers. To many, their genetic information is very private, and they prefer to get the results privately at home rather than through their physician, who will likely put the information in the patient’s medical record. It is much cheaper to get tested through 23andMe, which is currently offering its entire battery of genetic tests for only $99. It would cost many hundreds if not thousands of dollars to get the same tests through one’s physician, and health insurance does not cover the cost of most genetic tests presently. As a practical matter, most physicians are unlikely to order the complete set of genetic tests offered by 23andMe, so those who are interested and curious to get as much genetic information as possible will be blocked from doing so if they must go through their doctor.

The American Medical Association, an FDA advisory committee, and many genetics experts all support the FDA’s position that genetic testing should only be permitted through your doctor. Putting aside the self-interest that may be behind some of those recommendations, it is true that a consumer who receives genetic results showing a serious health risk should discuss those results with a medical professional. But there is no need or benefit in most cases to do that up front, before a person is tested. Most physicians practicing today have little or no genetic training and simply are not in a position in the 12 minutes or so they are allotted per patient appointment to make an informed judgment or engage in in-depth discussion about what genetic testing is appropriate for a patient and what the risks and benefits are. In contrast, many consumers who seek direct-to-consumer genetic testing spend a significant amount of time learning about the genetic tests, and their pros and cons, before and after signing up for such testing. And, once they get those test results, they can and often do go to their doctor to discuss.

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