DTC Genetic Tests and the Future of Regulation: Make Your Voices Heard

On March 8th, the FDA convened a two-day advisory panel meeting to discuss questions related to direct-to-consumer genetic tests. The questions focused on the benefits and risks of providing consumers with direct access to these tests, potential strategies for communication and education to mitigate any risks, and regulatory standards for ensuring that the tests are accurate and reliable. As one of the leading companies in this area, we felt it was important to outline our perspectives and broad requests on these topics, and were pleased to see many other companies from the industry join us in expressing similar views. Updated meeting materials are now available on the FDA website, and both presentations that 23andMe gave at this meeting are available here.

In the several years since the direct-to-consumer genetic testing industry made its debut, it has seen all manner of reaction. Many are fascinated by our newfound ability to peek into our genomes, to add another source of data to the ones we already collect, and to leverage it to know more about our connections to the world, whether that be literally through known and predicted relatives or through the relationship between genetics and our health and traits. Others may not be interested or may not want to know what their genetics might tell them. But some feel that all genetic tests and/or their interpretations should be available only through a physician.

For our part, 23andMe was founded on the belief that individuals have a right to access their own genetic information, and this conviction is still as firmly held as ever.

While the debate is clearly no longer academic — many more people are aware of and using these tests and the FDA is taking an active role in learning about and devising guidelines for this industry as a result — it is clear that challenges remain. Some observers fear that the panel’s recommendations will severely curtail direct access to genetic testing, but we agree with Dan Vorhaus of Genomics Law Report that the FDA will take a reasoned approach to integrating the feedback it received from its panel with other information pertinent to the issue.

The advisory panel meeting was in many ways a microcosm of the ongoing debate, with one exception. Although the panel had an individual representing the consumer and the patient, the panel did not have the opportunity to hear directly from consumers and others who have first-hand experience with the information provided by direct-access genetic testing services.

Fortunately, there are many channels through which you can make your voices heard. The FDA has reopened the public docket on this topic for the submission of additional comments (until May 2, 2011) and we strongly encourage those of you with an opinion or perspective on the questions posed by the FDA regarding DTC genetic tests to send in a comment. Regardless of the content of those comments, we believe that a larger number and a wider variety of comments will be beneficial for helping the FDA to guide its regulatory policies in this area.

  • Electronic comments can be submitted at http://www.regulations.gov/, referencing docket ID FDA-2011-N-0066.
  • Written comments, referencing docket ID FDA-2011-N-0066 in the header, can be sent to:
    Division of Dockets Management (HFA-305)
    Food and Drug Administration
    5630 Fishers Lane, Rm 1061
    Rockville, MD 20852

You can also post comments to the FDA Facebook page, or attend one of several FDA (Center for Devices and Radiological Health, or CDRH) town hall meetings. The next town hall meeting will be held in May in Orlando, FL, and there is also one planned for San Francisco at a place and time to be announced.

Finally, it may be helpful to make your congressional representatives aware of your views on this issue. You may contact members of the House Committee on Energy and Commerce, or find contact information online for your own House representative or Senator.






  • http://www.pqdna.com Andre Gous

    As the CEO of a DTC DNA biotech company, I read this blog post with mixed feelings. It makes me think of a really smart, strong and good kid going to a public school and continually being beat up. History suggests that he could stop or reduce the abuse if he made a stand, but instead he keeps appeasing his bullies by reasoning with them eloquently and politely, treating them as they were reasonable people and asking if they would please leave him some of his lunch money and if they please would not hit him in the face.

    As to the necessity of making a principled stand, good examples underlie much of the military history of the United States, as well as that of Britain when threatened by Nazi Germany. Neville Chamberlain favored appeasing Adolf Hitler; Winston Churchill favored opposing him. Unfortunately, by the time that policy of appeasement had been shown (yet again) to be a really bad idea, Hitler had had enough time to become greatly empowered, so Britain under Churchill faced a far more dangerous threat. If a bully keeps hearing that what he’s doing is morally OK, that he’s being reasonable, and that the only subject open to debate is the style of his bullying, then it’s only realistic to expect him to continue bullying and to become ever more empowered.

    If you think the above is an unfair comment, please re-read: “Some observers fear that the panel’s recommendations will severely curtail direct access to genetic testing, but we agree with Dan Vorhaus of Genomics Law Report that the FDA will take a reasoned approach to integrating the feedback it received from its panel with other information pertinent to the issue.”

    For the FDA to take a reasoned approach would require a complete reversal of its approach to date. History shows us that the worst butchers were the most sincere. They truly believed they had a historical role to play and that they were doing the right thing. Until I have reason to believe otherwise, I’m operating on the premise that the key decision-makers at the FDA, and behind the FDA, are sincere. They truly believe that individualism cannot be trusted and that their involvement is morally justified. On that premise, bureaucrats will diligently strive to expand the scope and reach of their power.

    Observing the events at the FDA-sponsored hearing in early March should shatter any doubts as to that point. The wolves howling for DTC blood aren’t simply going to stop existing. Although I would consider her as disqualified from being a spokesperson at any civil meeting, the FDA had the bad judgment to invite Nancy Wexler as a formal guest speaker, She advocates simply shutting down the entire DTC industry, period.

    FDA-sponsored panel at the hearing in general was a stampede towards subjugating DTC to control — of the FDA, of the MDs represented by the AMA, whatever. What basis does the DTC industry have to hope that the FDA suddenly make a complete course reversal and become reasonable? Why would it stop being driven by the agendas of those adamant about severe regulation of DTC — or worse?

    I like analogies, and the DTC industry as treated in the recent hearing reminds me of a professional dentist meticulously trying to ponder how best to deal with a patient’s dental problem, and then the FDA kicks the door open, says: “bad tooth? yank it!” and stomps out.

    If you feel inclined to rush to the moral defense of the FDA after reading this, think of the long history of atrocities that the FDA has committed, fundamental to its alleged reason for being. The basic premise behind its existence is opposition to the rights of individuals to interact and negotiate freely. Within its jurisdiction, the FDA declares solutions illegal on principle, and the only way that a solution can earn the bureaucratic seal of approval is if its proponent has massive funding and patience with which to grind his way through a bureaucratic gauntlet that comprises years of tedious work and millions of dollars.

    Nobody gets to opt out. If someone wants to offer his products to me as an individual consumer on the basis of whatever burden of proof he and I negotiate, then the FDA doesn’t recognize our right to interact as such. According to the FDA, everything in that field has to be FDA approved preemptively or it’s considered illegal. How many lives have been lost due to the FDA having delayed drugs from reaching the market sooner—or at all?

    I have commercial interests in fields other the DTC industry. On principle and in practice, I advocate a free-market economy, i.e., I have a problem with government regulation in general, not just for the DTC industry. But, I’m especially adamant about opposing government regulation in the field of DTC because this industry is so complex and delicate that government regulation is likely to have an especially negative effect. The sort of mind that can grasp the complexities involved in DTC is not the sort of mind that responds well to a regulated environment. As such minds have done since the dawn of time, the thinkers will withdraw and focus their energies elsewhere.

    Given all that, why is at anything but appeasement to announce that FDA regulation of DTC would, or could, ever be reasonable?

    In the face of this dilemma, what can one do? This is my biggest frustration with 23andme. It can so much to oppose this wrongdoing, and it doesn’t, thus putting at risk its very existence.

    I have recently read the precisely phrased, eloquent statement in Spittoon in which 23andme dismantled, last July, the statement officially published by the GAO. The 23andme statement shows the GAO as uninformed, and in no position to launch the sort of attack that underlies it entire campaign.

    Perhaps an analogy might be where the GAO audits carrot farms, and they study carrot seeds. The seeds look identical. But, even within the same farm, the carrots look very different! Some are large; some are small, some bent, and some straight. Clearly, there must be some tremendous inconsistency, something terribly wrong and crying out for government regulation, in how the farm grows its carrots because, dangit, how can they start multiple carrots from identical seeds and then gets such different results? The simple answer is that whoever drew such conclusions knows very little about carrots, and the entire study was a waste of time and money right from the start, if this was the sort of thought process being employed. Similarly, with DNA, expecting simple and consistent results shows a misunderstanding of the vast underlying complexities. By publishing its report, the GAO merely embarrassed itself — but it took someone with the eloquence of 23andme to explain this really well.

    That is one of the many reasons why I like 23andme. You understand the issues and you are eloquent in explaining them.

    So, here it is early 2011, and 23andme is in a battle against an FDA that (as I’ve described above) seems likely to shut it down. Every now and then, as I try to follow everything that’s going on, I read a 23andme statement emphasizing that 23andme supports FDA regulation but hopes for a better version than what is taking shape currently.

    In contrast with this approach, I am trying to build an alliance of DTC proponents whose opinion is: it makes no sense to appease the FDA and to support government regulation. To be blunt, at the rate we’re going, if you cheer for regulation, the only type of regulation you’re likely to get will be the type you saw taking shape at the Maryland hearings on March 8th, and they are likely to put 23andme out of business even if they don’t kill DTC off as a primary objective. Speaking out in favor of regulation is removing the only on-principle barrier, the only moral high ground, that there can realistically be against the FDA passing whatever measures it chooses to severely and destructively regulate DTC.

    I’m not writing this out of concern for just 23andme. In encouraging the FDA to come after the DTC industry on principle but with moderation, 23andme is also affecting other DTC companies (like mine) when the FDA decides to dispense with moderation, as we saw happen on March 8th.

    I’d prefer 23andme proponents of regulation to say (privately) that in your personal opinion, you would prefer a small amount of regulation as long as it met your standards of moderation. But, I hope you will also say publicly, officially, eloquently and loudly that any hope for moderation is unrealistic in the current context, and it would take a very differently-structured AMA, FDA and GAO before there is any hope of the moderation you would be OK with. So, realistically, if you endorse regulation, the only type of regulation you are — we are — likely to get is the sort of thing that is way worse — by your standards and mine — than no regulation.

    My hope is that 23andme comes out and says: “We have gone out of our way to play nice with the FDA. We have supplied speakers who are civil and reasonable. All that this has gained us is that the FDA mistook our civility for weakness. The FDA provided a highly biased panel whose agenda and methods are unacceptable, such as appointing Wexler as a speaker in what was supposed to be a civilly conducted hearing. Our approach of appeasement has failed. So, no more appeasement. If we don’t make a stand on principle, the FDA is simply going to proceed with its unreasonable agenda. If we can’t have regulation in moderation — and clearly we can’t — then the focus of the battle shifts, properly, to whether or not to have any regulation at all. And in that, the FDA is being unreasonably generous to itself in its usurpation of control, granting itself powers based on a 1976 law on medical devices, a law that was hardly written to kill off the DTC industry and whose application is, to put it mildly, a stretch. Since the only type of regulation we’re likely to get is unreasonable, we hereby retract our previous willingness to endorse regulation, and we’re now opposing the FDA on principle. The FDA had its chance to be moderate and it has failed. The FDA is out of control and it needs to be brought back under control. We will oppose the FDA (and its proxy, the AMA) morally and legally until enough people understand that the FDA is not a solution but a problem. Personal medicine is here to stay and those who oppose it are on shaky moral ground, and we plan to put out considerable eloquence into play to explain why.”

    In addition to the scientific and factual basis for such a stand, I’d like to refer you to the writings of author Ayn Rand, whose books have sold in the millions and whose ideas are having an ever-greater effect on American thinking. Ayn Rand has provided a logical analysis proving why government regulation isn’t just impractical but morally wrong. If 23andme chooses to make a stand on principle, there’s a lot of intellectual ammunition to draw on. The timing is interesting too, since Ayn Rand’s greatest novel, Atlas Shrugged, published in 1957, is coming out as a movie on April 15th. And, in the book, there is a part of the plot that has so many parallels to the GAO report that you almost expect to see “23andme” in the pages of the book.

    I hope that 23andme is ready to make a stand next to me, before it is too late. It is too late to fight for moderate regulation, but not too late to fight to maintain the status quo. Realistically, that’s our only hope. I’ve already started. I am asking 23andme to join me.

    Andre Gous
    CEO
    Precision Quality DNA

  • ryan s.

    How could genetic information given to a consenting, adult individual possibly cause harm?

    We aren’t ingesting it. We aren’t applying it to our bodies. It doesn’t give off radiation. IT’S INFORMATION. As long as it’s accurate, it’s no different than a personal story. My eye color, fingerprints, and other physical characteristics aren’t forbidden for me to see.

    Does the FDA think we are children? Or do MD’s just want to be able to make money off testing?

  • Jackson

    Matt Ridley discussed genetic testing and the FDA hearings in his Saturday 4/23 column in the WSJ
    http://tinyurl.com/ridley-WSJ-DNA

    He actually proceeded with his own personal DNA test (perhaps with 23andMe) because of a concern this easy avenue might not be available indefinitely.

    He basically agrees with the 23andMe position, partly out of an interest in the scientific findings that large-scale testing might uncover, and partly because the risk to the consumer is relatively intangible.

    Thanks for the original blog post above and keeping us informed.

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