Looking Ahead After the FDA’s DTC Meeting

Day one of the FDA’s two-day public meeting on the future of clinical DTC genetic testing is in the books. Those unable to attend in person were, unfortunately, forced to resort to Twitter coverage of the proceedings as the government declined to provide a live webcast. (I’m told there will not be a recorded webcast either. Perhaps the FDA is engaging in preventative cost-cutting.)

The first day was divided into three roughly equal parts: background presentations from the FDA and invited speakers, a second set of “public presentations” by companies and individuals who requested time to present their views and, finally, public deliberations by the Molecular and Clinical Genetics Panel (“MCGP”). Tomorrow will feature more public presentations, several more sessions of MCGP deliberations and, at the end of the meeting, recommendations from the MCGP to the FDA on the questions presented (pdf) by the FDA.

A Familiar Feeling to Day One. The first two sessions, which featured presentations to the MCGP, followed a fairly familiar script. Opponents of clinical DTC genetic testing worried that incorrect or misinterpreted tests could produce harmful outcomes, and questioned whether there was anything of value to be gained from the tests in the first place. Proponents argued that the DTC model empowered patients to explore their genetic selves without any ill effects. For those who attended or followed last summer’s two-day public meeting to discuss the FDA’s proposal to regulate laboratory developed tests (LDTs), much of the conversation echoed what was said on day two of that meeting during the direct-to-consumer (DTC) session.

At Genetic Future, Daniel MacArthur has done a very nice job of summing up the morning session, which included a well-balanced presentation from Dr. Elizabeth Mansfield, OIVD’s Director of Personalized Medicine, on the past and present of DTC genetic testing regulation, and a whirlwind tour of global trends in consumer genetics regulation by Dr. Stuart Hogarth of King’s College London. There was also some particularly strident anti-DTC rhetoric, which was followed by my own presentation urging both the FDA and the MCGP to provide clear and forward-looking DTC oversight.

The MCGP’s (Likely) Recommendations to the FDA. The purpose of all of the presentations, however, was merely to arm the MCGP with the necessary background information and context to deliberate and, tomorrow afternoon, offer a set of recommendations to the FDA on the appropriate regulatory strategy for clinical DTC genetic tests. When the MCGP hands out its recommendations I will, unfortunately, be on an airplane. But based on what transpired today, I have some strong suspicions about what the MCGP’s recommendations will entail.

First and foremost, I fully expect the MCGP to note, likely more than once, that given the complexity of the questions put to it by the FDA it should be afforded far more time to deliberate and research prior to making any recommendations. Particularly in today’s afternoon session, several panelists appeared frustrated by the FDA’s request to offer up or down votes on broad questions without being afforded adequate time to understand, let alone fully debate, all of the pertinent issues. However, given that the MCGP has met only once previously, despite being chartered in 2008 (pdf), additional deliberation is almost certainly not in the cards.

If taking time out for further debate isn’t an option, what is the MCGP likely to recommend? Based on today’s deliberations, I think it’s a safe bet that the MCGP will advise the FDA to (1) demand clear proof of analytical and clinical validity for all genetic tests and (2) require that most, or perhaps even all, genetic tests with demonstrated or potential clinical significance be (to use the FDA’s terminology) “routed through a clinician.” The format (21 panelists, with very limited time to discuss a large number of issues) makes anything resembling true “consensus” elusive, although a majority (but not all) of the panelists did appear to agree on those two general points.

In other words, I think the odds strongly favor an MCGP recommendation to the FDA that clinical (as defined by the FDA, which is itself a separate issue) direct-to-consumer genetic testing, when offered without a requirement that a clinician participate in the ordering, receipt and interpretation of the test, be removed from the marketplace. At least for the time being.

The (Likely) Significance of the MCGP’s Recommendations to the FDA. Of course, I could be wrong. The MCGP could surprise us all and offer a ringing endorsement of DTC genetic testing, citing individual autonomy, a need to pursue innovative models of genetics research and consumer education and an increasingly engaged and intelligent consumer cohort as reasons for the FDA to keep its hands off of DTC genetic testing. And pigs could fly.

Whatever the MCGP’s recommendations, whether for or against DTC genetic testing, my advice will be the same: move on.

Throughout the day the FDA was clear that it was asking the panel for assistance with a fairly narrow set of questions. Not on the table: whether DTC genetic tests will be regulated. They will be, at least for analytical and clinical validity. Exactly what that regulation will look like will be heavily influenced by how the FDA ultimately decides to regulate LDTs. For purposes of the MCGP’s recommendations, the FDA appears to be interested solely in the narrower question of when, if at all, a genetic test should be offered directly to consumers.

Even on this question, which is clearly an important one for the DTC industry, we should be careful not to inflate the importance of the MCGP’s recommendations. While they will be the most recent, and certainly the most public (by statute, MCGP meetings are open to the public absent a specific reason for closure) DTC recommendations, they will remain but one set of non-binding recommendations among many sets of recommendations, solicited and unsolicited, received by the FDA.

Furthermore, the MCGP’s composition (the panel’s 21 members feature 18 clinicians and academics, one consumer representative, one patient representative and one industry representative) and fairly obvious inexperience with DTC genetic testing technologies, products, companies and issues should diminish the weight the FDA lends to its recommendations. Whatever you may think of the FDA’s DTC policies to date, or lack thereof, the agency has been considering how to regulate DTC genetic tests for years, and is clearly more knowledgeable on this topic than its own advisory panel.

Ultimately, while it’s hard to find fault with the FDA for holding a public meeting on a topic of such public interest, it has been even harder to locate any indication that this meeting, or the MCGP’s recommendations, will significantly alter the agency’s thinking on the topic of clinical DTC genetic testing. Barring something completely unexpected tomorrow, I’m standing by my prediction (most recently here and here) that industry-wide DTC regulation by the FDA in 2011 is unlikely. Whether or not that’s a good thing, however, remains to be seen.