23andMe: State of the Debate

By Bio-IT World Staff

November 27, 2013 | In an email to 23andMe customers this afternoon, CEO Anne Wojcicki wrote: “I apologize for the limited response to the questions many of you have raised regarding the letter and its implications for the service. We don't have the answers to all of those questions yet, but as we learn more we will update you.”

The email is the latest installment in a storm of responses and updates since FDA’s letter to 23andMe was posted on Monday, and highlights how many questions are yet to be answered.

The one thing everyone agrees on is that the FDA’s letter dated November 22 was particularly stern. “23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device,” the regulatory body said.

Some people responded with outrage, accusing FDA of targeting 23andMe, shutting down the company, shutting down the industry, and being paternalistic. A petition, originating in Cambridge, Mass, called for the Obama administration to overrule the FDA’s decision. “The FDA grossly overstates the risks associated with 23andMe's assessments,” the petition, which has 2,446 signatures so far, says. Yet it then goes on to call the kits “life-saving diagnostics kits”. Daniel MacArthur thought that worthy of a facepalm hash tag:

Petition against FDA on @23andMe undermines itself by using term "potentially life-saving diagnostic kits": http://wh.gov/lKu2R #facepalm

A curious question is what the FDA letter actually demands of 23andMe. The letter directs the company to “discontinue marketing” their Personal Genome Service. The wording is unusual. “While the FDA is not necessarily requiring 23andMe to cease and desist sale of the product, prohibiting 23andMe from marketing the device effectively accomplishes the same thing,” Bass, Berry & Sims Healthcare regulatory attorney Meredith Edwards Collins told Bio-IT World. “In other words… 23andMe cannot ‘introduce the products into interstate commerce for commercial distribution’ until the FDA issues ‘marketing authorization.’”

Yet the kits are still available for purchase on the 23andMe site.

But for many, the key phrase in the FDA letter was not “immediately discontinue” but rather, “FDA has not received any communication from 23andMe since May.”

Revealing what seems to be cumulative frustration, the FDA letter details correspondence with the company since July 2009: “more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications.” Yet 23andMe has not responded to anything since May.

Matthew Herper at Forbes calls the move stupid:

“Either 23andMe is deliberately trying to force a battle with the FDA, which I think would potentially win points for the movement the company represents but kill the company itself, or it is simply guilty of the single dumbest regulatory strategy I have seen in 13 years of covering the Food and Drug Administration.”

23andMe did respond to the letter on Monday in a Facebook posting. The initial response, also posted on the 23andMe blog, is only 52 words long:

“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.”

The next day, Anne Wojcicki posted a longer note on the 23andMe blog (with some of the same wording used in the customer email today). She was adamant that 23andMe data are accurate, but also conciliatory toward FDA. “We… acknowledge that we are behind schedule with our responses,” she writes. “The relationship with the FDA remains critically important to 23andMe.”

The problem that many people have with 23andMe’s behavior is summed up by Wojcicki in her post. She acknowledged that this is new territory for FDA:

“This makes the regulatory process with the FDA important because the work we are doing with the agency will help lay the groundwork for what other companies in this new industry do in the future. It will also provide important reassurance to the public that the process and science behind the service meet the rigorous standards required by those entrusted with the public’s safety.”

If it’s so important, why isn’t 23andMe participating?

John Wilbanks sees 23andMe’s long silent treatment toward the FDA as a reflection on the strength of their data. With hundreds of thousands of gene panels performed, 23andMe has gathered more information than anyone on how genetic variants relate to human health. If they have refused to engage with the FDA, he posits, their tests are either so well validated that the company expects to emerge victorious from a confrontation, or so poorly validated they can’t afford to expose their data to the public eye.

Wilbanks worries that the latter is the case. They’ve framed themselves as a daring company, he says. “But they’re going after the FDA with this strategy. And if you come at the king, you best not miss.”

If the company has been stalling, they’ve been busy while doing so. Since May, when the FDA says 23andMe stopped communicating, Wojcicki announced that the company had dropped the price of genotyping to $99 in hopes of getting one million customers by the end of the year and enabling “really truly disruptive” research. In August, the company launched a television marketing campaign.

“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 sounds as though 23andMe did not just ignore the FDA, but, while walking briskly past it, quickly turned and spat in its face,” said Hank Greely in a blog for Stanford’s Center for the Law and the Biosciences.

Greely seeks to discern what role the FDA sees for itself in regulating direct-to-consumer (DTC) genetic tests. “The FDA thinks it can and should regulate, to some extent, those tests,” he points out, noting also that difficult-to-achieve clinical validation seems to be key to passing muster with the agency. But he also says the FDA has been promising a draft guidance on genetic tests for months, and hasn’t delivered.

He highlights FDA’s approval of Illumina’s clinical sequencing platform, MiSeq Dx, and cystic fibrosis tests—just days before the letter to 23andMe—as proof that the future is in clinical sequencing, and the DTC SNP chip era is ending.

If DTC isn’t dead, Michael Eisen takes a step back from this regulatory action to interrogate the ideal role for FDA in the DTC genetic testing market. Eisen (a 23andMe advisor) starts from the principle that people have a right to access and understand their own genomes. He points out that 23andMe is filling the vital niche of interpreting genetic data for those who lack the skill to interpret it themselves.

Since consumers generally have no way of fact-checking those interpretations, he says, “it is vital that the FDA protect consumers… by monitoring genetic information that is provided by [companies].” That said, the standards of medical devices are probably too strict for today’s genetic testing services, as human genetics are simply not well enough understood to deliver clinically validated reports. Eisen calls for a middle ground for honest reporting with regulatory oversight.