Sunday, December 8, 2013

FDA harries 23andMe

image from
Dec 5 2013
"After discussion with officials from the Food and Drug Administration today, 23andMe will comply with the FDA’s directive and stop offering new consumers access to health-related genetic tests while the company moves forward with the agency’s regulatory review processes."

"23andMe has been giving consumers access to health information for six years and is committed to finding the right regulatory path for our customers."

"Our lab partner adheres to strict quality standards that are part of the 
Clinical Laboratory Improvement Amendments of 1988."

"As we work with the FDA to get clearance, there will be some significant changes to the site.  Customers who purchased kits on or after the FDA’s warning letter of November 22nd will not have access to health-related results. Those customers will have access to ancestry-related genetic information and their raw data without 23andMe’s interpretation of that data. They may receive health-related results in the future, depending on FDA marketing authorization.

Customers who purchased kits before November 22, 2013 will continue to have access to all the reports they’ve always had."
"This is clearly a much different service than in the past, so we are offering customers who purchased kits on or after November 22, 2013 a full refund if they wish."
"Research is and will continue to be a significant priority for the company.  The 500,000+ customers we have today have given us more than 250 million survey data points."

Dec 3 2013
Other repercussions
"While Illumina supplies chips to the other three leading consumer genomics testing providers –, Family Tree DNA, and National Geographic's Genographic Project – Ro wrote that 23andMe is the "largest customer in this segment," and estimated that sales to 23andMe account for half of the firm's consumer genomics-derived revenues, or about $25 million."

Nov 26 2013
"We stand behind the data that we return to customers — but we recognize that the FDA needs to be convinced of the quality of our data as well."

"This is new territory for both 23andMe and the 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."

Nov 22 2013
"In a Nov. 22 warning letter, signed by Alberto Gutierrez, director of FDA's Office of In Vitro Diagnostics and Radiological Health, the agency asked 23andMe to "immediately discontinue marketing" its Personal Genome Service "until such time as it receives FDA marketing authorization for the device."

"FDA's action against the Google-backed, Mountain View, Calif.-based firm has ignited a public outcry, with customers petitioning the government to allow 23andMe to maintain its business and one California woman filing a class action lawsuit against the company and asking for her money back."

"Two groups have submitted petitions to We the People and to seeking to collect 100,000 and 10,000 signatures, respectively."

"With other prominent health-oriented DTC genetic testing companies like Navigenics and Decode Genetics being swallowed up by other firms and no longer offering DTC services, 23andMe has for some time been the only option for people who wished to know about their genetic predisposition for diseases and their likelihood for responding to various drugs without having to visit their doctors for a prescription."
--> Navigenics acquired by Life Technologies
--> DeCode acquired by Amgen

"It's clear from the FDA's warning letter that the agency and 23andMe have had extensive interactions – 14 meetings, hundreds of emails, and dozens of written exchanges – about its Personal Genome Service since 2009. "Even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions," the FDA states in its letter."

" the agency [FDA] informed the companies that it considered these types of tests medical devices, which require regulatory clearance or approval."

"Unlike its competitors, who in the face of regulatory pressure quickly shifted their marketing strategy to physicians, 23andMe fought to keep its direct-to-consumer philosophy during public hearings and before Congress."

"Based on the latest warning letter, however, FDA's issue with 23andMe seems not so much that the company performs genetic testing in a lab without its blessing, but that consumers can go online and order tests for serious health-related conditions without a doctor's prescription."

Opinions from The American Clinical Laboratory Association (ACLA), a group representing the interests of the lab industry that has been staunchly against FDA regulation of LDTs. "This is not really an issue of whether the spit kit is a component, and therefore any tests that have components that are regulated are medical devices. The issue is DTC. The whole issue there is how they're ordered and also how they're marketed."

Non-comprehensive testing by 23andMe
""We've actually had some of their customers come to us for BRCA testing and say that they thought that 23andMe was offering a more comprehensive test than they actually were," said Rogers. "That firm only tests for 0.02 percent of relevant bases that are important for gauging hereditary breast and ovarian cancer risk."

"What we learned [through discussion with the agency] is that the FDA doesn't want companies saying anything about a likely medical condition, unless the company is a doctor," Bennett Greenspan, Gene by Gene managing partner and CEO of subsidiary FamilyTreeDNA"

23andMe response
"23andMe declined to comment for this article. In a letter to customers, CEO Anne Wojcicki acknowledged that the firm had fallen behind schedule in responding to the agency's requests."

Disclaimer in 23andMe products:
"However, not every 23andMe customer will receive reports that are directly useful for their health like Durrett did. And 23andMe isn't promising that, at least not in the fine print. The company's terms of service, to which customers have to agree to before buying its tests, states in plain language that the results it reports are for research and informational use only and not meant as medical advice. "While we measure many hundreds of thousands of data points from your DNA, only a small percentage of them are known to be related to human traits or health conditions," the company says in the terms of service.
Furthermore, the company notifies customers that they might learn things about their health that they don't anticipate and they shouldn't change any behaviors based solely on 23andMe's reports. "You should not assume that any information we may be able to provide to you, whether now or as genetic research advances, will be welcome or positive," 23andMe says."

Online response
23andMe advocate: "The FDA seems to think that Americans can't be trusted with more information about their potential health risks because some people might make rash decisions with it. But banning personal genomics isn’t the answer," TechFreedom, a non-profit that promotes technological progress and individual choice"

Berin Szoka, president of TechFreedom and a 23andMe customer, wrote the petition based on his own experience discussing genetic testing with his doctor. The organization believes that instead of restricting 23andMe from offering genetic testing directly to its customers, the agency should educate doctors about the risk and benefits of such testing. "Those of us who have already used the site know the real problem is that doctors themselves are behind the curve," TechFreedom says in the petition. "The only profession slower to change how they do things than doctors is bureaucrats."

"Our point is that 23andMe is providing a much-needed catalyst for change in the medical profession: Getting patients to make the first move," Szoka told PGx Reporter over e-mail."

FDA Advocate : "Having spent some time at the FDA, Ramamurthy is rather amused by the argument that regulation of DTC genetics firms is paternalistic. "If I were to follow that logic, I would say drawing yellow lines on highways is paternalistic. I would think having speed limits is paternalistic," he quipped. "I find the argument about paternalism really disingenuous, unless we live in a free-for-all."

Education to the public
"Although Casey believes there are thousands of 23andMe customers who share her view and want their $99 back, it's hard to know at this point how strong her case is. "Who are the customers?" Conley posited in his blog post. Beyond the dedicated genetic hobbyists, "how many people can there be who (1) know enough to seek out a genetic testing product, but (2) know so little that they’d rely on a cheap and vastly underpredictive consumer product to make heath or reproductive decisions?"

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