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DTC Genetics Services Hit Hard on the Hill as FDA Mulls Options

By Matt Jones

NEW YORK (GenomeWeb News) – Three consumer genomics companies caught flak on Capitol Hill yesterday from lawmakers and government witnesses at a hearing focused on direct-to-consumer genetic tests and the way they are sold and marketed — and they heard about very germ-phase plans the US Food and Drug Administration may be developing to find ways to regulate them.

At the Committee on Energy and Commerce hearing, the companies including 23andMe, Navigenics, and Pathway Genomics, were surprised with the delivery of a stinging undercover report from the Government Accountability Office stating that their services had been 'deceptive' and 'fraudulent' and that their predictive modeling services were nearly useless.

The Subcommittee on Oversight and Investigations also heard from FDA about its move, also announced yesterday morning, to alert 14 companies that they are selling medical devices without FDA clearance.

The morning saw a combination-punch from government to a young industry that so far has not been regulated, beyond CLIA certification and some individual state actions, that is not well understood in the public or in the clinic, and that has captivated some as the splashy vanguard of personalized medicine.

As GenomeWeb Daily News reported yesterday, the GAO conducted an undercover consumer operation that revealed questionable practices and mixed results at all of the companies whose services it used, including 23andMe, Navigenics, and Pathway Genomics.

"Posing as consumers seeking information about genetic testing on the Internet and through phone calls and face-to-face meetings, we found that 10 of the 15 companies we investigated engaged in some form of fraudulent, deceptive, or otherwise questionable marketing practices," the GAO report said.

GAO's Managing Director of Forensic Audits and Special Investigations, Gregory Kutz, outlined the findings of the report and played audio tapes of GAO's undercover consumers receiving misleading and potentially fraudulent counsel from some of the companies' representatives.

"In conclusion, our investigation results show that the tests results that we have received are misleading, and in many cases not of much value to consumers," Kutz told the committee.

"This is particularly relevant today as these companies are attempting to market these tests in retail stores across the country. These results should not detract from the great promise of genetic testing for certain diseases … although, genetic testing today appears to be more of an art and less of a science," he said.

Snake-Oil or Science?

Some lawmakers during the proceedings began referring to consumer genetics tests as mere 'entertainment,' and suggested that the results of the tests are confusing, lacking in any standards to the point of being useless, and that they are effectively snake-oil being sold as cutting-edge science.

"No one is more vulnerable to consumer fraud than a concerned individual about a family history or a disease," Representative Parker Griffith (R-Ala.) said. "No one is more sensitive to the mysteries of their bodies and genetic testing. And so the marketing of this particular aspect of medicine is … a minefield of fraud and abuse pushed by the profit motive," he continued.

"You've got a lot of hypochondriacs in our country, out there, and we're going to make maniacs out of them, I fear," Rep. Phillip Gingrey (R-Ga.) added.

"I fear that patients may jump to wrong conclusions, indeed they may even jump off a building, and create snap medical decisions simply out of fear or ignorance. Therefore, I believe that patients should have the benefit of medical advice when considering such test results," he said.

The subcommittee also heard testimony from FDA's Jeff Shuren, who is director of the Center for Devices and Radiological Health, on letters the agency has been sending to consumer genetic testing companies that ask the companies to explain to FDA why the products they sell are not medical devices and should not be regulated as such.

"FDA supports consumers having information about their genetic profiles. We just believe consumers should have results that are accurate, supported by sound science, and understandable. We're not being paternalistic, we're being patient advocates," Shuren told the subcommittee.

"If there's any issue here with the FDA," he responded to a line of questioning about steps FDA has taken regarding DTC genomics, "it's why didn't we act sooner.

"We should have acted sooner," he said.

Shuren added that a recent agreement between Pathway Genomics and the drug store chain Walgreen's to sell DNA collection kits "lit a stronger fire" under the agency.

"We started to see these companies market for higher risk claims, [and] more claims, and we thought it was time to take action," he said. "We also tried to sift through if these companies were making tests that might fall under our enforcement discretion as lab-developed tests, and we do not believe that these companies are making lab-developed tests."

FDA's 'Out-of-The-Box' Plans

Some lawmakers, including Committee Chairman Bart Stupak (D- Mich.), asked Shuren if FDA decided it wanted to regulate DTC genetics companies how it would go about doing so.

Shuren said that, currently, FDA is considering taking "a completely out-of-the-box approach on genetic testing" that would carve out a unique space in its regulatory tableau. This approach could involve looking at subsets of validation data on genetic variants that would enable regulators to make assumptions to trust the industry partners about some of the others.

"What we're thinking about is FDA, along with [the National Institutes of Health], pulling in from the healthcare community, pulling in from patient groups, and actually sitting there and going through the science," Shuren said.

He explained that such a regulatory council could set standards based on the available science and on the breadth and scope and veracity of the claims that the company is making in its marketing.

"And when we set the standards of what's good enough and when it's ready, then [we would] allow those claims. Those companies then would not have to come back in the door with a new application. We'd say, 'You already have a validated test, you can now make this claim,'" he said.

Shuren said that such a regulatory approach would "allow for a lot of tests to be out there" and that it "would actually be a much less expensive way of doing it for these companies as well."

23andMe General Counsel Ashley Gould told the subcommittee that her firm is ready to work with FDA to address its concerns and to discuss a regulatory structure that may work.

"Tomorrow we will present our regulatory proposal to the FDA," she told the hearing in her prepared remarks. "Our plan takes into account rapid technological innovation and ensures the analytical and clinical validity of all laboratory tests. In addition, we think new regulations should provide transparency across the industry so that consumers know what they're getting from the services they choose."

Gould, along with Navigenics CEO Vance Vanier and Pathway Genomics CSO David Becker, who also were witnesses, were unable to respond to many of the sharpest allegations from the GAO report because they had not seen it before the hearing.

In a statement issued later on Thursday, 23andMe said that "the GAO refused to discuss its flawed report with us.

"However, we embrace the ideas that the FDA offered today and look forward to helping to develop a regulatory framework that provides standards and transparency across the industry."

A Navigenics spokesperson told GWDN in an e-mail that the company is reviewing the GAO report. The firm said that it too received no advance notice of the report's contents and that it has submitted a request to GAO for further information about the investigation.

"We are confident that we can address any specific concerns raised by the GAO report and intend to issue a more detailed response to the report as soon as possible," Navigenics added.

"Navigenics has a long history of working with the appropriate regulatory agencies to ensure proper compliance of our genetic analysis services," it said.

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