New York, New York (PRWEB) December 02, 2013
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs and medical devices, agrees with the recent move by the U.S. Food and Drug Administration (FDA) to stop 23andMe from marketing and selling its genetic testing products to the public because the devices require—and have not obtained—the agency’s approval. The FDA issued a warning letter to the company dated Nov. 22 in which it noted that the company has been selling its Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval, which puts the products in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act). The FDA explained that each product should be considered a medical device “because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.” A key problem for the FDA, according to the letter, is the public may misinterpret the results of the tests—which could be inaccurate to begin with—and then pressure their doctors into performing unnecessary medical procedures.
The FDA said that it found some of the intended uses of the PGS product particularly concerning, as a Nov. 25 Reuters report noted, adding that these uses included risk assessments for various kinds of cancers. Of particular concern for the agency, Reuters reported: false positive tests for certain breast or ovarian cancers—because they could cause a patient to undergo preventative surgery, including a mastectomy or other potentially risky procedures. At the same time, a false negative could result in a failure to recognize and act on an actual risk, Reuters added.
“False negatives and false positives are a major concern,” said Gary Falkowitz, Managing Attorney at Parker Waichman LLP. “It also seems likely that there is a greater chance for results to be incorrectly interpreted without the practiced eye of a doctor present to clarify results. We agree with the FDA that these products are medical devices and should be treated as such. Always better to err on the side of caution.”
The letter also highlighted that the FDA’s urgency in ordering the company to yank the products off the market has to do with 23andMe’s new marketing campaign, which includes television spots. The concern is that the campaign reveals that the company is planning “to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA.” Google-backed 23andMe “is accelerating its mass-market push with national ads and a media campaign,” Bloomberg Businessweek noted in a Nov. 27 report, adding that mainstream marketing increased the FDA’s concern over the risk that “less sophisticated consumers might cut off their breasts or stop taking a life-saving drug after reading an analysis of their spit.”
The FDA letter also revealed that 23andMe had been working on getting FDA approval, but didn’t follow through after its initial efforts. “… to date, your company has failed to address the issues described during previous interactions with the Agency or provide the additional information identified [in previous letters from the FDA]… To date, 23andMe has failed to provide adequate information to support a determination that the PGS is substantially equivalent to a legally marketed predicate for any of the uses for which you are marketing it…”
If you have purchased a genetic testing product from 23aboutMe or another company, you may have valuable legal rights. To find out more, please visit our 23aboutMe webpage or contact one of our experienced lawyers today at 1(800)-LAW-INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney