Genomics Law Report's Dan Vorhaus questions the distinctions in the FDA's policy on direct-to-consumer genetic testing kits. In a comment to the New York Times, Vorhaus says, the FDA seems to be singling out over-the-counter tests for regulatory review. But, Vorhaus asks, is point of sale really an appropriate distinction to make? Would the FDA's response have been different if Pathway Genomics had partnered with Wal-Mart or Amazon.com instead? As it turns out, Vorhaus writes, DTC genetic tests are already available on Amazon. "23andMe's Amazon availability certainly was not widely publicized in the way that Walgreens and Pathway Genomics announced their plan to stock Pathway's tests on Walgreens' shelves," Vorhaus says. "So, is that the fundamental difference here? That Pathway partnered with a commercial retailer and turned it into a PR event, while 23andMe did not? Or is it that the FDA simply is unprepared to take its regulatory approach to DTC genetic testing beyond the corner drugstore?" And 23andMe hasn't exactly been subtle when it comes to marketing, he adds. They've used blimps and product giveaways, hosted "spit parties," and Time Magazine even declared the company's "Retail DNA Test" the greatest invention of 2008. Whatever FDA's standards are, Vorhaus says, one thing is clear: "The FDA needs to deliver much clearer guidance to the DTC industry, including prospective DTC companies, customers, and investors."
FDA Cherry-Picking Its DTC Fights?
May 14, 2010