FDA/SCOTT GOTTLIEB: “Federal health officials this week allowed a genetic testing firm to sell kits to consumers to test whether they carry gene mutations that put them at higher risk for breast and ovarian cancer.
The action, part of a broader regulatory shift, is the first time the Food and Drug Administration has allowed a company—in this case 23andMe Inc.—to market such a cancer-risk test directly to the public.
It also touched off a debate about whether marketing such tests directly to consumers is an advance that will help them better understand their health risks, or a slippery slope to more mail-in tests that could be easily misread by patients and even doctors who don’t specialize in genetic mutations.
Under Commissioner Scott Gottlieb, the FDA has begun to ease the path to market of tests from an industry—called the laboratory-developed test business—that makes thousands of diagnostic tests and generates billions of dollars in annuals sales. In interviews and a policy address this week, Dr. Gottlieb laid out details of his lab-test deregulatory efforts, including the 23andMe decision. This new direction for the FDA generally reverses course from Obama-era plans to more closely scrutinize this industry.”
-Thomas M. Burton, “FDA Opens Way for You to Test for Cancer Risk by Mail,” The Wall Street Journal online, Mar. 9, 2018 05:30am