Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "FDA Tells 23andMe to Stop, Get Clearance."
Following is an excerpt:
In a public letter dated November 22, the Food and Drug Administration has instructed personal genome startup 23andMe to immediately stop selling its testing service until the offering receives de novo 510(k) clearance. Regulatory Focus first spotted the letter. ...
Bradley Merrill Thompson, an attorney for Epstein Becker Green and an expert on the FDA's regulation of medical devices, told MobiHealthNews there is an element of public performance to Gutierrez's letter.
"This letter to 23andme is a bit unusual in that the agency goes to great lengths to explain the effort the agency has put into helping this company come into compliance, apparently without success," he wrote in an email. "Apparently FDA is concerned about public opinion, and wanted to take this opportunity to let everyone know just how much the agency has invested in trying to help."
Thompson went on to say that FDA regulation of genetic testing is one of the more complicated sectors of FDA's purview.
"The issue is a very thorny one. FDA regulates disease-related claims, but not wellness related claims," he wrote. "Generally, companies marketing genetic tests directly to consumers have been in a tug-of-war with FDA to figure out exactly where the dividing line is between disease and wellness. Genetic testing companies argue that simply identifying the genetic makeup of a person is general information that allows for healthy living, but FDA seems to be arguing on a case-by-case basis that they are going beyond that into the realm of disease diagnosis and treatment."
