Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted by Bloomberg BNA in, “FDA Targets More Firms Marketing Genetic Tests.”
Following is an excerpt:
Attorney Bradley Merrill Thompson, of Epstein, Becker and Green, told Bloomberg BNA in a Dec. 9 e-mail, “I applaud the FDA for letting companies know when they have wandered into FDA regulated waters. These letters are gently worded in an effort to inform those who have accidentally crossed the line without knowing it.”
“I think what is going on here is that these companies have … drifted into a direct to consumer model,” Thompson said. “That heightens the public health risk substantially and is consistent with FDA’s approach that companies like 23andMe are regulated,” he said, referring to a prominent company that was the target of an FDA letter.