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 in The Wall Street Journal, in “FDA Signals Easier Rule on Genetic Tests,” by Thomas M. Burton and Brian Gormley. (Read the full version — subscription required.)
Following is an excerpt:
But the agency’s latest decision on the one 23andMe test, and others like it, was regarded as surprisingly lenient. “Not only are they clearing the 23andMe product, but they are also declaring that future tests will not need to undergo FDA clearance,” said Bradley Merrill Thompson, a Washington attorney with the firm Epstein Becker & Green. “A few years ago, I would never have dreamed FDA would take this action.”