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 multiple publications regarding the first direct-to-consumer genetic carrier test for bloom syndrome receiving FDA permission to market to consumers.
Following is an excerpt from MDDI:
“A few years ago, I would never of dreamed FDA would take this action,” said Bradley Thompson, member of the law firm Epstein Becker & Green P.C., in an e-mail. “But the agency genuinely seems to be trying to get out of the way of quality genetic testing. “23andme clearly gave FDA useful data – data that convincingly showed the safety and effectiveness of tests in this category. Frankly, in many cases, a little bit of data goes a long way. FDA needs some assurance that products are indeed safe and effective, and once they have that assurance they are able to lower the regulatory requirements.”
He added that the move shows how much can be achieved if the agency and industry can work collaboratively.
Modern Healthcare, 2/20/2015