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 Scrutiny Looms for Unapproved Research Tests." (Read the full version - subscription required.).
Following is an excerpt:
The U.S. Food and Drug Administration on Monday edged away from controversial plans to force manufacturers of unapproved diagnostic tests sold for research purposes to ensure that their customers don't use the products for commercial purposes, but there's still plenty of reason to believe that stronger enforcement is on the horizon, experts say. ?...
Bradley Merrill Thompson, an FDA expert at Epstein Becker Green, said the provision's removal was welcome and somewhat expected, given the amount of outcry.
"That was extreme, and they retreated a bit in the final guidance," Thompson said. ?...
Thompson offered a similar take, noting that the guidance "still says broadly that manufacturers must truly intend for their customers to use the product for research use only, or they run the risk of enforcement." ?...
"FDA's concern was that there was rather significant volume being sold for research purposes," Thompson said. "FDA was alleging that really nearly all of the companies in the industry were doing it to some degree or another."
