Bradley Merrill Thompson Quoted in Article, “Bill Risks Confusion to Curb FDA’s Already-Lax App Oversight”Law360 October 29, 2013
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 "Bill Risks Confusion to Curb FDA's Already-Lax App Oversight." (Read the full version — subscription required.)
Following is an excerpt:
A bipartisan bid to restrict federal oversight of mobile medical apps could create confusion as it tries to solve a problem many observers say doesn't really exist, given the U.S. Food and Drug Administration's hands-off approach to the software so far.
The bill unveiled last week, sponsored by three Republicans and three Democrats, would allow FDA to continue policing apps that function as medical devices but would bar the agency from supervising less-risky software. ?...
Bradley Merrill Thompson, a leading apps expert who practices at Epstein Becker & Green PC, described the rhetoric about oppressive regulation as baffling, given what seems to be a dearth of actual regulation.
"They have had a bee under their bonnet for months now, and I don't get it. I've been doing this for 30 years, and I have never seen FDA be this hands-off," Thompson said. ?...
Thompson said that concept would please manufacturers who "express great frustration" with FDA, but that it could backfire on the industry by muddying the regulatory waters.
"If in addition to separating the regulatory schemes we layer on top of that separating the regulators, we face the very real potential of having to deal with two different agencies trying to regulate the gray area in between," Thompson said.
"Personally," he added, "I think we need to view software collectively as a system and figure out a more unified approach, as opposed to trying to create distinctions and separations that lead to regulatory overlap and conflict."