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 "Attorney: Proposed mHealth Bill Will Do Little Without More FDA Funding." (Read the full article - subscription required.)
Following is an excerpt:
Rep. Mike Honda (D-CA) plans to introduce legislation in the lame duck session that he says will provide more support for mobile health developers, remove regulatory burdens to encourage involvement in healthcare technology, and ensure mobile health issues are "front and center" at FDA and other agencies. ?...
Bradley Merrill Thompson, an attorney at Epstein, Becker & Green, said the new office could add consistency to reviews of mobile health application platforms by centralizing reviews to one office, with applications currently reviewed by different divisions within FDA based on their therapeutic area.
"Platform issues at the heart will be the same and we want to make sure that they're dealt with in a consistent manner," he said.
The office also could provide educational outreach to people who needed to learn how to navigate FDA's requirements as well as serve as an advocate for mobile health development within the agency by evaluating how FDA guidance could impact mobile health, Thompson said.
Yet, Thompson said he was doubtful as to whether Honda's proposed bill would be able to address barriers to mobile health development like privacy issues. ?...
Further, Thompson said although the idea of having a separate mobile health office within FDA's Center for Devices and Radiological Health has been floated by industry groups, there was no specific push for legislation. He added that Honda has not mentioned providing additional funding to FDA for the proposed office. FDA needs more staff to support device center policy advisor Bakul Patel, who oversees mHealth activities at the agency, Thompson said.
"There's only so much Congress can do from Capitol Hill," he said. "Maybe creating this office is what they can do. The fact of the matter is offices don't make changes, people do. The first thing FDA will say is 'show me the money'. I'm very sympathetic to FDA's plight."
