Bradley Merrill Thompson Quoted in Article, “mHealth Coalition Presses FDA to Revamp Mobile App Guide, Seek More Input”FDA Week January 27, 2012
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 "mHealth Coalition Presses FDA to Revamp Mobile App Guide, Seek More Input," written by Alaina Busch.
Following is an excerpt:
A coalition of mobile health companies is pressing FDA to revamp its draft guidance on mobile medical applications to better define topics like accessories, wellness claims and electronic health records, and said the overhauled guidance should then go through a second comment period.
Bradley Merrill Thompson said the agency's lack of clarity is raising questions about development for companies trying to get into the mobile health market and enforcement for established companies already subject to a stringent regulatory framework.
"On the approvals side there are companies that are considering jumping into this space, but they don't know exactly where the lines are drawn," Thompson said.
Thompson pointed out that there has been little enforcement against companies making unapproved claims, which could impact the larger device companies that are already complying with regulations.
While on the one hand FDA is saying that mobile health is important and it does not want to hinder innovation, the agency should not refrain from taking enforcement action when necessary, Thompson said.
"They're basically going after these regulated markets with unregulated products," he said. Thompson said some mobile products are "so far over the line" that they do not get into the more nuanced questions about FDA's regulatory framework, which he says should be clarified before FDA expands enforcement.