Bradley Merrill Thompson Quoted in Article, “Draft Bill Aims to Clarify FDA Regulation of Mobile Medical Apps”The Gray Sheet July 15, 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 "Draft Bill Aims to Clarify FDA Regulation of Mobile Medical Apps."
Following is an excerpt:
Rep. Marsha Blackburn, R-Tenn., is circulating draft legislation with bipartisan co-sponsors aiming to limit and clarify FDA's purview over mobile medical apps.
The draft bill obtained by "The Gray Sheet" has been sent to stakeholders in the health information technology space for feedback, with comments due July 12. The lawmakers, including Reps. Diana DeGette, D-Colo.; Phil Gingery, R-Ga.; Gene Green, D-Texas; and Greg Walden, R-Ore., plan to incorporate changes to the bill based on the feedback soon, according to a source in Blackburn's office. The draft bill was also distributed to FDA officials.
While the proposal is still in discussion stage, it has attracted a broad critique from at least one stakeholder. Bradley Merrill Thompson, an attorney who heads the mHealth Regulatory Coalition, says he sees the draft as flawed both in its premise and its execution.
"I disagree with the cover message that declares FDA is somehow moving in the direction to hurt the industry and ultimately patients," Thompson wrote in an email to "The Gray Sheet." "I have seen no evidence of that, and certainly my reading of the mobile medical app draft guidance suggests FDA, in contrast, is actually trying to deregulate this area. To suggest that this legislation is necessary to hold off FDA is flat wrong."
Thompson also says the drafting of the bill is not tightly executed. "All [the legislation] does is shift certain technologies from the medical device definition into the newly created category called medical health technology. Once in that new category, products are subject to all of the same regulation at FDA as devices are."
Thompson argues that words like "integral" and other terms are overly broad and hard to interpret. "We have run several use cases through the legislation and it simply ends up absolutely befuddling us as to whether they are medical health technology or not."