Bradley Merrill Thompson Quoted in Article, “FDA: Bill Has Indirect Moratorium on Apps”POLITICO Pro May 17, 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 "FDA: Bill Has Indirect Moratorium on Apps," written by Brett Norman.
Following is an excerpt:
The FDA's head of device review says the mobile medical app provision added to the Senate's user fee bill Tuesday night is a de facto moratorium on its guidance for the app industry?...
The language, now backed by the HELP Committee leadership, requires FDA to undertake a sweeping multi-agency report that would lay out a strategy for "an appropriate, risk-based regulatory framework pertaining to medical device regulation and health information technology." It would have to produce the report with the FCC and the Office of the National Coordinator for Health Information Technology?...
West Wireless Institute sent a letter to HELP staff Wednesday objecting to the effective moratorium, and Brad Thompson, general counsel of the mHealth Regulatory Coalition, said his group strongly opposes the measure.
"I'm all for FDA moving with all speed to finalize the guidance. This kind of report, with the working group and three government agencies, could easily take the full 18 months," said Thompson, referring to the deadline provided in the Senate's user fee bill.
Thompson said the delay will leave the industry in the dark for that much longer as to what is expected from the FDA.