Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Pharma & MedTech Business Intelligence’s The Pink Sheet Daily, in “US FDA’s New Game Plan for Digital Health,” by Ferdous Al-Faruque. (Read the full version – subscription required.)
Following is an excerpt:
At least one industry representative said the announcement from Gottlieb was a highly positive development for health software developers. “Holy smokes. It’s amazing what an election will do;” said Bradley Thompson, counsel for the Clinical Decision Support (CDS) Coalition, an industry group of health-care software developers. “All in all, I feel like I’ve died and gone to heaven:” …
Thompson, with the CDS Coalition and also an attorney with Epstein Becker & Green, strongly supports the concept, and says it is one his group has advocated for. “In advocating for the pre-check idea, we have advanced the notion that software creates certain unique opportunities to collect data on an almost rea l-time basis from the marketplace, and make continuous improvement through changes to the software;” he said. “We’ve argued that that strength of the software development model could be used as a basis for creating the expedited pathway to market. It would seem as though FDA is interested in pursuing that line of thought:’ …
Thompson says that since 2011, the CDS Coalition has been urging FDA to publish guidance to clarify the scope of its oversight of clinical decision support software and tackle other unresolved digital health issues. While even just a few months ago, the agency seemed unsure what to do in the area, the attorney noted, Gottlieb now appears to be accelerating forward. “That is music to my ears;” Thompson said. “Indeed, it seems that FDA is committed to going beyond just the technology addressed in the 21st Century Cures Act;” he said. “Legislation always covers at best a few of the larger categories, and there is truly much more work to be done. Although it is not specifically addressed, we are very hopeful that the plan includes addressing software used in connection with pharmaceuticals:”
