Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Inside Health Policy Daily News, in “Senate Democrats Raise Major Concerns October 11, with FDA Software Pre-Cert Plan,” by David Roza. (Read the full version – subscription required.)
Following is an excerpt:
Three Democratic senators wrote to top FDA officials Wednesday (Oct. 10) that they have “serious concerns” about the agency’s emerging precertification program, where precertified software developers would not be subject to premarket review. In the letter, Sens. Elizabeth Warren (MA), Patty Murray (WA), and Tina Smith (MN) ask what statutory authority FDA has to establish the program; what criteria FDA will use to evaluate firms; and how FDA will continue to hold firms to standards of safety and efficacy once they are pre-certified. …
The questions raised in the letter closely resemble those raised by Brad Thompson, a member of the firm at Epstein Becker Green, who wrote to FDA in July, as general counsel for the Clinical Decision Support Coalition, saying that his group, while strongly supporting FDA’s pre-cert idea, worries that the initiative is outside the agency’s statutory authority.
“[I]t appears that the senators share our concern that FDA will need statutory authority for what the agency envisions doing,” Thompson wrote Inside Health Policy. “I think everyone — all stakeholders — are going to need some time, probably 90 days given the complexity of this program, to digest it and offer feedback to FDA before the agency launches into a pilot program. My fear is that if the agency invests time and money in testing the program before getting adequate feedback from the public on the design, the agency will be wed to its draft. I think there will be a lot of people who will suggest changes once the details become known. The details here are hugely important.”