Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MobiHealthNews, in “In-Depth: News, Novel Quotes, and Notable Trends From the mHealth Summit 2014,” from his participation as a speaker at the mHealth Summit 2014.
Following is an excerpt:
Later in that same session, Epstein Becker’s Brad Thompson responded to a question from AliveCor co-founder Dr. Dave Albert about health startups calling the FDA directly if they had a question. Thompson: “Calling the FDA has great advantages and two limitations. Number one, I think a lot of us can tell you that the answer you get depends on who you call. It’s kind of like the IRS hotline. They did a study on calling different operators there and getting different answers to the exact same question. So you have to understand the quality of the answer you are going to get depends on who you are asking. Then there is not a dilemma — a small part of it is, sometimes they don’t know collectively and so they may have to talk about it amongst themselves. Secondly, you are going to get the most conservative advice when you call the FDA. That may be just fine. If you really want to know what the FDA thinks and you are willing to do whatever they say, then go ahead and ask them. If you are worried you are going to get overly conservative advice, once you have that advice, it is really hard to ignore it.”
