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 the Bloomberg BNA Medical Devices Law & Industry Report, in “Final Rule Clarifies When Tobacco Products Are Regulated as Drugs, Devices,” by Bronwyn Mixter. (Read the full version – subscription required.)
Following is an excerpt:
“For years we struggled to understand intended use, and the potential impact of mere knowledge of an off-label use. And indeed, those concerns grew out of the tobacco litigation many years ago where that theory was advanced,” Thompson said. “So it's only fitting that in the tobacco realm FDA is now putting to rest that concern.”
Thompson said “this is a matter of fundamental fairness, because off-label promotion is potentially a criminal violation. And it always seemed to me to be a stretch to argue that someone could be effectively off-label promoting if they did absolutely nothing to promote the off-label use, but merely knew that's how other people were using their product. So this is an extremely healthy revision.”
