Briefing Room


Associate Professor Patricia Zettler quoted in Pink Sheet article discussing US FDA loss in Device Case

July 20, 2021 | Media News

An expert in the area of health law, Associate Professor Patricia Zettler was recently quoted in an article by Pink Sheet titled, “US FDA Loss In Device Case Might Have Implications For Agency’s Work On Off-Label Rx Promotion.”

“One thing that’s going on here is that the majority opinion is disagreeing with FDA‘s interpretation that the statue permits FDA to distinguish between devices based on their use. And that might have some implications for how other courts approach questions around off-label promotion,” said Zettler, a former associate chief counsel in FDA‘s Office of the Chief Counsel.