The FDA will not seek further review of the 2nd Circuit’s decision in U.S. v. Caronia as the agency doesn’t view the decision as a significant threat to its misbranding enforcement drive. However, the controversial ruling will likely factor into guidance development, FDA officials said Jan. 30. The agency will continue to monitor off-label speech, and civil and criminal prosecutions will continue where appropriate, Thomas Abrams, director of the agency’s Office of Prescription Drug Promotion (OPDP), said at CBI’s Pharmaceutical Compliance Congress in Washington, D.C.
Washington Drug Letter