Reduced Legal Oversight For FDA Warning Letters Amplifies Compliance And Liability Risks

January 15, 2010
This article examines a recent decision by the FDA to dramatically reduce the legal review of regulatory letters that do not present “significant legal issues” by the Agency’s Office of Chief Counsel (OCC). The measure was intended to increase enforcement activity and limit enforcement delays, but may instead result in an increase in the volume of regulatory letters that are legally deficient, leading to significant legal consequences, including civil litigation under state law.