The WLF has just published a thought piece, co-authored by your humble blogger and colleagues Jim Beck and Vincent Gallo, on how “Reduced Legal Oversight For FDA Warning Letters Amplifies Compliance And Liability Risks.”

Last summer, the Commissioner of the Food and Drug Administration reversed existing, sound policy that required prior legal review of regulatory letters (Untitled and Warning Letters) by the Agency’s Office of Chief Counsel. This reversal — eliminating review of regulatory letters for legal integrity except in cases of “significant legal issues” — is one of several changes instituted by the Commissioner to increase enforcement activity and purportedly to limit enforcement delays.

Our paper explores the potential problems with this policy reversal and the risks for industry.