FDA Basics: Alyson Saben – Eyes, Ears, and Muscle Behind FDA's Efforts to Protect Public Health



so the office of enforcement how does that play within the office of regulatory authority the office of enforcement is one of four headquarters offices that falls under the office of regulatory affairs and protection of the public health of course is FDA's number one priority and promoting voluntary compliance is often the best and quickest way to achieve compliance but voluntary compliance will only work if we have a strong enforcement program in place and what that means is that we through my office need to be prepared to take quick decisive efficient and effective enforcement action if voluntary compliance doesn't work this could mean that we work with our colleagues in the Department of Justice and US Attorneys offices to seize products that don't comply with our standards or even going to court and sinking an injunction action to enjoin a firm from not complying with our laws and regulations and some of your actions have actually put people in jail well our office of criminal investigations which is staffed by very experienced law enforcement professionals have the responsibility in the agency for pursuing criminal investigations which would result in someone going to jail but that too is part of our enforcement program to seek criminal prosecution along with seizures and injunctions so it seems like you walk softly but carry a big stick we walk softly but carry a big stick I can see a glint in your eye you seem to be really proud of what you do I really am there's nothing more rewarding really than waking up every day and then going to sleep that night knowing that the activities of me or my staff or my colleagues very well contributed to making sure that the food that was served to consumers that day on their dinner tables we contributed to making sure that that food was safe and effective or that evening before a grandmother took her blood pressure medicine to know that we had a role even if a small role in making sure that that medication was safe and effective

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