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《Enforcement and Public Health - WCC-PDA - Nov 09》.ppt 25页

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A Revised Vision for Effective Enforcement and Benefits to the Public Health WCC-PDA Meeting South San Francisco, California November 12, 2009 Mark Roh Regional Food and Drug Director Pacific Region The Last Decade of Enforcement A steady decline in enforcement actions Why? Administration policies Staff shortages Decrease in expertise Past emphasis on voluntary compliance FDA Seizures Fiscal Years 1998 – 2008 FDA Injunctions Fiscal Years 1998 - 2008 FDA Warning Letters Fiscal Years 1998 – 2008 Criminal Arrests and Convictions Fiscal Years 1998 – 2008 Recalled Products – All Centers Fiscal Years 1998– 2008 ORA FTE History: Loss of Expertise Why Enforcement Is Important Protect Public Health Fulfill FDA’s Mission Meet Expectations of Consumers and Industry Achieve Corrections Promote Deterrence Compliance Options Enforcement Actions Actions by States or other Federal Agencies Import Actions, e.g., DWPE, Refusals Civil Money Penalty Seizure Injunction Prosecution Current Enforcement Environment Emergent Public Health Hazards Increasing Volume and Complexity of Regulated Products Increasing Foreign Manufacturing and Distribution Line Between “Low Risk” and “High Risk” May Shift Increase in Recalls Increase in Congressional Oversight Loss of Consumer Confidence How to Improve Public Health Protection Through FDA’s Enforcement Program Embrace Enforcement Culture Reaffirm Agency’s Enforcement Policy Articulate Enforcement as a Shared Responsibility Throughout the Agency Emphasize Corporate Responsibility Strong Enforcement Regulated industry’s duty to meet FDA standards and comply with the law Effective enforcement has benefits to public health Improves public confidence in FDA oversight and product safety Confidence is critical to long term success of industry and FDA FDA Must Be Vigilant Strategic Quick Visible New Pathways to Effective Enforcement 1. Post inspection deadlines Prompt industry response to significant findings = no more than 15 da

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