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A Revised Vision for Effective Enforcement and Benefits to the Public Health

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?

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A Revised Vision for Effective Enforcement and Benefits to the Public Health

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  1. 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

  2. The Last Decade of Enforcement • A steady decline in enforcement actions • Why? • Administration policies • Staff shortages • Decrease in expertise • Past emphasis on voluntary compliance

  3. FDA SeizuresFiscal Years 1998 – 2008 * NB: A single seizure may involve more than one Center’s products.

  4. FDA InjunctionsFiscal Years 1998 - 2008

  5. FDA Warning LettersFiscal Years 1998 – 2008

  6. Criminal Arrests and ConvictionsFiscal Years 1998 – 2008

  7. Recalled Products – All CentersFiscal Years 1998– 2008

  8. ORA FTE History:Loss of Expertise

  9. Why Enforcement Is Important • Protect Public Health • Fulfill FDA’s Mission • Meet Expectations of Consumers and Industry • Achieve Corrections • Promote Deterrence

  10. Compliance Options Enforcement Actions • Actions by States or other Federal Agencies • Import Actions, e.g., DWPE, Refusals • Civil Money Penalty • Seizure • Injunction • Prosecution

  11. 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

  12. 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

  13. 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

  14. FDA Must Be • Vigilant • Strategic • Quick • Visible

  15. New Pathways to Effective Enforcement 1. Post inspection deadlines • Prompt industry response to significant findings = no more than 15 days OR FDA will issue a Warning Letter • Response must address all findings • Result = FDA will issue WLs more timely and facilitate prompt corrective action

  16. New Pathways to Effective Enforcement • FDA will speed issuance of Warning Letters • Limit Chief Counsel review to “significant legal issues”. • Streamlined review process consistent with historical practice.

  17. New Pathways to Effective Enforcement • Work with regulatory partners to develop effective risk control and enforcement strategies • Use local, state and international authorities for quicker action • Partners take immediate action while FDA develops long term response

  18. New Pathways to Effective Enforcement • Prioritize enforcement follow up • After WL or major recall, priority follow up to access corrections • Follow up within 6 months • Take appropriate action

  19. New Pathways to Effective Enforcement • FDA will act swiftly and aggressively, i.e., no more multiple WLs. • One WL, then if necessary, enforcement action • Action may be combined with WL or result from follow up inspection

  20. New Pathways to Effective Enforcement • Respond to firms after they have made necessary corrections • FDA developing a Warning Letter close out process • If and when all corrections are verified, FDA will issue a “Close-out Letter” • Close-out Letter will be posted on FDA Web Page

  21. New Resources and New Responsibilities • Significant funding resources in FY-10 and FY-11 • Accompanying responsibilities and authorities • New food authorities • Tobacco authority • Proposals for revision of cosmetic, drug and medical device authorities

  22. Recent Action • Warning to consumers concerning promotion of products to treat H1N1 • As of August 6th, FDA issued 65 WLs to offending web sites covering >125 products • Increased action against manufactures of body-building supplements containing steroid ingredients

  23. Outcomes Versus Outputs • Success measured by impact on public health, not be number of enforcement actions • Enforcement is not the end but a step toward improving public health • Program Performance Management Initiative – measure what we do and link to public health outcomes

  24. In Summary • Partnerships • Inspection – Verification – Enforcement • New Strategic Framework • Focus on Prevention • Baseline Data • Respond Quicker • Update and Integrate

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