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Improving FDA’s Regulatory Effectiveness Globally

Improving FDA’s Regulatory Effectiveness Globally. 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.

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Improving FDA’s Regulatory Effectiveness Globally

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  1. Improving FDA’s Regulatory Effectiveness Globally 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 – 2010 * NB: A single seizure may involve more than one Center’s products.

  4. FDA InjunctionsFiscal Years 1998 - 2010

  5. FDA Warning LettersFiscal Years 1998 – 2010

  6. Criminal Arrests and ConvictionsFiscal Years 1998 – 2010

  7. Recalled Products – All CentersFiscal Years 1998– 2010

  8. ORA FTE History-Loss of Expertise2002 - 2010

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

  10. 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

  11. 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

  12. 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 Update: policy is in place in ORA

  13. 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 Update: Policy in place in ORA • Office of Chief Council is ready to take more cases • OCC developing a strategic enforcement policy • OCC and OE reducing paperwork necessary for seizures and injunctions

  14. 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 Update: Contracts and Partnerships being developed - 50 State meeting in August 2010

  15. 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 Update: ORA policy in effect. Currently conducting review of all OAI firms for last 5 years and developing F/U schedule by end of June 2011.

  16. 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 Update: Commissioner level review of all violative inspectional activity - requires ORA explanation

  17. 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 Update: ORA policy in effect - resource intensive - details being developed

  18. Recent Action • Warning to consumers concerning promotion of products to treat H1N1 • In 2011 FDA issued 300+ WLs to offending web sites covering multiple products. 8 issued to firms peddling rad scanners and KI for radiation following Japanese earthquake • Increased action against manufactures of body-building supplements containing steroid ingredients

  19. 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

  20. Top 10 Drugs Observations Used in Turbo EIR • 1. CFR 211.22(d) The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. • 2. CFR 211.100(b) Written production and process control procedures are not [followed in the execution of production and process control functions] [documented at the time of performance]. • 3. CFR 211.110(a) Control procedures are not established which [monitor the output] [validate the performance] of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

  21. Top 10 Drugs Observations Used in Turbo EIR • 4. CFR 211.160(b) Laboratory controls do not include the establishment of scientifically sound and appropriate [specifications] [standards] [sampling plans] [test procedures] designed to assure that [components] [drug product containers] [closures] [in-process materials] [labeling] [drug products] conform to appropriate standards of identity, strength, quality and purity. • 5. CFR 211.192 There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its components to meet any of its specifications] whether or not the batch has been already distributed. • 6. CFR 211.100(a) There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

  22. Top 10 Drugs Observations Used in Turbo EIR • 7. CFR 211.25(a) Employees are not given training in [the particular operations they perform as part of their function] [current good manufacturing practices] [written procedures required by current good manufacturing practice regulations]. • 8. CFR 211.165(a) Testing and release of drug product for distribution does not include appropriate laboratory determination of satisfactory conformance to the [final specifications] [identity and strength of each active ingredient] prior to release. • 9. CFR 211.188 Batch production and control records [are not prepared for each batch of drug product produced] [do not include complete information relating to the production and control of each batch]. • 10. CFR 211.67(b) Written procedures are not [established] [followed] for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

  23. Top 10 Devices Observations Used in Turbo EIR • Top 10 Devices Observations Used in Turbo EIR • 1. CFR 820.100(a) Procedures for corrective and preventive action have not been [adequately] established. • 2. CFR 820.198(a) Complaint handling procedures for [receiving] [reviewing] [evaluating] complaints have not been [established] [defined] [documented] [completed] [implemented]. • 3. CFR 803.17 Written MDR procedures have not been [developed] [maintained] [implemented].

  24. Top 10 Devices Observations Used in Turbo EIR • 4. CFR 820.100(b) Corrective and preventive action activities and/or results have not been [adequately] documented. • 5. CFR 820.75(a) A process whose results cannot be fully verified by subsequent inspection and test has not been [adequately] validated according to established procedures. • 6. CFR 820.22 Quality [audits][reaudits] have not been performed. • 7. CFR 820.22 Procedures for quality audits have not been [adequately] established.

  25. Top 10 Devices Observations Used in Turbo EIR • 8. CFR 820.30(a) Procedures for design control have not been established. • 9. CFR 820.20 Management with executive responsibility has not ensured that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization. • 10. CFR 820.30(i) Procedures for design change have not been [adequately] established.

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

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