CDER Compliance Update

Transcription

1 CDER Compliance Update Douglas Stearn, JD Deputy Director for Policy and Analysis FDA/CDER/Office of Compliance FDLI Enforcement, Litigation and Compliance Conference Washington, DC December 12,

2 Overview Focus and recent activities International collaboration FDASIA What s around the corner? 2

3 Office of Drug Security, Integrity and Recalls (ODSIR) Focus Identifying and addressing the increase supply chain threats Supply chain integrity life cycle approaches to ensure public health 3

4 ODSIR recent activities Industry benchmarking Report of preliminary review of Office of Criminal Investigations counterfeit/diversion case info Counterfeit alerts Issued Warning Letters to internet pharmacies Secure supply chain pilot Operation Pangea BeSafeRx campaign Drug shortages and recalls 4

5 Total Event vs Product Recalls FY One contract packaging site caused packaging mix-ups accounting for approximately 670 recalls. One contract manufacturer accounted for 1335 product recalls resulting in various CGMP violations discovered during an inspection. Also, one tablet Two firms with over 850 manufacturer recalled 190 Rx Single products. firm recalls more products than 800 for Penicillin products crosscontamination cross-contamination. and bacterial resulting from Penicillin Also, one firm recalls 114 contamination products for in microbial alcohol pads. contamination of non-sterile products.

6 Total Product Recalls by Class FY Three major product recall events contributed to majority of Class II recalls. Three major product recall events contributed to majority of Class II recalls. One cross-contamination event contributed 452 products. Two firms with over 850 products for Penicillin crosscontamination and bacterial contamination in alcohol pads.

7 Total Product Recalls by Type FY 08-12

8 Class I Product Recalls FY Despite recent decline in number, about 60% of Class I product recalls since 2007 have involved dietary supplements containing undeclared APIs.

9 Office of Unapproved Drugs and Labeling Compliance Focus Unapproved drugs enforcement Quality of compounded drugs Health fraud Center for Medicare and Medicaid Services (CMS) collaborations 9

10 OUDLC recent activities Marketed unapproved drugs Updated Compliance Policy Guide (CPG) Enforcement actions - Oxycodone Consumer safety alerts drugs with undeclared ingredients Warnings about dietary supplements spiked with API Joint action with FTC to remove homeopathic HCG weight loss products from the market 10

11 Office of Scientific Investigations (OSI) Focus Data Integrity Enforcement focus Quality systems in clinical trials International collaboration 11

12 OSI recent activities 1 st post-marketing requirement based warning letter GCP EMA pilot program GCP inspection risk model pilot program Data standards collaborative efforts for information that supports inspections Draft guidance for industry: Oversight of clinical investigations - Risk based approach to monitoring Clinical Trials Transformation Initiative - Quality by Design Project 12

13 Office of Manufacturing and Product Quality Focus Compliance with Current Good Manufacturing Practices (CGMP) Commitment to quality At the local and system levels International collaboration and leveraging Outreach and education 13

14 OMPQ recent activities Joint CGMP programs.api Program and Finished Drug Pilot Program Collaborative NDA review and inspection of QbD applications CDER/OPS, CDER/OC, and ORA PIC/S membership Consent decrees: Ranbaxy, McNeil, H&P/Triad Positron Emission Topography (PET) CGMP regulations Drug shortage prevention/mitigation/remediation Requested or shared over 75 inspection reports with foreign authorities Placed 12 firms under import alert this fiscal year Participation in ICH Q10 training conferences 14

15 International collaboration efforts API Program (FDA/EMA/EDQM/TGA/WHO) and FD Pilot (FDA/EMA) Mutual Reliance Pilot (FDA/EMA) Regulatory Cooperation Council Pilot (FDA/Health Canada) FDA India Office OTC Drug Pilot Common Regulatory Database (planning stages) -China Office de-registered sites (planning stages) -GMP Summit (September 2012 Washington, DC) -APEC Roadmap for Global Medical Product Quality and Supply Chain Integrity -FDA-EMA GCP Collaboration -FDA-EMA Bioequivalence Initiative 15

16 Title VII Drug Supply Chain Increased Risk Information Registration (foreign & domestic) with UFI Excipient information Electronic system Information exchange Standards of admission for imported drugs Registration of commercial importers Notification Enhanced Tools Administrative destruction Prohibit inspectional delay, limitation, denial, refusal Administrative detention Protection against intentional adulteration Penalties for counterfeiting drugs Extraterritorial jurisdiction Global Supply Chain Risk-based inspections Records for inspection Recognizing foreign govt. inspections Enhancing safety and quality of drug supply / QMS 16

17 Title X: Drug Shortages Expedite review of applications OR inspection or re-inspection that could help mitigate or prevent a shortage OR Communication: prior to any enforcement action or issuance of a warning letter that could reasonably be anticipated to lead to a meaningful disruption in supply, drug shortages program shall be consulted to determine if action or letter could cause or exacerbate a shortage Action: if it is determined that an action or warning letter could reasonably cause or exacerbate a shortage, Secy shall evaluate the risks associated with the impact of a shortage upon patients and those risks associated with the violation before taking action, unless imminent risk of serious adverse health consequences or death to humans 17

18 GDUFA implementation GMP and BE inspection ramp up Develop/revise policies and procedures Shift to surveillance approach Shift to domestic/foreign parity 18

19 What s around the corner? GDUFA implementation ANDA backlog GMP and bioequivalence inspection and compliance program ramp up Includes implementation of a surveillance inspection program in parallel with the current application-based inspection model Enhance collaborations with foreign regulators Conducting inspections- GMP, GCP, BE, PV Sharing inspectional information Implementation of FDASIA Continue with marketed unapproved drugs initiative Further secure drug supply chain 19

20 Thank You!!! Douglas Stearn, JD Deputy Director for Policy and Analysis FDA/CDER/Office of Compliance 20