CDER Office of Compliance Priorities and focus
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1 CDER Office of Compliance Priorities and focus ILISA B.G. BERNSTEIN, Pharm.D., J.D. Deputy Director, Office of Compliance Center for Drug Evaluation and Research U.S. Food and Drug Administration Pharmaceutical Compliance Congress Conference Washington DC, January 29, 2014
2 CDER Office of Compliance Office of Compliance Office of Drug Security, Integrity and Recalls Office of Manufacturing and Product Quality Office of Scientific Investigations Office of Unapproved Drugs and Labeling Compliance 2
3 What s we ve been up to.. Quality initiatives Food and Drug Administration Safety and Innovation Act (FDASIA) implementation Drug Quality and Security Act (DQSA) Compounding (Title I) Supply chain integrity (Title II) Global focus Compliance and enforcement actions.among other things!! 3
4 Quality initiatives Improved overall approach to regulating pharmaceutical quality Comprehensive approach Planning to make coordinated organizational, process, and policy changes that will move us more towards the new vision NEW Office of Pharmaceutical Quality (OPQ) Principles for change: Clinically relevant standards Lifecycle approach and integrated review/inspection Clear enforcement policies Surveillance using quality metrics 4
5 Additional quality initiatives Increase focus on contracting Quality agreements draft guidance Promoting modernization and innovation (collaborations, continuous manufacturing, etc.) Shortage prevention and mitigation 5
6 Drug shortages: Strategic plan First strategy is to strengthen FDA response Streamlining internal processes Improving data tracking Better communication including targeted communication Second strategy is to implement new efforts to prevent quality issues from occurring Exploring incentives for manufacturers Creation of a new Office of Pharmaceutical Quality Working to develop ways to identify early warning signals at manufacturers Working with outside stakeholders to better understand the range of factors that contribute to shortages 1/31/ CDER Drug Shortages
7 Drug shortages: What s needed? Must have industry commitment to culture of quality manufacturing Many firms are building new plants Need better manufacturing practices, methods and quality testing Need more production redundancy Promptly report and correct even small production and quality problems 1/31/ CDER Drug Shortages
8 FDASIA Implementation PDUFA V (Title I) GDUFA (Title III) Drug Supply Chain (Title VII) Drug Shortages (Title X) 8
9 FDASIA Title VII Drug Supply Chain Increased Risk Information Registration (foreign & domestic) Excipient information Interoperable electronic systems Information exchange Standards of admission for imported drugs Registration of commercial importers Notification Global Supply Chain Risk-based inspections Records for inspection Recognizing foreign govt. inspections Enhancing safety and quality of drug supply / quality management sytems Enhanced Tools Administrative destruction Prohibit inspectional delay, limitation, denial, refusal Administrative detention Protection against intentional adulteration Penalties for counterfeiting drugs Extraterritorial jurisdiction 9
10 New Drug Supply Chain Security Act (Track and Trace) Outlines steps to build an electronic, interoperable system to identify and trace certain Rx drugs as they are distributed in the U.S. Product identification Product tracing Product verification Detection and response Notification Wholesaler (WDD) licensing/standards Third-party logistics provider licensing/standards Enhanced system 10 years Penalties National uniform policy 10
11 Supply chain integrity Secure supply chain pilot Program for expediting the importation of APIs and drug products into the US 2-year pilot program, from Feb 2014 through Feb 2016 Tackling new distribution scheme of counterfeits/unapproved drugs to doctors/clinics Outreach letters were sent to over 1,500 Medical Clinics/Doctors to educate them on avoiding counterfeit and unapproved drug purchases. 11
12 12
13 13
14 Global focus Observational/Joint inspections GMP, GCP, BE PIC/S Pharmaceutical Inspection Cooperation Scheme ICH International Conference on Harmonization APEC Asia Pacific Economic Cooperation Supply chain integrity roadmap WHO World Health Organization Others. 14
15 Other compliance and enforcement activities. CGMP Program Post Marketing Requirements (PMR) Enforcement Program Homeopathic drug products Unapproved marketed drugs initiative Data integrity More.. 15
16 What s next???? Quality initiatives FDASIA DQSA Compounding Supply chain integrity International collaborations Compliance and enforcement actions.among other things!! 16
17 Thank you!!! ILISA B.G. BERNSTEIN, Pharm.D., J.D. FDA/CDER/Office of Compliance 17 17
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