FDA and the Global Integrity of the Supply Chain for Pharmaceutical Ingredients Randall Lutter, PhD Deputy Commissioner for Policy U.S. Food and Drug Administration 15 September 2008
FDA Update: Resources FDA resources on an upswing Congress approved $150 million in supplemental resources for FY 2008 President has requested an increase in FDA s budget by $325 million for FY 2009 Hiring surge Since beginning its hiring surge in April 2008, FDA has met its goal of filling over 1300 positions. 770 are new jobs and 547 are posts left vacant by people leaving the agency for other jobs or due to retirement. 5
Implementation of Food and Drug Administration Amendments Act of 2007 (FDAAA) FDAAA provided FDA additional responsibilities in the areas of: Food safety Reportable Food Registry Standards for Pet Food Processing and Ingredients Drug Safety: Risk Evaluation and Mitigation Strategies (REMS) Post market studies Labeling changes 6
Globalization: Recent and Future Recent episodes: Challenges Melamine in infant formula manufactured from China. Salmonella Saintpaul outbreak from peppers from Mexico. Contaminated heparin from China. Globalization and complexity in the food and drug supply chain will only increase in the future. 7
Globalization of Pharmaceutical Supply Chain Globalization has created unique challenges to supply chain security: private & public sector Need to consider the lifecycle of the product Starting materials Administration of finished dosage form Existing, new, and emerging technologies for track and trace hold promise 8
Overview Staying ahead of the globalization of the marketplace: FDA international efforts Import safety action plan Beyond our borders China MOA WHO IMPACT Domestic supply chain security FDA Counterfeit Drug Initiative Regulatory tools/approaches Technology Standards development for track/trace & authentication 9
Safety Standards Certification Good Importer Practice Penalties Foreign Collaboration and Capacity Building Common Mission Interoperability New Science Recall Federal-State Rapid Response Technology 10
Beyond Our Borders Initiative FDA in-country offices Awareness Capacity building Standards/inspections Collaboration Leveraging opportunities Locations: China, India, EU, Latin America, Middle East Leveraging projects Pilots/Info sharing EMEA pilot 11
World Health Organization s International Medical Products Anti-Counterfeiting Task Force (IMPACT) Developing a Toolkit with: Experience from different countries Model legislation & regulations Training materials and methodologies Tools and manuals to assist national authorities in implementing activities Tools and methodologies for the assessment of national/regional situations Largest and most coordinated international public/private public health effort for counterfeit medical products 12
Examples of Tools: Revised Good Distribution Practices (GDP) Guidance for combating counterfeit medical Products sold over the internet Revised Good Pharmacy Practices Strategy for sampling marketplace Rapid response measures for regulators in the event of suspect counterfeit 13
China Memorandum of Agreement (MOA) Designated drugs, registration, and certification requirements Greater information sharing Increased access to production facilities Stronger product integrity and security Implementation and establishing key benchmarks Encouraging China s involvement in international regulatory and public health bodies 14
Counterfeit drug cases opened by FDA s Office of Criminal Investigations per fiscal year
Who is involved? (Besides the counterfeiters and diverters!!) Private Sector Manufacturers (legitimate) Wholesalers/Distributors Repackagers Dispenser Pharmacy (retail/hospital) Clinic Doctor office Long term care facility Other outlets Consumers/Patients Others Public Sector FDA State regulatory authorities (Boards of Pharmacy) State/local police State/local health departments FBI, ICE, DEA, CBP, other enforcement/investigative authorities Justice Dept. Judiciary (courts/judges) Congress International counterparts Others 16
Framework U.S. Action Plan Secure: product and packaging movement of drugs through the supply chain business transactions Ensure appropriate regulatory oversight and enforcement Increase penalties Heighten vigilance and awareness International collaboration 17
Nanotechnology RFID Encryption Taggant Holograms Color-shifting ink Bar codes
What is the US supply chain doing? Drugs Anti-counterfeiting features Manufacturers use for product packaging, labeling, product itself Supply chain partnering on pilots Manufacturers exploring mass serialization RFID/2D barcodes Standards development Manufacturers sharing reference standards with FDA s Forensic Chemistry Center 19
RFID implementation efforts: Status Snapshot Progress toward implementation Few products on the market with tags Pilot programs cross-supply chain individual companies FDA compliance policy guide- 400.210 Drug products (not biologics) Enforcement discretion Call for data on impact of RF on drug product Standards under development GS1/EPCglobal FDA Others Product quality testing Little data submitted 20
Secure the movement of drugs through the supply chain Pedigree documenting each sale or transaction of the product Knowledge of:» Who had the product» When they had the product» How long they had the product» Who they bought it from» Who they sold it to» Other information.. Universal and Uniform Pedigree-- ideal Identical format for all 50 states Passed by all supply chain stakeholders Electronic Pedigree -- ideal 21
Regulatory Tools Pedigree laws Federal law Prescription Drug Marketing Act Challenges in the current pedigree law Not all transactions Need new law for universal and uniform pedigree Litigation RxUSA v HHS State laws Florida California Food and Drug Administration Amendments Act of 2007 (FDAAA) Authority to develop standards for Drugs Authority to develop standards for Unique Identifier for Devices 22
FDA Standards Development (New 505D of the Act) Secretary shall prioritize and develop standards for Identification Validation Rx drugs Authentication Tracking and Tracing Serialization deadline: March 2010 23
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What s next? Borders are expanding will only grow and become more complex Need to stay vigilant private and public sector Need to continue aggressive enforcement strategies.risk-based Find ways to leverage resources and trusted partners Application of technology API s vs. FDF; developed vs developing countries 25