Promoting Supply Chain Security and Integrity to Assure Patient Safety

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1 Promoting Supply Chain Security and Integrity to Assure Patient Safety Steven Wolfgang, Ph.D. Acting Associate Director, Risk Science, Intelligence and Prioritization Office of Compliance Center for Drug Evaluation and Research U.S. Food and Drug Administration PDA/FDA Conference Washington, DC September 20, Problem Statement Patients depend on us to assure that products are safe, of high quality and perform to expectations The landscape of drug manufacturing continues to expand outside of our borders As supply chains grow in complexity new risks are apparent THESE RISKS DEMAND OUR UTMOST ATTENTION! 2

2 Magnitude of What FDA Faces Up to 40% of drugs Americans take are manufactured outside US Up to 80% of APIs in those drugs are manufactured outside US In 2011 we expect nearly 24 million shipments of FDA regulated products to arrive at ports (vs. 6 million a decade ago) More than 130,000 importers of FDA-regulated products from more than 300,000 foreign sites in 150 countries Source: April 13, 2011, FDA Commissioner testimony before US House Energy and Commerce subcommittee on Oversight and Investigations 3 Level of Staffing Dedicated to Managing Importation of All FDAregulated Commodities Not Keeping Pace with Growth Source: FDA Strategic Plan Item 2.2 Strengthen the Safety and Integrity of the Global Supply Chain 4

3 Greater Potential for Illicit Activity Counterfeit drugs Dietary supplements with APIs Opaque or fuzzy supply chains and questionable legitimacy, security and authenticity of drug components CoA laundering Show and shadow factories Falsification, fabrication Substitution motivated by increased profit margins 5 Recurring Covert Substitution Upstream in Supply Chain Leading to Fatalities DEG for Polyols Glycerin, Propylene Glycol Melamine for Protein Wheat Gluten Milk OSCS for Heparin 6

4 Risks Downstream from Finished Drug Manufacturing Diversion of legitimate product through illicit channels back into legitimate supply chain Cargo theft Devious distributors (dilution) or poor distribution practice (improper storage cond.) Unsuspecting legitimate wholesalers and pharmacies Fake medicines made by criminals Illegal rogue pharmacy websites that appear legitimate Customers lured by price Infiltration into legitimate supply chain through unsuspecting or complicit wholesalers 7 June 2011 FDA Commissioner Unveils Pathway to Global Product Safety and Quality Global production of FDA-regulated goods has exploded over the past ten years... making the distinction between domestic and imported products obsolete, said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. "There has been a perfect storm - more products, more manufacturers, more countries and more access. A dramatic change in strategy must be implemented." lproductpathway/ucm pdf 8

5 Pathway to Global Product Safety and Quality 1) FDA, in close partnership with its foreign counterparts, will assemble global coalitions of regulators dedicated to building and strengthening the product safety net around the world. 2) With these coalitions, FDA intends to develop a global data information system and network in which regulators worldwide can regularly and proactively share real-time information and resources across markets. 3) FDA will continue to expand its capabilities in intelligence gathering and use, with an increased focus on risk analytics and thoroughly modernized IT capabilities. 4) FDA will effectively allocate agency resources based on risk, leveraging the combined efforts of government, industry, and public- and private-sector third parties. 9 June 2011 CDER Office of Compliance unveils its new super-office structure OC creates Office of Drug Security Integrity and Recalls (ODSIR) to implement FDA strategy across entire pharmaceutical supply chain Drug Component Supply Chain Finished Drug Product Supply Chain Drug Importation/Exportation Policy and Communication Recalls Risk Management Approach to Prioritization of Efforts 10

6 Manufacturers are Responsible for Managing Vast Global Supply Chain API supply chains Suppliers of starting materials, reagents, solvents, catalysts, etc. Inactive ingredient supply chains Suppliers of bulk commodities Packaging material supply chains Glass, polymer and cellulosic material and associated chemical additive supply chains Contract manufacturers Service providers, e.g., pest control 11 Drug Defects Can Be Traced to Supply Chains Glass containers for injectable drug products shed glass lamellae Product odor traced to lumber used to fabricate wooden pallets upon which HDPE containers for the products were stored Excipients caused recalls of several modified release drugs due to dissolution failures Contamination traced to excipients Chemical Particulate Microbiological 12

7 FDA Detects High Levels of Peroxide in Crospovidone Issuing a Drug Safety Advisory on 10/21/ Peroxide levels found (1700 ppm) in imported Crospovidone were 30-40x typical levels Peroxides can degrade APIs resulting in sub-potent drug Impurity levels were not being monitored by the manufacturer of Crospovidone USP revising all monographs to add limit of peroxide 13 Responsible parties Drug manufacturer Responsible for release of product into commercial distribution Non-manufacturing entity whose name appears on product Can be held responsible for causing an adulterated product to enter interstate commerce Other responsibilities might be delegated Contract manufacturers including testing labs Upstream supply chain Downstream supply chain 14

8 Regulatory Requirements Pertaining to Contract Manufacturing Relationships Primary manufacturer is responsible 21 CFR (b) The Food and Drug Administration.. regards extramural facilities as an extension of the manufacturer s own facility. 21 CFR (a) Quality Control Unit (QCU) is ultimately responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company 15 Contractor and Contract Giver are Liable for Adulterated Product The Federal FD&C Act (the Act) states that a drug is considered to be adulterated if the drug is not manufactured in conformance with CGMP [21 U.S.C. 351(a)(2)(B) ] Applies to finished drug products, drug components and all sites under contract to manufacture or supply drugs and drug components Manufacturer and private label distributor can both be held liable Introducing or causing the introduction of adulterated drugs into interstate commerce is prohibited. [21 U.S.C. 301] 16

9 ICH Q9 - Quality Risk Management Provides Guidance Regarding Outsourcing Members of the supply chain are partners play a role in determining success Q9 recommends a comprehensive evaluation of suppliers and contract manufacturers including auditing and implementing supplier quality agreements A manufacturer's quality system will drive the management of outsourced processes and entities (risk and quality management) 17 ICH Q9 - Application of Quality Risk Management to Making Sourcing Decisions How does one quantify the true cost of ownership in in a sourcing relationship? What are the worst case scenarios? Will there be some learning curve that dictates a need to be present at contractor? How well do the supplier s quality systems assure product quality? Systems often look good on paper Trust and confidence are built gradually 18

10 ICH Q10 - Pharmaceutical Quality Systems Guidance Regarding Purchased Goods and Services Control and review of all outsourcing activities is an element of a manufacturer s pharmaceutical quality system. Manufacturer is ultimately responsible to ensure processes are in place to assure the control of outsourced activities and quality of purchased materials. A manufacturer should have adequate procedures for auditing and qualifying facilities prior to outsourcing and throughout the process and for contract management and supervision. 19 Quality and the Drug Component Supply Chain Upstream Supply Chain Agricultural commodities brokers and traders involved Crude chemicals many are commodities Manufacturers of APIs, excipients and intermediates Fine chemicals often produced for multiple markets Finishing steps affording no purification milling, etc. Subdivision for pharmaceutical customer repackaging Distribution of Ingredients Transportation Warehousing Multiple transfers of ownership Importation 20

11 Factors Enabling Tragic Events There was a lack of transparency in upstream supply chain Members of supply chain were willing and able to falsify test data and label claim Shipments were accepted without any testing or testing was deficient 21 Opportunities More robust supplier qualification and maintenance programs Audits (knowing who you deal with and quality of their practices) Assurance of suitability of excipients for intended use Better ability to trace and authenticate throughout the entire supply chain Photo and spectral libraries for ingredients Identifying characteristics for products System to track pedigree 22

12 FDA Pharmaceutical Screening Program Deployment of portable instrumentation in field IMS, X-ray, NIR, Raman Increased capacity to screen for abnormality and to focus on highest risk articles Development of spectral methods for known adulterants in drug components spectral libraries for drug authentication FDA and IPEC published a position paper in American Pharmaceutical Review (July 2011) requesting participation by manufacturers and distributors of excipients to secure supply chain 23 Compendial Modernization FDA role is to establish USP priorities to address methodology gaps placing drugs at risk and inconsistencies within monograph families Acetaminophen containing products (PAP, inconsistency) Povidone (assay, inconsistency) Talc (asbestos) 24

13 FDA Builds Networks for Global Regulatory Cooperation and Establishes Global Presence Sharing of Information from Inspections Under Confidentiality Agreements EMA TGA Joined PIC/S Established Foreign Offices Outreach to Developing Foreign Regulatory Agencies ICH Guidance Development 25 Leveraging of Industry Efforts Initiative by Consortia and Trade Associations Guidance Development GMP, GDP, importation practice, agricultural practice experts can best establish standards standards improve industry compliance and consistency tool for building quality within supply chain Third Party Auditing potential for certification Sharing of Information About Emerging Risk provides timely communication to all stakeholders can stave off a major global quality catastrophe 26

14 Closing Remarks Knowledge is basis for sound risk management Basis toward assuring supply chain integrity and security Basis for building drug quality Monitoring allows manufacturers to maintain the highest level of assurance (testing, examination, auditing) Trust but verify! 27 Our mission is to promote and protect the public health Drug safety is our priority Drug quality is our priority Patient safety is our priority These must be your priorities too!!! 28

15 Contact Information Subject Contacts: DER/ucm htm Questions & Answers on Drug CGMP: RegulatoryInformation/Guidances/ucm ht m 29 30

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