Regulation and Risk Management of Combination Products

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1 Regulation and Risk Management of Combination Products Katherine Ulman Associate Scientist Global Regulatory Compliance Manager Dow Corning Healthcare Jim Curtis Senior Specialist, Healthcare Applications Engineering & Technical Services Dow Corning Corporation

2 INTRODUCTION Combination products incorporate two or more medical product types to provide novel or improved solutions to healthcare problems for better patient outcomes. But this unique combination of technologies does not always face a clear regulatory pathway. Determining something as seemingly simple as whether the product should be regulated as a drug or a device can be challenging. This simplistic division does not recognize the unique properties of drug-device combination products or the potential technical challenges involved in the manufacturing process. Manufacturers of these combination products need to consider the design and development of both the drug and device components, as well as the interaction between the two. This white paper outlines the regulatory environment for combination products as well as how supply-chain security and management specifically related to raw materials suppliers will help ensure regulatory compliance and mitigate risks. IS IT A DRUG OR DEVICE? FDA defines a combination product as: A product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. 1 Regulated by FDA s Center for Biologics Evaluation and Research, biological products include vaccines, blood products, and gene therapies. Most combination products, however, incorporate a drug and a medical device. Common examples include drug-eluting stents, metered dose inhalers, and prefilled syringes. The first step to ensuring compliance is to determine the regulations with which the combination product and its manufacturing process must comply, and thus which agency center will be assigned lead jurisdiction. In many regions, including the United States and Europe, this will depend on the product s primary mode of action basically whether the drug or the device aspect of the combination product provides the main therapeutic function. 1 1 US Food and Drug Administration. About Combination Products. Retrieved from: FDA s definitions of a medical device and a drug share the following characteristics: 2 Intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animal (devices also can be intended for the diagnosis of other conditions besides disease) Intended to affect the structure or any function of the body of man or other animals Recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them (drugs can also be recognized in the official Homoeopathic Pharmacopoeia of the United States) The main differences are: The term drug refers to an article, while the term device refers to, an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory A drug achieves its primary intended purposes, through chemical action within or on the body of man or other animals and is dependent upon being metabolized for the achievement of its primary intended purposes. None of this is true for the U.S. FDA definition of a device. MATERIALS IN THE SPOTLIGHT The regulatory environment for combination products has become increasingly challenging over time. Among the growing number of hurdles in the regulatory pathway is an increased emphasis on supply-chain security and traceability. And as part of this mounting focus on the supply chain, raw materials, in particular, have been the subject of increased regulatory scrutiny due to their role in several recent high-profile incidents. In 2008, for example, FDA found that more than twenty Chinese suppliers had provided contaminated raw materials for use in the common blood thinner heparin, Products/ucm htm 2 US Food and Drug Administration. Classification of Products as Drugs and Devices and Additional Product Classification Issues. Retrieved from regulatoryinformation/guidances/ucm htm

3 which was linked to 80 deaths in the United States and numerous cases of allergic reactions. Materials were also at the center of the metal-on-metal hip implant controversy when mounting evidence indicated that metallic wear particles were being generated at far higher rates than anticipated, causing inflammation and damage to the bone and other tissue surrounding the implant. In 2013, a well-known medical device manufacturer initiated a global recall of its drug-eluting stent based on reports of malfunction (tip separation) of the catheter used to deliver the combination product to the proper position within the blocked artery. FDA classified this as a Class 1 recall, 3 the most serious type, indicating a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 4 With such events endangering patients and attracting public outcry, heightened scrutiny on raw materials has emerged as an issue in both the United States and abroad. FDA is increasingly citing raw materials in warning letters while the International Conference on Harmonization (ICH) has recently issued a draft guideline 5 for elemental impurities in drug products, and the European Medicines Agency has implemented new rules for elemental impurity standards for new products. The agency is also in the process of applying these standards to existing products, although this process has been delayed. 6 Elemental impurity standards are also being released in other countries. SUPPLY-CHAIN RELIABILITY AND SECURITY In the face of challenging regulatory pathways, complex technologies, and scrutiny of raw materials, manufacturers of combination products want to be particularly diligent about supply-chain security and reliability. In the United States, a key step to ensuring a reliable supply chain is to look for a supplier that follows U.S. FDA s Current Good Manufacturing Practices (cgmps), which are detailed in the Code of Federal Regulations 21CFR820 for devices and 21CFR210/211 for drugs. These technically apply only to the combination product s manufacturer; however, choosing a supplier very familiar with and actively practicing the critical components of cgmps can offer assurance that the component or material meets key quality system requirements. FDA does, on the other hand, require that a manufacturer oversees its suppliers and ensures that they have adequate quality management processes in place. This is spelled out in the Code of Federal Regulations Title 21: Section 820:50 (Purchasing Control): Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements. Similar statements can be found in other U.S. FDA regulations. For example, FDA s Guidance for Industry Q10: Pharmaceutical Quality Systems requires pharmaceutical companies to manage outsourced activities and purchased materials, including making sure that they comply with appropriate GMPs. Additional details on cgmp for finished pharmaceuticals, specifically pertaining to the control of components and drug product containers and closures, can be found in 21CFR While FDA s GMPs apply to companies whose products are in interstate commerce in the United States, the term GMP is not only a U.S. concept. The European Union, Canada, and even the World Health Organization, for example, have established their own GMP standards as 3 U.S. Food and Drug Administration. Background and Definitions. Retrieved from ucm htm 4 U.S. Food and Drug Administration. Cook Medical, Inc Zilver PTX Drug-Eluting Peripheral Stent: Class 1 Recall - Complaints of Delivery System Tip Separation. Retrieved from tion/safetyalertsforhumanmedicalproducts/ucm htm 5 International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Guideline for Elemental Impurities Q3D. Retrieved from Products/Guidelines/Quality/Q3D/Q3D_Step2b.pdf 6 Council of Europe. The European Pharmacopoeia Commission revises its strategy regarding the implementation of Chapter 5.20 "Metal catalyst or Metal reagent residues". Retrieved from Pharmacopoeia-revises-its-strategy-regarding-implementation- of-chapter-520-metal-catalysts-or-metal-reagent-residues html?mbID=128

4 well. In addition, international organizations such as the International Conference on Harmonization and the International Medical Device Regulators Forum (IMDRF) have establish GMP guidelines 7 for active pharmaceutical ingredients and medical devices in the form of ISO and ISO GMPs for Medical Devices. These guidelines are being adopted as regulations by some countries. TRACEABILITY In the context of raw material suppliers, traceability is the ability to identify and trace a material throughout the supply chain. Key to ensuring traceability is an integrated supply chain, which entails a system for coordinating all activities across partners. While the buyer typically creates this system, the buyer needs to work together with the supplier to implement it. Having an integrated supply chain one where the supplier uses raw materials and intermediate produced within their own organization helps a supplier to ensure good traceability of the upstream materials they use. RISK MANAGEMENT To reduce risk in the supply chain, manufacturers should evolve these relationships and start viewing their suppliers as partners. Building long-term relationships is a crucial step in this process. A manufacturer should develop a tailored quality agreement with each supplier instead of using generic templates. These agreements should include individual preferences in addition to regulatory requirements. For critical materials, a manufacturer should perform an audit of the supplier s manufacturing facility or, when available, consider accepting a third-party certification for the desired quality system requirements. The supplier, in turn, should have a program in place to audit its critical raw material suppliers, as well as its distributors. Manufacturers should have additional riskmanagement systems in place for suppliers, including a 7 International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH HARMONISED TRIPARTITE GUIDELINE Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients Q7. Retrieved from /Guidelines/Quality/Q7/Step4/Q7_Guideline.pdf corrective and preventive action (CAPA) plan and key performance indicators (KPIs). When it comes to sourcing materials, supply-chain management is a particularly important part of risk management because a relatively minor modification in material can cause unexpected changes in the device or drug. A manufacturer should ensure that the supplier has rigid processes in place for change management and notification of change. This ensures that when a supplier modifies a material, the manufacturer has adequate time to investigate whether this change will impact the final product and require the company to update and/or file a new application with FDA. Material suppliers also should have a rigid system for material testing. Necessary tests will depend on the material, its purpose, and the nature of the finished device; however, some examples are testing for residuals, leachables and extractables, drug dissolution, stability during the shelf-life period, and elemental impurities. The supplier should also keep retainers of key materials in case questions arise later. This is especially important for combination products that are categorized as drugs. CONCLUSION Many manufacturers today see risk management as an issue far beyond regulatory compliance, and are establishing supply-chain oversight processes that exceed regulatory standards. Risk management can minimize the likelihood and severity of recalls, warning letters, and adverse events that could jeopardize a company s reputation. But ultimately, risk management is about protecting the patient who will one day use the combination product, and ensuring that the product serves its true purpose of improving or extending the patient s life. ABOUT DOW CORNING A global supplier of silicones and silicone solutions, Dow Corning operates manufacturing sites registered with the FDA as medical device and drug establishments. Dow Corning s staff is well trained in the regulation of excipients, finished drugs, as well as finished medical devices, and can readily provide regulatory profiles and other useful resources to customers upon request.

5 Dow Corning also can supply pertinent documents to regulatory authorities, including an EU certificate of suitability, GMP statements from manufacturing sites, the creation of master and technical file documentation, and a master file letter of authorization for customers. Dow Corning has proactively categorized all products used at healthcare sites and has developed a strategy in which each family of materials is tested for elements of impurities. These standard profiles are available to customers upon request. Because a majority of the raw materials Dow Corning uses to create its silicone products are sourced from other Dow Corning manufacturing sites, the company s supply chain is integrated to help ensure excellent material traceability and change-management throughout the process. Dow Corning is globally certified to ISO 9001:2008 standards and is compliant with applicable medical device quality system regulations and pharmaceutical GMP system requirements. LIMITED WARRANTY INFORMATION PLEASE READ CAREFULLY The information contained herein is offered in good faith and is believed to be accurate. However, because conditions and methods of use of our products are beyond our control, this information should not be used in substitution for customer s tests to ensure that our products are safe, effective and fully satisfactory for the intended end use. Suggestions of use shall not be taken as inducements to infringe any patent. Dow Corning s sole warranty is that our products will meet the sales specifications in effect at the time of shipment. Your exclusive remedy for breach of such warranty is limited to refund of purchase price or replacement of any product shown to be other than as warranted. TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, DOW CORNING SPECIFICALLY DISCLAIMS ANY OTHER EXPRESS OR IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE OR MERCHANTABILITY. DOW CORNING DISCLAIMS LIABILITY FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES. Dow Corning is a registered trademark of Dow Corning Corporation. We help you invent the future is a trademark of Dow Corning Corporation Dow Corning Corporation. All rights reserved. Printed in USA Form No

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