After Heparin: - The Pew Charitable Trusts

More documents

Recommendations

Info

—Chapter 1— Policy recommendations A. Require 21st-century quality systems to protect drug safety through statute and regulation. 1. Companies selling drugs in the United States should have in place a quality system to ensure the safety and integrity of their products, including drug ingredients manufactured by a contractor or supplier. A quality systems model is a holistic, preventive strategy to ensure that the drugs we take are safe. A quality systems provision in legislation would specify basic key components, but would not conflict with detailed technical requirements, such as those found in cGMPs (which are established through the FDA’s regulation and permit recognition of evolving industry technologies). The FDA has shown clearly in guidance how a quality systems approach is harmonized with and can support adherence to cGMPs. 2. Quality systems should have the following key components (see recommendations B and D for additional discussion): a. Management responsibility: Management should be responsible for establishing the quality systems and ensuring that they are adequately resourced and function appropriately. b. Supplier management: Manufacturers should assess suppliers and contractors prior to engagement with them, and should perform periodic on-site audits to ensure adherence to quality and safety standards. Pre-assessment and periodic on-site audits are not currently required under U.S. cGMPs. c. Risk assessment: Companies should establish procedures to identify, monitor and evaluate risk factors that could impact product quality, safety, strength, purity and identity. d. Assessment and revision of analytical methods: Manufacturers should review and, where necessary, update tests to ensure that they are robust and are able to screen for substances that could affect product quality, safety, strength, purity and identity. B. Industry should also independently improve its control of contract manufacturers and suppliers. 1. Strengthen supplier contracts to facilitate and improve oversight. Contracts should establish the authority of the purchaser to conduct on-site audits of suppliers. When necessary, contracts should specify that the drug company has the right to audit subcontractors involved in manufacturing the suppliers’ products. Contracts should also specifically require drug company approval of any changes in ingredients sourcing or manufacturing processes. 42 Pew Health Group
PHARMACEUTICAL MANUFACTURING: GLOBALIZATION AND QUALITY MANAGEMENT 2. Require clear, strong, quality agreements for suppliers. Quality expectations should be clearly established for, and contractually agreed to, by suppliers. Agreements should acknowledge U.S. quality requirements and establish that, if necessary, FDA officials will have access to a supplier’s plant. Agreements should also require suppliers and contractors to report manufacturing changes to the purchasing company. If possible, quality agreements should be included as a part of main supplier contracts to clearly set expectations. 3. Increase information sharing among industry to ensure supply chain safety. Industry should share information on suppliers, risk signals, and other global market data that might help to ensure product quality and safety. Legal barriers to information sharing should be actively addressed through antitrust waivers, if necessary, or safe-harbor provisions in contracts. C. Enhance documentation and transparency of the upstream manufacturing supply chain through legal requirements. 1. Companies should know and be able to document the companies involved in their upstream manufacturing supply chain. Drug companies must know the entities involved in the manufacture, processing, and transportation of their drugs and active ingredients. This documentation should be available to regulators on demand. 2. Require all drug companies to state country of origin for their drugs and active pharmaceutical ingredients on their websites. Pharmaceuticals should not be subject to less transparency than other consumer products. Country of origin should be listed for both the finished drug and the drug’s active ingredients. While pharmacy dispensing may make country-of-origin labeling on drug bottles less useful for consumers, this information could be made available to the public through other means, such as package inserts or on a company’s website. D. Improve testing standards 1. Industry and regulators must continually seek to develop better testing methods to ensure the identity, purity and safety of drugs. Manufacturers must be responsible for ensuring the purity of their drugs and drug components through robust testing methods, and should review and update analytic methods in an ongoing manner. Regulators and industry stakeholders agree that better methods for detecting and measuring drug contamination are needed. In addition to improving their methods, drug companies could use multiple assays as a check against bad actors who might try to design fake ingredients that are able to fool specific tests. 2. Require continual assessment and updating of public testing standards. Compendial testing standards should be regularly reviewed to ensure adequacy. The FDA and USP should work together to ensure that public standards are robust and up to date, and identify and prioritize those assays that need to be updated and/or revised. After Heparin: PRotecting Consumers from the Risks of Substandard and Counterfeit Drugs 43
Page 1 and 2: After Heparin: Protecting Consumers
Page 3 and 4: TABLE OF CONTENTS 1.4 Problems with
Page 5 and 6: Executive Summary In late 2007, U.S
Page 7 and 8: Executive Summary eventually being
Page 9 and 10: Introduction and Background U.S. ph
Page 11 and 12: INTRODUCTION AND BACKGROUND less ri
Page 13 and 14: 50 0 INTRODUCTION AND BACKGROUND un
Page 15 and 16: INTRODUCTION AND BACKGROUND in Chin
Page 17 and 18: CHAPTER1 PHARMACEUTICAL MANUFACTURI
Page 19 and 20: PHARMACEUTICAL MANUFACTURING: GLOBA
Page 37: PHARMACEUTICAL MANUFACTURING: GLOBA
Page 41 and 42: 500000000 0 —Chapter 2— Figure
Page 43 and 44: —Chapter 2— FDA inspected only
Page 45 and 46: —Chapter 2— foreign offices hav
Page 47 and 48: —Chapter 2— plants. However, th
Page 49 and 50: —Chapter 2— Revived use of the
Page 51 and 52: —Chapter 2— 2.5 Pew conference
Page 53 and 54: —Chapter 2— 2. Use comprehensiv
Page 55 and 56: —Chapter 2— 3. Allow the FDA to
Page 57 and 58: CHAPTER3 PHARMACEUTICAL DISTRIBUTIO
Page 59 and 60: PHARMACEUTICAL DISTRIBUTION As dist
Page 61 and 62: PHARMACEUTICAL DISTRIBUTION Case st
Page 63 and 64: PHARMACEUTICAL DISTRIBUTION Sidebar
Page 65 and 66: PHARMACEUTICAL DISTRIBUTION which i
Page 67 and 68: PHARMACEUTICAL DISTRIBUTION the age
Page 69 and 70: PHARMACEUTICAL DISTRIBUTION 3.4 Pew
Page 71 and 72: PHARMACEUTICAL DISTRIBUTION d. If t
Page 73 and 74: REFERENCES 16 Fagan, Kevin. Testimo
Page 75 and 76: REFERENCES 58 Schwartzkopff, France
Page 77 and 78: REFERENCES 111 NSD Bio Group. “Po
Page 79 and 80: REFERENCES 155 State Food and Drug
Page 81 and 82: REFERENCES 195 U.S. Food and Drug A
Page 87 and 88: REFERENCES 332 Public Law 111-8—M
Page 89 and 90:
REFERENCES 378 Villax, Guy. Board M
Page 91 and 92:
REFERENCES 429 U.S. Supreme Court,
Page 93 and 94:
REFERENCES 479 Michelle M. Ciolek,
Page 95 and 96:
REFERENCES 521 21 USC §828 (a). 52
Page 97 and 98:
APPENDIX A Expert Interviews Bill A
Page 99 and 100:
APPENDIX B Pew Stakeholder Conferen
Page 101 and 102:
APPENDIX C Pew Stakeholder Conferen
Page 103 and 104:
Pew Stakeholder Conference Agenda T
Page 105 and 106:
acknowledgments We gratefully ackno
show all

After Heparin: - The Pew Charitable Trusts

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?