After Heparin: - The Pew Charitable Trusts

More documents

Recommendations

Info

INTRODUCTION AND BACKGROUND raw ingredients through the delivery of a finished drug to the patient (see figure 1). Substandard and counterfeit products may reach patients through legitimate supply chains as happened with heparin (see case study 1) or through illicit routes. Every step in the complex pathway of the pharmaceutical supply chain—from raw materials (see sidebar 1) to finished products to patient delivery—is an opportunity for adulteration. A typical pharmaceutical supply chain might proceed as follows: raw materials for a drug’s active ingredient are purchased from suppliers and undergo initial processing. Processed raw materials then move to an active active-ingredient manufacturing site, sometimes through consolidators or brokers. This site prepares the finished active ingredient and sends it to another plant, where active and inactive ingredients, provided by yet other suppliers, are combined to create the finished drug. After the finished drug is packaged and enters distribution, it may change hands between brokers and wholesalers, be repackaged into different quantities and then stored for periods of time. Eventually, the product arrives at hospitals, pharmacies and doctors’ offices, where it is dispensed to patients. GMP Warning Letters By Category Figure 1 The pharmaceutical supply chain with examples of vulnerabilties Manufacturing Distribution Raw Materials Ingredients from unknown sources sold as if made at approved plants Fake raw materials enter the heparin supply chain, associated with adverse events including deaths Inactive Ingredients Active Ingredients Final Product Toxic fake glycerin is sold through brokers to Panama for use in cough syrup; at least 78 die National & Regional Wholesalers Smaller Wholesalers Stolen insulin later appears at chain pharmacies in three states. Patients report poor blood sugar control Hospitals and Pharmacies Medicaid drugs dispensed to patients are resold into distribution Epogen ® relabeled by a counterfeiter to resemble a higher strength enters distribution and reaches patients Several factors offer opportunities to adulterate a product or ignore quality controls (see sidebar 2). In regions where regulation, compliance and vigilance are weak, the quest for lower-cost materials can drive the trade of substandard or falsified drug ingredients. These may be introduced into manufacturing processes or sold as legitimate products by distributors and brokers. In countries with less developed regulatory systems than that of the United States, manufacturing standards may also be less rigorous—or 14 Pew Health Group
INTRODUCTION AND BACKGROUND less rigorously observed. Those same countries receive much less FDA oversight than U.S. manufacturing facilities, creating additional potential for poor quality medicines to reach U.S. consumers (see section 1.3). The Federal Food, Drug, and Cosmetic Act (FDCA) penalizes adulteration, misbranding and counterfeiting at a maximum of $10,000 or three years in prison. 23 These penalties may be too low to present meaningful deterrents to violations and crime, particularly for pharmaceutical counterfeiting, which is additionally incentivized by high profitability. By one estimate, the return on counterfeit prescription drugs may be 10 times greater than that of the sale of illegal narcotics. 24 In the United States, the penalties for trafficking drugs such as heroin and cocaine can have jail sentences up to life and fines in the millions of dollars. 25 Although counterfeiting can be prosecuted under trademark law, with a maximum sentence of 10 years, the FDCA, with its lower penalties, is the most common statute used for prosecuting counterfeit drug cases. 26 The FDA regulates many thousands of drugs and medical devices intended for the U.S. market. The various entities involved in the manufacture of these products may be located within U.S. borders, or partly or completely overseas—and the overseas component is growing. The United States imported 393 million kilograms of pharmaceuticals and medicines in 2009 (see section 1.2.1). * FDA-regulated imports represented 20 million shipments into the United States in 2010, a threefold increase over 10 years. 27 Human drugs, though a small percentage of the total, amounted to over 300,000 shipments of pharmaceuticals in 2007, more than double the volume in 2002. 28 The number of foreign establishments named in U.S. drug marketing applications more than doubled over a seven-year period (779 vs. 2,019 in years 2002 and 2008, respectively). 29 Imported drugs and their ingredients, each with intricate manufacturing, packaging and distribution supply chains, are made at thousands of sites around the world, 30 and arrive at any one of hundreds of U.S. points of entry every day. 31 * From a dataset provided by the U.S. Census Bureau, Foreign Trade Division. After Heparin: PRotecting Consumers from the Risks of Substandard and Counterfeit Drugs 15
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: Introduction and Background U.S. ph
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 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 83 and 84:
Page 85 and 86:
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

Create successful ePaper yourself

Delete template?

Save as template?