Regulatory Intelligence on Biologics Recalls - Immunoglobulins and Vaccines are Involved in More Recalls than Other Drug Classes

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Regulatory Intelligence on Biologics Recalls – Immunoglobulins and Vaccines are Involved in More Recalls than Other Drug Classes

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Regulatory Intelligence on Biologics Recalls – Immunoglobulins and Vaccines are Involved in More Recalls than Other Drug Classes

Summary

GBI Research's report, "Regulatory Intelligence on Biologics Recalls – Immunoglobulins and Vaccines are Involved in More Recalls than Other Drug Classes", provides in-depth analysis of biologics recalls issued or reported with the US Food and Drug Administration (FDA) and its constituent agencies. The report analyzes biologics recalls on the basis of the reason for recall, therapy area, drug class, dosage forms and the recalling company, on a year-to-year basis from 2007–2010. The report is built on data and information sourced from the FDA database of biologics recalls and in-house analysis by GBI Research's team of industry experts.

GBI Research found that biologics recalls have significantly increased from 2004–2010 due to a number of underlying causes, which are explained in detail in the report. Of biologics recalls made between these years, recalls for vaccines and immunoglobulins were higher than other drug classes. The reasons for recalls varied from serious adverse events, labeling errors and quality defects, to manufacturing defects. Of the biologics recalled since 2004, the highest number of recalls occurred in 2010, followed by 2008. In 2010, the infectious diseases and immunodeficiency disorders therapy areas had the most biologics recalls.

Scope

- Data and numerical figures on the number of biologics recalls issued according to the year of recall and recalling firm, from 2007–2010.

- Analysis of leading therapeutic areas and dosage forms for major biologics recalls.

- Analysis of reasons for recall, along with in-depth analysis of underlying reasons and patterns from 2007–2010.

- Case studies of companies that have recalled biologic products and re-released products with manufacturing changes or labeling changes.

Reasons to buy

- Understand the pattern of biologics recalls, along with their underlying causes, in order to enable you to undertake strategies to protect products from encountering safety issues.

- Analyze the key reasons for recalls, along with the therapy areas and class of recalled biologics most vulnerable, so as to strengthen the areas which may lead to quality defects in your company's products.

- Reinforce quality and manufacturing strategies in order to be complaint with the current regulatory norms.

- Develop strategic initiatives through understanding of the key focus areas of biologics recalls.

1 Table of Contents

1 Table of Contents 3

1.1 List of Tables 5

1.2 List of Figures 6

2 Introduction 8

2.1 Drugs and Biologics Inspections and Warning Letters 8

2.2 Public Health Service Act and Biologics 9

2.3 Drug Recall Process 9

2.4 Drug Recalls Reported by CDER 11

2.5 Drug Recalls Reported by CBER 13

2.6 GBI Research Report Guidance 16

3 Regulatory Intelligence on Biologics Recalls: Overview 17

3.1 Overview of Biologics 17

3.2 Overview of Biologics Manufacturing Process 18

3.3 Biologics Recalls 19

3.4 Reasons for Recalls 19

3.5 Risk Management for Drugs and Biologics 20

3.5.1 Labeling Revisions on ESAs Following FDA Recommendation and CMS Changes to Reimbursement 20

3.5.2 Updated Labeling of Tysabri to Warn Against Increased Risk of Progressive Multifocal Leukoencephalopathy (PML) 21

3.6 Regulatory Responsibilities and Procedures Involving Recalls 21

3.6.1 Reasons for Manufacturers to Initiate Recalls 21

3.6.2 FDA Responsibilities and Procedures Outline 22

3.6.3 Responsibilities of the Agencies Involved 22

3.7 Case Study 1 - Octagam 5% Returned to Market after Resolution of Manufacturing Issues by Octapharma 23

3.7.1 Octagam 5% Recalled from Markets Due to Increase of Thromboembolic Events (TEEs) 23

3.7.2 Changes to the Manufacturing Process 23

3.7.3 Favorable Opinion of Regulatory Authorities and Approval of the Product 23

3.8 Case Study 2 - Heparin Crisis a Reflection of FDA Failure 24

3.8.1 Heparin Contamination Forced Several Companies to Recall Products 24

3.8.2 Source of Contamination was in China 24

3.8.3 Regulatory Failure Led to Contaminated Heparin Distribution 24

3.9 Case Study 3 - Shortened Expiration Period for 2009 H1N1 Vaccine in Pre-filled Syringes by Sanofi Pasteur 25

3.9.1 Five Lots with Lower than Pre-Specified Potency Levels Recalled from the Market 25

3.9.2 Change of Expiration Date for the Remaining Lots as a Protective Measure 25

4 Regulatory Intelligence on Biologics Recalls – Trends Analysis 26

4.1 Analysis of Biologics Recalls 2004–2010 26

4.1.1 Reasons for Biologics Recalls 32

4.1.2 Biologics Recalls by Therapy Area 33

4.1.3 Biologics Recalls by Drug Class 35

4.1.4 Biologics Recalls by Different Dosage Forms 37

4.1.5 Biologics Recalls by Companies 39

4.2 Analysis of Biologics Recalls 2007–2010 43

4.2.1 Reasons for Biologics Recalls 43

4.2.2 Biologics Recalls by Therapy Area 44

4.2.3 Biologics Recalls by Drug Class 45

4.2.4 Biologics Recalls by Dosage Form 46

4.2.5 Biologics Recalls by Companies 47

4.3 Analysis of Biologics Recalls – 2007 49

4.3.1 Reasons for Biologics Recalls, 2007 49

4.3.2 Biologics Recalls by Therapy Area, 2007 50

4.3.3 Biologics Recalls by Drug Class, 2007 51

4.3.4 Biologics Recalls by Dosage Form, 2007 52

4.3.5 Biologics Recalls by Companies, 2007 53

4.4 Analysis of Biologics Recalls – 2008 55

4.4.1 Reasons for Biologics Recalls, 2008 55

4.4.2 Biologics Recalls by Therapy Area, 2008 57

4.4.3 Biologics Recalls by Drug Class, 2008 58

4.4.4 Biologics Recalls by Dosage Form, 2008 59

4.4.5 Biologics Recalls by Companies, 2008 60

4.5 Analysis of Biologics Recalls – 2009 61

4.5.1 Reasons for Biologics Recalls, 2009 61

4.5.2 Biologics Recalls by Therapy Area, 2009 62

4.5.3 Biologics Recalls by Drug Class, 2009 62

4.5.4 Biologics Recalls by Dosage Form, 2009 62

4.5.5 Biologics Recalls by Companies, 2009 63

4.6 Analysis of Biologics Recalls – 2010 64

4.6.1 Reasons for Biologics Recalls, 2010 64

4.6.2 Biologics Recalls by Therapy Area, 2010 66

4.6.3 Biologics Recalls by Drug Class, 2010 67

4.6.4 Biologics Recalls by Dosage Form, 2010 68

4.6.5 Biologics Recalls by Companies, 2010 69

5 Regulatory Intelligence on Drug Recalls - Appendix 70

5.1 Market Definitions 70

5.2 Abbreviations 70

5.3 Research Methodology 71

5.3.1 Coverage 71

5.3.2 Regulatory Intelligence on Biologics Recalls – Overview 71

5.3.3 Regulatory Intelligence on Biologics Recalls – Trend Analysis 71

5.4 Contact Us 72

5.5 Disclaimer 72

5.6 Sources 72

1.1 List of Tables

Table 1: Regulatory Intelligence on Biologics Recalls, Total Number of Recalls by All Agencies, 2007–2010 10

Table 2: Regulatory Intelligence on Biologics Recalls, Drug Recalls by CDER, 2007, 2008 and 2010 11

Table 3: Regulatory Intelligence on Biologics Recalls, Number of Drug Product Recalls by CDER by Class, 2007, 2008 and 2010 12

Table 4: Regulatory Intelligence on Biologics Recalls, Drug Recalls by CBER, 2007, 2008 and 2010 13

Table 5: Regulatory Intelligence on Biologics Recalls, Number of Biological Product Recalls by CBER by Class, 2007, 2008 and 2010 14

Table 6: Regulatory Intelligence on Biologics Recalls, Product Recalls by CDER, CBER and Other Agencies, 2007, 2008 and 2010 15

Table 7: Regulatory Intelligence on Biologics Recalls, Total Number of Biologics Recalls, 2004 26

Table 8: Regulatory Intelligence on Biologics Recalls, Total Number of Biologics Recalls, 2005 27

Table 9: Regulatory Intelligence on Biologics Recalls, Total Number of Biologics Recalls, 2006 27

Table 10: Regulatory Intelligence on Biologics Recalls, Total Number of Biologics Recalls, 2007 28

Table 11: Regulatory Intelligence on Biologics Recalls, Total Number of Biologics Recalls, 2008 29

Table 12: Regulatory Intelligence on Biologics Recalls, Total Number of Biologics Recalls, 2009 30

Table 13: Regulatory Intelligence on Biologics Recalls, Total Number of Biologics Recalls, 2010 31

Table 14: Regulatory Intelligence on Biologics Recalls, , Biologics Recalls by Reason for Recall, 2004–2010 32

Table 15: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall, By Year, 2004–2010 33

Table 16: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area, 2004–2010 34

Table 17: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area, By Year, 2004–2010 34

Table 18: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class, 2004–2010 35

Table 19: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class, By Year, 2004–2010 36

Table 20: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form, 2004–2010 37

Table 21: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form, By Year, 2004–2010 38

Table 22: Regulatory Intelligence on Biologics Recalls, Recalls by Companies, 2004–2010 40

Table 23: Regulatory Intelligence on Biologics Recalls, Recalls by Companies, By Year, 2004–2010 42

Table 24: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall, 2007–2010 43

Table 25: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area, 2007–2010 44

Table 26: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class, 2007–2010 45

Table 27: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form, 2007–2010 46

Table 28: Regulatory Intelligence on Biologics Recalls, Recalls by Companies, 2007–2010 48

Table 29: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall, 2007 49

Table 30: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area, 2007 50

Table 31: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class, 2007 51

Table 32: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form, 2007 52

Table 33: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Companies, 2007 53

Table 34: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall, 2008 55

Table 35: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area, 2008 57

Table 36: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class, 2008 58

Table 37: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form, 2008 59

Table 38: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Companies, 2008 60

Table 39: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall, 2009 61

Table 40: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Companies, 2009 63

Table 41: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall, 2010 64

Table 42: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area, 2010 66

Table 43: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class, 2010 67

Table 44: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form, 2010 68

Table 45: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Companies, 2010 69

1.2 List of Figures

Figure 1: Regulatory Intelligence on Biologics Recalls, Total Number of Recalls by All Agencies, 2007–2010 10

Figure 2: Regulatory Intelligence on Biologics Recalls, Drug Recalls by CDER, 2007, 2008 and 2010 11

Figure 3: Regulatory Intelligence on Biologics Recalls, Number of Drug Product Recalls by CDER by Class, 2007, 2008 and 2010 12

Figure 4: Regulatory Intelligence on Biologics Recalls, Drug Recalls by CBER, 2007, 2008 and 2010 13

Figure 5: Regulatory Intelligence on Biologics Recalls, Number of Biological Product Recalls by CBER by Class, 2007, 2008 and 2010 14

Figure 6: Regulatory Intelligence on Biologics Recalls, Product Recalls by CDER, CBER and Other Agencies, 2007, 2008 and 2010 15

Figure 7: Regulatory Intelligence on Biologics Recalls, Biologics Manufacturing, Biologics Classification, 2009 17

Figure 8: Regulatory Intelligence on Biologics Recalls, Biologics Manufacturing, Biologics Manufacturing Steps, 2009 18

Figure 9: Regulatory Intelligence on Biologics Recalls, Reasons for Manufacturing Initiating Recalls 21

Figure 10: Regulatory Intelligence on Biologics Recalls, FDA Responsibilities 22

Figure 11: Regulatory Intelligence on Biologics Recalls, Total Number of Biologics Recalls, 2004–2010 26

Figure 12: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall, 2004–2010 32

Figure 13: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area, 2004–2010 33

Figure 14: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class, 2004–2010 35

Figure 15: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form, 2004–2010 37

Figure 16: Regulatory Intelligence on Biologics Recalls, Recalls by Companies, 2004–2010 39

Figure 17: Regulatory Intelligence on Biologics Recalls, Recalls by Companies, By Year, 2004–2010 41

Figure 18: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall, 2007–2010 43

Figure 19: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area, 2007–2010 44

Figure 20: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class, 2007–2010 45

Figure 21: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form, 2007–2010 46

Figure 22: Regulatory Intelligence on Biologics Recalls, Recalls by Companies, 2007–2010 47

Figure 23: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall (%), 2007 49

Figure 24: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area (%), 2007 50

Figure 25: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class (%), 2007 51

Figure 26: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form (%), 2007 52

Figure 27: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Companies (%), 2007 53

Figure 28: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall (%), 2008 55

Figure 29: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area (%), 2008 57

Figure 30: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class (%), 2008 58

Figure 31: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form (%), 2008 59

Figure 32: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Companies (%), 2008 60

Figure 33: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall (%), 2009 61

Figure 34: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Companies (%), 2009 63

Figure 35: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall (%), 2010 64

Figure 36: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area (%), 2010 66

Figure 37: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class (%), 2010 67

Figure 38: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form (%), 2010 68

Figure 39: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Companies (%), 2010 69

To order this report:

Drug and Medication Industry: Regulatory Intelligence on Biologics Recalls – Immunoglobulins and Vaccines are Involved in More Recalls than Other Drug Classes

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