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
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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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