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

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.

Report Highlights
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.

Biologics are drugs in which the active substance is produced by or extracted from a biological source. They represent an important part of the therapeutic field. Although a new drug or biologic is approved after elaborate scrutiny of its efficacy and safety, complete understanding of the new drug or biologic is only partial at the time of approval, particularly with reference to the safety profile. This is due to a variety of causes, including limited sample size and the design of randomized controlled trials. This is applicable in the case of small molecules, but biological products and biologics have definite risks. Biologics are derived from living sources such as humans, animals, cells and microorganisms, unlike small molecules, which are synthesized chemically. This makes production and purification processes for biologics more complex. Small differences and changes in the production process could have an impact on the safety profile of biologics. For example, patients treated with recombinant human epoetin can have an incidence of pure red cell aplasia, a rare complication induced by antibodies. This is elevated in patients who take one particular formulation of recombinant human epoetin, in which human serum albumin is replaced with polysorbate 80 and glycine. The exact mechanism underlying the increased risk of pure red cell aplasia after the change in formulation has not been completely ascertained. In addition to this, the risk of contamination with pathogens by the donor is another problem related to the production process for products extracted from human blood or plasma. In October 2005, Biomedical Tissue Services (BTS) recalled human tissue after the company was made aware of the possibility that tissue had been procured from donors without proper medical or social histories. The information also prompted other companies, such as Regeneration Technologies, Inc. and Tutogen Medical, Inc., to recall human tissue products due to information provided by BTS regarding the nature of the tissue obtained from donors.

Immunoglobulins and Vaccines are More Prone to Recalls than Other Drug Classes

There were 14 biologics recalls for vaccines and 13 for immunoglobulins from 2007–2010. This was greater than in other drug classes. The reasons for recalls were serious adverse events, labeling errors, quality defects and manufacturing defects. This indicates that immunoglobulins and vaccines were more prone to recalls than other drug classes.

The Most Biologics Recalls were in 2010

From 2004–2010, there were 63 biologics recalls. There were 17 biologics recalls in 2010, which was the highest number of recalls in a given year in this period. This was followed by 14 recalls in 2008. In 2010, the infectious diseases and immunodeficiency disorders therapy areas recorded the most biologics recalls.

The number of recalls made in 2008 more than doubled from 2007. From 2008–2009, recalls decreased by 71%; however, recalls increased by 325% from 2009–2010.

Quality Defects were the Most Frequent Reason for Biologics Recalls

The majority of errors that occurred from 2004–2010 were due to quality defects, followed by manufacturing errors, labeling errors, serious adverse events and packaging errors. Quality defects encompassed a variety of underlying reasons, such as reduced levels of potency compared to pre-specified levels and the presence of glass particles.