Drug Recalls and Warning Letters - Increasing Numbers Caused by Manufacturing Errors and Regulatory Noncompliance Issues

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					Drug Recalls and Warning Letters - Increasing Numbers Caused by Manufacturing
Errors and Regulatory Noncompliance Issues

Number of Warning Letters Issued by the US FDA Have Increased From 117 In 2007 To
523 In 2010 at a CAGR of 65%

The FDA is composed of various agencies, such as the Center for Drug Evaluation and
Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for
Devices and Radiological Health (CDRH), Center for Food Safety and Applied Nutrition
(CFSAN) and Center for Veterinary Medicine (CVM). The total number of warning
letters issued by the FDA agencies is exhibiting an increasing trend, which is attributable
to the introduction of new regulatory reforms during 2007-2010. The lack of good
manufacturing practices is one of the major reasons for manufacturing defects in
marketed products.

Warning letters have increased at a CAGR of 65% in 2010, compared to 2007. There was
an increase of 8.5% in the number of warning letters in 2008, compared to 2007. An
increase of 22% was exhibited by warning letters from 2008 to 2009. This trend
continued in 2010 and from 2009 to 2010, the number of warning letters increased by
21.9%. The growing number of warning letters is posing a threat to manufacturing
companies. Companies should rethink and evaluate their manufacturing strategies,
because the majority of warning letters were issued due to quality and manufacturing
defects. A significant number of warning letters were also caused by labeling errors.

The major reasons for increasing the number of drug recalls are manufacturing errors,
packaging errors, labeling errors, quality errors and a failure to maintain the required
regulatory compliance. The US FDA has been vigilant and strict, when the
pharmaceutical companies fail to adhere to cGMP guidelines enforced by the agency. For
instance, the agency mandated all heparins imports to be stopped at the US border and
inspected for contamination when serious adverse reactions were observed in the patients
due to contaminated heparin in 2008. Due to the heightened FDA scrutiny there were an
increased number of recalls in 2010 compared to 2007-2009, including some high profile
recalls such as the aforementioned heparin and Over-the-Counter (OTC) products from
Johnson & Johnson. The increased number of recalls due to defects in pharmaceutical
products has led to the development of increased vigilance practice by healthcare
providers.

For Sample Pages, please click or add the below link to your browser:
http://www.gbiresearch.com/RequestSamplePages.aspx?ID=Drug-Recalls-and-Warning-
Letters-Increasing-Numbers-Caused-by-Manufacturing-Errors-and-Regulatory-Non-
compliance-
Issues&Title=Pharmaceuticals_and_Healthcare&ReportType=Industry_Report&Compan
yID=dcsto

GBI Research’s report, “Drug Recalls and Warning Letters- Increasing Numbers Caused
by Manufacturing Errors and Regulatory Non-compliance Issues”, provides in-depth
analysis of Warning Letters, drug recalls issued or reported with the US Food and Drug
Administration (FDA) and its constituent agencies. The report analyzes warning letters
from the issuing agencies and reason for these warning letters. The report contains year
by year detailed analysis about warning letters issued for various reasons by regulatory
authorities. The report is built on data and information sourced from the FDA database of
warning letters and drug recalls and in-house analysis by GBI Research’s team of
industry experts.

The numbers of warning letters and drug recalls issued by and reported to the US Food
and Drug Administration (FDA) are increasing; this is causing a significant loss of
revenues for pharmaceutical companies. The adulteration of active ingredients and
contamination of finished products are key causes of warning letters and drug recalls. The
major therapy area with the highest number of drug product recalls reported was Lifestyle
Disorders. Erectile dysfunction and sexual disorders are the two most common lifestyle
disorders in which a high number of product recalls was noted. Product recalls in these
indications are more frequent and it is increasing.

For further details, please click or add the below link to your browser:
http://www.gbiresearch.com/Report.aspx?ID=Drug-Recalls-and-Warning-Letters-
Increasing-Numbers-Caused-by-Manufacturing-Errors-and-Regulatory-Non-compliance-
Issues&ReportType=Industry_Report&coreindustry=ALL&Title=Pharmaceuticals_and_
Healthcare&CompanyID=dcsto

Visit our report store: http://www.gbiresearch.com

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Description: Number of Warning Letters Issued by the US FDA Have Increased From 117 In 2007 To 523 In 2010 at a CAGR of 65%