FDA Warning Letters Study

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Randolf Smith
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FDA Warning Letters Study A Look at Warning Letters for Pharma/Biotech, Medical Device, and Food & Beverage Industries Since 2007 A Warning Letter is official correspondence that notifies the

1 FDA Warning Letters Study A Look at Warning Letters for Pharma/Biotech, Medical Device, and Food & Beverage Industries Since 2007 A Warning Letter is official correspondence that notifies the highest-ranking known official of a regulated company that a serious violation of organizational regulations has been committed. These letters are published on the FDA website and are available for review by other government agencies, businesses, consumers, and the media.

2 FDA Warning Letters Issued by Year The average growth rate for warning letters issued between 2007 and 2012 was 15.8% per year. The issuing of FDA Warning Letters increased 78% from 2007 to 2013, even with a 12.4% decrease from 2012 to Increased by an average of 15.8 % Total increase of 104 % Decreased by 12.4 % Decreased by 27.5 % per year (2007 to 2012) from 2007 to 2012 from 2012 to 2013 comparing the first 6 months of 2013 to the first 6 months of We wanted to understand: What industries contributed the most to the increase and why? 2012 June 30, 2014 We believe the decrease was due to fewer FDA inspections as a result of reduced funding for the FDA 1 and an industrywide freeze on manufacturers FDA fees. 1.

3 Industry Comparison Tobacco Consumer Products Since FDA warning letters are made available to the public, we did some digging to find which industries accounted for the highest number of warning letters. Three industries comprised % of all FDA warning letters that were received between 2007 and Pharmaceutical/ Biotechnology Food & Beverage Pharmaceutical/Biotechnology Medical Device Food & Beverage Medical Device

4 250 Pharmaceutical/ Biotechnology In 2009, FDA warning letters to Pharma/Biotech companies increased by %. The following areas accounted for the increase (actual numbers): 28 letters for clinical investigations (failing trial research standards) 33 letters were issued due to violations of Current Good Manufacturing Practice (CGMP) 35 letters for products related to the H1N1 virus Clinical Trials CGMP H1N1 In 2011, China s Ministry of Health adopted Good Manufacturing Practice (GMP) requirements 1 and we saw another surge in letters in the US: letters related to Current Good Manufacturing Practice (CGMP) 14 letters related to clinical investigations (failing trial research standards) 1.

5 Medical Device A steady increase in letters within the Medical Device industry resulted in the number of FDA-issued letters nearly DOUBLING from 2007 to FACTOR: Each year, we ve seen an increase in consumer access to new medical device applications and modified versions of medical devices that do not require Premarket Approval (PMA) or Section 510(k) Clearances from the FDA

6 Food & Beverage The Food Safety Modernization Act signed by President Obama on January 4, 2011 drove a 41 % increase in letters issued to Food & Beverage companies

7 A Downward Trend in 2014 There have been 267 Warning Letters issued in 2014 so far (as of June 30, 2014), which suggests a downward trend for the total amount of warning letters for the year. Among the letters received through June 2014, 44% were in the Food & Beverage industry, 26% were in the Pharma/Biotech industry, and 24% were in the Medical Device industry. 69 letters for Pharma/Biotech 65 letters for Medical Device 117 letters for Food & Beverage 16 letters for Consumer Products & Tobacco

8 What s in Store for 2015 and Beyond With a proposed significant budget increase for the FDA in , we expect the number of warning letters to rise significantly for 2015 starting a new upward trend in total warning letters issued in the coming years. RESEARCH BROUGHT TO YOU BY 1

2/17/2018. Prof. Steven S. Saliterman Department of Biomedical Engineering, University of Minnesota

2/17/2018. Prof. Steven S. Saliterman Department of Biomedical Engineering, University of Minnesota Department of Biomedical Engineering, University of Minnesota http://saliterman.umn.edu/ FDA Authority Medical Device Act of 1976 FDA Modernization Act of 1997 Federal Food, Drug and Cosmetic Act (FFDCA)