FDA Warning Letter Trends

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. 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 2013. Increased by an average of Total increase of Decreased by Decreased by 15.8% 104% 12.4% 27.5% comparing the first 6 months of 2013 to the first 6 months of 2014 per year (2007 to 2012) from 2007 to 2012 from 2012 to 2013 2007-2012 2012-June 30, 2014 We wanted to understand: What industries We believe the decrease was due to fewer FDA inspections contributed the most to the increase and why? as a result of reduced funding for the FDA' and an industry- wide freeze on manufacturers' FDA fees. 1. http://www.politico.com/story/2013/02/fda-commissioner-margaret-hamburg-2013-budget-cuts-mean-less-safe-food-88241.html Consumer Tobacco Products AA Industry Comparison 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 Pharmaceutical/ Biotechnology Food & Beverage 95.72% of all FDA warning letters that were received between 2007 and 2013. • Pharmaceutical/Biotechnology Medical Device • Medical Device • Food & Beverage Pharmaceutical/ Biotechnology In 2009, FDA warning letters to Pharma/Biotech companies increased by 48.59%. 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 250 In 2011, China's Ministry of Health adopted Good Manufacturing Practice (GMP) requirements' and we saw another surge in letters in ulilu Clinical Trials 200 CGMP 150 H1N1 the US: • 83 letters related to Current Good Manufacturing Practice (CGMP) 100 50 > 14 letters related to clinical investigations (failing trial research standards) 2007 2008 2009 2010 2011 2012 2013 1. http://eng.sfda.gov.cn/WS03/CL0768/65113.html Medical Device FDA-issued letters nearly DOUBLING from 2007 to 2012.' 250 FACTOR: • Each year, we've seen an increase in 200 consumer access to new medical device applications and modified versions of medical devices that 150 do not require Premarket Approval (PMA) or Section 510(k) Clearances A steady increase in letters within the Medical Device industry resulted 100 from the FDA.2 50 2007 2008 2009 2010 2011 2012 2013 1. http://www.emergogroup.com/blog/2013/05/fda-data-shows-increase-warning-letters-medical-device-firms-2005 2. http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/510kclearances/default.htm Food & Beverage The Food Safety Modernization Act signed by President Obama on January 4, 2011 drove a 400 350 41% ulli 300 increase in letters issued to 250 Food & Beverage 200 companies.' 150 100 50 2007 2008 2009 2010 2011 2012 2013 1. http://www.choicesmagazine.org/choices-magazine/submitted-articles/the-fdas-food-safety-modernization-act-and-its-economic-implications 31 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 65 117 16 letters for Pharma/Biotech letters for Food & Beverage letters for Consumer letters for Medical Device Products & Tobacco What's in Store for 2015 and Beyond With a proposed significant budget increase for the FDA in 2015', 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. 1 http://blogs.fda.gov/fdavoice/index.php/2014/03/whats-new-in-the-fdas-2015-budget/ RESEARCH BROUGHT TO YOU BY Sparta Systems n the number of