Regulatory Focus™ > News Articles > In Transparency Move, FDA Makes its Enforcement Data Easier to View

In Transparency Move, FDA Makes its Enforcement Data Easier to View

Posted 02 October 2014 | By Alexander Gaffney, RAC

In Transparency Move, FDA Makes its Enforcement Data Easier to View

The US Food and Drug Administration (FDA) has just unveiled a new web-based tool intended to make it easier to dive into the agency's regulatory enforcement data.

The tool, unveiled by Ann Ferriter, director of the Center for Devices and Radiological Health's (CDRH) Division of Analysis and Program Operations at the Regulatory Affairs Professionals Society's (RAPS) The Regulatory Convergence conference this week, is meant to simplify regulatory intelligence for researchers and industry professionals alike.

"This new dynamic tool represents a departure from the downloadable spreadsheet-based datasets that we have posted in the past," explained Douglas Stearn, FDA's director of the Office of Enforcement and Import Operations within FDA’s Office of Regulatory Affairs, said in a blog posting. "Instead, the FDA data dashboard presents information in an easy-to-read graphical format. It also provides access to the underlying data allowing anyone interested to see related data and trends."

Global Inspections Breakdown

For example, the "Data Dashboard" tool allows users to quickly see how many inspections FDA has conducted in each country around the world since the start of Fiscal Year 2009.

Top 10 Countries Inspected by FDA Since FY 2009
CountryInspections
United States81,971
Puerto Rico1,000
Canada782
China780
India692
Germany618
Italy461
Japan431
United Kingdom431
France417

Inspectional Data

FDA has also made it much easier to detect broader enforcement trends as well. Take, for example, what happened to companies inspected by FDA.

Inspection Classification by FDA by Year
Fiscal YearNo Action Indicated (NAI)Official Action Indicated (OAI)Voluntary Action Indicated (VAI)
200910,5506595,572
201012,8728517,418
201115,4191,0478,506
201215,3859007,621
201313,2796366,058

As the data show, despite a surge in 2011 for OAI letters—letters indicating that a facility is out of compliance with regulations and must bring itself into compliance immediately—FDA is issuing enforcement notices at about the same rate as it did in 2009.

FDA's dashboard also makes it easy to dig into the behaviors of each respective center.

Inspection Classification by Center – FY 2013
CenterNAIOAIVAIOAIs as % of Total
CBER1,54084520.4%
CDER1,033719553.4%
CDRH2,0331861,2215.4%
CFSAN7,0832653,0642.5%
CTP24010.0%
CVM1,5661063655.2%

As the data show, while FDA's Center for Food Safety and Applied Nutrition (CFSAN) conducted the most inspections (10,412), the Center for Devices and Radiological Health (CDRH) actually issued the most OAI letters as a percentage of total inspections (5.4%), followed closely by the Center for Veterinary Medicine (CVM) with 5.2%.

Foreign Inspections Surge

FDA's data also show that it is conducting far more foreign inspections than it did in 2009—more than twice as many, in fact.

Domestic and Foreign Inspections Conducted by FDA
Fiscal YearDomesticForeignForeign as %
200912,9241,1128.6%
201016,0321,3958.7%
201117,5612,24712.8%
201216,8592,57015.2%
201313,7942,51918.3%

When foreign inspections are taken as a percentage of domestic inspections, FDA is now inspecting more foreign facilities than at any time in the last five years—and perhaps ever. Notable, however, is the decrease in domestic inspections conducted by FDA. After reaching a peak of 17,561 domestic inspection in 2011, FDA conducted 3,767 fewer inspections in 2013. FDA's data don't indicate a reason for this trend, but potential reasons include budget cuts, shifting inspection priorities, a one-time surge in inspections in 2011, or the added time and cost of foreign inspections diverting resources from domestic inspections.

Warning Letters and More

FDA's data also shows what happens when OAIs are elevated to Warning Letters—letters sent by FDA indicating that unless changes are made immediately to the agency's satisfaction, further enforcement actions will be taken by FDA.

Warning Letters Sent by Program/Center - 2013
CenterWarning Letters Sent
CBER17
CDER95
CDRH195
CFSAN210
CTP6052
CVM96
Direct Reference133

But beyond the breakdown of letters sent, FDA's data also show that the number of Warning Letters sent has increased dramatically over the last few years.

Warning Letters Sent by Fiscal Year
Fiscal YearWarning Letter
2009489
2010698
20111788
20124913
20136798

 The vast majority of that increase, however, appears to be due to the Center for Tobacco Products (CTP), which has sent a shopping 11,271 Warning Letters since FY2009 began—almost 10 times as many as the next center, CFSAN (1,166).

FDA Data Dashboard


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