FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed: GAO-10-961:

GAO-10-961: 

GAO Highlights: 

Highlights of GAO-10-961, a report to the Committee on Oversight and 
Government Reform, House of Representatives. 

Why GAO Did This Study: 

Globalization has placed increasing demands on the Food and Drug 
Administration (FDA), an agency within the Department of Health and 
Human Services (HHS), in ensuring the safety and effectiveness of 
drugs marketed in the United States. Drugs manufactured in more than 
100 countries were offered for entry into the United States in fiscal 
year 2009. FDA inspects drug manufacturing establishments in order to 
ensure that the safety and quality of drugs are not jeopardized by 
poor manufacturing practices. 

In 1998 GAO identified weaknesses in FDA’s foreign drug inspection 
program. In 2008 GAO found, among other things, that from fiscal years 
2002 through 2007, FDA inspected relatively few foreign establishments 
each year. GAO also determined that, because of inaccurate information 
in its databases, FDA did not know how many foreign drug 
establishments were subject to inspection. 

In 2008 GAO recommended that FDA increase inspections of foreign drug 
establishments and improve information it receives to manage the 
foreign drug inspection program. This report examines FDA’s progress 
since 2008 in (1) conducting more foreign drug inspections, and (2) 
improving its information on foreign drug establishments. GAO analyzed 
information from FDA databases, reviewed documents related to FDA’s 
efforts to both improve these databases and supplement its existing 
information on foreign drug establishments, examined staffing and 
funding information, and interviewed FDA officials. 

What GAO Found: 

FDA increased the number of foreign drug inspections it conducted from 
fiscal year 2007 to 2009, but still conducts relatively fewer foreign 
drug inspections each year than it conducts domestically. In fiscal 
year 2009, FDA conducted 424 foreign inspections, compared to 333 and 
324 inspections conducted in fiscal years 2007 and 2008, respectively. 
Using a list FDA developed to prioritize foreign establishments for 
inspection, GAO estimated that FDA inspected 11 percent of foreign 
establishments on this list in fiscal year 2009. At this rate, GAO 
estimated it would take FDA about 9 years to inspect all 
establishments on this list once. In contrast, in that same year, FDA 
conducted 1,015 domestic inspections, inspecting approximately 40 
percent of domestic establishments. GAO estimated that at this rate 
FDA inspects domestic establishments approximately once every 2.5 
years. Further, FDA’s approach in selecting establishments for 
inspection is inconsistent with GAO’s 2008 recommendation that FDA 
inspect, at a comparable frequency, those establishments that are 
identified as having the greatest public health risk potential if they 
experience a manufacturing defect, regardless of whether they are a 
foreign or domestic establishment. Instead, its foreign inspections 
continue to be driven by the establishments listed on an application 
for a new drug, instead of those already producing drugs for the U.S. 
market. 

FDA is taking steps to improve the information it receives from the 
drug establishment registration and import databases the agency uses 
to manage its foreign drug inspection program. For example, FDA is 
working to obtain more accurate information for its database that 
contains information about foreign establishments registered to market 
their drugs in the United States. In addition, FDA has an initiative 
underway to eliminate duplicate information from its database 
containing information about foreign establishments whose drugs are 
offered for import into the United States. However, these efforts are 
in the early stages. In addition, FDA is exploring other options for 
obtaining better information about foreign drug establishments, such 
as by collaborating with foreign regulatory authorities to exchange 
information about planned inspections and the results of completed 
inspections. 

In 1998, and again in 2008, GAO reported that FDA needed to conduct 
more inspections of foreign establishments and that it was vital that 
the agency strengthen the data it uses to manage its foreign drug 
inspection program. FDA has begun to respond to GAO’s recommendations; 
however, it has not yet fully addressed these weaknesses at a time 
when the volume of imported drugs and the number of foreign 
establishments producing these drugs have been increasing. Given the 
long-standing nature of these challenges and the nation’s reliance on 
drugs manufactured overseas, it is urgent that FDA implement GAO’s 
prior recommendations to better protect public health. HHS reviewed a 
draft of this report and agreed that more progress is needed in order 
to meet the challenge of safeguarding the nation’s drug supply in 
today’s global marketplace. 
To read the remainder of the report, click here.