United States Government Accountability Office: GAO: Report to Congressional Committees: February 2015: What FDA Needs to Do Regarding Compounding Included

What Remains to Be Done: 

FDA has made considerable progress in the last 2 years, particularly 
in ensuring the safety and effectiveness of medical devices. FDA has 
developed meaningful action plans and has already shown--and must 
sustain--strong leadership in addressing management challenges. While 
these action plans and strong leadership are two of the five criteria 
an agency must meet for the high-risk designation to be removed, the 
oversight of medical products remains on our High Risk List because 
more needs to be done before the remaining three criteria can be met 
in the areas of globalization and drug availability. FDA needs to 
demonstrate that it has the capacity to address the challenges we have 
identified, along with effective monitoring strategies. In addition, 
FDA must demonstrate clear and sustained progress in implementing 
these measures. Finally, FDA should implement our prior 
recommendations to resolve new and previously identified concerns. 
Specifically, FDA needs to: 

* conduct more inspections of foreign establishments manufacturing 
medical products for the U.S. market and utilize its authority to take 
a risk-based approach in selecting foreign drug establishments to 
ensure that they are inspected at a frequency comparable to domestic 
establishments with similar characteristics; 

* establish a set of performance goals and measures that can be used 
to demonstrate contributions of its overseas offices to long-term 
outcomes related to the regulation of imported products and develop a 
strategic workforce plan to ensure the agency is able to recruit and 
retain staff with necessary experience; 

* strengthen its ability to prevent, mitigate, and resolve drug 
shortages by systematically tracking data on shortages; ensure the 
accuracy of the data it collects; conduct periodic analyses of the 
data to proactively identify trends, clarify causes, and resolve 
problems before drugs go into short supply; and develop relevant 
results-oriented performance metrics to gauge the agency's response to 
shortages; and: 

* take steps to consistently collect reliable and timely information 
on inspections and enforcement actions associated with compounded 
drugs, and collect information that clearly differentiates 
manufacturers of FDA-approved drugs that are inspected for compliance 
with good manufacturing practices from those entities that are 
compounding drugs that are neither FDA approved nor routinely 
inspected. 

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