Medical Product Oversight
Americans depend on the Food and Drug Administration (FDA) to oversee the safety and effectiveness of medical productsdrugs, biologics, and medical devices. FDAs medical product responsibilities are far-reaching and demands on the agency have soared in recent years.
FDA is encountering multiple challenges that threaten to compromise its ability to protect public health, including:
- FDA has a limited ability to respond to critical shortages of prescription drugs. From 2006 through 2010, the number of shortages increased dramatically and a record number (196) were reported in 2010.
Figure 1: Number of Drug Shortages Reported January 1, 2001, through June 20, 2011, by Year
- Medical device recalls were often prolonged. FDA did not complete timely assessments of whether firms had taken sufficient actions to prevent problems from recurring for more than 70 percent of the highest risk, or class I, recalls initiated in 2005 through 2009. (See figure 2.)
Figure 2: Percentage of Medical Device Recalls Terminated More than 90 Days after Completion Date, for Recalls Initiated in Calendar Years 2005 through 2009
- FDA conducts relatively few foreign drug inspections and many foreign drug establishments may never have been inspected. (See table 1.)
Table 1: Numbers of Establishments in FDAs Inventory That May Never Have Been Inspected by FDA and the Total Estimated Number of Establishments in Its Inventory, by Country, Fiscal Year 2009
FDA has many challenges to address, including the need to:
- respond to globalization,
- react quickly to public health needs,
- enhance postmarket safety, and
- improve planning and resource management.